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Over the summer, the FDA issued recalls for several medications and devices, including certain digoxin tablets, intra-aortic balloon pumps, and catheters.

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Recalls on digoxin tablets and devices used for the inflation and deflation of aortic balloons have been the focus of cardiology-related Food and Drug Administration (FDA) MedWatch safety alerts this summer. 

FDA Drug Recalls

Lanoxin® (digoxin)1 

On August 31, 2023, the FDA announced a recall for digoxin tablets, manufactured by Marlex Pharmaceuticals, for incorrect labeling: certain lots of bottles labeled as digoxin 0.125 mg contain 0.25 mg, while other lots of bottles labeled as digoxin 0.25 mg contain 0.125 mg.

  • Recalled lots:
    • Digoxin 0.125 mg tablet: lot number, E3810; NDC, 10135-0747-01; expiration, 2/2025
    • Digoxin 0.25 mg tablet: lot number, E3811; NDC, 10135-0748-01; expiration, 2/2025

Digoxin 0.25 mg tablets are white to off-white, circular, beveled, uncoated tablets scored between “N” and “202” on one side and plain on the other side. Digoxin 0.125 tablets are yellow, circular, beveled, uncoated tablets scored between “N” and “201” on one side and plain on the other side.

Digoxin is used to treat mild to moderate heart failure in adults, increase the contractility of the heart muscle in children, and control the resting ventricular rate in adults with chronic atrial fibrillation. 

Patients unaware of the labeling mistake who continue to take these pills can over- or underdose on digoxin. Patients who normally take digoxin 0.125 mg, but unknowingly take digoxin 0.25 mg can experience significant drug toxicity (eg, mental disorientation, dizziness, blurred vision, memory loss, and fainting) from the unintended overdose. Patients who take digoxin 0.25 mg, but unknowingly take digoxin 0.125 mg can experience abnormal heart rate and heart failure exacerbation due to the underdose. 

There are no active reports by Marlex Pharmaceuticals of adverse events linked to this recall. 

FDA Medical Devices Recalls

Update: Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps2

The FDA has classified 6 voluntary recalls for the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices manufactured by Getinge, Maquet, and Datascope, as class I, the most serious type of recall. 

Despite concerns revolving around device shutdowns and pump stop events related to the class 1 recalls, the FDA notes that “these devices may continue to be used to provide circulatory support when necessary.”

On August 31, 2023, the FDA provided an update on the recall. 

  • Reasons for recall: 
    • Electrical failures in the power source path 
    • Failures in the printed circuit board assembly in the charging path
    • Device sitting in power cart incorrectly and unable to charge the batteries
    • Device unable to auto refill the helium to inflate the balloon
    • Sensitive high priority gas change alarms halting therapy until corrected or device replaced 
    • Internal device temperature exceeds a threshold of 80° C (176°F)

IABP devices are placed in the artery of the descending aorta to electromechanically inflate and deflate intra-aortic balloons and support the left ventricle through counter pulsation.  An interruption in therapy using an IABP can result in serious patient injury or death.

Due to ongoing device failures, the FDA recommends providers consider having additional charged IABP devices available to use in the event of device failure, and to review the recent urgent medical device correction notices from Getinge, Maquet, and Datascope. 

Impella RP Flex with SmartAssist3

The FDA issued a statement on the Abiomed voluntary recall for the Impella RP Flex with SmartAssist on August 17, 2023.

  • Reason for recall:
    • Inadequate labeling of precautions for treating patients with a reduced anticoagulation clotting time. 

Patients with central venous lines and cardiac cannulas with systemic anticoagulation of less than 160 to 180 seconds are most at risk for blood clot formation or deposition when Impella RP Flex with SmartAssist catheters are used. 

The Impella RP Flex with SmartAssist System catheter is placed via the internal jugular vein and can be used up to 14 days in patients who develop acute right heart failure after left ventricular assist device implantation. The device pumps into the pulmonary artery to support the right ventricle. 

There have been 12 reported injuries related to this recall, but no reports of death. Impella RP Flex with SmartAssist can still be used with the caveat that providers maintain systemic anticoagulation between 160 to 180 seconds with central venous lines and consider the risk for blood clots on indwelling lines placed before the use of Impella RP Flex with SmartAssist System. For further information, physicians can refer to the recommendations in the “best practices pathway” on Figure 5.2 of the Instructions for Use.

Drug Safety-Related Labeling Changes 

Carospir® (spironolactone)

CMP Pharma provided an update to spironolactone use in specific populations to include a recommendation against treatment of hypertension in pediatric patients. Prior to this update, recommendation for the use of spironolactone in pediatric patients was not established.

  • Use in specific populations update:
    • Not established and not recommended for the treatment of hypertension in pediatric patients due to potential risks associated with the antiandrogenic, progestogenic, and estrogenic properties of spironolactone.

The oral suspension of spironolactone is indicated for the treatment of adults with New York Heart Association class III to IV heart failure and reduced ejection fraction, hypertension, or edema caused by cirrhosis. 

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The Effect of Lifestyle Modifications on Risk for Valvular Heart Disease https://www.thecardiologyadvisor.com/home/topics/valvular-heart-disease/effect-of-lifestyle-modifications-on-risk-for-valvular-heart-disease/ Fri, 29 Sep 2023 14:37:16 +0000 https://www.thecardiologyadvisor.com/?p=111143 Top-view-of-a-heart shaped-plate-surrounded-by-a-knife-and-a-fork-and-some-healthy-food-such-as-a- salmon-fillet,-broccoli,-oat-flakes,-chia-and-flax-seeds,-cherry-tomatoes,-carrots,-almond,-avocado,-spinach-and-olive-oil.

A discussion of the effect of lifestyle modifications on risk for valvular heart disease with Dr Neel Chokshi, Dr Katarzyna Gil, Dr Justin Bachmann, and Dr Mariell Jessup.

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For many cardiologists, advising patients on healthy lifestyle behaviors is a key component of daily practice. While a substantial portion of one’s risk for cardiovascular disease can be attributed to genetic susceptibility, lifestyle factors also have a significant role in managing cardiovascular risk and disease.1,2

In a prospective cohort study published in June 2023 in the European Journal of Preventive Cardiology, Jia et al aimed to elucidate the contributing roles of lifestyle and genetic factors in the risk of developing valvular heart disease (VHD) among 499,341 individuals without VHD at baseline. Smoking, diet, alcohol intake, physical activity, and sleep comprised the lifestyle factors examined in the study.3

Compared with participants with an unhealthy lifestyle, the results showed a lower risk of VHD in those with intermediate (hazard ratio [HR], 0.81; 95% CI, 0.76–0.86) and healthy lifestyles (HR, 0.81; 95% CI, 0.76–0.87) over a median follow-up period of 10.8 years. Additionally, this association was found to be independent of genetic risk.3

These findings highlight the potential role of lifestyle interventions in reducing the global burden of VHD, the authors concluded.3

Social determinants of health have a marked impact on our patients, particularly those living in food or health care deserts.

To discuss effective methods of counseling patients on lifestyle changes to minimize the risk of VHD, we interviewed the following experts:

  • Neel Chokshi, MD, MBA, associate professor of clinical medicine at the Perelman School of Medicine at the University of Pennsylvania, medical director of the Penn Sports Cardiology and Fitness Program, and director of the Penn Center for Digital Cardiology in Philadelphia, Pennsylvania
  • Katarzyna Gil, MD, clinical assistant professor of internal medicine and multi-modality imaging cardiologist at The Ohio State University Wexner Medical Center in Columbus, Ohio
  • Justin Bachmann, MD, MPH, cardiologist and assistant professor of medicine, biomedical informatics, and health policy at Vanderbilt University Medical Center in Nashville, Tennessee
  • Mariell Jessup, MD, FAHA, chief science and medical officer of the American Heart Association (AHA)

Recent research by Jia et al found that adherence to a healthy lifestyle is linked to a reduced risk of VHD, regardless of genetic susceptibility.3 What has been your experience with counseling patients to begin lifestyle modifications in an achievable and sustainable way to reduce heart disease risk? What are some counseling methods that you’ve been successful with?

Dr Chokshi: A key aspect to addressing lifestyle changes is getting an accurate sense of a patient’s daily routine and the social determinants of health that may be contributing to their cardiovascular risk. It is also important to include the patient in identifying areas for improvement and in the design of the intervention. The effectiveness of lifestyle interventions hinges upon these factors.  

Dr Gil: I find it helpful to take time to understand each patient’s motivation and lifestyle before counseling. This allows me to come up with a personalized plan that is realistic and tailored to their needs, preferences, and circumstances. Breaking down larger goals into smaller achievable targets and encouraging patients to focus on gradual progress, rather than immediate and drastic changes, increases the likelihood of them adhering to the plan. 

Assistance and support are more effective than lectures. It is also crucial to recognize which patients might require additional support from the interdisciplinary team. Positive reinforcement cannot be overestimated, so I remember to celebrate every little step forward during appointments.  

Dr Bachmann: Counseling techniques are highly individualized to both clinicians and patients. In my own experience, I’ve found motivational interviewing to be very effective.4 This is a collaborative, goal-oriented communication technique that focuses on eliciting the patient’s own reasons for wanting to begin lifestyle change. Interested clinicians can learn more about motivational interviewing from various organizations including the Motivational Interviewing Network of Trainers.

Dr Jessup: The causes of valve problems can often be linked to birth defects, related to age, or caused by another condition. Although you cannot reverse damage to a heart valve, in some cases you can slow further damage by managing other heart conditions and risks. Managing cardiovascular diseases and risks by eating healthy, exercising regularly, and not smoking can help keep valve disease symptoms at bay. Of course, more developed heart valve disease may require intervention beyond exercise, such as medication or a surgical procedure. In general, lifestyle modifications help people manage the consequences of heart valve disease more effectively—lifestyle modifications are for everyone.

Patients in food and health care deserts face various challenges with beginning and maintaining healthy lifestyle modifications. Can you discuss some of those issues and the unique challenges physicians face in counseling this population on lifestyle modifications to reduce the risk for VHD?

Dr Chokshi: The guidance on lifestyle modifications for valvular disease is the same as for cardiovascular disease prevention in general. Financial aspects often pose an obstacle to improving lifestyle, specifically diet. Processed foods can be more cost-effective, and individuals are often trying to provide for their families within a limited budget. Similarly, working patients often rely on fast food options for convenience in addition to cost benefits. 

Additionally, physicians spend significant effort educating patients on foods and dietary habits that may be unhealthy for their heart. Performing this effectively takes time and effort from both the patient and clinician to customize strategies for each situation. Relatedly, coaching on exercise, smoking cessation, and sleep all require significant time and expertise to be effective. At our institution, we have specific consultations with a dietician, exercise physiologist, and smoking cessation experts to address these challenges. However, there is limited reimbursement for these visits, making such services challenging to access for patients.

Dr Bachmann: Social determinants of health have a marked impact on our patients, particularly those living in food or health care deserts. It’s important for clinicians to have a way of connecting these patients with resources that can help them navigate a challenging environment with regards to their health. The best way to start is to have a discussion with our colleagues in social work about the availability of such resources—the work they do is incredibly important.

Dr Jessup: Making lifestyle changes can be difficult, even when we know we should. In a scientific statement, the AHA outlined 5 issues that make it harder to adhere to healthy eating patterns: targeted food marketing, structural racism, neighborhood segregation, unhealthy built environments, and food insecurity—also known as nutrition insecurity.5 Creating living environments that facilitate a heart-healthy diet and enable physical activity is a public health imperative.

An important facet of our work at the AHA is to make healthy living possible for everyone. A healthy lifestyle has been associated with much more than a reduction in heart disease—or heart valve disease in this case; it can also reduce the incidence of diabetes and hypertension, for example.

What barriers have patients expressed to you that impede their efforts to adopt healthier lifestyle behaviors such as smoking cessation, decreasing alcohol consumption, eating a more nutritious diet, increasing activity, and improving sleep hygiene, and what are some ways that you address these barriers in practice?

Dr Chokshi: Stress in all forms—financial, work-related, familial, personal—is a frequent barrier to behavior change. A key strategy is providing multiple options for patients to impact their heart health and then utilizing a shared decision-making process to identify 1 specific intervention to start. Targeting multiple problems, as they often cluster, can be a setup for failure.  

It is important to engage the patient in designing the intervention and goal setting to ensure the change is feasible. For example, a patient may not have time to formally exercise due to a busy work schedule. One feasible strategy for them may be to walk 30 minutes during their lunch break, perhaps to go pick up their lunch. Doing so on a daily basis would provide a meaningful dose of physical activity. 

It is also important to design strategies that could be sustained by patients over time, as any meaningful impact on valve or coronary health requires long-term change. Additionally, technology such as wearables, app-based exercise and nutrition programs, and gaming have increased our ability to get creative in developing programs to overcome obstacles for patients.6  

Dr Gil: Lack of motivation, knowledge, social support, time, as well as financial constraints and emotional factors can all decrease the chance of a patient making long-term lifestyle changes. Individual patients may have unique barriers, and I tailor my approach accordingly. I address each issue individually and focus on setting one manageable and realistic goal at a time. 

Providing education, resources, and evidence-based information increases awareness and understanding. Dedicating time to understanding patients allows me to offer strategies for overcoming setbacks or obstacles. I do not forget to ask patients for their feedback regarding solutions that I offer. 

Dr Bachmann: A major barrier for many patients is their home environment, which may not be conducive to goals such as stopping smoking or drinking alcohol, for example. My clinical focus is cardiac rehabilitation, and 1 of the reasons it is so effective is that it provides a place for patients to participate in physical activity in a social environment that promotes healthy lifestyle behaviors.

Dr Jessup: Symptoms of heart valve disease, such as fatigue, lightheadedness, and shortness of breath, can inhibit physical activity and may be dismissed as normal signs of aging. In addition, efforts to stop lifelong habits, such as smoking or alcohol use, can put stress on the mind and body, making these changes particularly difficult when a patient is already experiencing cardiovascular health issues. 

Change is hard, and too often, people can only see a huge change in their habits as meaningful. The AHA encourages small steps at first, with tiny goals, as these ultimately add up to significant benefits and success.

From Wii Sport to virtual reality, there are now numerous ways for patients to be more active. What are some benefits and disadvantages of technology-based activity for patients at risk of VHD?

Dr Chokshi: Any degree of physical activity counts towards improving cardiovascular health, with more activity having incremental benefit. The key is for patients to engage in activity that will be sustainable in the long run. Technology-based programs often provide engagement and enjoyment that are useful to this end. Competition and gamification strategies have been shown to promote physical activity.7 Similarly, engaging individuals with their social networks, such as family and friends, can help increase participation in walking.  

Tech interventions like video games can leverage both of these behavioral strategies to promote cardiovascular health. Pragmatically, this may also provide a means for families to exercise together. I frequently play “Just Dance” on the Wii with my 10-year-old and 7-year-old. Of course, there are likely some health benefits from outdoor or “live” activities such as weight bearing or resistance training and exposure to sunlight. Therefore, virtual activities should probably be utilized as part of a broader exercise program.

Dr Bachmann: Technology-based activities have a lot of promise, and I think it is great for patients to use these tools. One of the chief advantages of virtual and augmented reality tools is that they promote access, as patients can participate in these activities at home. The major disadvantages are the cost and learning curve involved in using these technologies. At present, virtual reality has a relatively steep learning curve, as many of the current headsets have a complicated setup process, such as requiring measuring interpupillary distance, for example. 

Dr Jessup: Only about one-half of Americans meet the recommended guidelines for physical activity.8 A big reason for that is that many adults and children choose sedentary “screen time” over being physically active. Meeting people where they are with incremental change is important for people who are not engaging in any activity—and virtual game play can be a great way to do that. Any physical activity is better than none, and while participating in actual sports is ideal, active gaming compares well with sitting in a chair. 

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Clinician Insights on How to Manage Semaglutide-Induced Gastroparesis: Part II https://www.thecardiologyadvisor.com/general-medicine/how-to-manage-semaglutide-induced-gastroparesis-bono-do-yusupov-do/ Mon, 25 Sep 2023 12:47:01 +0000 https://www.thecardiologyadvisor.com/?p=110818 Male-doctor-and-young-male-patient-sitting-at-desk-in-a-clinic-having-a-discussion-while-using-a-digital-tablet.

Beyond performing a differential diagnosis, how can clinicians manage gastroparesis that results from a GLP-1 receptor agonist like semaglutide?

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Patients who receive treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, such as semaglutide, may experience delayed gastric emptying due to the drug’s mechanism of action (MOA).1 Symptoms may include nausea, vomiting, heartburn, pain, or bloating.2 However, the symptoms of delayed gastric emptying resulting from GLP-1 receptor agonists may be similar to symptoms of gastroparesis.3

Recent reports have revealed that patients who receive semaglutide-containing medications, such as Ozempic® and Wegovy®, have developed gastroparesis.4,5 Given the resemblance in symptoms between delayed gastric emptying and gastroparesis, it is essential for clinicians to gain awareness of the best approach for managing gastroparesis in patients receiving GLP-1 receptor agonists. How should clinicians perform a differential diagnosis? What are counseling points patients should receive regarding GLP-1 receptor agonists’ MOA?

To shed light on the aforementioned questions and more, we spoke with 2 clinicians: Nancy Bono, DO, chair of family medicine at New York Institute of Technology College of Osteopathic Medicine (NYITCOM), and Eleanor Yusupov, DO, assistant professor of clinical specialties at NYITCOM.

If symptoms persist despite dietary and lifestyle modifications or become severe, semaglutide needs to be stopped.

What are probing questions clinicians should ask patients who come in with generic gastric symptoms in order to perform a differential diagnosis for gastroparesis?

Dr Bono: Start with a review of system (ROS), an inventory of body systems obtained by asking a series of questions to identify signs and/or symptoms the patient may be experiencing or has experienced. This includes constitutional symptoms — for example, fever and weight loss — as well as gastrointestinal (GI) symptoms like abdominal pain, constipation, diarrhea, heartburn, loss of appetite, nausea, and vomiting. 

Dr Yusupov: Patients should be asked in-depth questions regarding their GI symptoms, including nausea, vomiting, abdominal pain, abdominal distention, painful or difficult swallowing, bloating, early satiety, diarrhea, or constipation. In addition, the presence of fever, weight loss, location, and description of the abdominal pain, as well as any association of symptoms with meals should be ascertained. Patients should be asked about their medications, history of diabetes, motility disorders, and surgeries.

What are some key differential diagnoses clinicians should keep in mind when patients present with prolonged broad generic gastric symptoms, such as nausea, vomiting, and diarrhea, if they are a patient with type 2 diabetes or obesity who initiated a GLP-1 receptor agonist? What is the benchmark for these symptoms being expected adverse events of new therapy vs a concern?

Dr Bono: You need to review the patient’s diet. One recommendation would be smaller meals, which can help alleviate nausea by reducing the amount of food that needs to be digested at once. Smaller, more frequent meals can help to stabilize blood sugar levels, which, in turn, can help to prevent nausea caused by dips in blood sugar. Another recommendation would be to avoid high-fat foods, fried foods, and fatty foods, including fast food, as well as foods high in sugar, which tend to be the toughest for the body to digest and the most likely to cause nausea while taking a GLP-1 medication. 

Hydration is also key to preventing or minimizing nausea. Zofran can be prescribed to lessen nausea for a few days. The main concern is to stop treatment when you suspect pancreatitis, the pain felt in the upper left side or middle of the abdomen. The pain may be worse within minutes after eating or drinking at first, more commonly if foods have a high fat content. It may also become constant and more severe, lasting for several days. Amylase and lipase tests are used to detect pancreatitis. If the enzymes circulating in your bloodstream are elevated, then the medication needs to be stopped. 

Dr Yusupov: Clinicians should keep in mind viral illness, acute pancreatitis, gallbladder disease, and kidney injury. Nausea, vomiting, diarrhea, or constipation are common with initiation or dose increase of GLP-1 agonists. However, we get concerned any time the symptoms are severe, do not improve quickly, or are associated with abdominal pain.

If a patient is experiencing medication-induced gastroparesis due to semaglutide, what patient-specific and disease-specific factors should physicians consider when determining the next steps to manage the gastroparesis?

Dr Bono: Reglan (metoclopramide). This medication increases the movements in your digestive system, helping the food to pass through more quickly and efficiently to treat gastroparesis.

Dr Yusupov: Delayed gastric emptying is expected while taking semaglutide; it is related to the MOA of this drug. However, individual patient tolerability of the associated symptoms is critical. Most patients experience mild GI symptoms and learn to manage them. Therefore, they are able to continue treatment. If symptoms persist despite dietary and lifestyle modifications or become severe, semaglutide needs to be stopped.

What treatment options should be considered for patients who develop gastroparesis when on a GLP-1 receptor agonist? Does management for gastroparesis in this patient population differ from current guidelines?

Dr Bono: Reglan (metoclopramide). No.

Dr Yusupov: Patients should be counseled to eat smaller meals, avoid foods with high fat content, as well as avoid eating close to their bedtime. GLP-1 agonist dose should not be increased unless patients can tolerate the medication without significant GI side effects. The approach to gastroparesis management in this patient population is similar to current guidelines. [The] GLP-1 agonist should be stopped due to its effect on motility. The use of prokinetic medications (metoclopramide) is off-label in patients without diabetes. Ondansetron can be tried (off-label) to manage nausea and vomiting due to gastroparesis.

For physicians with patients newly on GLP-1 receptor agonists, specifically semaglutide for weight management, what are critical counseling points for the patient?

Dr Bono: Semaglutide is a peptide that works by mimicking a hormone called glucagon-like peptide 1 (GLP-1), which targets an area of the brain that regulates appetite and food intake. Semaglutide must be taken consistently to see long-term weight loss effects. As soon as someone stops taking the drug, their body fat and former appetite tend to return. The analogy can be similar to someone having high blood pressure — you’re taking the medication for life.

Dr Yusupov: Patients should be counseled that GLP-1 agonists slow stomach emptying and decrease appetite. They should also be informed how to make specific nutrition changes, as well as what to expect when initiating the treatment or increasing the dose. It is critical to advise patients to drink plenty of water (I recommend 64 oz of water a day). In addition to GI effects of this medication class and ways to prevent or minimize these effects, patients should be informed of the potential risk of thyroid C-cell tumors and advised to report voice changes, painful or difficult swallowing, or neck lumps.

How can physicians communicate to patients the severity of gastric symptoms and when to seek help during the counseling process?

Dr Bono: [Explain] that most drugs have their risks and side effects, and semaglutide is no different. Consideration can be to stay on the same dose for a few weeks instead of going up in dose, which can lessen the effects of the GI symptoms. 

Dr Yusupov: It is important to counsel patients to call their physician if they develop vomiting or abdominal pain, fatigue, persistent diarrhea, or constipation. We definitely want to hear back from our patients if they are experiencing significant abdominal pain.

This is the second article in a 2-part series on gastroparesis. The first article What We Know About Semaglutide Adverse Events and Gastroparesis: Part I is available here.

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What We Know About Semaglutide Adverse Events and Gastroparesis: Part I https://www.thecardiologyadvisor.com/general-medicine/what-we-know-about-semaglutide-adverse-events-and-gastroparesis-part-1/ Fri, 22 Sep 2023 12:58:30 +0000 https://www.thecardiologyadvisor.com/?p=110776 Closeup-of-individual-clutching-their-stomach-from-pain.

As more reports surface about gastroparesis developing in patients who receive treatment with semaglutide, what should clinicians keep in mind?

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Semaglutide-containing medications sold under the brand names Ozempic® and Wegovy® have made headlines after being linked to gastroparesis. Both medications belong to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. GLP-1 is a regulator of appetite and caloric intake and is known to have various drug interactions due to delayed gastric emptying as a result of therapy.

In a 2-year study (ClinicalTrials.gov Identifier: NCT03693430) of semaglutide use in patients with overweight or obesity, researchers found that 82.2% of patients taking semaglutide experienced mild to moderate gastrointestinal (GI) adverse events compared with 53.9% in the placebo group. There were no reports of gastroparesis in the study.

While semaglutide and other GLP-1 agonists cause adverse events, such as nausea, vomiting, diarrhea, and a range of other GI symptoms, these effects of delayed gastric emptying are reported to be reduced after 20 weeks of use. 2  

[T]here are some cases where gastroparesis may resolve if discontinuing the medication.

What Are Other Causes of Gastroparesis? 

Diabetes is the most common underlying cause of gastroparesis and can damage the vagus nerve, leading to impaired muscular function in the stomach and small intestine.3 Studies show that the 10-year cumulative incidence of diabetic gastroparesis is estimated to be 5.2% among patients with type 1 diabetes and 1% in patients with type 2 diabetes.4 

Other known causes of gastroparesis include celiac disease, neurological disorders such as Parkinson disease and central nervous system tumors, collagen vascular disorders such as scleroderma and systemic lupus erythematosus, hypothyroidism, and medications.5

Medications that can result in delayed gastric emptying leading to gastroparesis include proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, opioid analgesics, progesterone, lithium, cyclosporin, and levodopa.5

Research on semaglutide-induced gastroparesis is limited, but patient reports have been increasing.

Case Studies of GLP-1-Induced Gastroparesis

1. A 52-year-old woman with a 10-year history of diabetes presented with a 7-month history of postprandial epigastric pain with concomitant fullness, bloating, and nausea that was unrelieved after proton pump inhibitors and antispasmodics. She was initiated on weekly semaglutide subcutaneous injection 1 month prior to symptom onset, and her diabetes is currently well-managed (A1c, 5.7%). A 4-hour scintigraphic gastric emptying (SGE) test indicated delayed gastric emptying. Semaglutide was held for 6 weeks, leading to symptom resolution.6

2. A 57-year-old woman with a 16-year history of diabetes presented with a year history of abdominal bloating, nausea, and vomiting. The patient was initiated on dulaglutide subcutaneous weekly injection 15 months prior and has an A1c of 8.2%. A SGE confirmed delayed gastric emptying. Dulaglutide was held for 4 weeks, resulting in a gradual resolution of symptoms.6

3. A 52-year-old man with a history of diabetes, hypertension, and hyperlipidemia presented with a 1-week history of nausea, abdominal distension, and pain. The patient was receiving daily liraglutide for glycemic control (A1c, 7%). After temporary discontinuation of liraglutide, dietary modification, and a short course of antiemetics and metoclopramide, the man’s symptoms resolved.7

Semaglutide and Gastroparesis in the News

In July 2023, 3 women told CNN that they developed severe GI symptoms after receiving treatment with semaglutide injections. Two of the women were diagnosed with severe gastroparesis.8

Then, in early August 2023, a woman sued Novo Nordisk and Eli Lilly, the manufacturers of semaglutide and tirzepatide injections, alleging that the companies failed to warn patients of severe GI symptoms. The woman reported stomach pain, severe vomiting, GI burning, hospitalization due to stomach issues, and a loss of teeth due to excessive vomiting.

While both medication package inserts state that delayed gastric emptying is possible with the medication and may affect drug absorption, they do not specifically state that gastroparesis is a potential risk.10 The GI adverse events listed on the semaglutide package inserts appear to be mild to moderate, including nausea, stomach pain, bloating, constipation, diarrhea, and vomiting.10-12 

As the popularity of these medications increases, experts expect an increase in GI adverse event reports in the future. The US Food and Drug Administration (FDA) told CNN in a statement that they have “received reports of gastroparesis with semaglutide and liraglutide, some of which documented the adverse event as not recovered after discontinuation of the respective product at the time of the report.”8 

However, the FDA also told CNN that they are unable to confirm if the medications directly caused gastroparesis or an alternative etiology.8

Active IngredientBrand NameFDA-Approved Indication10-15Formulation10-15
SemaglutideWegovy; OzempicDiabetes: Adjunct to diet and exercise to improve glycemic control in adults   Chronic Weight Management: Adjunct to a reduced caloric diet and increased exercise in adultsSubcutaneous injection
SemaglutideRybelsusDiabetes: Adjunct to diet and exercise to improve glycemic control in adultsOral tablet
DulaglutideTrulicityDiabetes: Adjunct to diet and exercise to improve glycemic control in patients 10 years and older and reduce risk for major adverse cardiovascular eventsSubcutaneous injection
LiraglutideSaxenda; VictozaDiabetes: Adjunct to diet and exercise to improve glycemic control in adults   Chronic Weight Management: Adjunct to a reduced caloric diet and increased exercise in children and adultsSubcutaneous injection
Table 2. GLP-1 Agonists Approved by the US Food and Drug Administration

Clinician Guidelines for Managing Gastroparesis

Clinicians do not recommend semaglutide for patients who experience symptoms of gastroparesis.4 An SGE over a duration of 3 hours is recommended when evaluating for gastroparesis in patients with upper GI symptoms. If an SGE assessment is not feasible, wireless motility capsule or a stable isotope breath test is a reasonable alternative.16

Dietary modifications with small-particle, low-fat, nondigestible food are recommended to provide symptom relief and enhance gastric emptying. Metoclopramide, domperidone, or 5-HT4 agonists are recommended to improve gastric emptying. Antiemetics are suggested for symptom control but do not improve gastric emptying. Central neuromodulators, ghrelin agonists, and haloperidol are not recommended in therapy.19

There is limited research on the management of medication- or drug-induced gastroparesis. Based on current case studies, management includes discontinuation of the medication, symptom control with antiemetics and prokinetic agents per guidelines, nutritional support, and dietary modification.7 Further research is warranted to identify next steps for patients who develop gastroparesis after semaglutide use, and whether reinitiation of therapy is possible after discussion of benefit vs risk with their health care provider.

This is the first article in a 2-part series on gastroparesis. The second article Clinician Insights on How to Manage Semaglutide-Induced Gastroparesis: Part II is available here.

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Barriers to Timely Follow-up for Heart Failure Hospitalization https://www.thecardiologyadvisor.com/home/topics/heart-failure/barriers-to-timely-follow-up-for-heart-failure-hospitalization/ Fri, 15 Sep 2023 15:01:26 +0000 https://www.thecardiologyadvisor.com/?p=110339

Researchers examine patient barriers when receiving follow-up for heart failure hospitalization.

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According to guidelines, patients hospitalized with heart failure should have an ambulatory follow-up visit within 1 to 2 weeks of discharge. This recommendation is not only best practice, but it is critical. Dire statistics plague heart failure patients, including an average 25% readmission rate within 30 days of discharge and a 33% fatality rate in the year following hospitalization.1

A study published in 2023 revealed that timely follow-up simply isn’t happening for most patients in underserved populations. When analyzing the Medicaid data of 9859 patients with diabetes and heart failure in Alabama, researchers found that about 31% of patients completed their postdischarge visit late (within 60 days), and almost 27% had no visit. In addition, the vast majority (over 70%) followed up with their primary care doctor, while only 12% saw a cardiologist.2

Social barriers, such as lack of transportation and limited access to medical care, increase heart failure complications and readmission rates.3 By understanding the impact of these social determinants of health, progress can be seen for reducing heart failure, a disease impacting over 6.5 million Americans, leading to over 1.9 million hospitalizations, and costing the country at least $31 billion each year.4 Here’s why so many patients never make it to their postdischarge appointment and how successful programs are testing blueprints to reverse the trend.

What Are the Social Determinants of Health?

The social determinants of health are the conditions that impact health care outcomes beyond an individual’s clinical risk factors. These encompass 5 domains: economic stability, education access and quality, health care access and quality, neighborhood and built environment, and social and community context.

Read more: Patient Education

Social determinants of health may also be viewed as the “conditions in which people are born, live, learn, work, play, worship, and age.”3

Intentionally reaching patients, even using existing resources, can make all the difference in overcoming barriers and raising short-term monitoring and survival rates.

There are many well-established connections between the social influences of health. Data published in 2021 by the World Health Organization estimated that 30% to 55% of health outcomes are directly related to social determinants of health.3 The American Heart Association has also acknowledged the impact of social factors, like environment, lifestyle, and stress, on chronic disease management, calling for individual and neighborhood-wide initiatives. Patients require more support with both navigating the health care system and learning to care for their chronic conditions at home.

As researchers narrow the focus to heart failure, more opportunities for progress arise. For example, poverty increases toxic stress associated with physical consequences like high blood pressure and inflammation.3 Unsafe neighborhoods limit outdoor exercise, and substandard education reduces health literacy and the ability to manage chronic conditions. Additionally, patients with a network of support are more likely to have caregivers, help with transportation, and lower levels of anxiety and depression.3 While there are no easy fixes for these complex issues, better data enables the design of value-based care models for holistic patient care.

Challenges in Quantifying the Problem

Despite the value of social data, it is not always easy to measure. For instance, some studies rely on whether the patient is married or has children to determine their level of social support. While this information can be readily sourced from electronic medical records (EMR), it is not necessarily validated or guaranteed to paint an accurate picture. Current EMRs are not necessarily designed to capture the many social determinants of health that exist. Therefore, collecting less concrete information, like a patient’s level of spirituality, remains a challenge.3

In addition, patients are multifaceted and don’t always fit neatly into a box based on their social determinants of health. Characteristics overlap and interact, such as race, sex, and income. While associations with outcomes like heart failure follow-up are helpful, they tend to fall short of producing a comprehensive patient profile. Fortunately, there’s no harm in providing interventions that help patients schedule appointments, get easier access to care, and learn how to manage their health. Taking a more proactive and hands-on approach offers potential payoffs for heart failure patients from all walks of life.

Effective Interventions Worth Repeating

A study on 261 heart failure patients reviewed how interventions can produce significantly higher rates of postdischarge follow-up. Those in the intervention group had a 40% referral rate and 24% completion of a cardiology visit within 7 days of discharge, compared to just 12% referral rate and 10% completed visit in those receiving standard care. By 14 days postdischarge, 55% of the intervention group had a scheduled appointment versus 31% of nonintervention patients. Not only was the intervention successful in boosting timely postdischarge visits, but it was also associated with a 41% lower rate of emergency department visits, all-cause hospitalizations, and deaths 30 days after discharge.1

To achieve these promising results, researchers implemented a transitional care pathway at the Phoenix Veteran’s Affairs Medical Center.1 They asked the hospitalist team to refer all patients admitted with a primary diagnosis of heart failure within 7 to 14 days postdischarge. In the triage process, a heart failure clinic consult was created for these patients, prompting a meeting with the cardiology nurse before discharge. During this visit, the nurse instructed the patient on self-care, providing them with a blood pressure cuff and a scale. The nurse also ordered laboratory tests and scheduled a postdischarge heart failure clinic appointment. Patients were given the clinic’s contact information and daytime access to the nurse by phone to answer questions, refill medications, facilitate clinic scheduling, and address any concerns once they returned home. The clinic had 12 spots each week where patients could meet with a newly hired cardiologist or 1 of 3 preexisting nurse practitioners. In addition, telehealth monitoring and Veterans Health Administration home nursing services were available.

This study is just one example of how a targeted intervention can improve outcomes for heart failure patients. Intentionally reaching patients, even using existing resources, can make all the difference in overcoming barriers and raising short-term monitoring and survival rates. Providing a nurse liaison, patient resources, and increasing clinic capacity greatly impacted how many patients ended up with timely follow-ups. Continued research on the long-term effects of this type of intervention can help quantify the value of heart failure interventions, both in health care dollars and quality of life measures.

Can Specialists Be All Things to All People?

Ultimately, medical care cannot be effective without reaching the patients that need it. No matter the specialist’s skill set or the advancements in medical technology, sometimes there is no substitute for supportive nursing staff and a clinic with the capacity to see more patients. Heart failure statistics show that there is still much work needed to keep patients from falling through pivotal gaps in care. Robust health care networks must utilize social workers, nursing staff, and community resources to ensure the welfare of their patients after they leave the hospital.

Specifically, vulnerable heart failure patients must be reached in the early days postdischarge to reduce readmissions and improve survival rates.1 From redesigning EMRs to include the social determinants of health to implementing comprehensive outreach programs initiated before discharge, efforts along the health care continuum can save future burdens to the medical system and the individual patients it serves. If “an ounce of prevention is worth a pound of cure,” initiatives for better follow-up care in postdischarge heart failure patients is well worth the initial investment.

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Insight into the Updated AHA/ACC Guidelines on Treating Chronic Heart Disease https://www.thecardiologyadvisor.com/general-cardiology/insight-into-the-updated-aha-acc-guidelines-on-treating-chronic-heart-disease/ Fri, 08 Sep 2023 13:40:00 +0000 https://www.thecardiologyadvisor.com/?p=110015 Heart on top of a scan with a stethoscope.

A discussion of the updated AHA/ACC guidelines for treating chronic heart disease with Dr Dave L Dixon, PharmD, and Dr Salim S Virani, MD, PhD.

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Heart on top of a scan with a stethoscope.

In July 2023, the American Heart Association and the American College of Cardiology released an updated guideline on the management of chronic coronary disease (CCD), in collaboration with several other professional organizations.1 The previous recommendations on the topic were published more than a decade ago.

“This guideline provides a much-needed update to the 2012 guideline on the management of stable ischemic heart disease, so there are a lot of changes,” said one of the guideline authors, Dave L Dixon, PharmD, the Nancy L and Ronald H McFarlane Professor of Pharmacy and professor of internal medicine in the division of cardiology at Virginia Commonwealth University in Richmond, Virginia, and member of the ACC Prevention of Cardiovascular Disease Council. 

Along with recommendations on new medication classes and updated recommendations on the use of beta blockers in patients with CCD, some of the most notable additions to the new guideline include “several concepts regarding the importance of social determinants of health and how we leverage a team-based approach to care” for this patient population, according to the lead author of the guideline, Salim S. Virani, MD, PhD, professor in the sections of cardiology and cardiovascular research at Baylor College of Medicine in Houston, Texas. Available evidence on the relationship between environmental exposures in patients with CCD are also discussed. 

Selected highlights from the new guideline are summarized below.

Multidisciplinary, Team-Based Approach

Patients with CCD should be seen for follow-ups at least once per year for assessment of symptoms, functional status, adherence to medications and lifestyle interventions, and complications of disease or treatments.

Long-term CCD management should be based on a patient-centered, multidisciplinary team-based approach that emphasizes shared decision-making between clinicians and patients (class of recommendation [COR], 1; level of evidence [LOE], A). This approach has been linked to improved health outcomes, patient self-efficacy, health-related quality of life (QOL), health service utilization, and management of atherosclerotic cardiovascular disease (ASCVD) risk factors in CCD patients.

To facilitate the shared decision-making process, the care team should routinely assess for social determinants of health (SDOH), which affect all aspects of CCD management (COR, 1; LOE, B-R).

Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is low to moderate.

“Routine SDOH screening in patients with CCD… should encompass assessment of mental health, psychosocial stressors, health literacy, sociocultural influences (language, religious affiliation, body image), financial strain, transportation, insurance status, barriers to adherence to a heart healthy diet (food security), neighborhood or environmental exposures, and viable options for regular physical activity and social support,” as explained in the guideline. “Based on identified barriers or needs, collaborative cardiovascular care teams can provide tangible and practical community-based resources and services to patients.”

Nonpharmacologic Strategies

Guidance on nonpharmacologic approaches to CCD management includes nutritional recommendations such as adherence to a diet emphasizing fruits and vegetables, legumes, nuts, whole grains, and lean proteins (COR, 1; LOE, B-R) and minimizing intake of saturated fat, sodium, refined carbohydrates, and processed meats (COR, 2a; LOE, B-NR).

In addition, consumption of trans fat, such as those found in certain baked goods and fried foods, should be avoided due to evidence linking trans fat to increased rates of morbidity and mortality in patients with CCD and the general population (COR, 3: Harm; LOE, B-NR).

The guideline also noted the lack of evidence supporting the use of dietary supplements such as omega-3 fatty acids, calcium, and vitamin D in reducing the risk of acute CV events (COR, 3: No benefit; LOE, B-NR).

Other recommendations in the area of nonpharmacologic strategies include regular assessment and cessation interventions for tobacco use, and guidance on minimizing alcohol intake to reduce CV mortality and all-cause death. 

In terms of physical activity, an exercise regimen consisting of at least 150 minutes of moderate-intensity aerobic activities or at least 75 minutes of higher-intensity aerobic activities per week is recommended to improve functional capacity, QOL, hospital admission rates, and mortality rates in patients with CCD who do not have contraindications to such a regimen (COR, 1; LOE, A).

In the absence of contraindications, strength training exercises on 2 or more days per week are also recommended (COR, 1; LOE, B-R), as well as non-exercise activities–such as gardening and taking walking breaks at work–to reduce sedentary time (COR, 2a; LOE, B-NR).

For eligible patients, cardiac rehab may reduce CV morbidity and mortality.

Minimization of environmental exposures, including ambient air pollution (COR, 2a; LOE, B-NR) as well as extreme temperatures and wildfire smoke (COR, 2b; LOE, B-NR), is recommended to reduce the risk of CV events in patients with CCD.

Pharmacologic Therapies

SGLT2 inhibitors and GLP-1 receptor agonists. The use of an SGLT2 inhibitor or a GLP-1 receptor agonist with proven CV benefit is recommended for patients with CCD and type 2 diabetes to reduce the risk for major adverse cardiac events (MACE; COR, 1; LOE, A).

Regardless of diabetes status, the use of an SGLT2 inhibitor is recommended for patients with CCD and heart failure with a left ventricular ejection fraction (LVEF) of 40% or less, to reduce the risk of CV death and hospitalization due to heart failure and improve QOL (COR, 1; LOE, A). The use of an SGLT2 inhibitor may also reduce heart failure hospitalizations and improve QOL in those with heart failure with an LVEF of more than 40%, regardless of diabetes status (COR, 2a; LOE, B-R).

Beta blockers. The use of beta blockers is recommended for patients with CCD and an LVEF of 40% or less, regardless of myocardial infarction (MI) history, to reduce the risk for future MACE (COR, 1; LOE, A).

The use of sustained release metoprolol succinate, carvedilol, or bisoprolol with titration to target doses is recommended over other beta blockers for patients with CCD and an LVEF of less than 50% (COR, 1; LOE, A).

In those who were previously initiated on beta blocker therapy after MI and with no history of or current LVEF of 50% or less, angina, uncontrolled hypertension, or arrhythmias, the guideline states that “it may be reasonable to reassess the indication for long-term ([more than] 1 year) use of beta blocker therapy for reducing MACE” (COR, 2b; LOE, B-NR).

As a new addition to the guideline, the use of beta blockers is not recommended for reducing MACE in patients without previous MI or LVEF of 50% or less or another primary indication for beta blocker therapy (COR, 3: No benefit; LOE, B-NR).

Antiplatelet therapy and oral anticoagulants. Other key updates in the new guideline include a “shift toward shorter durations for dual antiplatelet therapy in select patients,” Dr Dixon said.

Among the evidence supporting this shift, a meta-analysis of 10 RCTs with a combined total of 31,666 patients, a shorter duration of dual antiplatelet therapy (DAPT) was associated with lower all-cause mortality compared to a longer duration of DAPT after drug-eluting stent implantation.2 While rates of mortality, MI, and stent thrombosis were similar between patients treated with DAPT for 6 months or less and those treated with 1-year DAPT, rates of major bleeding were lower in patients treated with DAPT for 6 months or less compared to 1 year.2

Another large meta-analysis found that short-term DAPT (less than 6 months) followed by P2Y12 inhibitor monotherapy was associated with a reduced risk for major bleeding compared to 12-month DAPT after drug-eluting stent implantation.3

“Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is low to moderate,” according to the guideline.

Dr Virani advised that clinicians review the guideline and determine “how their current practice patterns align with these recommendations, whether they need to make any changes and what evidence supports these changes, and then utilize the excellent resources available on the ACC and AHA websites.”4,5

He noted that the recommendations can be implemented over time and suggested that clinicians initially focus on Class 1 and Class 3 recommendations—what should be done and what should be avoided, respectively—before aiming to incorporate recommendations of a lower class, such as 2a and 2b.

In sum, “This is an essential guideline for clinicians because it encompasses aspects of multiple guidelines into one to provide a comprehensive guide on managing patients with chronic coronary disease,” Dr Dixon stated.

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COVID-19 Infection Increases Likelihood of Kidney Function Decline https://www.thecardiologyadvisor.com/general-medicine/covid-19-infection-increases-likelihood-of-kidney-function-decline/ Wed, 30 Aug 2023 14:00:00 +0000 https://www.thecardiologyadvisor.com/?p=109502 Assisting a patient while barged to prevent infection.

Research documents both direct and indirect effects of the COVID-19 pandemic on kidney health.

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Assisting a patient while barged to prevent infection.

Rapid kidney function decline often follows COVID-19 infection, including in patients with moderate to severe chronic kidney disease (CKD), a new study finds. Other research identified plasma biomarkers that may predict major adverse kidney events (MAKE) in patients hospitalized with COVID-19.

Among 97,203 insured patients with CKD G3-4, a total of 8695 patients (8.9%) contracted SARS-CoV-2. Investigators propensity score matched 4475 patients with and 4426 patients without COVID-19. Of this subset, 63% had CKD G3a, 28% had CKD G3b, and 9% had CKD G4.

Rapid kidney function decline, defined as a 40% or greater annual decline in estimated glomerular filtration rate (eGFR), occurred in 2.5% of the COVID-19 group compared with 1.5% of the uninfected group, Clarissa Jonas Diamantidis, MD, MHS, of Duke University School of Medicine in Durham, North Carolina, and colleagues reported in Kidney Medicine. The COVID-19 group had significant 1.6-fold increased odds of rapid kidney function decline.

In the overall cohort, the eGFR slope was significantly steeper for patients with vs without COVID-19 during the pandemic: -2.94 vs -2.36 mL/min/1.73m2, the investigators reported. For three-quarters of patients with CKD, kidney function worsened during the pandemic regardless of infection. Noninfection-related experiences of the pandemic may have indirectly contributed to rapid kidney function decline, the investigators suggested.

Patients with CKD stages G3b and G4 were twice as likely to experience rapid kidney function decline during the pandemic compared with patients with CKD stage G3a. Rapid progressors prior to the pandemic had 3-fold increased odds of rapid kidney function decline during the pandemic. Higher vs lower Charlson Comorbidity score also was significantly associated with 1.1-fold increased odds of rapid decline.

Dr Diamantidis’ team further found that Asian patients had 4.2-fold increased odds of rapid kidney function decline during the pandemic compared with White patients.

Separate research by Ashish Verma, MBBS, of Evans Biomedical Research Center in Boston, Massachusetts, published in Kidney Medicine, documents greater proportions of kidney-disease related deaths overall among Asian (and Black) adults compared with White adults in the United States. The highest kidney disease proportional mortality rate was among Filipino individuals aged 60 years or older (2.4%). The death rate was higher for South Asians than East Asians with CKD. The investigators noted that the COVID-19 pandemic may have led to early deaths in some groups.

…Elevations in sTNFR1 and sTNFR2 in the setting of COVID-19 may serve as markers of disease severity, with prolonged inflammation leading to worse kidney outcomes

“Taken together, these findings support CKD as both a risk factor for severe COVID-19 and a consequence of COVID-19. Therefore, close monitoring of the CKD population for long-term consequences of COVID-19 is warranted,” Dr Diamantidis’ team wrote.

She noted that adverse kidney outcomes after COVID-19 disease often follow acute kidney injury (AKI).

In another study, published in the American Journal of Kidney Diseases, Chirag R. Parikh, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, Maryland, and colleagues investigated the ability of 26 plasma biomarkers of injury, inflammation, and repair to predict COVID-19-associated major adverse kidney events (MAKE). Among 576 patients hospitalized with COVID-19 (30% with pre-existing stage 3 CKD or higher), 95 patients (16%) experienced MAKE, defined as KDIGO stage 3 AKI, dialysis-requiring AKI, or mortality within 60 days.

Each standard deviation increase in soluble tumor necrosis factor receptor 1 or 2 (sTNFR1 or sTNFR2) was significantly associated with a 2.3-fold increased risk for MAKE, the investigators reported. The C index of sTNFR1 and sTNFR2 was 0.80 and 0.81, respectively. Clinical models (including age, sex, race, baseline serum creatinine, diabetes, hypertension, obesity, and WHO COVID-19 severity score) yielded C indexes of 0.86 and 0.85 when sTNFR1 and sTNFR2 were added, respectively.

“Given their role in the body’s response to inflammation, elevations in sTNFR1 and sTNFR2 in the setting of COVID-19 may serve as markers of disease severity, with prolonged inflammation leading to worse kidney outcomes,” Dr Parikh and colleagues wrote.

The investigators proposed cutoffs for sTNFR1 and sTNFR2 of 2130 pg/mL and 14,670 pg/mL because they had high negative predictive values of 92% and 94%, respectively, for MAKE within 60 days.

Identification of high-risk patients who meet these cutoffs would allow outpatient nephrologists to take extra steps to slow or prevent CKD progression, according to Dr Parikh’s team.

Disclosure: The Kidney Medicine COVID-19 research was supported by OptumLabs. Please see the original reference for a full list of disclosures.

Disclosure: Some study authors in the American Journal of Kidney Diseases study declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

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COVID-19: Effects on the Cardiovascular System https://www.thecardiologyadvisor.com/general-cardiology/covid-19-effects-cardiovascular-system/ Fri, 25 Aug 2023 14:40:00 +0000 https://www.thecardiologyadvisor.com/?p=109616 COVID-19 cardiovascular system

COVID-19 induces a range of negative cardiac effects, such as hypoxic respiratory failure and hypoxemia, microvascular injury, venous thromboembolism, and pulmonary embolism.

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COVID-19 cardiovascular system

SARS-CoV-2, the virus that causes COVID-19 infection, damages the lungs, impairing gas exchange and depriving the body of oxygen. It also has significant cardiovascular effects, particularly in patients with preexisting cardiovascular disease (CVD). The reduced oxygen supply to the heart muscle causes inflammation, tissue damage, and arrhythmias and decreases cardiac output. Infection and inflammation further impair cardiac biochemical and fibrinogen pathways and diminish cardiac muscle integrity, leading to myocardial injury and dysfunction while also increasing the metabolic demand on many organs, including the heart.

Heart damage caused by COVID-19 without other causes is referred to as myocardial infarction type 2.1 It is diagnosed using cardiac biomarker measurements, such as high-sensitivity cardiac troponin l (cTnI) and N-terminal pro-B-type natriuretic peptide (NT-proBNP). Treatment is based on increasing knowledge of the SARS-CoV-2 life cycle and its association with host cells and involves preventing exposure, diminishing viral proliferation, and attenuating inflammatory responses. Educating patients on available treatment options, including potential side effects and complications, is important.

Cardiovascular Complications of COVID-19

COVID-19 induces a range of negative cardiac effects, such as hypoxic respiratory failure and hypoxemia leading to hypoxia-induced myocardial injury (3%–33%), microvascular injury, venous thromboembolism (23%–27%), causing small vessel ischemia, and pulmonary embolism, which can result in acute right ventricular failure [33%–47%], and left ventricular dysfunction (10%–41%).2 Other cardiac complications of COVID-19 include arrhythmias (9%–17%), (eg, atrial and ventricular fibrillation), ventricular tachyarrhythmia, myocarditis, acute myocardial injury, and venous thromboembolism.

Preexisting CVD increases the risk for these complications. In a New York City area analysis of 5700 patients hospitalized with COVID-19, the most common comorbidities were hypertension (57%), obesity (42%), and diabetes (34%).3 In a meta-analysis of 6 studies on cardiometabolic comorbidities of COVID-19 in China (N=1527;), the most common cooccurring diseases were hypertension (17.1%), cardia-cerebrovascular disease (16.4%), and diabetes (9.7%).4 Cardiovascular diseases — hypertension, in particular — are also associated with the highest morbidity rate (10.5%) after the development of COVID-19.3 Other comorbidities, such as chronic pulmonary disease, diabetes, and cancer, increase mortality as well.

Regardless of the presence of preexisting conditions, severe inflammation of the heart muscle can cause life-threatening myocarditis.1 Case studies show that COVID-19 viral infection injures cardiomyocytes, leading to acute myocardial injury in 8% patients.4 Acute cardiac injury, as shown by elevated cTnI levels, occurs in 8% to 62% of patients hospitalized with COVID-19 and is associated with greater severity, the need for mechanical ventilation, and death.2 In Wuhan, China, 5 of the first 41 patients diagnosed with COVID-19 had elevated cTnI levels (>28 pg/mL).3

Hospitalized patients with COVID-19 frequently present with acute cardiac compromise, as demonstrated by acute heart failure (3%-33%), ventricular dysfunction (right, 33%-47%; left, 10%-41%; biventricular, 3%-15%), venous thromboembolism (23%-27%), cardiogenic shock (9%-17%), arrhythmias (9%-17%), myocardial ischemia or infarction (0.9%-11%), stress cardiomyopathy (2%-5.6%), and arterial thrombosis secondary to viral-mediated coagulopathy.2 In a recent report on 138 individuals hospitalized with COVID-19, arrhythmias were the second most common serious complication after acute respiratory distress syndrome, occurring in 16.7% of patients.3 Arrhythmias were present in 44% of patients who required treatment in the intensive care unit (ICU) and 7% of those who did not.3

Even in the absence of COVID-19-related lung damage and after the acute phase of illness has resolved, healthy adults can experience cardiac problems.1 Such extrapulmonary manifestations can have long-term consequences.2

Pathophysiology

The inflammatory response to infection interferes with cardiac biochemical pathways, diminishes the integrity of cardiac muscle, and initiates abnormal clotting cascades, leading to myocardial injury and dysfunction.

SARS-CoV-2 enters host cells via a viral spike protein and angiotensin-converting enzyme 2 (ACE2) receptors.1 ACE2 has broad expression in the heart, lungs, gastrointestinal system, and kidneys and is vital in the neurohumoral management of the cardiovascular system. It regulates the renin-angiotensin-aldosterone system, which converts angiotensin II, a vasoconstrictor and proinflammatory mediator that can damage the capillary endothelium, to angiotensin, a vasodilator. As the virus binds with and down-regulates ACE2 to infiltrate cardiac myocytes and alveolar epithelial cells, levels of angiotensin II increase, causing lung and heart injury.1

The inflammatory response disrupts the coagulation cascade, leading to coagulopathy, disseminated intravascular coagulation (DIC), and the formation of pulmonary and cardiovascular emboli.5 Initially, this is evidenced by elevated levels of D-dimer and fibrinogen/fibrin degradation products and abnormalities in coagulopathy parameters. In DIC, micro-clots form in the blood and can become lodged in the lungs, arteries, other blood vessels, or extremities, leading to complications. DIC also interferes with the body’s ability to dissolve the clots and depletes platelets and clotting factors, presenting challenges in patients with bleeding problems.

Diagnosis

Cardiac injury is measured by cTnl and NT-proBNP levels. The significant relationship between these biomarkers demonstrates the close association of inflammation and myocardial stress. Elevated cTnl is a predictive marker for COVID-19, regardless of the presence of pre-existing CVD. Myocardial injury also confirms the presence of more severe systemic inflammation, further demonstrated by increased levels of other biomarkers, such as leukocyte counts, procalcitonin, creatine kinase, and myoglobin.1

Cardiac injury is strongly associated with worse COVID-19 outcomes, as evidenced by a trend toward rising serial cTnl and NT-proBNP measurements in individuals with poor clinical outcomes vs those who recover. A recent review demonstrated a significant difference in in-hospital mortality rates for patients who had increased cTnI levels compared with those who did not (51.2% vs 4.5%, respectively).1 Another review showed elevated cTnl levels in few survivors of uncomplicated COVID-19 (1%-20%),  many severely ill patients (46%-100%), and nearly all ICU-level patients and non-survivors.2 Autopsies have revealed evidence of COVID-19-associated lymphocytic myocarditis (14%-40%), , small vessel thrombosis (19%), focal pericarditis (19%), endocardial thrombosis (14%), and right ventricular strain (19%).2

COVID-19 is responsible for progressive systemic inflammation leading to respiratory distress, sepsis, multiorgan failure, and death. Studies to date demonstrate a delay between symptom onset and myocardial damage; therefore, cardiac magnetic resonance imaging (MRI) is used to detect typical signals of acute myocardial injury. The gold standard diagnostic test, endomyocardial biopsy (EMB), identifies myocyte necrosis and mononuclear cell infiltrates with viral causes; myocarditis can also have other autoimmune-mediated causes. Biopsy studies in European patients with acute myocarditis, for example, found viral etiology in 37.8% to 77.4% of cases. Evidence describing myocardial injury in COVID-19 is scarce and based on individual case studies, highlighting the need for systematic assessment.3

Treatment Options

Treatments for COVID-19 have been developed, but the illness remains incurable.1 Preventive and therapeutic strategies are based on the sequence of pathogenic events and increasing understanding of the SARS-CoV-2 life cycle. The overarching goal is the prevention of COVID-19 via social distancing, mask wearing, and vaccination. Recent randomized trials for the mRNA vaccine have “reported ≈95% efficacy with very low incidence of serious adverse events demonstrated across race, ethnicity, and age groups.”2 However, long-term safety and durability, as well as efficiency in different populations, remain key research topics.

The next steps in treatment are inhibiting viral proliferation and impeding inflammatory responses in the body. This involves 3 subclasses of therapies: repurposed previously approved therapeutics, biologics, and small-molecule therapeutics. Prevention of virus–host cell receptor binding is a common approach to decreasing virus proliferation and involves targeting the COVID-19 spike protein or ACE2. This has been achieved using a lipopeptide to negate cell–cell fusion via the spike protein, to disrupt the spread of the virus into airway epithelial cells.2 Other entry inhibitors have been repurposed from existing therapeutics, such as clemastine, trimeprazine, amiodarone, bosutinib, flupenthixol, toremifene, and azelastine.2 In emergent situations, antiviral treatment with remdesivir, nirmatrelvir-ritonavir, or molnupiravir  may diminish the severity of COVID-19 complications, but these medications must be administered soon after symptom onset to be effective: 7 days for remdesivir and 5 days for nirmatrelvir-ritonavir and molnupiravir.6 In addition, steroids, hydroxychloroquine, i.v. immunoglobins, and active mechanical life support have been used to treat COVID-19.

Finally, organ-specific therapies are used to improve complications, such as a prothrombotic state, acute kidney injury, or stroke syndromes. Continuous heparin infusion along with additional anticoagulation therapy can inhibit microvascular injury and thrombosis, preventing small-vessel ischemia, pulmonary embolism, or stroke syndromes. Continuous renal replacement therapy filters blood and removes waste, allowing the kidneys to recover from acute injury. Extracorporeal membrane oxygenation provides cardiac and respiratory support when the lungs are unable to provide adequate gas exchange or perfusion. Even with these advanced processes and devices, outcomes are bleak for those requiring such strategies.

Education

The long-term cardiac consequences of COVID-19-associated myocardial injury include evidence of myocardial fibrosis or myocarditis in 9% to 78% of patients after acute COVID-19 infection.2 Although evidence-based recommendations for post-COVID-19 follow-up evaluations are lacking, patients with cardiac involvement should receive close monitoring every 1 to 3 months, including 12-lead and Doppler echocardiograms.3 Continued monitoring and cardiac plans, including medication regimens, scheduled follow-up visits, referrals, and upcoming procedures, should be in place for any patient with cardiac complications of COVID-19. Patients should receive education about this to support adherence.

Health care providers also require ongoing education on the appropriate management of COVID-19 and its complications. For example, some physicians prescribe the antibiotic azithromycin to decrease the severity of the virus. Unfortunately, azithromycin is known to cause QT prolongation, which can lead to torsades de pointe and serious arrhythmias and increase the risk for sudden death. The use of other medications, including chloroquine and hydroxychloroquine, has been suggested; however not enough clinical data exist to support this approach. If these agents are prescribed, recipients should be monitored for QT prolongation and other adverse effects.1

Limitations

Because of the lack of long-term research on COVID-19, current studies may be limited by inclusion bias or small cohorts. Information based on early population exposure and untested medications and methods has likely evolved. Other factors affecting study applicability include the finite nature of hospital resources, including staffing, and uneven access to testing kits and treatment, which initially limited the categories of people tested. In addition, asymptomatic individuals who have been inoculated may not seek testing or treatment. These realities contribute to the challenge of assessing the true occurrence, prevalence, and mortality of COVID-19.3

Conclusion

The mechanisms underlying COVID-19-related myocardial injury remain unclear, with questions around systemic vs local reactions and the initiation of ischemic vs inflammatory processes yet to be answered. However, clinical evidence indicates that COVID-19 negatively affects the cardiac system. Similarly, other acute viral infections are well documented to cause cardiac injury and acute myocarditis.3 Preexisting cardiac diseases such as hypertension and CVD increase the risk for COVID-19-related complications; and comorbidities such as obesity, pulmonary diseases, and diabetes increase the complexity of the illness and are associated with worse clinical outcomes.

Treatment involves prevention of the virus via vaccination and social distancing and medications to decrease the absorption and spread of COVID-19 throughout the body. Education on the effects of current medication therapies and monitoring of cardiac function after recovery are important for the long-term management of this illness.

Seva McKee, RN, BSN, practices in the cardiac catheterization laboratory and is working on her doctor of nursing practice degree at the University of North Florida in Jacksonville.

References

1. Soumya RS, Unni TG, Raghu KG. Impact of COVID-19 on the cardiovascular system: a review of available reports. Cardiovasc Drugs Ther. Published online September 14, 2020. doi: 10.1007/s10557-020-07073-y

2. Chung MK, Zidar DA, Bristow MR, et al. COVID-19 and cardiovascular disease: from bench to bedside. Circ Res. Published online April 16, 2021. doi: 10.1161/CIRCRESAHA.121.317997

3. Guzik TJ, Mohiddin SA, Dimarco A, et. al. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. Published online April 30, 2020. doi: 10.1093/cvr/cvaa106

4. Li B, Yang J, Zhao F, et al. Prevalence and impact of cardiovascular metabolic diseases on COVID-19 in China. Clin Res Cardiol. Published online March 11, 2020. doi:10.1007/s00392-020-01626-9

5. Srivastava S, Garg I, Bansal A, Kumar B. COVID-19 infection and thrombosis. Clin Chim Acta. Published online July 24, 2020. doi: 10.1016/j.cca.2020.07.046

6. Centers for Disease Control and Prevention. COVID-19 treatments and medications. Updated May 26, 2023. Accessed July 19, 2023. https://www.cdc.gov/coronavirus/2019-ncov/your-health/treatments-for-severe-illness.html

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Impact of Recent Climate Change Events on Health https://www.thecardiologyadvisor.com/home/topics/prevention/health-effects-of-climate-change/ Tue, 22 Aug 2023 16:03:36 +0000 https://www.thecardiologyadvisor.com/?p=109238 climate change

Rising global temperatures have been linked to an increase in severe weather, which can have a significant negative impact on public health.

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climate change

Over the years, we have experienced an increase in extreme weather-related events as a result of climate change. This global phenomenon affects health on many levels, making it of critical importance to physicians. Climate change refers to the change in temperature and weather patterns that have been occurring globally.1 According to the Intergovernmental Panel on Climate Change (IPCC) within the United Nations, the main drivers of climate change have been human activities, including burning fossil fuels such as gas, coal, and oil.2 Given the consistent change in global temperatures, extreme weather events will continue to occur until serious action is taken.

Climate Change Is a Public Health Crisis

At the 2022 annual meeting of the American Medical Association (AMA), climate change was declared a public health crisis. AMA Board Member Ilse R. Levin, DO, MPH, stated that “the scientific evidence is clear — our patients are already facing adverse health effects associated with climate change, from heat-related injuries, vector-borne diseases, and air pollution from wildfires to worsening seasonal allergies and storm-related illness and injuries. Taking action now won’t reverse all of the harm done, but it will help prevent further damage to our planet and our patients’ health and well-being.”3

Human health can be both directly and indirectly affected by climate change. The rising global temperatures are directly leading to an increase in severe weather, causing storms, floods, droughts, heat waves, and wildfires. These severe weather events can cause injury, starvation, heat stroke, and burns, for example. However, these weather events can also indirectly affect health by disrupting water quality and food availability, and causing air pollution, among other adverse effects.

Severe Weather Events Affect Patient Health

At present, more than 800 active wildfires are burning throughout Canada and more than 200 wildfires are burning in the United States, causing serious air pollution across both nations.4 The smoke from these wildfires is composed of toxic gases and fine particulate matter that can irreparably damage the lungs.5

These particulates have also been linked to cardiovascular disease, including stroke, heart attack, heart failure, and atrial fibrillation.6 Damage to the lungs and heart can also leave patients susceptible to infectious diseases,7 which continues to be a significant concern with the recent COVID-19 pandemic still looming.

In 2016, persistent rainfall from a summer storm resulted in disastrous flooding in the state of Louisiana, having dropped 7.1 trillion gallons of water on the state.8 This storm was later attributed to climate change. Authors of a study published in 2016 estimated that the rise in global warming since 1985 has increased rainfall by up to 20%.9 In addition to leaving nearly 150,000 homes damaged as a result of flooding,10 a major result of this and similar floods is the rise in mosquito populations.11

The increase in precipitation and rising temperatures due to climate change encourage mosquito survival and replication. Certain infectious diseases — including those spread by mosquitoes — are increasing as a result of climate change. These diseases — referred to as vector-borne diseases — are caused by living organisms that transmit infections to humans.12 An example of vectors are blood-sucking insects, including mosquitoes, ticks, and fleas, which transmit such diseases as malaria, Zika, Lyme disease, and plague, among many others. 

Malaria — a blood-borne disease caused by the Plasmodium parasite — can progress to severe illness and death within 24 hours if left untreated.13 Malaria outbreaks in the United States are rare, with the last outbreak occurring in 2003. As of July 2023, there have been 8 confirmed, locally acquired cases of malaria, with more likely to occur by the end of the year.14 The frequency of mosquito-borne diseases like malaria is predicted to increase in the years to come as a direct result of climate change.15

Mental Health Risks Due to Climate Change

In addition to physical health effects, climate change is also having direct effects on mental health. Changes in mental health as a result of climate change may be difficult to detect; however, addressing them is critical to ensuring overall well-being.

“Climate grief” is the experience many patients feel as a result of the looming effects of climate change. This phenomenon includes anxiety and fear about how the Earth will change over the coming years, as well as depression and stress over how to help reduce global warming, given the scope of the problem.16 

Climate change can also affect mental health directly, as in the case of anxiety, depression, or/or post-traumatic stress disorder (PTSD) experienced by in those who experience a natural disaster, including floods17 and wildfires.18

Authors of a 2021 study published in Behavioral Sciences reported that patients who lived in communities damaged by wildfires experienced increased rates of PTSD up to 10 years after the fires ceased.18

Authors of another study published in 2022 in Neurotoxicology found that those who live in communities affected by heavy smoke exposure are at increased risk of developing anxiety and depressive disorders. These diagnoses have been linked to living in areas with drastically elevated air pollution levels.19

How Can Physicians Be Prepared To Discuss Climate Change With Patients?

Climate change affects human health in widespread and complex ways. Physicians therefore need to be prepared to handle the health-related effects of climate change.

The first step toward helping patients is to become educated on how climate change can affect health. The health effects of climate change are expansive and multifaceted. Numerous online continuing medical education (CME) courses on the health effects of climate change are available for physicians.20-22 These courses provide background information on the types of events caused by climate change, as well as the health risks to patients and treatment options for physicians.

Additionally, the World Health Organization (WHO) provides information on climate change and how it affects human health, and this information can serve as a useful tool for physicians.23 The WHO also organizes a Global Conference on Health and Climate Change every 2 years; this symposium supports engagement, education, and policy change.24

It is important for physicians to be aware of the effects of climate change so that they can consider these environmental changes in diagnoses. For example, if a patient presents with unusual symptoms, physicians should consider the potential increase in vector-borne diseases that may otherwise be overlooked. In an episode of “AMA Moving Medicine,” Renee Salas, MD, MPH, MS, a climate and health expert and emergency physician at Massachusetts General Hospital, encourages physicians to approach medicine with a “climate lens.” This approach includes considering all the current and future climate changes and how they can affect health and the provision of health care.25 

In 2021, a physician treating a woman in the emergency department of a British Columbia hospital cited climate change as the underlying cause for her condition. The patient presented with dehydration and asthma, both of which occurred as a direct result of the heat wave and air pollution from wildfires caused by climate change.26 This unprecedented diagnosis serves as an example of how physicians need to consider the impact of climate change on health when evaluating patients.

By recognizing the effects of extreme weather caused by climate change, physicians can be better prepared to address symptoms and appropriately diagnose patients.

Physicians should also be aware of the mental health changes that can occur due to extreme weather events resulting from climate change, as well as the mental health changes that could be expected within their geographic region. Physicians should be prepared to talk to their patients about mental health and be aware of the resources available to them — including referring patients to mental health providers, when necessary.

Methods for Communicating Health Risks to Patients

The spread of misinformation within the United States has been on the rise in recent years.27,28 Physicians play an important role in countering misinformation as they have an ethical duty to provide patients with information regarding their health. By accurately educating patients on climate change and the health effects of climate change-related weather events, physicians can help overcome misinformation. However, some physicians may hesitate to discuss the effects of climate change with patients for a  number of reasons, including avoidance of political resentment, lack of time, and a lack of knowledge as to how to appropriately broach the subject.29 The following are several approaches that physicians can use to discuss this topic with patients.

1. Incorporate Brief Educational Messages

Physicians can broach the topic of climate change and health by using brief educational messages with their patients. This could include mentioning that air pollution is currently higher than usual due to wildfires in Canada and the United States, and that difficulty breathing and increased coughing may occur as a result. By simply mentioning the change that is occurring and how it can affect the patient, the physician can avoid controversy while still delivering an educational message.

2. Ask Permission to Discuss Controversial Topics

Physicians can ask permission of their patients prior to discussing controversial topics. By first asking permission, the physician respects the patient’s decisions and feelings. This strategy helps to build trust and mitigate resistance and arguments when discussing difficult or sensitive topics.

3. Emphasize the Consequences to the Patient

An effective method for discussing the effects of climate change is to emphasize the health consequences of the weather event. By starting a discussion about how a particular symptom is caused by climate change, physicians can appeal to the patient’s main interest. For example, if a patient presents with asthma and difficulty breathing, physicians can start the conversation by mentioning that the difficulty breathing is likely a result of high air pollution caused by climate change. By first beginning with the cause of their symptoms, physicians can set the scene and allow the conversation to evolve.

4. Acknowledge the Difficulties Associated With Changes

If air pollution is the current issue a physician is trying to convey, simply stating that a patient should not go outside can be met with resistance and dismissal. Physicians can make sure to include statements of understanding at the arduous task of avoiding pollution when being outside is a part of a patient’s daily lifestyle. Providing simple alternatives (eg, wearing a pollution-filtering mask when outside) and qualifying that they recognize how frustrating it is for the patient can help to convey the importance of the message while building trust through empathy.

5. Be Open to Different Approaches

It is important for physicians to be open to trying different approaches with their patients. Each patient has a unique set of experiences and world views. Strategies that work for one person might not be appropriate for another. While this can make effectively conveying health risks to patients difficult, it is essential that physicians alter their approach to fit each patient’s needs.

Be an Advocate for Change

Physicians should consider the impact they can make on climate change. Providing community assistance can mean volunteering at local shelters and food banks, giving talks on how people can prepare for weather-related health events (eg, air pollution or extreme heat), and advocating for changes to the environmental footprint. Physicians can work to reduce the energy bill at their practice or support programs that work to reduce the environmental footprint in the community. Physicians can also encourage eco-friendly transportation, such as the use of bike paths and public transportation, instead of commuting by car. Small changes can have a huge impact, and encouraging others to make changes is the first step toward a global effect on climate change.

“Climate Change is Widespread, Rapid, and Intensifying”

The IPCC reported that “climate change is widespread, rapid, and intensifying.”2 The effects we are seeing so far are only the beginning, and they will continue to worsen in years to come unless significant changes are implemented. The unfortunate reality is that we all need to be prepared to handle these changes, and it is the duty of physicians to be prepared to educate their patients on how to do this. Although this is a difficult task, becoming educated on the events, how they affect human health, how to effectively convey these messages, and how to help combat these changes are necessary for physicians to ensure positive outcomes among their patients.

Originally appeared on Infectious Disease Advisor.

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How Oral Estrogen Impacts Cardiovascular Risk After Menopause https://www.thecardiologyadvisor.com/general-cardiology/how-oral-estrogen-impacts-cardiovascular-risk-after-menopause/ Fri, 18 Aug 2023 14:40:00 +0000 https://www.thecardiologyadvisor.com/?p=109376

A review of the impact of oral estrogen therapy on risk for cardiovascular disease after menopause.

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Menopause often includes a range of unpleasant symptoms, like hot flashes, night sweats, sleep disturbances, and mood changes. Unfortunately, the change of life also brings a higher risk for heart disease. Estrogen therapy mitigates these effects, but not for every patient. In addition, some forms of estrogen come with more significant risks than others.

The Women’s Health Initiative (WHI) shed light on the pitfalls of aggressive menopause hormone therapy, particularly in older women with cardiovascular histories.1 As a result, today’s physicians have more considerations to weigh before selecting the best treatment options.

Quantifying the Risks

Health care providers can reduce potential upticks in cardiovascular events by choosing the route of estrogen administration carefully. Although preferred by many patients, oral estrogen is associated with a 19% higher risk for hypertension than vaginal creams or suppositories and a 14% higher hypertension risk than transdermal estrogen creams.2 Fortunately, these different forms of estrogen are equally effective, so providers can educate patients on choosing their safest option.1

Cerebral stroke rates do not increase for women receiving menopause hormone therapy who are aged younger than 60 years or within 10 years of starting menopause.3 However, menopause hormone therapy does raise the risk for ischemic stroke, but not hemorrhagic stroke, in women aged over 60 years. As a result, experts advise transdermal administration and lower-dose menopause hormone therapy to mitigate this risk while still supplying patients with the benefits of estrogen therapy.

After age 60 years, the risk for venous thromboembolism increases for all women. Additional risk factors include BMI, history of thromboembolism, and genetic factors, particularly the factor V Leiden mutation.3 Menopause hormone therapy almost doubles the risk for venous thromboembolism in women aged 60 years and older, particularly during the first year of treatment. By increasing thrombin activity and downregulating plasmin activity, oral estrogen increases risk for thromboembolism for at-risk groups. Adding progesterone to estrogen therapy increases this risk more than estrogen alone.

Aside from assessing the indications and contraindications, prescribers should evaluate alcohol and smoking history, along with significant family history…

There’s a marked discrepancy between the risk for coronary artery disease (CAD) and menopause hormone therapy for women of different age groups. While some studies suggest a preventative effect in those under the age of 60 (28% reduction), studies that included older patients showed no primary prevention and a 50% to 80% higher risk for CAD during the first year of treatment, which declined as treatment continued. Researchers concluded that menopause hormone therapy initiated within 10 years of menopause is associated with a 48% reduction in cardiovascular mortality.3 However, the reasons for initiating menopause hormone therapy should not be solely for CAD prevention.3

Studies on estrogen-only therapy show that conjugated equine estrogen promotes hypertension more than estradiol. In addition, longer durations and higher doses of estrogen increase hypertension risk.4 One of the most common complaints of menopause is vasomotor symptoms, including hot flashes. Low-dose menopause hormone therapy is similarly effective for this symptom as standard doses.3 An individualized and conservative approach to treatment during and after menopause should guide decisions about the proper duration, dosage, and administration of menopause hormone therapy. It all starts with appropriate screening.

Screening for the Right Menopause Treatments

When initiated during the first 10 years of menopause, menopause hormone therapy helps prevent diabetes, metabolic syndrome, and cardiovascular disease. It can also lower the risk for colon cancer and, potentially, Alzheimer’s.1 However, certain patients may be risking cardiovascular events by using menopause hormone therapy. Therefore, some absolute contraindications to menopause hormone therapy related to the cardiovascular system include congenital coagulation disorders, acute myocardial infarction, acute stroke, and unstable hypertension.1

Physicians must conduct a thorough examination before prescribing menopause hormone therapy. Aside from assessing the indications and contraindications, prescribers should evaluate alcohol and smoking history, along with significant family history (particularly for cardiovascular disease and venous thromboembolism).3 Lipid tests, blood pressure, height and weight, thyroid function tests, and blood glucose screenings can also help identify cardiovascular risk factors. Additionally, customized tests may be necessary for individual risk factors.

Follow-ups every 1 to 2 years can help catch any concerning changes and allow for adjustments. Instructing patients to monitor their health between appointments (such as by taking periodic blood pressure readings at home) can be a proactive and collaborative approach to managing risk.

According to a 2022 article in Global Health Journal, “To reduce the risk of venous thromboembolism and stroke, transdermal estradiol (gels, patches,) should be used, in free combination with progesterone or dydrogesterone as ‘golden standard’ in patients with increased risk.”1 Because the liver doesn’t process transdermal estrogen, it is more suitable for women with diabetes, high blood pressure, and other cardiovascular risk factors.3 Ultimately, hormone therapy should be prescribed with adjunct therapies and lifestyle changes based on the severity and frequency of menopause symptoms to improve quality of life and minimize potential harm.3

Alternative Therapies to Consider

The ideal candidate for menopause hormone therapy is aged 60 years or younger, are 10 years or less from the onset of menopause, and otherwise healthy with no history of cardiovascular disease.5 This period is frequently called the “window of opportunity” for menopause hormone therapy. However, as any practicing physician knows, ideal patients are rare. Postmenopausal women need solutions to manage their symptoms, even if their age or medical history makes menopause hormone therapy too risky. As women live longer and obesity rates continue rising, heart health becomes an even more critical consideration for postmenopausal patients.6

Aside from recommending a non-oral route for estrogen administration, physicians can mitigate cardiovascular risks by exploring different options, including non-hormone-derived drugs and herbal supplements.1 For instance, vasomotor menopause symptoms may improve with off-label use of citalopram, clonidine, desvenlafaxine, escitalopram, gabapentin, opipramol, paroxetine, and venlafaxine.

Tibolone is a combined steroid and derivative of 19-nortestosterone.3 After transformation in the liver and stomach, tibolone has characteristics of androgen, progesterone, and an estrogen metabolite. Tibolone is a selective tissue estrogen activity regulator because it reduces estrogen activity in the breast tissue, making it a safer option for those with a breast cancer risk or history. It helps with menopausal symptoms, including headache, libido, insomnia, osteopenia, hot flashes, urinary symptoms, and vaginal dryness. Tibolone also lowers total cholesterol and does not appear to increase the risk for venous thromboembolism or CAD in at-risk patients aged older than 60 years. However, older patients may still have a higher stroke risk.

The herbal product black cohosh (Cimicifuga racemosa) also helps through the activation of the serotonin transmitter system.1 But health care professionals should be aware of the potential contamination of some preparations, which may warrant liver function monitoring with long-term use. Finally, other forms of Chinese Traditional Medicine, including acupuncture, may be effective menopause management tools in patients contraindicated for menopause hormone therapy.

Encouraging Successful Lifestyle Changes

It is no secret that regular exercise is essential, especially with aging. Encouraging patients to engage in consistent physical activity may improve both their postmenopausal symptoms and cardiovascular risk.6 Studies show that women who exercise regularly don’t experience the same age-related resting metabolic rate decline as their sedentary counterparts.6 In addition, weight loss interventions lower the incidence of hot flashes.6

Social support and accountability can make all the difference in a patient’s success with lifestyle interventions. Thinking beyond traditional one-to-one patient-provider counseling sessions offers opportunities for better outcomes, especially in patients for whom menopause hormone therapy is contraindicated. Therefore, group nutrition classes, walking programs, or stress management clinics are some additional ways beyond menopause hormone therapy for doctors to treat patients and promote heart health and well-being during menopause.

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Medical Specialties: Finding Your Niche in Medicine https://www.thecardiologyadvisor.com/home/topics/practice-management/medical-specialties-finding-your-niche-in-medicine/ Thu, 17 Aug 2023 16:39:17 +0000 https://www.thecardiologyadvisor.com/?p=109148 medical specialty

Because it allows physicians to create meaning in their medical practice, finding one’s niche may protect against burnout and other negative effects of work-related stress.

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medical specialty

As it relates to a person’s occupation, a “niche” is defined as a place, activity, status, or employment for which someone is best suited.1 Finding one’s niche in medicine can be akin to choosing a specialty or identifying a space within a chosen specialty where a physician finds purpose and pride. 

Given the nature of their work, physicians are more susceptible to high stress levels and burnout compared with workers in other fields.2 Because it allows physicians to create meaning in their medical practice, finding one’s niche may protect against burnout and other negative effects of work-related stress.3 This article will provide physicians with a framework for identifying and acting on their niche.

How Do You Identify Your Niche? 

The first step in identifying your niche in medicine is to make an honest assessment of your passions and interests within the field. The American Academy of Family Physicians (AAFP) shares questions to consider when choosing a medical specialty, which is an essential step toward finding your niche.4 These and other relevant considerations are reviewed in the Table.

Table. Questions to Answer When Choosing a Medical Specialty 

CategoryQuestions
Goals, Skills, and ValuesWhat were your goals when you chose to become a physician? How have these goals changed throughout medical school, if at all? Which of your skills make you feel most prideful, and are they best suited for a particular specialty within medicine? Do you envision incorporating research into your practice? Is advocacy work important to you? Are you passionate about alternative or complementary medicine?
Physician-Patient RelationshipWhat do you value most about the physician role? What types of physician-patient interactions are most rewarding to you? Do you feel uncomfortable in specific clinical situations? 
Daily ResponsibilitiesDo you have a preference for clinical visits vs surgical procedures or a combination of the two? What type of work-life balance works for you? Do you envision a slow or fast-paced lifestyle? 
IncomeWhat are your income goals? Do you have student loans to pay? If yes, do you have a payment timeline?
LocationWhere do you see yourself practicing medicine? Do you prefer working in a community, academic, or hospital setting? What are the job opportunities in your preferred location in your desired specialty like? How saturated is the job market?
ResidencyWhat duration of training is required for your desired specialty? What does a particular residency program train you to do? What are the differences between different programs within the same specialty? Is there potential for further training after residency? Is that okay with you?
From AAFP.4  

Answering these questions can help with choosing a specialty that aligns with your goals and values. Identifying physician mentors in your desired specialty is also essential. Mentors have a wealth of experience to share, including strategies for applying to residency programs, managing work-related stress, and setting personal and professional priorities.5 

Because choosing a specialty is only the start of the process to define your niche as a physician, mentors can also support you beyond this decision. Within specialties, there are also subspecialties to consider for people who want to focus their practice on a specific aspect of medical care.

After exploring your desired specialty or subspecialty, engagement with your community can help further explore your niche in the medical field. Your patients make up the majority of the community where you train or work. Understanding their priorities and concerns from their perspective can identify meaningful ways to integrate community health promotion into your practice.

Since exposure to new facets of the healthcare system and your community may spark unexpected interests, discovering and refining your niche continues as you complete your training and move into independent practice. Personal priorities may also change as you progress through life. The process of identifying a medical niche is highly individual, but having a framework like the one outlined above can help guide the process.   

How Do You Act On It Once You’ve Identified Your Niche?

Putting your medical niche into practice typically begins with applying for residency. The residency application process can be grueling, but it presents several opportunities to ensure your choice of residency is the best fit for you.

Talking with people you meet while applying for residency — including current residents and program faculty — can offer insight into the environment and culture of an institution and community.7 Asking how they chose their current program and how they feel about the program will allow you to determine if their motivations and values align with yours.

When comparing different programs within your chosen specialty, it is important to compare them based on factors that directly affect the daily experience of residency training, as opposed to name recognition or prestige.7  These factors include location, curriculum details, interpersonal experiences with current residents and faculty, institutional values, and investment in community health. You should also consider these factors when applying for a fellowship once your residency has been completed. 

Residency, potentially followed by a fellowship, is your first practical opportunity to self-assess the fit between you and your chosen specialty/residency program. Because of the extreme demands of residency and fellowship, physicians may experience burnout and question their career choices during this time.8 Signs of burnout include9:

  • Feeling ineffective or meaningless at work;
  • Low motivation;
  • Lack of personal accomplishment;
  • Self-doubt; 
  • Emotional exhaustion; 
  • Depersonalization; and 
  • Feeling helpless.

If you experience signs of burnout, addressing them should be a top priority. Interventions to prevent and reduce burnout often require institutional action; however, there are a number that are within your control, including9

  • Engaging in effective self-care practices;
  • Going to therapy to process trauma and learn effective mindfulness/coping strategies;
  • Seeking advice and support from trusted friends, family, or mentors; and 
  • Defining and acting on your passions.

During times of stress and burnout, reminding yourself why you chose your particular medical niche can reconnect you to joy and motivation.9 However, difficult experiences times may also lead to changed perspectives and goals.

Adapting to Change

During your career, you may discover new passions or technologies that change the way you practice. You may even discover that your clinical focus or clinical work, in general, is no longer fulfilling for personal or professional reasons. Adaptability is key to navigating these changes and fulfilling your niche. 

Although making big career changes in medicine can feel impossible, many physicians have moved through them successfully, and their experiences can provide guidance and inspiration. Bonnie Darves interviewed several physicians who for various reasons decided to pursue nonclinical work, either alone or in combination with clinical work, and published her findings in The New England Journal of Medicine (NEJM) Career Center.10

Heather Fork practiced dermatology for 10 years before deciding she wanted to help people in a different way through career coaching.10 She now runs The Doctor’s Crossing, a company dedicated to supporting physicians who are looking for a career change. 

In her interview with Ms Darves, she encourages physicians to explore their interests within and outside of medicine if they are feeling unfulfilled.10 Taking inventory of your current circumstances and interests can help identify areas for improvement in your current role or illuminate an entirely new career path.

Yasmine Ali, a cardiologist, applied these principles to her career.10 When she was feeling unfulfilled after 10 years of cardiology practice, she looked to her interests for inspiration and decided to combine writing and preventive medicine in a new, gratifying career path. Now, Dr Ali is the president of LastSky Writing, LLC, a company that provides medical consulting and writing services, and runs a preventive medicine practice. 

Hodon Mohamed, an obstetrician-gynecologist, has also combined clinical and nonclinical work to achieve a career that works for her.10 Along with working 2 clinical shifts per week, she also works as a medical director, in utilization management, and as a career coach. She finds coaching physicians particularly rewarding, noting that physicians often do not discuss their issues, and she enjoys helping them discover their passions. 

Importantly, career changes such as these can take time to develop. Feliciano Yu is a pediatrician whose career has evolved over the past 2 decades from pediatric clinical practice to a full-time administrative role focused on informatics, care quality, and outcomes research.10 This evolution began as an interest in computers that led to Dr Yu obtaining degrees in both public health and health informatics. In his current role, Dr Yu feels like he is still caring for patients, just in a new way. 

These are just a few examples of physicians who have successfully changed their careers. Their stories emphasize the importance of frequent and honest self-assessment of your job fulfillment and that the right niche in medicine looks different for every physician. 

Be True To Yourself

Finding a niche in medicine that aligns with your priorities and values is essential to long-term job satisfaction. In a field in which burnout may be becoming more commonplace, pursuing a medical career that feels purposeful and promotes your wellness is a radical and important act. You are not alone in this pursuit; look to friends, family, and mentors for support, while also remaining true to yourself and your goals. 

Originally appeared on Dermatology Advisor.

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With Twitter (Now X) in Flux, Is #MedTwitter Under Threat? https://www.thecardiologyadvisor.com/general-medicine/with-twitter-now-x-in-flux-is-medtwitter-under-threat/ Tue, 15 Aug 2023 13:05:00 +0000 https://www.thecardiologyadvisor.com/?p=109151 TheTwitter "X" app's new logo is displayed on the screen of a smartphone.

Oncology professionals share what #MedTwitter means to them and where they might go if Twitter (now X) becomes obsolete.

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TheTwitter "X" app's new logo is displayed on the screen of a smartphone.

Since Elon Musk bought Twitter in October 2022, the site has seen a lot of changes, including a recent rebranding to “X.”1

Many of the changes — such as charging for verification, limiting the number of tweets users can read, and preventing them from retweeting certain posts — have prompted some users to migrate to other social media platforms.1-5

There’s been widespread speculation that users will continue to leave and Twitter will go the way of sites like MySpace and Vine. This would put an end to #MedTwitter — a space where medical research and insights are shared by medical professionals, researchers, patients, and organizations.6

Losing this community could greatly impact all of these parties, according to users.

“Twitter is such an extensive network we didn’t know we needed. Now, we can’t live without it,” said Tanya Dorff, MD, section chief of the genitourinary disease program at City of Hope in Duarte, California.

Exchanging Information, Ideas

For now, there is still a critical mass of medical professionals, researchers, and patients on Twitter who can exchange information and ideas in a manner that’s hard to do elsewhere with exactly the same transparency or sense of community.7-10

“I like that Twitter raises patient voices and perspectives into my awareness in a way I don’t necessarily hear in the clinic,” said Stephanie Graff, MD, associate professor of medicine at Warren Alpert Medical School of Brown University and director of breast oncology at Lifespan Cancer Institute in Providence, Rhode Island.

Dr Graff added that she values Twitter “for sharing and consuming recent work. It isn’t unusual that I see papers, press releases, or news first on Twitter.”

Dr Dorff said she primarily uses Twitter when attending medical conferences “as a way to highlight important changes based on new data. If I miss a conference, I check in on Twitter about what was presented and how people reacted to it.”

Twitter has become a forum for discussions and debates on research in general but particularly on studies presented at medical conferences.7,9 This allows interested parties to weigh in on discussions that can have practical applications across specialties.

A recent example is exchanges about data from 2 trials on rectal cancer — PRODIGE 23 and PROSPECT — that were presented at ASCO 2023, said Mark Lewis, MD, a medical oncologist and director of gastrointestinal oncology at Intermountain Health in Murray, Utah.11,12

The trial results “arguably changed our therapeutic paradigm, and there was a vigorous discussion necessarily involving the relevant specialties — radiation, surgical, and medical oncology — on how best to sequence treatment for the best possible outcomes,” Dr Lewis said. “In its best incarnation, Twitter serves as a forum for precisely these exchanges when new trials require us to be fluid in our thinking and in adapting our practice along with our colleagues.”

Medical professionals and patients alike can benefit from the scientific information shared on Twitter.7-10

“I use hashtags to look for information, and patients can seek it out from big meetings like ASCO or the American Society of Hematology,” said Michael Thompson, MD, PhD, vice president of clinical partnerships at Tempus Labs, Inc.

It creates opportunity for collaboration and helps you to become part of the oncology community, to feel more in touch

“I create top picks for myeloma abstracts from meetings at #myeloma. I look at what others have posted and can quickly see what different world experts have picked. This helps me provide feedback for patients and advocates who look forward to my review every year.”

Dr Thompson noted that, for a rare cancer like multiple myeloma, patients can find basic information in 5 minutes and next-level information in a few hours on Twitter.

Expanding Networks, Career Advancement

Twitter can also help expand networks. “It creates opportunity for collaboration and helps you to become part of the oncology community, to feel more in touch,” Dr Dorff said. “It’s helpful to engage with colleagues in a quick way. I support colleagues’ tweets about an article I find valuable by retweeting to support their efforts.”

Younger researchers and medical professionals may also use Twitter to have their voices heard.

“Twitter gives me a platform to demonstrate, as an early career scientist, the vision for my research and why I do that research in the niche field of Pacific Island health,” said Kekoa Taparra, MD, PhD, a fourth-year resident in radiation oncology at Stanford Medicine in California.

Dr Taparra has received opportunities through Twitter to present grand rounds at MD Anderson Cancer Center in Houston and to talk in front of the US Food and Drug Administration and the pharmaceutical industry.

The post With Twitter (Now X) in Flux, Is #MedTwitter Under Threat? appeared first on The Cardiology Advisor.

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Navigating Parental Education in Pediatric Cardiology https://www.thecardiologyadvisor.com/home/topics/pediatric-cardiology/navigating-parental-education-in-pediatric-cardiology/ Fri, 11 Aug 2023 13:40:00 +0000 https://www.thecardiologyadvisor.com/?p=109138

An expert roundtable regarding challenges related to providing health care education to parents of pediatric cardiology patients.

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Each year in the United States (US), roughly 1% of infants are born with congenital heart disease (CHD).1 Additionally, research from the Centers for Disease Control and Prevention showed that nearly 1 million US children aged 0 to 17 years (1.3% of the pediatric population) had a current heart condition in 2016, based on responses to parent surveys. Compared with healthy children, those with a heart condition had 1 or more special health care needs, such as prescription medications, speech or occupational therapy, or mental or behavioral health counseling.2

Providing optimal medical care for these patients requires close collaboration with their parents, and having discussions regarding the diagnosis, prognosis, and treatment of a child with cardiovascular disease can be challenging for clinicians. Among the potential communication barriers that may affect these conversations, findings have demonstrated that approximately one-third of US adults have low health literacy, and more than one-third of pediatric medical residents and faculty have received no training in health literacy.3

Despite the important influence of parental knowledge on the quality of care and quality of life of children with CHD, researchers have observed significant gaps in parental knowledge about CHD in this population.4 One study found that only 16.4% of parents of a child with CHD received education about how to care for the child at home following discharge from the hospital.5

For recommendations regarding effective strategies in educating parents of children with complex cardiovascular diagnoses such as CHD, we interviewed the following experts:

  • Madeleine Townsend, MD, pediatric cardiologist at Cleveland Clinic Children’s Hospital in Cleveland, Ohio
  • David Brown, MD, cardiologist at Boston Children’s Hospital and professor of medicine at Harvard Medical School in Boston, Massachusetts
  • Daphne T. Hsu, MD, chief of cardiology at Children’s Hospital at Montefiore and professor of pediatric cardiology at Albert Einstein College of Medicine in Bronx, New York
  • Amanda J. Shillingford, MD, FACC, physician at the Cardiac Center at Children’s Hospital of Philadelphia and medical director of the Fetal Heart Program Annex at CHOP’s Bryn Mawr Specialty Care Center in Pennsylvania

When speaking with the family of children with complex diagnoses, how do you taper your information dissemination as it relates to diagnosis, treatment, and prognosis without overwhelming them? Is it preferable to share all the information at once or incrementally over multiple visits?

Dr Townsend: Explaining new and life-changing diagnoses to families is inevitably a very challenging conversation to open. The complexity of explaining new terminology, various treatment options, and particularly the range of outcomes to shocked parents who are grieving their “healthy” child can be very overwhelming. Medical providers understandably feel they are trying to convey too much information at once, while also battling the necessity of ensuring families are able to make informed decisions on next steps in care.

Open and clear communication in these settings often involves opening the conversation with information on the diagnosis and the next steps that need to be considered, with a plan to allow this information to settle and then come back for another meeting to evaluate parental understanding and continue to expand on the conversation with additional details. The timeline of follow-up meetings is often dependent on the need to make quick decisions on next steps in care—for example, with prenatal diagnoses where termination may be an option.

Providers can help families in these situations by acknowledging emotions, clearly communicating specific information with the help of nonverbal teaching tools such as diagrams or models, providing well-vetted online resources such as websites and parental support group information for further education at home, and being aware of how the provider is presenting the information.6

Parental perception of provider empathy and compassion has been found to be inversely linked with the likelihood of seeking a second opinion.7 Allowing adequate time for detailed conversation and remembering the importance of nonverbal communication, such as body posture and position, can ensure that families feel heard and valued.

Using a multidisciplinary team approach can also be helpful, with the incorporation of additional supports such as palliative care or psychology, as these providers may have different ways of communicating with families that can help clarify the information, as well as expose any misunderstandings that families do not bring to the pediatric cardiologist’s attention.

The “teach back” technique can be helpful, with open questions to families such as “What have you heard me say?” and “Tell me how you will explain this to your other family members.” Making sure families know there will be additional opportunities to speak again and reminding them to write down questions before the next meeting can also help to ease parental anxiety about the need to understand everything immediately.

Dr Brown: I find the approach that works best for families of children with complex diagnoses is to consider the first discussion the beginning of a conversation that will continue and evolve over time. That first conversation is important, as you are creating a framework upon which you and the family will build understanding over time.

It is easy to overload families with too much information and detail in that first meeting, particularly for those hearing about complex diagnoses for the first time—sometimes all they remember from that conversation is that their child has a serious problem. I usually try to have simple goals for that first conversation—what is the diagnosis, what are the treatments that might be required, and what is the expected longer-term outcome and quality of life for their child.

Just like any conversation, families will give cues—both verbal and nonverbal—about how they are processing the discussion, and those cues can help you determine if you are giving them too much information, not enough, or about right. Leaving time and space for comments and questions is really important, and if they are not asking clarifying questions, one can ask them questions to probe understanding or find out which questions or concerns they might have that you haven’t addressed.

With the next conversation, you can fill out the framework that began with the first conversation. I will often start by asking what they understand about their child’s diagnosis, as this can help you understand where to pick up the conversation. I usually plan on discussing these same things again, regardless—diagnosis, treatments, outcomes—with perhaps more detail about the treatment options and anticipated outcomes, again taking cues from the family about where they are in their understanding of these issues.

Dr Hsu: I view the first conversation as a way to set the stage for the ongoing conversations that will take place while I am caring for the child. I start by giving a “big picture” of the problem, focusing on what the clinical issues are that are impacting the child and what treatments are available to help improve them. Discussion of treatments includes outlining the risks and benefits, and most importantly, which particular treatment should make the child better and why. The idea of getting better or worse is the essence of prognosis, so that is a natural part of the conversation.

One of the rewards of our field is that the cardiac team establishes a relationship with a patient and family that may be lifelong, so it is important to let the patient and family know that the first conversation is one of many and at each time they should be comfortable asking questions and getting answers. 

Dr Shillingford: This can definitely be a challenge, as there are multiple factors that should be considered when counseling parents about a new diagnosis of complex CHD. As a fetal and outpatient pediatric cardiologist, I deliver information to parents under variable circumstances. Parents present with a broad range of educational and mental health foundations, religious beliefs, and psychosocial supports, all of which impact how they will receive and process the information. 

There is emerging research revealing high rates of mental health disturbances – including post-traumatic stress, anxiety, and depression—in parents of children with complex CHD, which has lasting effects on coping and parenting.8 However, there are also multiple studies engaging parent feedback specifically related to what is helpful and what is not helpful during counseling. What I have learned from these studies is that parents want a balanced delivery—they request honesty and realism, but they also want to have hope for their child’s future.

The complexity of explaining new terminology, various treatment options, and particularly the range of outcomes to shocked parents who are grieving their ‘healthy’ child can be very overwhelming.

Fetal cardiology and prenatal diagnosis of CHD are my particular areas of interest.   Depending on the timing of diagnosis during the pregnancy, parents may be considering their options regarding continuation of the pregnancy and delivery location, which may require geographical relocation. For me personally, I adjust my counseling content based on the severity of the disease, what I have learned about the parents from questionnaires or records available in the EMR and real time feedback based on my interaction with them.

I begin the session by asking the family what they have been told about the fetal cardiology appointment or the need for a fetal echo. I do believe that it is important to be honest and provide realistic expectations to families, especially if parents are making decisions about pregnancy continuation. If the pregnancy is beyond termination limits, and definitely if the parent is significantly emotionally distressed, I will abbreviate the counseling sessions and utilize multiple visits.

Sometimes, parents will be upfront and state, “I can’t hear all of this now, just tell me if there is a treatment,” or, “I have researched this diagnosis and here is the information I know. Please tell me CHOP’s experience, services, and outcomes.”  For the CHOP Fetal Heart Program, we have incredible psychosocial supports for families, with nursing, social work, and psychology as part of the “counseling team.”

A few principles I use for counseling the more complex forms of CHD when I walk in the room:

  • Acknowledge that a heart defect was identified and that a treatment strategy is available.
  • Describe “normal” cardiac physiology – many people really have no idea about CHD, and it is difficult to explain why certain interventions are needed without understanding why the child’s heart is different.
  • Discuss a plan for pregnancy monitoring – in most CHD cases, the baby can still have a “normal” delivery, and most newborns appear quite normal early after birth.
  • Review the general perinatal plan for the postnatal assessment, monitoring, and planning, and reassure families that in most cases, they will be able to hold their baby after birth and before surgery, will likely be able to feed a bit, and that breastfeeding will be an option.
  • Discuss the general surgical plan and postoperative care, as well as the need for life long follow up.
  • I tend not to get into details regarding the specific [numerical] risk of morbidity and mortality for each procedure, but rather emphasize that pediatric cardiac centers are developed so that the specialized providers are all familiar with their child’s cardiac condition and will do everything possible to reduce these risks.
  • I include a discussion about potential risks balanced with the reality that the vast majority of children who have undergone newborn heart surgery can progress through “normal” childhood and adult activities.
  • I invite questions throughout the counseling session, and I emphasize the fact that they have received a lot of information that may be very difficult to process and that they will have the opportunity to hear the information again.
  • I always provide contact information for me or my team to be available for follow-up counseling after the appointment.
  • I ask parents—sometimes only mothers—about their supports. Some families will look to peer supports or internet resources. I do try to guide them to educational content on reputable websites, and I will provide information for parent CHD groups which some parents find helpful—although with the caveat that it is important to understand that not every internet CHD story can be extrapolated to their case.
  • It is also important to alleviate parental guilt by simply stating, “We do not know what causes CHD. This is not your fault. We are here to support you through this process.”

In the outpatient world, I still follow many of the principles above. In this situation, the children may be older or the severity of CHD may be less. In this scenario, parents may not be expecting to find out their child has a cardiac problem requiring surgery or medication. I will still balance having realistic expectations. However, I may spread out the discussions over several visits. I often try to call families a few days after such an office visit in order to check in and give them an opportunity to ask questions. When applicable, I contact the primary physician to update them on a new diagnosis.

What resources do you use in educating families with low health literacy, and how do you gauge their level of comfort or understanding? What are some resources or strategies you would recommend for your peers who work in settings with high rates of low health literacy?

Dr Townsend: Lower health literacy has been linked to decreased understanding by families of their child’s medical diagnosis.3 Identifying families with lower health literacy is an important first step when meeting new families, as extra care should be taken when communicating information in order to improve family understanding, which can then lead to increased adherence and improved outcomes.9

Utilizing diagrams and models and other nonwritten communication tools can be a useful strategy to improve understanding of a diagnosis and proposed treatment options. It is also important to ensure information is written at the appropriate literacy level and in the family’s preferred language, which can mean reaching out nationally to other pediatric cardiology providers who may have access to written information in different languages or utilizing a translator service within the hospital system or online.

The same techniques discussed above are helpful to gauge understanding, especially the teach back system, as well as ensuring that follow-up meetings are scheduled to evaluate initial understanding and address any questions or concerns that arise.

Dr Brown: When it comes to complex medical diagnoses, many families will find it challenging to understand, especially the first time they hear about them. For those with low health literacy, images or physical models are often very helpful when used appropriately. For example, with a particular heart defect, you can use a graphic of a normal heart to point out normal structures, and then modify the drawing to show where the problem is with their child’s heart.

Three-dimensional heart models are also very helpful in that families can hold them and turn them around in space to get a better understanding of the problem. There are also excellent online resources available now, including 3-D reconstructions from imaging studies—for example, from MRI or CT—of children with similar diagnoses that can help families arrive at a better understanding of the problem.

Dr Hsu: I assume that virtually all patients and families have a low health literacy when it comes to heart diseases in children, as they are extremely rare and families are unlikely to have had prior personal experiences with the issues that arise in pediatric heart diseases. For imparting knowledge about the child’s specific heart problem, it is difficult to refer patients to web- or paper-based materials, as they are often too general to be applicable and can confuse or cause increased anxiety, so I prefer that there is a give and take between the cardiac team and the family about specific decisions.

That said, the impact of a serious illness on the child and family cannot be underestimated, and it is important to talk about ways families cope with this type of stress. I let patients and families know that there are many excellent organizations where they can hear other families’ experiences and get general information about diseases and treatment, and I make sure they always feel free to bring that knowledge back to the team so that any questions can be answered. In the field of heart transplant, matching a patient and family with a family that has been through the process can be invaluable because it makes them feel less alone.


The importance of having a good understanding of the patient and family’s cultures, support system, social supports, and challenges cannot be overstated. The impact of a serious illness on all aspects of a family’s life has the potential to impact the child’s disease, and identifying how best to help a family and patient be the best partners in a patient’s care is essential. For patients who are not native English speakers, the use of translators is crucial to making sure that the finer details of care are addressed and that patients can ask more complex questions comfortably. 

Asking the patient to tell you in their own words what they understood about the problem and treatments that were discussed at the visit is a great way to gauge their understanding of what is planned and why, and this can let the team know if there are gaps that can be addressed.

Dr Shillingford: I provide some sort of written documentation of the diagnosis, which includes a picture. Although not a perfect strategy, I begin any counseling discussion by asking parents if they have a medical background and what they understand about the heart already—this is more relevant for fetal CHD, which is often referred to us from another provider who diagnosed or suspects a cardiac defect. I write down the medical diagnosis as well as the more basic description—for example, “Ventricular Septal Defect = ‘Hole’ between the bottom chambers of the heart.”

For CHD specifically, there are numerous online resources which can be accessed. I use the American Heart Association and the CDC descriptions of CHD, and there are also Spanish versions of these resources. Children’s Heart Foundation is an advocacy and fundraising group with excellent CHD resources, including a book called It’s My Heart, which covers many CHD topics in plain language since it was vetted by parents. Mended Little Hearts is another organization geared towards parental support and advocacy, and they also have online resources.

How can a physician best gauge a child’s potential readiness to be involved in discussions regarding management of their illness?

Dr Townsend: With the growing population of children with CHD surviving and thriving into adulthood, there is an increasing need to support successful transition of care from the pediatric to adult setting. Multiple tools exist to gauge an adolescent patient’s readiness for transition, including the Transition Readiness Assessment Questionnaire, the MyHeart scale, the General Self-Efficacy scale, and the Children’s Uncertainty in Illness Scale.10

Starting transition discussions early, at the onset of adolescence, with age-appropriate education on the patient’s diagnosis and long-term care needs, as well as helping guide families toward giving increasing autonomy to their children, can help to provide gradual readiness for transition of care as well as increased involvement in medical decision making.

Dr Brown: Some basics are helpful and important in assessing readiness to be involved, such as the age of the child and whether there are any barriers to communication such as spoken language or developmental delay. Families can often help you understand if a child has certain fears or concerns that should be approached carefully. The older the child, the more agency and voice they should have in these discussions.

Just as adults do in these conversations, children will give verbal and nonverbal cues about what they are understanding and whether they would like to be involved in illness management discussions. An invitation to be part of the conversation is often the best approach, and can be as simple as asking, “What questions do you have about this?” or “What do you think about what we have been talking about?”

Dr Hsu: Speaking directly to the child during the visit is an important way to make them feel included. As soon as the child can answer questions about level of activity, play, and interests at school, this is a great way to establish a relationship with the child. Letting the child ask questions is a great way to gauge understanding and address the important issues. I also try to speak directly to the child at the end of the visit to offer reassurance to the child about their heart disease, as children may not understand all the nuances of the conversations that take place during the visit. 

Dr Shillingford: This is also a challenge because parents have different ways that they involve their child in decision making. Generally, pre-adolescence is the time when I start to speak more directly to the child about the findings from their visit and make sure to allow the child time to ask questions. I ask them if they are interested in looking at an echocardiogram picture for example, but if the child does not ask many questions and the parent is not actively including them in the discussion, then I will defer detailed discussions with the child until the late teens years when I talk about the future need to transition to an adult provider. CHOP has a Transition to Adulthood program which we can refer to, but the “transition” process may take several years before all of the patient’s care is fully with an adult provider.

It can be physically and emotionally challenging for cardiologists working with complex cases, especially when there are language and health literacy barriers. How do you balance your work and mental health to prevent burnout and compassion fatigue?

Dr Townsend: Caring for children with CHD and their families can be challenging, particularly for patients who spend extended periods of time in the hospital. We live in in the day-to-day ups and downs of complex medical care with patients and their families, and we experience heartbreak when things go poorly—and jubilation when kids get better and can go home.

It is important to purposefully detach from the work environment, spending time away with friends and family as well as focusing on one’s own health with regular exercise and sleep. Often those times away are enough of a mental break to allow clinicians to return to the hospital energized. It is truly the personal connections we make with our patients daily that provide joy and satisfaction that the hard work we do is worthwhile, and if the opportunity arises to see them outside the hospital—for example, at a heart camp—that can help confirm the benefit of the time and care we put into helping children achieve their best lives. 

Dr Brown: Often this type of communication is not done solo but as part of a team, which can be incredibly helpful. Taking the time to reflect with others on challenging cases or difficult conversations, and simply sharing that experience with others, is a very powerful way to lessen the mental and emotional burden. Most physicians are now paying more attention to self-care and making sure there is time to do things that bring relaxation and joy outside of work and allow relationships to be nurtured that can keep fatigue and burnout at bay.

Dr Hsu: Being able to help families and patients at a critical time in their lives is a great privilege and carries with it great rewards because of the appreciation that comes along with the work. Having a family light up when you enter a room because you are a familiar face and they know that you are doing everything you can to help is an experience that is unlike any other. We often speak of purpose in life, and purpose is something caring for children with heart disease has in large quantities.

Personally, I love the fact that I get to be a part of so many different lives, and that part of my job is learning about different cultures, social structures, hobbies, and the hopes and dreams of my patients. Sad things happen in what we do, and in those times, I try to remember what one of my teachers used to say: “We didn’t give them the disease, we are just trying to help.” Working with the patients and families also makes me have a greater appreciation for the good things I have in my life. 

Dr Shillingford: I wish I had an answer for this question. I currently have teenagers at home, and I have missed many games and school events because I am with a patient or parent who requires more attention. It is a constant struggle to balance these demands. I have at times tried to set boundaries or limit patient loads in order to “refuel,” but there is some degree of guilt which comes with that as well. I have wonderful colleagues who I love working with, however I also have activities and friends who have no affiliation with my work which allows me to “escape” when I leave work.

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How Do Myocardial Infarction Symptoms Differ Between Women and Men? https://www.thecardiologyadvisor.com/home/topics/acs/how-do-myocardial-infarction-symptoms-differ-between-women-and-men/ Fri, 04 Aug 2023 15:58:46 +0000 https://www.thecardiologyadvisor.com/?p=108857

A discussion of the differences in myocardial infarction symptoms between men and women.

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Across an ample body of research, findings consistently show that women fare worse than men in a range of outcomes associated with cardiovascular disease (CVD). Among patients with myocardial infarction (MI), diagnosis and treatment are often delayed in women, who also experience higher rates of in-hospital mortality and complications associated with MI compared with men.1 These delays in care may be partly related to a lack of awareness regarding unique aspects of MI presentation in women.

MI Symptoms in Women vs Men

“In general, when experiencing acute coronary syndrome (ACS) or MI, the majority of women present with the same symptoms as men, such as chest pain described as pain, pressure, tightness, or discomfort,” said Lena Mathews, MD, MHS, medical director of cardiac rehabilitation and assistant professor of medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland. “However, women often have unique presentations of MI with additional symptoms such as palpitations, jaw or neck pain, shortness of breath, fatigue, or epigastric symptoms including indigestion.”2

In a 2022 meta-analysis, Cardeillac et al examined 15 prospective studies (N=10,730) and found that the following symptoms were more common among women vs men with suspected ACS: dyspnea (relative risk [RR], 1.13; 95% CI, 1.10-1.17), arm pain (1.30; 95% CI, 1.05-1.59], nausea and vomiting (1.40; 95% CI, 1.26-1.50), fatigue (1.08; 95% CI, 1.01-1.16), palpitations (1.67; 95% CI, 1.49-1.86), and pain in the shoulder (1.78; 95% CI, 1.02-3.13). Consistent results were observed in a subgroup of patients with confirmed acute coronary syndrome.3

These findings align with a 2018 study by Lichtman et al, in which similar rates of young women (87.0%) and young men (89.5%) with acute MI presented with chest pain; however, women were more likely to present with 3 or more additional non-chest symptoms compared to men (61.9% vs 54.8%; P <.001).2 Adjusted analyses of data from patients with ST-segment-elevation AMI revealed that women were 1.5 times more likely than men to present without chest pain (95% CI, 1.03–2.22).2

According to Dr Mathews, differences in pathophysiology may represent 1 of the mechanisms driving these differences, “Men are more likely to have obstructive disease of epicardial vessels with plaque rupture while women are more likely to have MI with non-obstructive disease (MINOCA), spontaneous coronary artery dissection, stress cardiomyopathy, and plaque erosion as opposed to plaque rupture.”4,5

. . . women often have unique presentations of MI with additional symptoms such as palpitations, jaw or neck pain, shortness of breath, fatigue, or epigastric symptoms including indigestion.

She pointed to sex differences in pain perception as another potential factor driving MI disparities in women vs men, as “evidence shows that nervous system pain processing of visceral pain can be different in women.”1

MI in Women Often Overlooked

Despite these findings, physician and public awareness of these differences remains subpar, resulting in diagnostic and treatment delays, and ultimately worse outcomes, for women experiencing MI.

“Women are less likely to attribute their symptoms to coronary artery disease or MI and instead attribute them to anxiety or stress, and thus may seek care only when their symptoms are severe and hard to ignore,” Dr Mathews explained. In addition, clinicians are more likely to categorize women as having a lower cardiovascular risk even in the presence of traditional risk factors, and they often fail to account for sex-specific risk factors that increase the risk for developing CVD, including premature menopause and pregnancy complications such as pre-eclampsia and gestational diabetes.6

In the study by Lichtman et al, women were more likely than men to perceive their AMI symptoms as stress or anxiety (20.9% vs 11.8%; P <.001), and providers viewed prodromal symptoms as non-heart-related in 53% of women vs 37% of men (P <.001).2

“Women who are having a heart attack tend to show up to ER later than men and, because they have atypical symptoms, clinicians are testing and treating them for MI later than their male counterparts,”7 said Leslie Cho, MD, director of the Women’s Cardiovascular Center at Cleveland Clinic in Cleveland, Ohio, and chair of the American College of Cardiology’s Cardiovascular Diseases in Women Council. “This has an enormous impact because time is muscle.”

Improving Awareness of MI in Women

To improve MI detection and outcomes in women, clinicians should remain aware that “women can have MI despite having no traditional risk factors such as coronary artery dissection,” and they should “investigate symptoms that indicate ischemia or MI in women and not dismiss them as non-cardiac symptoms,” Dr Mathews advised. Clinicians should also educate their patients—especially those with risk factors for MI—about symptoms of MI and increase awareness that women can have atypical symptoms.

Recent study results underscore the importance of efforts to spread awareness of CVD risk and symptoms in women. “Despite aggressive campaigns by the American Heart Association (AHA) and other organizations like the American College of Cardiology, only 44% of women surveyed in 2019 listed CVD as the leading cause of death for women,” Dr Cho said.8 “This is a stark decrease from 2009, when 65% of women identified CVD as the leading cause of death for women. The decline in awareness of CVD risk is alarming.”

Awareness of CVD risk is especially low among underrepresented minority women, particularly Black and Hispanic women, although CVD risk is higher among these groups compared to age-matched White women.8

Dr Cho further noted that if women are unaware of their heart disease risk, they are less likely to address hypertension, high cholesterol, and other morbidities that contribute to the development of CVD. “We need to keep educating our patients and physicians. We cannot be complacent,” she emphasized.

Remaining Research Gaps

Along with the critical need to educate physicians and increase public awareness about MI differences in women, there are numerous research questions that require ongoing investigation in this area.

For example, “Are gender differences in presentation of MI due to the underlying pathophysiology of coronary artery disease, due to the nervous system perception of pain, or due to differences in recognition of symptoms?” Dr Mathews asked. As women have been underrepresented in clinical trials investigating MI-specific treatments, there is also a need to examine whether these therapies work the same in women compared with men, and evidence-based management strategies are needed for management of unique presentations of MI in women vs men, such as MINOCA and coronary artery dissection.

“There is so much work that needs to be done in regards to gender differences in CVD – from the most basic fundamental things like understanding platelet differences, plaque and atherosclerosis differences, all the way to drug and device response differences between men and women, more research is warranted,” Dr Cho stated.

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Cardiac Amyloidosis: Tips For Early Recognition and Treatment https://www.thecardiologyadvisor.com/general-cardiology/cardiac-amyloidosis-diagnosis-treatment/ Wed, 02 Aug 2023 13:05:00 +0000 https://www.thecardiologyadvisor.com/?p=108735 Cardiac Amyloidosis

Cardiac amyloidosis is underrecognized in patients with heart failure; however, recent improvements in the understanding of this disease have led to developments in diagnosis and treatment.

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Cardiac Amyloidosis

Cardiac amyloidosis is a cardiomyopathy caused by the extracellular accumulation of misfolded light chain (AL) proteins in the myocardium. These misfolded proteins are unstable, leading to further misfolding, aggregation, and deposition as amyloid fibrils in the body. More than 30 proteins can form amyloid fibrils, with classification based on the precursor protein.1 The misfolded ALs derive from the anomalous clonal propagation of plasma cells or transthyretin (TTR) proteins (previously known as prealbumin), which are synthesized by the liver and typically involved in the transportation of thyroxine and retinol-binding protein.1

Cardiac amyloidosis is underrecognized in patients with heart failure; however, recent improvements in the understanding of this disease have led to developments in diagnosis and treatment. These include noninvasive imaging modalities that can be used without the need for confirmatory endomyocardial biopsy, as well as improved therapies. Early patient identification is important, as current treatments are most effective when initiated before the development of significant symptoms of cardiac dysfunction.

Etiology and Pathophysiology

Two main etiologies of cardiac amyloidosis have been identified: light chain cardiac amyloidosis (AL-CA) and TTR cardiomyopathy (ATTR-CM).

AL-CA

AL-CA is the most common form of cardiac amyloidosis. It is caused by the production of misfolded AL proteins by clonal plasma cells and the deposition of these proteins in organs, leading to dysfunction. Approximately 90% of patients with AL-CA develop cardiac involvement, 50% develop diastolic heart failure, and 75% die from heart failure complications or fatal arrhythmias.2 Cardiac dysfunction results from the deposition of AL in the extracellular space and ensuing cytotoxic events, such as apoptosis, cellular dysfunction, and oxidative stress.2 Because the symptoms of cardiomyopathy can be vague, the disease may go unnoticed.

ATTR-CM

ATTR-CM arises from the extracellular deposition of insoluble TTR amyloid fibrils in the myocardium. TTR is composed of 4 beta sheets that circulate as tetramers and serve as carrier proteins. The misfolding of these proteins results in the extracellular deposition of amyloid fibrils and consequent tissue dysfunction. The 2 main types of ATTR-CM are the wild type (ATTRwt) and the mutated or variant type (ATTRm or ATTRv).

In ATTRwt, the TTR gene is not genetically altered; however, it is considered an unstable protein that deposits in tissue. Cardiac manifestations are seen at later stages, generally in patients aged 60 years or older. A recent review found that ATTRwt was present on autopsy in approximately 25% of patients older than 80 years.2 ATTRm is the autosomal-dominant inherited point mutation in the TTR gene that causes amyloid formation. The single amino acid substitution creates an unstable tetramer and the amyloidogenicity of the change determines the ability of the transition to destabilize the tetramer.2 Manifestations of ATTRm include both neurologic and cardiac deficits. The specific mutations that result in only cardiac manifestations include Thr60Ala, Ile68Leu, Leu111Met, and Val122Ile.2 Some of these mutations are geographically specific; Leu111Met occurs in only Danish families and Val30Met in individuals from Europe, specifically in areas including  Portugal, Sweden, and Majorca .2,3

Clinical Presentation

AL-CA

AL-CA can affect all organ systems except the central nervous system. Because of the vague nature of the disease, it is rarely diagnosed before symptoms present. The most common early manifestation is dyspnea on exertion, followed by peripheral edema and ascites. Other presentations include exercise intolerance, fatigue, and lower-extremity edema.

Nephrologic manifestations of AL-CA include heavy proteinuria (>0.5 g/d), composed mainly of albumin, with detectable Als.2 Renal amyloidosis can occur; a renal biopsy is necessary to confirm the diagnosis but samples from other biopsy sources may be used. Approximately 20% of patients present with peripheral nerve involvement such as bilateral carpal tunnel syndrome, and 15% may exhibit macroglossia or other pathognomonic manifestations, which are highly suggestive of AL.2 Hepatic manifestations such as hepatomegaly, evidenced by increased serum alkaline phosphatase levels, may be evaluated and diagnosed. Respiratory manifestations such as interstitial lung disease result from amyloid deposits in the interstitium. Periorbital ecchymosis in patients with heart failure is considered pathognomonic of AL-CA.

Severe hypotension precipitated by the use of angiotensin receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEis) should raise suspicion of AL-CA. Physical examination is used to diagnose right-sided heart failure, including assessment for jugular venous distension with the absence of respiratory variation, displaced apical impulse due to extracellular deposition, auscultation of a loud fourth heart sound, discernable pedal edema, and hepatomegaly. Other clues warranting further evaluation include heart failure with preserved ejection fraction (HFpEF) without hypertension, recurrent embolic strokes, and an atrioventricular block.

The prevalence of AL-CA is similar across genders, with onset typically after 50 years of age. Early identification is essential, as median survival from the onset of heart failure is 6 months.2

ATTRm-CM

ATTRm-CM also presents with diverse symptoms, resulting in the potential for diagnostic delays of up to 8 years.2 Common initial symptoms include carpal tunnel syndrome, which occurs in approximately one-third of patients with ATTRm-CM, and peripheral and autonomic neuropathy.2 Autonomic dysfunction may manifest as nausea, vomiting, constipation, orthostatic hypotension, urinary retention, or sexual dysfunction. Due to the deposition of amyloid plaque in the subarachnoid space, ischemic stroke, intracerebral hemorrhage, or focal subarachnoid bleeding may occur, leading to ataxia, headache, seizures, or psychosis. Cardiovascular effects may result in slowly progressive heart failure with complications such as HFpEF, conduction block, or sudden cardiac death. Amyloid angiopathy and leptomeningeal amyloidosis may be present, but infrequently.

ATTRm-CM is more common in men than women and typically occurs in patients older than 40 years.

ATTRwt-CM

ATTRwt-CM presents with cardiac manifestations such as systolic dysfunction, atrial fibrillation, heart failure, and ventricular arrhythmias necessitating the use of an implantable cardioverter-defibrillator (ICD). Onset is insidious, with a slow gradual decrease in stamina, steady weight loss, and exercise intolerance. Other manifestations include carpal tunnel syndrome and renal insufficiency. A unique feature in 33% of patients (1 in 1000 individuals) with ATTRwt is rupture of the biceps tendon.2

ATTRwt-CM occurs more often in men than women, with onset after 70 years. The development of cardiomyopathy in older individuals should warrant suspicion of cardiac amyloidosis.4

Diagnosis and Differential Diagnosis

Cardiac amyloidosis should be considered in patients with a left ventricle wall thickness of more than 12 mm or criteria such as positive family history, peripheral neuropathy, autonomic dysfunction, proteinuria, macroglossia, ecchymosis, bilateral carpal tunnel syndrome, biceps tendon rupture, lumbar spinal stenosis, and plasma cell dyscrasia.5  Cardiac manifestations that necessitate further consideration of cardiac amyloidosis include persistently elevated biomarkers, heart failure in the presence of a nondilated left ventricle, unexplained right-sided heart failure, and aortic stenosis.5 Anomalies on electrocardiogram, echocardiogram, or cardiac magnetic resonance imaging (MRI) should warrant further workup for cardiac amyloidosis.

Specific assessment for cardiac amyloidosis may involve testing for monoclonal proteins via serum or urine and bone tracer cardiac scintigraphy scan. Follow-up with cardiac MRI and cardiac or other tissue biopsy may be indicated based on the results of the initial evaluation. For example:

  • If monoclonal protein testing and scintigraphy scans are negative, then cardiac amyloidosis may be unlikely; otherwise, cardiac MRI and tissue biopsy may be warranted.
  • A negative monoclonal protein testing and positive scintigraphy scan with grade 2 or 3 uptake are diagnostic for ATTR cardiac amyloidosis, eliminating the need for biopsy. If uptake is grade 1, then a biopsy may be necessary to confirm the diagnosis of ATTR.
  • A positive monoclonal protein testing and negative scintigraphy scan indicate the potential for AL amyloidosis and necessitate further testing with cardiac MRI.
  • Negative cardiac MRI indicates that cardiac amyloidosis is unlikely, whereas positive cardiac MRI necessitates tissue biopsy for confirmation.5

Potential for AL or ATTR or combined cardiac amyloidosis can be inferred with positive monoclonal protein testing and scintigraphy; however, it necessitates cardiac tissue biopsy for diagnostic confirmation.5 All ATTR-CM diagnoses warrant a referral to a geneticist with further testing necessary to determine prognosis, treatment choice, and screening of family members.

Treatment and Follow-Up

The prevention and management of complications associated with cardiac amyloidosis are essential. Complications include heart failure, atrial fibrillation, thromboembolism, conduction disorders, ventricular arrhythmias, and aortic stenosis. Because of the risk for significant hypotension, ACEis and ARBs should be used with caution. Discretion should also be used with digoxin because of the risk for toxicity.

Treatment for ATTRwt-CM or hereditary acquired ATTR includes tafamidis, which stabilizes TTR and prevents proteins from misfolding.5 In addition, patients with polyneuropathy may receive patisiran, which silences TTR genes and prevents the production of variant and wt TTR.5 Because of cardiac amyloidosis is a progressive disease, organ transplant may also be considered.5

An ideal approach to follow-up and serial testing of cardiac amyloidosis has not been determined. Referral to a specialist is essential.

Evidence for Diagnostic and Treatment Recommendations

Testing for monoclonal ALs and bone scintigraphy is considered a grade B recommendation for patients with cardiac amyloidosis.6 The initiation of a TTR tetramer stabilizer to reduce cardiovascular morbidity and mortality in cases of ATTRwt-CM or ATTRm-CM with New York Heart Association Class I to III heart failure symptoms is considered a grade B recommendation.6 Tafamidis provides low economic value in ATTRwt-CM and ATTRm-CM with heart failure, as its cost is more than $180,000 per quality-adjusted life year.6

Kristie Branham, BSN, RN, is an emergency department nurse interested in endocrinology, cardiology, psychiatric/mental health, and emergency medicine. She is currently enrolled in a Doctoral Family Nurse Practitioner program.

References

1.    Kittleson MM, Maurer MS, Ambardekar AV, et al. Cardiac amyloidosis: Evolving diagnosis and management: A scientific statement from the American Heart Association. Circulation. Published online June 1, 2020. doi: 10.1161/CIR.0000000000000792. Errata in: Circulation. 2021;144(1):e10 and Circulation. 2021;144(1):e11.

2.    Pour-Ghaz I, Bath A, Kayali S, et al. Review of cardiac amyloidosis: Presentation, diagnosis, and treatment. Curr Probl Cardiol. Published online August 20, 2022. doi:10.1016/j.cpcardiol.2022.101366

3.   Damy T, Kristen AV, Suhr OB, et al. Transthyretin cardiac amyloidosis in continental Western Europe: an insight through the transthyretin amyloidosis outcomes survey (THAOS). Eur Heart J. 2019;43(5):391-400. doi:10.1093/eurheartj/ehz173

4.    Motwani M, Arumugam P, Rocci A, Venetucci L. Evaluating suspected cardiac amyloidosis. JACC Case Rep. 2019;1(2):141-145. doi:10.1016/j.jaccas.2019.06.027

5.    Garcia-Pavia P, Rapezzi C, Adler Y, et al. Diagnosis and treatment of cardiac amyloidosis: A position statement of the ESC working group on myocardial and pericardial diseases. Eur J Heart Fail. Published online April 7, 2021. doi:10.1002/ejhf.2140

6.    Heidenreich PA, Boxkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: Executive summary: A report of the American College of Cardiology/American Heart Association joint committee on clinical practice guidelines. J Am Coll Cardiol. Published online April 1, 2022. doi:10.1016/j.jacc.2021.12.011

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Patient Education & Information Overload: How Much Is Too Much? https://www.thecardiologyadvisor.com/home/topics/practice-management/patient-education-overload/ Mon, 31 Jul 2023 16:20:04 +0000 https://www.thecardiologyadvisor.com/?p=108632 Doctor and patient in conversation, looking at digital tablet

To ensure patients have useful information they can benefit from, it is important to avoid patient education overload. Here clinicians are provided with tools to ensure clear and effective communication.

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Doctor and patient in conversation, looking at digital tablet

As health care providers, we want to do everything we can to help our patients achieve wellness. It can be tempting to share all of the information we have learned with them toward that goal of patient education and health literacy. However, all the best information can’t be helpful if our patients can’t act on it because they don’t remember it.

To ensure patients have useful information they can benefit from, it is important to avoid patient education overload. Health care providers should help patients improve their health literacy and use effective 2-way communication to achieve better patient commitment to treatment and satisfaction.

Is More Information Always Better?

Research has consistently found that patients often forget information given to them by their physicians.1 Patients can immediately forget 40% to 80% of the medical information and recommendations they receive. Of the information they remember, only about one-half of it is typically recalled correctly.2 For any recommendation to be effective, patients must be able to remember what it is and how to achieve it.

A lower ability to recall medical information is associated with several factors, including3,4:

  • Older age;
  • Low health literacy;
  • High and low anxiety; 
  • Large amount of information; and 
  • Low level of education.

The type, structure, and length of information can influence how much of the information a patient can retain.5 The more recommendations a patient is given, the higher the likelihood they will be forgotten. A 2011 study conducted at a family practice in Slovenia found that there is a higher likelihood that recommendations will be forgotten when patients are given 3 or 4 at one time, compared with just 1 or 2 recommendations. The study authors recommend that if more than 1 or 2 recommendations are needed, a follow-up appointment should be scheduled.4 

Effective Communication

Effective communication can improve patient satisfaction and recall, ultimately improving patient outcomes.6 

A component of optimal health care delivery is ensuring that health information as communicated by clinicians is understood by their patients. The most effective type of communication will differ among patients. Health care providers have the responsibility of providing patients the information they need to achieve health and wellness, and patients have the responsibility of acting on the information.7 

Health Literacy

Improving patient care and communication should focus on improving patient health literacy. Health literacy refers to an individual’s ability to find, understand, and use health-related information to make decisions and take action. According to the Agency for Healthcare Research and Quality (AHRQ), health literacy in the United States is low, with only 12% of Americans demonstrating health literacy skills adequate to navigate the complex health care system.8

Health literacy is one of the best predictors of a patient’s health. Low health literacy is linked to9:

  • Poor management of chronic illness;
  • Decreased ability to participate in shared decision-making with health care providers; and
  • Lower levels of adherence to medical therapies. 

Although health literacy can be an important factor in predicting a patient’s outcomes, clinicians do not necessarily need to evaluate their patient’s level of health literacy. Instead, health care providers should use universal precautions for all patients, regardless of their health literacy level. Universal precautions aim to10:

  • Simplify communication;
  • Confirm patient understanding;
  • Improve the navigability of health care services; and
  • Support patients.  

Barriers to Patient Education

Health care providers should be aware of what potential barriers may exist for patients to understand medical information. 

Recall of medical information is strongly associated with patient education levels. One study found that people with less than a high school diploma recalled approximately 38% of recommendations made during an ambulatory care visit, while people with a college degree were able to recall approximately 65% of recommendations.1 

It may not be possible for a clinician to be able to determine patient education levels, but patients with low health literacy often have red flags, such as11:

  • Missed appointments;
  • Incomplete written forms;
  • Lack of adherence to medication;
  • Inability to state the name or purpose of a medication;
  • Inability to provide a complete or coherent history; and
  • Lack of follow-through on testing or laboratory appointments. 

Strategies to Improve Health Literacy & Patient Education

Even if a patient has high health literacy, clinicians should still take precautions to ensure comprehension. AHRQ provides a health literacy universal precautions toolkit to help health care providers promote better understanding for everyone.10 The toolkit is available here

Use Clear Communication

Clear communication can help patients to better understand medical information. Tips for clear communication include12:

  • Maintaining a friendly attitude;
  • Avoiding the use of medical jargon;
  • Using the patient’s own words;
  • Speaking at a moderate pace; and
  • Avoiding interrupting patients when they are speaking.

Focus on What the Patient Needs To Know

Health care providers should prioritize the information that needs to be discussed. Information should be limited to 3 to 5 key points. Repeating these key points can also help with patient recall.12 

Key points should be specific and focus on the steps the patient must take when they leave the examination room and when they return home to successfully follow treatment instructions. Patients are more likely to remember specific advice compared with generalized information.3

Key information should be prioritized based on the patient’s goals. For example, the key points for a patient being seen to diagnose a new condition will be different from those provided to a patient following up on an existing condition.12 

Use the Teach-back Method

The teach-back method allows health care providers to ensure that medical information is given to patients in a way they can understand and act on. This method has been shown to help2:

  • Improve a patient’s understanding and adherence to recommendations;
  • Reduce the number of canceled appointments;
  • Decrease the number of callbacks; and
  • Increase patient satisfaction.

The teach-back method should be framed as a test of how well the health care provider explained knowledge instead of a test of the patient’s knowledge. Instead of asking yes or no questions to confirm knowledge (such as, “Does that make sense?”), use open-ended questions where the patient must summarize recommendations in their own words.2

Examples of starter phrases that can be used in the teach-back method include2:

  • “We covered a lot today. To make sure I explained things clearly, can you describe 3 actions you agreed to take today?”
  • “This is a new diagnosis for you. To make sure you understand, can you tell me what this condition means?”
  • “I’ve noticed lots of people have trouble remembering how to use their medication. Can you show me how you use your medication?”

Health care providers should check for understanding throughout the patient encounter instead of waiting until the end. Incorrect or incomplete understanding should be corrected immediately before moving on.2

Some providers may feel that the teach-back method feels awkward or time-consuming when they first incorporate this method into their practice. However, when used over time, it can improve patient outcomes and satisfaction without increasing the length of a visit.2 

Use Alternative Teaching Styles

The use of different types of patient education materials may encourage effective retention of information among patients with different learning styles. Although oral communication is a faster way to share information, written communication may result in better patient recall. Ideally, information should be provided in more than 1 form.3

Health care providers should consider having patient education materials available in different formats, such as13:

  • Printed materials;
  • Pictographs and infographics;
  • Videos;
  • Slide presentations;
  • Models/props;
  • Group classes; and
  • 1:1 teaching.

It is important to evaluate a patient’s ability to effectively use the educational materials they are given. Materials should be provided in a language the patient speaks and ideally in their native language.14 

Written materials should be easy to understand. The average US adult reads at approximately an 8th-grade level, but up to 20% of adults read at or below a 5th-grade level. Written materials should be written at a 5th- or 6th-grade level to ensure all patients can understand the information.14 Pictographs or drawings serve as a useful form of communication for all patients, especially when literacy is unknown.3 

Before using technology, it is important to make sure the patient is able to use it. For example, if a patient is instructed to watch a YouTube video, they should have access to a computer and know how to search for the video.14 

It may help to keep a tally of which materials are given to patients most often or how often the office runs out of each printed material. 

Measuring Patient Education Outcomes 

The continuous measuring of outcomes is important to improve the health literacy of patients. One of the fastest and easiest ways to measure outcomes is to ask for patient feedback. Feedback can be obtained verbally during the encounter or by a written survey at the end of a visit. Examples of feedback questions include15:

  • “Which parts of today’s visit did you find clear and easy to understand?”
  • “Which parts did you find confusing?”
  • “What information has been helpful for you?”
  • “Is it clear what you need to do based on the information given to you today?”

Other methods for receiving patient feedback include15:

  • Suggestion boxes;
  • Shadowing patients during visits and while using health tools (such as a patient portal); and
  • Walkthroughs with a person unfamiliar with the practice. 

The rate of patient adherence to treatment can also indicate the efficacy of communication. Studies show that patients with chronic conditions such as hypertension and type 2 diabetes who are satisfied with their provider’s communication are more adherent to their treatment.16,17 

Patient Education & Health Literacy is Key

Patients are only able to take action on medical recommendations they understand and remember. Health care providers are responsible for improving health literacy by providing recommendations in a way that patients can understand.

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PAH: Changing Approaches to Diagnosis, Treatment, and the Patient Journey https://www.thecardiologyadvisor.com/home/topics/vascular-medicine/changing-approaches-to-pah-diagnosis-treatment-and-the-patient-journey-2/ Fri, 28 Jul 2023 14:11:42 +0000 https://www.thecardiologyadvisor.com/?p=108596

In recent decades, a sea change in our understanding of pulmonary arterial hypertension has affected treatment approaches, prognosis, and the patient journey.

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In recent decades, there’s been a sea change in the understanding of pulmonary arterial hypertension (PAH), which in turn has affected the patient journey in this disease. The prognosis of PAH has evolved from impending death with few treatment options to a chronic condition notable for improved survival.1

Improved patient survival has been realized due to the development of effective therapies and the expansion of risk-stratification scores, which aid clinicians in clinical decision-making. Although PAH can now be better controlled — with improved quality of life and clinical course for patients — patients still face barriers to care. The treatment burden is cumbersome and hinders quality of life, and many with the condition initially present with advanced or end-stage disease.1

Changes and Challenges in Disease Diagnosis

A focus on early disease detection and new clinical outcomes findings have changed the definitions of PH and PAH.2-4 According the 2022 ESC/ERS Guidelines for Pulmonary Hypertension, patients with a mean pulmonary artery pressure of more than 20 mmHg measured by right heart catheterization are now considered to have PH. A pulmonary vascular resistance or more than 2.0 Wood units and pulmonary arterial wedge pressure of at least 15 mm Hg further implies the existence of PAH.3,4  

“These lowered thresholds aim to identify patients early in the disease course, which is important because delay to diagnosis of PH is common and linked to elevated morbidity and shortened lifespan,” according to the author of a review published in the Journal of the American Heart Association.2

Once patients understand the disease itself and the medications/therapies, the next step really would be to help them understand risk assessment and goals of low-risk status.

Although the 2022 ESC/ERS Guidelines for Pulmonary Hypertension cover the whole spectrum of PH, these updated guidelines include “an emphasis on diagnosing and treating pulmonary arterial hypertension.”4

Within the 2022 guidelines, the principal diagnostic algorithm for PH has been streamlined to a 3-step approach3 that includes:

  1. suspicion by first-line physicians;
  2. detection by echocardiography; and
  3. confirmation via right-heart catheterization at PH specialty centers.

In an exclusive interview, Jean Elwing, MD, FCCP, Chair of the Pulmonary Vascular and Cardiovascular Network with the American College of Chest Physicians, provided guidance on how to best recognize PH in patients, and to then identify PAH.

“Pulmonary hypertension can present with multiple nonspecific symptoms and can be very challenging to diagnose,” she said. “When patients have progressive dyspnea, exercise limitation, and exertional chest discomfort, we have to think about potential causes that are both pulmonary and cardiac. When we are thinking of cardiac causes, one of the best tools to use is an echocardiogram. The echocardiogram will give us insight into the likelihood of pulmonary hypertension.”

She advised that PH should be a differential diagnosis in anyone with unexplained dyspnea/exercise limitation or other nonspecific symptoms such as intermittent chest discomfort with exertion, dizziness, lightheadedness, fatigue, and swelling. The index of suspicion should be high in patients with a higher risk of developing the disease, and their clinical trajectory should be followed closely.

For instance, if a patient with HIV, liver disease with portal hypertension, or connective tissue disease develops shortness of breath, an echocardiogram should be performed followed by right-heart catheterization, if needed, to rule out PH. 

Socioeconomic Factors Affecting PAH

Dr. Elwing also remarked on the impact of socioeconomic factors in the recognition of PH. “Social challenges and socioeconomic status can play a significant negative role in pulmonary hypertension diagnosis and lead to delays in care. This is an area where we need to be very mindful and consider all patients equally when assessing symptoms and pursuing further work-up of pulmonary hypertension,” she stated.

For instance, women and men present with PH and PAH in a similar fashion, but due to a lower prevalence of the disease in men, symptoms could be overlooked.

As for race and ethnicity, she said, “We believe that different races/ethnicities present with similar symptoms of pulmonary hypertension but the etiologies of pulmonary hypertension in these populations may differ. Hispanic patients are more at risk for congenital heart disease-associated pulmonary arterial hypertension and have an increased risk of viral hepatitis increasing their risk of portal hypertension and portopulmonary hypertension. Connective tissue disease-associated pulmonary hypertension has been shown to be more common in Black patients in available registry data.”

The Evolution of PAH Treatment

Over the past 3 decades, much has been clarified regarding pulmonary hypertension treatment; 30 years ago, the only treatment available involved high dosages of calcium-channel antagonists, which improved survival only in a handful of those with pulmonary arterial hypertension.5

Approved medical treatments for PAH (along with their routes of administration) include the following2:

  • prostacyclin derivatives (inhaled iloprost, intravenous [IV] epoprostenol, IV/subcutaneous or inhaled or oral treprostinil);
  • selective prostacylin (intraperitoneal injection) receptor agonist (oral selexipeg)
  • endothelin receptor antagonists (oral bosentan, oral ambrisentan, oral macitentan)
  • PDE5 inhibitors (oral/IV sildenafil, oral tadalafil)
  • soluble guanylyl cyclase stimulator (oral riociguat)

In the aggregate, these agents help improve outcomes such as exercise tolerance and capacity, as well as mitigating clinical deterioration.2

In addition to pharmacologic therapies, there are also nonpharmacologic interventions that may improve patient well-being. These revolve around diet, sleep, and exercise, said Dr. Elwing. 

“A balanced diet with monitoring of salt and fluid intake can have a major impact on right heart-failure management and other comorbidities. Exercise can improve dyspnea and tolerance of many health conditions. This is important for exercise tolerance as well as overall well-being,” she said.

“Sleep is imperative for mood and resilience. Good sleep hygiene and assessment of sleep disorders is critical for patients to feel well and have the reserve to care for themselves with this complex medical condition,” she added.

The Patient Journey in PAH

Helping patients with PAH through the rigors of diagnosis and treatment requires empathetic conversations by specialists. Unfortunately, due to time constraints, it is hard for clinicians to make patients comfortable enough to open up about their goals and to revisit these goals over time. Instead, expedient visits pinpoint clinical factors, therapy, and medication adherence/tolerability.1

Outside of clinicians, there are a few options patients and their caregivers may be encouraged pursue for further information and support, including Living with PAH, an online support and discussion community, and the American Lung Association Patient & Caregiver Network.

Dr. Elwing recommends that specialists take time to partner with patients to improve care.

“Knowledge is power, especially in complex diseases like pulmonary hypertension. Taking the time to educate patients will pay off for the patient and the provider in multiple ways,” she stressed. “Successful treatment and best outcomes can be achieved with joint efforts of the care provider as well as the patient. In order to achieve this, patients need to be educated on the disease and made aware of the importance of medication adherence, close follow-up, testing, and potential for medication changes.”

 She added, “Once patients understand the disease itself and the medications/therapies, the next step really would be to help them understand risk assessment and goals of low-risk status. Calculating a risk score in PAH is not just a number. Using a risk assessment tool helps guide medical therapy and provides some insight in terms of prognosis for that individual.”

On a final note, Dr. Elwing exhorted providers to take time to consider the patient in a holistic sense.

“We need to understand their level of medical literacy, ability to communicate, social support, and the severity of the illness. We assess patients’ risk status and design a treatment approach based on that. We choose the type of medications and the delivery system based on what the patient is able to tolerate and use safely,” Dr Elwing noted.

“We should closely monitor every PAH patient and provide opportunities to use our most aggressive therapies but may have to tailor medications based on that individual patient’s needs for the patient’s safety and ability for them to use medications consistently,” she added.

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The Bidirectional Relationship Between Sleep Disorders and Stroke https://www.thecardiologyadvisor.com/home/topics/stroke/bidirectional-relationship-sleep-disorders-stroke-sandeep-prakash-khot-md-mph/ Fri, 21 Jul 2023 13:44:54 +0000 https://www.thecardiologyadvisor.com/home/news/bidirectional-relationship-sleep-disorders-stroke-sandeep-prakash-khot-md-mph/ Young_woman_ lying_on_bed_with_ hand_on_forehead.

Sandeep Prakash Khot, MD, MPH, discusses how sleep disorders can add to the burden of stroke and recurrent stroke, and how to improve prevention and treatment strategies for both conditions.

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Young_woman_ lying_on_bed_with_ hand_on_forehead.

Stroke is one of the major causes of disability and mortality worldwide, and the prevalence of stroke is expected to increase due to an aging population. People who suffer from a stroke can experience a wide range of symptoms, including sleep disorders, which can increase the risk for subsequent stroke. Additionally, patients with preexisting sleep disorders are at a greater risk for stroke.1

“Sleep disorders are associated with worsened stroke outcome, including both recurrent stroke and worsened functional recovery,” said Sandeep Prakash Khot, MD, MPH, associate professor of neurology at the University of Washington, and director of the Harborview Medical Center Consult Service in Seattle. 

As the incidence of stroke increases in the US, organizations such as the American Heart Association and American Stroke Association recommend that more sleep studies be conducted to help prevent stroke recurrence or transient ischemic attack (TIA).2 

While sleep is one of the most important physiological processes for healing, the relationship between sleep disorders and stroke is under continued investigation. 

Sleep disorders are associated with worsened stroke outcome, including both recurrent stroke and worsened functional recovery.

Bidirectionality of Sleep Disorders and Stroke

Different types of sleep disorders are shown to be associated with stroke, including sleep-related breathing disorders, rapid eye movement (REM) sleep behavior disorders, and sleep-wake cycle disorders.3

Sleep-disordered breathing (SDB) is the most common sleep disorder experienced poststroke, with the most prevalent type being obstructive sleep apnea (OSA).4 “Obstructive sleep apnea is found in over 60% of stroke survivors in the acute setting, whereas insomnia, a sleep-wake cycle disorder, is prevalent in about 30% to 40% of stroke survivors,” Dr. Khot noted. 

OSA is an established modifiable risk factor for stroke and is estimated to double the risk for stroke.3 This direct relationship was established in the Sleep Heart Health study, which reported an association between OSA severity and stroke risk.5 More recently, evidence shows that some comorbidities, such as stroke and heart failure, may predispose an individual to develop OSA.6 

The bidirectional nature of sleep disorders and stroke could potentially lie in mechanisms for individual comorbidities. A 2022 study published in the European Respiratory Review demonstrates that poststroke sleep architecture can impair breathing control mechanisms centrally and can impact upper airway muscle function. Additionally, patients with OSA who present with stroke have higher National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale scores upon discharge.6

A 2019 study published in Sleep Medicine Reviews reported that prolonged sleep duration, defined as at least 8 hours of sleep or more, was associated with a 3.90-fold increased risk for stroke. Researchers also found that the endogenous sleep rhythm is disrupted after stroke and can be associated with increased stroke severity and worsened outcome. This study also identified that shift work, a circadian rhythm disorder, was another risk factor for all-cause stroke (risk ratio [RR], 1.05; 95% CI, 1.01-1.09).7

Nonapnea sleep disorders, such as restless leg syndrome (RLS), REM sleep behavior disorder, and insomnia also increase the risk for an acute ischemic stroke. Sleep-related movement disorders were associated with an increased risk for all-cause stroke, with a hazard ratio of 2.29 (95% CI, 1.42-3.80).8

The Role of CPAP in Poststroke Treatment

Continuous positive airway pressure (CPAP) is the mainstay of treatment for OSA, but its role in poststroke treatment has conflicting recommendations. 

Many studies show that CPAP use in treating OSA for patients with stroke provides more benefits compared with those who do not receive or are noncompliant with treatment.9 Some studies suggest beneficial effects in sleepiness, depression, and functional recovery.10-12 Other studies reported no apparent advantages in vascular event recurrence and no significant improvement in neurologic cognition, despite improvements in motor function.13,10

“CPAP use after stroke is currently limited. Screening for OSA is rarely initiated after stroke, estimated to occur in only about 6% of patients within 3 months of stroke,” Dr. Khot explained. “Stroke patients with OSA are not like OSA patients in the general population in that they are not typically overweight, sleepy, or even likely to snore, which makes our clinical suspicion of the disease difficult and makes the screening questionnaire insensitive.” 

While an early diagnosis and treatment of OSA prior to stroke is strongly recommended, the role of screening and prevention for OSA is unclear poststroke. “Based on limited data, the American Stroke Association does not recommend routine screening in acute stroke but does suggest a role for stroke prevention,” Dr. Khot stated. “There may be more of an understanding that OSA is common and portends worse outcomes, but actual testing is rarely offered to many patients who might benefit, including those with refractory hypertension.”

Future Studies and Recommendations

One of the primary initial recommendations for people with sleep disorders and stroke is improving sleep hygiene by limiting noise and light in the bedroom. Another recommended therapy is cognitive-behavioral therapy (CBT) for patients with chronic sleep disorders. This therapy has been shown to reduce insomnia after stroke, although the long-term effects are not clear.1

In addition to patient education and therapy recommendations, further research is necessary to answer unresolved questions in this area.

“It’s important to understand that along with the effect on stroke recovery, OSA is an independent risk factor for stroke and is known to worsen other common stroke risk factors, such as hypertension, diabetes, and atrial fibrillation. It may be that the changes are too well-established for studies to show a significant effect of CPAP or that CPAP is just not the best therapy for this population as it is in the general population. Thus, there is an important knowledge gap and a need for rigorous trials in the field,” said Dr. Khot, on the need for further CPAP research.

A 2021 study published in Stroke assessed the body of data surrounding CPAP and poststroke OSA and proposed some considerations for future studies. Some suggestions were to ensure that patients are using CPAP for at least 4 hours, to initiate therapy within 48 hours of stroke, and to include patients with varying OSA severity and compliance.14

The American Heart Association and American Stroke Association also recommend future studies to consider the following: 

  • Selection of patients who would likely benefit from CPAP;
  • Timing of CPAP treatment and testing relative to stroke onset;
  • Home testing vs facility testing; and
  • Dosing and type of CPAP.15 

Dr. Khot highlights a particular ongoing study with the potential to have a profound clinical impact in treatment of sleep disorders and stroke, stating “There is a large multicenter trial called Sleep for Stroke Management and Recovery Trial or Sleep SMART (ClinicalTrials.gov Identifier: NCT03812653), which will evaluate in over 3000 participants the treatment of OSA with CPAP on both secondary prevention and acute stroke recovery. The study is part of a network of hospitals across the country called NIH StrokeNET.”

Other ongoing studies highlighted by the American Heart Association and American Stroke Association include the Recovery in Stroke Using PAP (RISE-UP) trial (ClinicalTrials.gov Identifier: NCT04130503) and the Addressing Sleep Apnea Post Stroke/TIA (ASAP) trial (ClinicalTrials.gov Identifier: NCT04322162). The RISE-UP trial is determining the optimal timing of CPAP initiation poststroke and the ASAP trial is focused on assessing a quality improvement initiative in the Veterans Affairs Medical Administration.15 

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Expert Roundtable: Improving Peripartum Blood Pressure in Hispanic Patients https://www.thecardiologyadvisor.com/home/topics/hypertension/expert-roundtable-improving-peripartum-blood-pressure-in-hispanic-patients/ Fri, 07 Jul 2023 14:14:23 +0000 https://www.thecardiologyadvisor.com/?p=107855

Johanna Contreras, MD, Natalie Cameron, MD, Aarthi Sabanayagam, MD, and Nicole Mitchell, MD, discuss ways to improve peripartum BP in Hispanic patients.

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Pregnancy-related complications affect women from minoritized racial and ethnic groups at a substantially higher rate compared to non-Hispanic White women.

In May 2023, the American Heart Association (AHA) launched a campaign to address inequities in maternal health outcomes among Hispanic/Latina women in particular, with a focus on increasing awareness regarding the importance of managing blood pressure during pregnancy. As noted in the AHA press release describing this initiative, Hispanic/Latina women may develop hypertension at younger ages and have higher average blood pressure compared with women from other non-Black racial and ethnic groups.1

Through social media outreach and other resources, the AHA’s awareness campaign aims to engage and educate Hispanic/Latina women on the topic and encourage them to visit their health care provider or pharmacy to check their blood pressure, continue to self-monitor, and follow established lifestyle guidance on maintaining healthy blood pressure.1

We interviewed the following experts to further discuss disparities in cardiovascular and maternal outcomes in this patient population:

  • AHA volunteer expert Johanna Contreras, MD, cardiologist and associate professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, New York, medical director of the Hispanic Heart Center at Mount Sinai
  • Natalie Cameron, MD, internal medicine specialist and instructor of general internal medicine at Northwestern University Feinberg School of Medicine in Chicago, Illinois
  • Aarthi Sabanayagam, MD, cardiologist and associate clinical professor of cardiology at the University of California San Francisco (UCSF) School of Medicine and co-director of the UCSF Pregnancy and Cardiac Treatment Program
  • Nicole Mitchell, MD, obstetrician and gynecologist and faculty director of the OB/GYN Diversity and Inclusion Program at Keck School of Medicine at the University of Southern California in Los Angeles, California 
The rising trend in maternal deaths due to CVD appears to be due to acquired rather than congenital heart disease, such as the effects of hypertension acquired during one’s lifetime.

The AHA notes that “adverse outcomes related to cardiovascular diseases disproportionately affect Hispanic/Latina mothers.” What are some examples of these outcomes, and what factors may be driving these disparities?

Dr Contreras: Many factors are driving these disparities, including social determinants of health. Findings show a lack of prenatal care, as many Hispanic/Latina women do not have insurance2 and often do not receive preventative medications before pregnancy. These women tend to have a lower level of education and socioeconomic status, and they have jobs or multiple jobs that usually do not provide health insurance. In some cases, they depend on insurance from their partner or husband, and many times those are absent.

There is also a higher incidence of hypertension, hypercholesterolemia, and diabetes in Hispanic/Latina women, which can vary by country of origin and immigration status.3 All of these factors are well known to be associated with an increased risk of cardiovascular disease (CVD). Often, during pregnancy or due to the stress of pregnancy, these factors can manifest or worsen during pregnancy, making them difficult to treat and control and likely increasing the risk of CVD—which is the leading cause of maternal mortality.4

Additionally, Hispanic/Latina women have been underrepresented at every level, including in clinical trials.

Dr Cameron: From 2019 to 2020, maternal mortality increased significantly—from 12.6 to 18.2 per 100,000 live births—among Hispanic individuals in the US, representing a 44% relative increase in just 1 year.5 Similar increases were not seen among non-Hispanic White individuals. Although we do not yet know the cause of this increase, the COVID-19 pandemic has likely played a key role.

Given that CVD is the leading cause of maternal mortality,4 understanding the influence of the pandemic on cardiometabolic complications of pregnancy, such as hypertensive disorders of pregnancy and gestational diabetes, in Hispanic individuals is essential.

From 2007 to 2019, Hispanic individuals showed the greatest annual percent change in the incidence of new-onset hypertensive disorders of pregnancy compared to other racial and ethnic groups, with a 7.7% increase per year among those in urban areas.6

In 2019, the risk of gestational diabetes was about 1.15 times higher among Hispanic women compared with non-Hispanic White women.7 We are still working to understand how the pandemic has influenced prevalence and disparities in these complications and maternal mortality.

Drivers of disparities in adverse pregnancy outcomes are complex and multifaceted. Key contributors are differences in access to healthy and affordable foods, safe places to exercise and play, health care access and health insurance coverage, and reliable interpretation services for those who do not speak English. Historical and structural racism have perpetuated these disparities.

Dr Mitchell: CVD affects 1% to 4% of nearly 4 million pregnancies in the US each year8 and is now the leading cause of death in pregnant and postpartum women, accounting for 26.5% of US pregnancy-related deaths, or 4.23 deaths per 100,000 live births. For comparison, that’s almost twice the rate found in the United Kingdom.4

The rising trend in maternal deaths due to CVD appears to be due to acquired rather than congenital heart disease, such as the effects of hypertension acquired during one’s lifetime. The most common conditions include heart failure, myocardial infarction, arrhythmia, and aortic dissection. 

Disparities are present amongst these statistics, especially when considering race/ethnicity and age. Per the American College of Obstetricians and Gynecologists (ACOG), non-Hispanic Black women have a 3.4 times higher risk of dying from CVD-related pregnancy complications compared with non-Hispanic White women, independent of other variables.9

Between 2011 and 2013, there were 43.5 pregnancy-related deaths per 100,000 live births for non-Hispanic Black women compared with 11.0 and 12.7 pregnancy-related deaths per 100,000 live births for Hispanic and non-Hispanic White women, respectively.9 Age older than 40 years increases the risk of myocardial infarction in pregnancy by 30 times compared to the risk for women younger than 20 years.10

Reasons for these disparities include a combination of structural, institutional, and systemic barriers such as racial and ethnic bias, access to care, and overt systemic racism.

Dr Sabanayagam: Some examples of these outcomes are pre-eclampsia around the peripartum period during pregnancy. When women are affected by adverse pregnancy outcomes such as pre-eclampsia, gestational diabetes mellitus, placental diseases, and low-birthweight babies, they are at increased risk for CVD later in life, such as stroke, myocardial infarction, and coronary artery disease.   

Factors that drive disparities in outcomes in both African American and Hispanic women are highly complex and multifactorial in nature. Some of the factors are age, educations levels, employment and insurance coverage, language literacy, and access to care both during pregnancy and in the postpartum period. The COVID-19 pandemic brought many of these disparities to the forefront, highlighting the importance of understanding the associated factors when providing care to these women.  

In addressing these disparities, why is the emphasis on managing blood pressure during pregnancy especially important?   

Dr Contreras: Hypertension is highly prevalent in Hispanic/Latina women and in certain countries, including Mexico and Puerto Rico, and it has been found to be a top risk factor for disease and for pre-eclampsia and eclampsia during pregnancy.

It is important that all adult women know their blood pressure before pregnancy and to understand what the numbers mean and how to manage blood pressure.  

Dr Cameron: Hypertensive disorders of pregnancy are important risk factors for maternal morbidity and mortality. Managing blood pressure before pregnancy, during pregnancy, and in the postpartum period may prevent other adverse pregnancy outcomes, such as maternal death and delivering a small for gestational age infant. Emerging evidence also suggests the potential for intergenerational transmission of poor cardiovascular health and high blood pressure from mother to baby.11

Dr Mitchell: Controlling blood pressure is extremely important to begin addressing these statistics. Hypertension affects up to 10% of pregnancies, and severe and early-onset hypertension put women at increased risk of cardiac problems during pregnancy or postpartum.12 For example, in pregnancies complicated by hypertension, the incidence of myocardial infarction and heart failure is 13-fold and 8-fold higher, respectively, than in healthy pregnancies.13

Dr Sabanayagam: Pre-eclampsia affects approximately 2% to 8% of pregnancies; however, it affects 30% of pregnancies in those with underlying chronic hypertension.14,15 The recent CHAP (Chronic Hypertension and Pregnancy) trial from the University of Alabama showed a 20% reduction in pregnancy complications of pre-eclampsia and pre-term births in women who were treated for hypertension with stricter cutoffs of 140/90 mm Hg instead of 160/105 mm Hg.16 

What are key recommendations for physicians in terms of addressing this issue and advising patients on reaching and maintaining healthy blood pressure?

Dr Contreras: Patients should be advised to know their numbers, take their blood pressure at home, and understand when it is high so they can seek treatment.

Providers should understand that many medications to control blood pressure are contraindicated during pregnancy, so it is important to change those when patients are looking to become pregnant or are pregnant.

Also, lifestyle modifications are very important to control blood pressure, such as exercise, low-salt diet, cholesterol control, stress reduction, no smoking, and adequate amounts of good-quality sleep.

Even during pregnancy, it is important to maintain a good level of activity, healthy diet, sufficient sleep, and support.

Dr Cameron: First, we need to move upstream to improve blood pressure control and cardiovascular health before pregnancy. In a recent study, we found that less than one-half of individuals enter pregnancy in favorable cardiometabolic health.17 Emphasizing the importance of optimizing cardiovascular health early in the life course, both at the physician and policy level, is key.

Second, pregnancy is a time of high health care utilization and, therefore, can be an opportunity to empower patients with knowledge regarding cardiovascular health optimization, blood pressure monitoring, and blood pressure goals. Screening for social determinants of health and identifying barriers to controlling blood pressure are essential steps to developing patient-centered plans of care anytime during the peripartum period.

Finally, it is essential to facilitate transitions of care from pregnancy to postpartum. Individuals with hypertension during pregnancy should be seen by a cardiologist or primary care physician for ongoing preventive care and blood pressure management after pregnancy. Unfortunately, many of these patients are lost to follow-up during the first year postpartum. Promoting team-based care and creating systems to facilitate follow-up are key steps to ensuring patients get timely and appropriate care.

Dr Mitchell: On the individual level, physicians should work to identify and mitigate biases during patient care and avoid gaslighting patients to avoid missed diagnoses or inappropriate treatment.

Dr Sabanayagam: Physicians are advised to care for these patients based on their risk profile longitudinally with a multidisciplinary team consisting of internists, cardiologists, obstetricians, and high-risk maternal fetal medicine as well as OB anesthesia, amongst others. ACOG currently recommends a stricter blood pressure target of 140/90 mm Hg during pregnancy, and women with higher blood pressures are advised to start antihypertensive therapy.18

Over the last decade, initiation of 81mg to 162 mg of aspirin up until delivery has also been advised in some women based on their risk profile, and as early as the 11th week of gestation to reduce the risk of pre-term pre-eclampsia.  

What are a few of the most critical measures needed to foster improvement in this area, such as public health efforts and topics of research to focus on? 

Dr Contreras: Some of the most pressing needs include early diagnosis, treatment, and medical access, blood pressure control, and addressing disparities and social determinants of health. There also needs to be an increased focus on cooking and eating healthy food.

It is important that all women have basic medical care, preventive medicines, increased health coverage during pregnancy and at least 1 year postpartum, as cardiovascular conditions can manifest during the postpartum period, and it is key to control these conditions to improve long-term patient outcomes. Also, if patients have cardiovascular health issues during pregnancy, they are more likely to develop CVD later in life, so care must continue throughout the patient’s life.

We need to empower women to understand how to take better care of their health. We need to increase our education efforts, and they need to be available in Spanish and culturally sensitive to our patients. We need to eliminate structural racism, discrimination, and unconscious bias in our current health care practices to provide better care to all our patients.

We also need to intensify our efforts to increase representation of Hispanic/Latina women in all aspects of care, especially in clinical trials. We need to understand how disease manifests in these populations and if there are differences that need to be understood and better treated. We do not even have any solid epidemiologic data in many countries, not even in the US, regarding CVD in Hispanic/Latina women.

Dr Cameron: The US has the highest maternal mortality rates among developed countries, with persistent disparities by race and ethnicity. Research must continue to identify the drivers of these disparities to help design targeted public health efforts that equitably improve cardiovascular health during the peripartum period. We must also continue to work with local communities to better understand both their assets and barriers to promoting maternal health, and form partnerships that empower communities to make lasting change.

Dr Mitchell: On the system level, we need to enhance multi-disciplinary education for OB/GYN, emergency, pediatric, and internal medicine to recognize and manage cardiac conditions pre-pregnancy and during pregnancy and postpartum, improve access of care—especially to higher-level specialty care—for patients with cardiac conditions, enhance translation services to address language barriers, enhance education for providers and systems regarding anti-racism and cultural humility and proficiency, and enhance community education programs to help aid in educating and treating cardiac-related conditions.

Dr Sabanayagam: The unfortunate rise in recent years in maternal morbidity and mortality is a public health emergency. There have been large efforts across many public health institutions and professional societies to understand these factors, including the social determinants of health, addressing disparities and the lack of access to care, as well investigating ways to improve early diagnosis and treatment of hypertensive disorders in pregnancy to mitigate both short-term and long-term adverse outcomes.   

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Cardiovascular Polypill Programs: Addressing Barriers to Care https://www.thecardiologyadvisor.com/home/topics/stroke/cardiovascular-polypill-programs-addressing-barriers-to-care/ Fri, 23 Jun 2023 14:23:27 +0000 https://www.thecardiologyadvisor.com/?p=107422

Polypill therapy for cardiovascular disease may help address some barriers to care and health care disparities.

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Is there a magic pill for the world’s leading cause of death? Some experts believe a combination medicine, or “polypill,” can offer dynamic protection against heart disease. However, critics are wary about broadly dispensing treatment without individualized care and monitoring. Could a polypill erase disparities in underserved populations, or does it just put a Band-Aid on a larger problem? Here’s how the research stacks up.

What Is a Polypill?

A polypill contains 3 to 4 low-dose pharmaceuticals designed to decrease multiple cardiovascular risk factors at once.1 Cardiovascular polypills usually contain at least 1 antihypertensive and 1 statin, and may or may not have other additions like aspirin and folic acid. Researchers introduced the polypill concept in 2003, advocating for the proactive treatment of everyone older than 54 years, regardless of their lipid levels or blood pressure.Using data from clinical trials and meta-analyses, early polypill researchers predicted an 88% reduction in ischemic heart disease and an 80% decrease in occurrence of stroke with mass administration.1

Today, proponents of polypill therapy say it improves adherence through the simplicity of a single daily pill. Other advantages of this fixed low dose include an optimal safety profile and a decreased need for follow-up visits for dose adjustments.2 As an effective preventative tool against stroke, polypill therapy also has the potential for significant cost savings, both in health care dollars and quality years of life. However, the jury is still out on how polypill therapy will affect large populations in the absence of supervised care.

Is Polypill Therapy Effective?

Large-scale trials of cardiovascular polypills have not entirely lived up to their originator’s predictions. Nonetheless, polypills have demonstrated significant benefits in stroke prevention. For example, in the 2016 HOPE-3 trial, a polypill containing candesartan, hydrochlorothiazide, and rosuvastatin produced a 44% decrease in stroke risk compared with placebo.1 Another study, known as the Polylran study in 2019, found that a polypill had a 56% reduction in nonfatal strokes and a 62% reduction in fatal strokes.1 Finally, the 2021 TIPS study demonstrated that an aspirin-containing polypill led to similar effects, lowering stroke occurrence by 58% compared with placebo.1

A polypill-based strategy led to greater reductions in systolic blood pressure and LDL cholesterol level than were observed with usual care in a socioeconomically vulnerable minority population.

In 2019, the New England Journal of Medicine published a randomized, controlled trial on 303 low-income adults from Alabama receiving care through a federally-qualified community health center.2 Participants had an average annual income below $15,000 and were randomly assigned to receive standard care or a polypill. Each polypill contained 10 mg atorvastatin, 2.5 mg amlodipine, 25 mg losartan, and 12.5 mg hydrochlorothiazide and cost $26 per month. After 1 year of treatment, those taking the polypill had an average systolic blood pressure reduction of 9 mm Hg, compared to just 2 mm Hg in the standard care group. The polypill group also experienced an average 15 mg/dL low-density lipoprotein cholesterol (LDL-C) level decrease versus 4 mg/dL for the standard care group.

The researchers concluded, “A polypill-based strategy led to greater reductions in systolic blood pressure and LDL cholesterol level than were observed with usual care in a socioeconomically vulnerable minority population.”2

The New England Journal of Medicine later published a phase 3 randomized controlled trial of older adults with a recent history of myocardial infarction in 2022.3 The researchers randomly assigned 2499 participants to receive either polypill treatment or standard care for a median of 36 months. This polypill contained aspirin, ramipril, and atorvastatin. Participants in the polypill group had a lower frequency of cardiovascular events than those receiving standard care during the study period. The researchers attributed some of this benefit to better compliance with polypill therapy. Overall, patients with high adherence to their prescribed medications experienced a 27% lower cardiovascular risk.

Overcoming Barriers With Polypill Therapy

Public health officials have identified glaring disparities among underserved populations. Various socioeconomic factors lead to marked outcome differences, including a 2-fold higher incidence of fatal cardiovascular heart disease events in non-Hispanic Black men versus non-Hispanic White men between the ages of 45 to 64 years and a 1.44-fold higher risk for Black women versus White women of the same age group.4

The American Heart Association has identified 7 core health behaviors and factors that define heart health. These include smoking, physical activity, diet, body mass index, cholesterol levels, blood pressure, and glucose control. Perhaps one of the biggest contributors to higher stroke risk is poor diet quality, with observational studies noting a dose-response relationship between healthy eating and cardiovascular death and disability.4

Diet quality directly correlates with socioeconomic status, race, ethnicity, education level, and the use of food assistance programs. Racially-segregated neighborhoods, food insecurity, and food deserts remain despite the efforts of government food assistance programs. A polypill may help decrease some stroke risk, but it doesn’t address these critical issues.

The obvious benefits of polypill therapy include measurable outcome differences in stroke risk and better adherence to proven preventative medications. However, nutrition, smoking, and physical activity still warrant attention as their impacts are far-reaching beyond cardiovascular health, extending to general well-being and other disease prevention. As more research on polypill therapy continues to unfold, it may very well earn a place in the primary prevention of strokes, especially when combined with risk modification programs and the continued promotion of healthier living.5

Where Do We Go From Here?

Polypill therapy promises a simple solution for a serious problem. In underserved communities plagued with heart-related death and disability, polypill therapy shows clear potential to make a lasting impact. However, any benefits from polypill therapy must not overshadow the continued need for individualized healthcare and comprehensive lifestyle programs. Pairing thoughtful administration of polypill therapy with community and personalized risk reduction can build a bridge between the best of both worlds.

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Artificial Intelligence Poses Threat to Patient Privacy https://www.thecardiologyadvisor.com/home/topics/practice-management/artificial-intelligence-poses-threat-to-patient-privacy/ Wed, 21 Jun 2023 13:28:56 +0000 https://www.thecardiologyadvisor.com/?p=107300

One concern is that AI could make it possible to re-identify patients from anonymized data.

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Specific regulations for artificial intelligence (AI) technologies may be warranted to ensure the confidentiality of patient data. Currently, hospitals may use anonymized patient data or share or sell it to further development of AI, which can pose risks to patient privacy. “AI also makes it easier to re-identify patients from de-identified data that’s been shared by triangulating from different data sources,” according to W. Nicholson Price II, a professor of law at the University of Michigan Law School in Ann Arbor, who specializes in intellectual property, health law, and regulation.

He pointed out that potential risks to patients may not have manifested yet, but could occur as the AI technologies become powerful. Businesses and consumers and others affected by these systems have a right to know if technologies have been adequately vetted and risks have been appropriately mitigated, according to Price.

Health care providers, Price said, need to be careful about how they share and use patient data. “The HIPAA safe harbor [rules] means that sharing de-identified patient data is still probably okay for now from a HIPAA perspective, though that could potentially change,” he said. “We need to have a conversation about how health data are used to develop AI. Right now, it’s too easy to get data for some entities and too hard for others. We’re not getting the balance right, and that needs to change. How we get to a better place, though, is a really tough question.”

Niam Yaraghi, PhD, an assistant professor of business technology at Miami Herbert Business School of the University of Miami in Florida, agrees, saying we are in a new era in terms of policing protected health information (PHI). In principle, AI is a set of statistical methods designed to uncover patterns in data. With recent advances in this area, it is now easier than ever to uncover patterns that we may have not been aware of in the past.

They can no longer assume that their older methods of masking the data would still protect the privacy of their patients.

“This could create a major threat to re-identification of anonymized data, especially when such data are merged with other sources of data across multiple platforms,” said Dr Yaraghi, who also is a Senior Fellow at the Brookings Institution’s Center for Technology Innovation in Washington, DC. “Our privacy protection laws, including HIPAA, are outdated and do not have provisions to help protect the privacy of patients in these new situations.”

One of the biggest issues facing physicians is educating their employees and vendors. Many physicians may not realize how their patient data are being used, Dr Yaraghi said. “As AI makes it easier to mine the data, the benefits for the AI users increase, while the privacy risks for the patients also increase. It is a win-lose game between the data miners and the patients,” he said.

Physicians should not underestimate the threat AI technology poses to medicine and the delivery of care, he noted. “They have to be extra vigilant about the possibility of re-identification when it comes to sharing of their data outside their organization,” he said. “They can no longer assume that their older methods of masking the data would still protect the privacy of their patients.”

On April 25, 2023, 4 federal agencies jointly pledged to uphold America’s commitment to the core principles of fairness, equality, and justice as emerging automated systems and AI become increasingly common in peoples’ daily lives. It is impacting not only patient privacy but also civil rights, fair competition, consumer protection, and equal opportunity. The Civil Rights Division of the United States Department of Justice, the Consumer Financial Protection Bureau, the Federal Trade Commission, and the Equal Employment Opportunity Commission released a joint statement outlining a commitment to enforce their respective laws and regulations.

All 4 agencies have previously expressed concerns about potentially harmful uses of AI and resolved to vigorously enforce their collective authorities and to monitor the development and use of automated systems. Now that AI has spread to every corner of the economy, it is paramount that regulators stay ahead of its growth.

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The Future of Virtual Reality in Neurorehabilitation: An Expert Roundtable https://www.thecardiologyadvisor.com/home/topics/stroke/future-virtual-reality-in-neurorehabilitation-expert-roundtable/ Fri, 02 Jun 2023 13:26:51 +0000 https://www.thecardiologyadvisor.com/?p=106671 Close-up-of-senior-women-happy-using-virtual-reality-headset-at-a-retirement-home.

Two stroke specialists and a physiotherapist discuss the emergence of virtual reality (VR) in neurorehabilitation and the future of VR research.

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Close-up-of-senior-women-happy-using-virtual-reality-headset-at-a-retirement-home.

In the past 15 years, virtual reality (VR) technology has gained traction as a valuable tool in neurorehabilitation.1 In patients with multiple sclerosis (MS), for example, several studies published in 2023 demonstrated improvements in manual dexterity and upper limb motor function, as well as measures of daily functioning, quality of life, mood, and treatment satisfaction, following VR training.1-3

Additionally, in a 2022 meta-analysis published in the journal Neurological Sciences, researchers found that home-based VR training was associated with improvements in postural balance in patients with MS, Parkinson disease, and stroke.4

In a 2020 multicenter, single-blind randomized controlled trial published in Developmental Medicine & Child Neurology, the researchers compared the effects of a VR rehabilitation intervention combined with conventional occupational therapy to conventional therapy alone in children with cerebral palsy. The VR group showed greater improvements in upper-limb dexterity functions, activities of daily living, and forearm supination.5

Upon the completion of a 6-week home-based VR exercise program, some older adults with mild cognitive impairment reported physical benefits, and a few noted cognitive benefits, according to a 2020 study published in the Journal of Aging and Physical Activity. 6 The intervention was also shown to be safe and feasible, although no significant change in physical or cognitive outcome measures was observed.

In an ideal world, we would see high-quality clinical trials evaluating VR in all of these patient groups.

To learn more about the state of research and practice of VR technology in neurorehabilitation, we spoke with the following experts:

  • Hillel M. Finestone, MDCM, FRCPC, professor in the division of physical medicine and rehabilitation at the University of Ottawa and director of stroke rehabilitation research at Elisabeth Bruyere Hospital in Ontario, Canada
  • Lisa Sheehy, PhD, physiotherapist and research associate at the Bruyère Research Institute at the University of Ottawa
  • Sean Dukelow, PhD, professor in the department of clinical neuroscience at the University of Calgary in Alberta, Canada, and medical director of stroke rehabilitation for the Calgary Stroke Program

What are some positive ways that VR has transformed the neurorehabilitation space, especially in terms of patient engagement and commitment to treatment?

Dr. Finestone: In general, patients enjoy the ‘exer-gaming’ activities provided by VR technology. Some of them said it was less boring and that ‘the time goes quicker.’ Of course, the response depends on the game itself — some are very simplistic and can be perceived as ‘boring,’ but that is typically not the case.

Dr. Dukelow: I think of VR as a tool that we can use to gamify the rehabilitation experience, which can help with patient engagement. In a typical rehabilitation setting, VR can be used to augment things that a clinician might be working on with a patient. One of the exciting facets of VR is that it may be used to do things that are unique and difficult to pull off in a standard rehabilitation setting or a completely natural environment. One example might be trying to train a patient to scan for objects in an area where they have lost visual fields or have attentional impairment — this is something that can fairly easily be accomplished in VR.

Many patients really enjoy VR because of the game-based approach. It has a bit of an addictive side to it — consider the amount of people who loved to play games like Tetris and Candy Crush in the past. Certainly, we now have a whole generation of people who grew up with video games coming through the health care system, so the idea of doing some of the rehabilitation by playing a VR game isn’t so foreign.

What are the differences and potential barriers in getting adults vs children to use VR in rehabilitation therapy?

Dr. Dukelow: I think one of the barriers to VR engagement has been the use of headsets in older adults, which could cause some problems with nausea. Traditionally, this has been dealt with by slightly less immersive VR systems — think big screens — but the newer headsets have higher refresh rates, so we are seeing less of those issues. 

Can you discuss the neurobiologic mechanism that makes VR successful in neurorehabilitation?

Dr. Sheehy: Use of VR follows many of the principles of motor learning — that is, repetition, task-specific practice, meaningful practice, augmented feedback, observational learning, and motivation. There are studies that show enhanced neural activity in the affected brain due to participation in VR therapy.7

What makes VR use in neurorehabilitation such an intriguing option to clinicians? 

Dr. Sheehy: VR can be implemented by therapists, rehabilitation assistants, family members, or volunteers. It can be used as a therapy modality or as an adjunctive therapy, or to provide extra rehabilitative exercise. It can be used for inpatients, outpatients, in the community, and in the home. It can be used for people with sub-acute and chronic conditions.

Dr. Dukelow: As I mentioned, VR is an intriguing option for clinicians because it can augment what they are doing in their 1-on-1 or group therapy sessions in the real world, and it can go beyond what the clinician is able to do in the real world. I’m not sure there is a well-established mechanistic explanation for why VR may be outperforming other therapies. Some have suggested that it has to do with increased engagement. We know that if a patient is more engaged and motivated, they are more likely to do their exercises.

In neurorehabilitation, how much you do matters, but most clinicians would argue what you do matters too.

Can you describe the evolution of VR-based interventions for physical and cognitive rehabilitation for various neurologic conditions?

Dr. Dukelow: In general, when a technology initially comes into neurorehabilitation, it often gets tested by an individual or group of people who have access to a certain patient population and think they might benefit from that technology. Over time, as the technology becomes more widely available, more and more people see it and think of its potential applications for other populations. You see a ‘creep’ or ‘spread’ in the indication.

This has happened for lots of different interventions in the neurorehabilitation space, from electrical stimulation, to robotics, to non-invasive brain stimulation. When a technology is non-invasive like VR, then it is very easy for clinicians to try it for different conditions. I think it’s important to state here that, at some point, the new technology needs to be properly tested in well-conducted clinical trials to see if it actually improves these conditions.

What are some conversations you’ve had with patients newly exposed to VR technology?

Dr. Sheehy: Most patients enjoy VR, and it inspires them to do more therapy. This also goes for patients who are older — even in their 90’s — or who have no previous experience with VR or with computers at all. Some who are very tech-adverse or too overwhelmed with their new reality are not interested. Those with a lot of gaming experience tended to find it dull and rather unpolished.

Patients prefer the games that are most intuitive and the most “gamified” — i.e., the scoring system reflects success — and some participants in our research had the most difficulty with games that incorporated complex visuospatial tracking.6

Dr. Dukelow: Quite honestly, these are usually pretty short conversations. Of course, we have to walk through the potential risks and benefits of any treatment, but generally people are keen to try it out because the risks are minimal. Do we have people who aren’t interested? Sure, we have an occasional person who isn’t at all interested in video games or trying something tech-related, but most people want to give it a shot.

Which patient population do you believe will benefit the most from VR, and which population do you think should be the main focus of research in this area?

Dr. Finestone: I think VR-enhanced neurorehabilitation is a useful adjunct to traditional rehabilitation methods. I don’t think it can completely replace physiotherapists and occupational therapists. I do think that most neurorehabilitation patients would benefit from this technology. My vision for the future is that there will be specific games that target specific neurologic losses and disabilities.

For instance, a patient who has loss of balance due to a cerebellar infarct will be challenged with VR games targeting gait, sitting, and standing balance, and other similar activities. A patient with hemiparesis will play games targeting the weakened right arm and leg. There are currently specific exercise programs, particularly with physiotherapy, which are VR-based.

Dr. Dukelow: VR is a tool, and rehabilitation tools have the ability to cross different patient populations. With that lens, I think we are seeing that there are potential benefits for cognition, gait, and balance, and I think there exists considerable potential for motor recovery. You’ll notice these areas cross patient populations.

Would I like to see more efforts and funding put into stroke? Selfishly, as a stroke specialist, I would say yes, but I think there is significant potential in the other patient groups that you have brought up, and these patients also have tremendous needs for better interventions. In an ideal world, we would see high-quality clinical trials evaluating VR in all of these patient groups.

Editor’s Note: This interview was edited for clarity and length.

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FBI Report Offers Bleak Outlook on Cybercriminal Activity https://www.thecardiologyadvisor.com/home/topics/practice-management/fbi-report-offers-bleak-outlook-on-cybercriminal-activity/ Tue, 30 May 2023 12:58:17 +0000 https://www.thecardiologyadvisor.com/?p=106495

In 2022, the FBI’s Internet Crime Complaint Centers received 800,944 complaints about cyber incidents.

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In a recently released report about the increasing threat of cybercrime, the FBI emphasized that it is crucial for individuals and entities to report cyber incidents to its Internet Crime Complaint Center (IC3), “as that valuable information helps fill in gaps that are crucial to advancing our investigations. Your efforts are critical to our ability to pursue the perpetrators and share intelligence to protect your fellow citizens.”

The IC3 enables the FBI to collect data, identify trends, and pursue threats related to cybercriminal activity.

“Today’s cyber landscape has provided ample opportunities for criminals and adversaries to target U.S. networks, attack our critical infrastructure, hold our money and data for ransom, facilitate large-scale fraud schemes, and threaten our national security,” the 32-page Internet Crime Report 2022 report reads. “At the FBI, we know ‘cyber risk is business risk’ and ‘cyber security is national security.’”

Cybercrime Statistics

As of December 31, 2022, the IC3 had received more than 7 million complaints, according to the report. In 2022 alone, the IC3 received 800,944 complaints. Although this was a 5% decrease from 2021, the potential total dollar loss jumped from $6.9 billion in 2021 to more than $10.2 billion in 2022. California led the nation in the number of cyber victims in 2022 (80,766), followed by Florida (42,792) and Texas (38,661).

“We have seen cyber threats emanate from around the world and witnessed the scope and sophistication of these scams and attacks deepen,” according to the report. “As these threats increase, we continue to encourage victims to report cyber incidents and cyber-enabled frauds to the FBI so that we may impose risks and consequences on malicious cyber actors.”

“In the medical world, it is well known that washing hands and wearing masks is essential hygiene. The same is true in cybersecurity; there are several essential security hygiene practices that make it easier to both evade threats and to quickly detect those attacks that get through.

Freezing of Assets

The FBI’s Recovery Asset Team (RAT), which was established in 2018, streamlines communications with financial institutions and FBI field offices to assist freezing of funds for victims of cybercriminal activity. In 2022, RAT initiated the Financial Fraud Kill Chain (FFKC) on 2,838 Business Email Compromise (BEC) complaints involving domestic-to-domestic transactions with potential losses of over $590 million. A monetary hold was placed on approximately $433 million, which represented a 73% success rate. In 2022, RAT saw a 64% increase in FFKCs initiated compared to 2021.

State Actors Especially Dangerous

Mikhail Gofman, PhD, Director of the Center for Cybersecurity at California State University in Fullerton, said so far this year the number and sophistication of cyber attacks are both on the rise. “Especially dangerous are state actors looking to attack the critical infrastructure, including health care, with ransomware being a popular form of attack against health care organizations,” Dr Gofman said.

He added, “It is critical that all health care organizations implement good security governance where security policies govern all operational aspects of the organization, the policies are enforced, and each employee is trained in their obligations of protecting the organizational security.” 

By quickly reporting cyber attacks, Dr Gofman said, all affected parties can take the proper measures to help limit the negative impacts. Further, he noted that the affected organizations can receive assistance from their vendors, contractors, and federal and state agencies in limiting the impacts of the breach. All these entities can help investigate the cause.

“In addition, reporting one’s incidents will have an overall positive effect on national security by prompting organizations to prepare and take proper measures,” he said. “For example, when a health care organization is a victim of a ransomware attack, reporting the incident can help other health care organizations prepare for and prevent the attack.”

John Pescatore, Director of Emerging Security Trends at SANS Institute, a private US for-profit company specializing in information security and cybersecurity training, said rapidly determining the extent of an attack and notifying impacted customers is critical for businesses and government agencies. “That often results in press coverage, but it is always better to be the one who tells your customer first,” Pescatore said. “Notifying law enforcement or other officials is less important, but often required by regulations.”

Cybercriminals Getting Better

In general, he said, regulatory officials are not going to help health care businesses directly.  However, once regulatory agents have knowledge of the issues they can generate statistics.

“Attackers are continually getting faster in exploiting vulnerabilities and more sophisticated in avoiding detection,” Pescatore said. “In the medical world, it is well known that washing hands and wearing masks is essential hygiene. The same is true in cybersecurity; there are several essential security hygiene practices that make it easier to both evade threats and to quickly detect those attacks that get through.”

He said 90% of successful attacks use phishing emails to steal reusable passwords. “Using multi-factor authentication, as simple as an added text message, thwarts over 90% of those attacks,” Pescatore said.

Noah Jellison, Executive Director for The Risk Institute at Fisher College of Business at The Ohio State University in Columbus, said there are tens of thousands of cyber attacks, if not more, that occur on a daily basis, and the number keeps increasing. “Therefore, it is virtually impossible to report every single cyber attack that occurs,” Jellison said. “In some cases, it could take months or even longer to definitively identify whether a cyber attack had occurred or not.”

Vigilance Is Tough

Cyber attackers can leverage the knowledge of knowing who business partners are, according to Jellison. If an attacker knows that your health organization is doing business with another organization that has potentially less mature cyber security standards and practices than you, then they might directly target and attack that health care organization to get to you. He said it is now much more like a game of chess where you must try and think so many steps ahead of the opponent. “Even staying vigilant becomes an overwhelming endeavor, especially in the health care space and especially with physicians and smaller medical practices, which may not have the resources, funds and/or technical expertise to be vigilant enough,” Jellison said.

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Ready for Retirement? Financial Planning for Physicians https://www.thecardiologyadvisor.com/home/topics/practice-management/ready-for-retirement-financial-planning-for-physicians/ Fri, 19 May 2023 13:20:09 +0000 https://www.thecardiologyadvisor.com/?p=106130

It is never too early to start planning for retirement, especially for people entering the medical field.

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While there are other important financial and nonfinancial goals, the greatest financial task of your life is to build a nest egg that will allow you to live a comfortable retirement over multiple decades after you no longer can or wish to work. For most physicians, this will require an accumulation period of 10 to 30 years of hard work, methodical saving, and disciplined investing.

The greatest wealth building tool for most physicians is their income. While the average household income in America is around $70,000 per year, according to the 2022 Medscape Physician Compensation Report, the average cardiologist is earning $490,000.1 While that sort of an income is accompanied by a large tax bill, there is still plenty of money left after taxes to support a robust investing plan. However, the first challenge for any physician interested in a dignified retirement is to carve out a large chunk of that income and designate it for retirement.

Financial independence or retirement is best thought of as a sum of money, rather than an age. The length of your career from the time you leave training until you are financially independent is most dependent on your savings rate. The bad news about retirement is that it requires a large sum of money, approximately 25 times your annual spending.2 The good news is that over a traditional full career, a reasonable investing plan will ensure your money (and compound interest) do a lot of the heavy lifting of accumulating that large sum. You only need to save about 20% of your gross income, assuming reasonable investment returns. However, if you wish to retire early, a savings rate of more than 20% of your gross income, perhaps as high as 50% of your gross income, is required. The higher the rate, the earlier the retirement.

It would not be unusual for a cardiologist with a mid to high 6 figure income to have an effective tax rate of 25 to 30% of gross. Add a 20% savings rate to that and it quickly becomes clear that spending more than half of your gross income is a bad idea. Thus, the first challenge for graduating cardiology fellows is to avoid ever growing into their full income. In fact, a short period of time (2-5 years) of “living like a resident” after completing training can really jumpstart the process (as well as pay off student loans).

It is critical to understand how each of the accounts available to you works in order to maximize your benefits.

The government and your employer want to encourage you to save more for retirement. They both provide important benefits to you that can boost your after-tax returns and protect your assets from lawsuits, speeding up the process of accumulating a large nest egg. While anyone can save and invest an unlimited amount in a nonqualified, fully taxable brokerage account, retirement accounts are a better way to save for retirement whenever possible. Accounts such as Roth IRAs, 401(k)s, 403(b)s, 457(b)s, cash balance plans, and solo 401(k)s are commonly used by physicians. Each of these accounts allows for tax-protected growth as well as either an upfront tax deduction (traditional, tax-deferred accounts) or tax-free withdrawals (Roth accounts). These accounts also receive substantial asset protection benefits. That means that if you are in the rare position of facing a malpractice judgment above policy limits that is not reduced on appeal and you are forced to declare bankruptcy, you get to keep your retirement account money.

Employers may also offer matching or profit-sharing contributions. Not contributing enough to obtain the full match is the equivalent of leaving part of your salary on the table. It is critical to understand how each of the accounts available to you works in order to maximize your benefits. For instance, many doctors don’t realize they can still contribute to a Roth IRA each year despite their high income; they just have to do it indirectly via a process known as “The Backdoor Roth IRA.” Physicians are also often surprised to learn that they may be able to use more than 1 401(k) if they have 2 unrelated employers or have some self-employment income.3 Most of the investments in these types of accounts are mutual funds, and the data is clear that it is generally best to use low-cost, broadly-diversified index mutual funds when available.

Some physicians have the time, interest, and funds to seek out nontraditional investments. Real estate is a common choice, whether done actively by directly owning rental properties, or passively through private investments such as funds, Real Estate Investment Trusts (REITs), and syndications. Others find an entrepreneurial itch to scratch and open their own small businesses, which may or may not be related to their practice. These sorts of investments not only help to build a nest egg, but can also provide substantial passive income that can be spent along the way instead.

While it is entirely possible (and recommended) for a physician to become financially knowledgeable and disciplined enough to do this themselves, most physicians will benefit from obtaining professional financial planning advice and investment management services. The key is to obtain good advice at a fair price. While good advice can be difficult to recognize without actually being financially knowledgeable enough to do it yourself, a fair price ranges from $5,000 to $15,000 per year for a “full-service” advisor. It is also possible to pay a flat hourly rate to get occasional advice and do a periodic check-in to ensure you’re on track, essentially blending the do-it-yourself and the professional methods. Naturally, there is no price low enough for bad advice, which is unfortunately the vast majority. Most financial professionals calling themselves financial advisors are actually commissioned salespeople masquerading as advisors. Make sure your advisor is an experienced, fee-only fiduciary with a meaningful designation and commitment to the profession such as a Certified Financial Planner (CFP).

Your hospital or group may also offer resources including education or even formal advice. While you should take advantage of these resources, don’t assume they are competent just because they are associated with the employer or your retirement plan. The same conflicts of interest still exist. Take advantage of free resources. There has never been as much high-quality, free educational financial material on the internet as there is today. Physician financial blogs, email newsletters, podcasts, videos, online courses, books, forums, and conferences are now widely available and can be used to supplement or even replace a traditional financial advisor.

Unfortunately, the date of your retirement may not be entirely in your control. Death, disability, illness, burnout, and family factors can shorten a career or otherwise dramatically impact the ability of a physician to earn. Becoming financially independent provides a doctor the option to retire early, but many financially independent doctors continue to practice on their own terms well beyond that point. Financial freedom has many benefits besides the ability to leave paid work at a time of your choosing.

Was this article relevant to you or your practice? We, at Cardiology Advisor, would like to cover topics that cater to the needs of health care providers in the cardiology field. If you have a moment, please feel free to click the following link to fill out our survey regarding potential future feature topics. Thank you for your time and we look forward to hearing from you!

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Did Hospitals Violate EMTALA by Failing to Provide Abortion Care? https://www.thecardiologyadvisor.com/general-medicine/hospitals-violate-emtala-abortion-care-2/ Fri, 12 May 2023 13:51:45 +0000 https://www.thecardiologyadvisor.com/?p=105842 doctors looking at patient on a gurney emergency care

CMS investigates 2 hospitals for EMTALA violations related to abortion care for a pregnancy-related emergency.

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doctors looking at patient on a gurney emergency care

The Centers for Medicare and Medicaid (CMS) launched an investigation of 2 Medicare-covered hospitals — one in Missouri and one in Kansas — that failed to offer necessary stabilizing abortion care to a patient experiencing an emergency medical condition stemming from a miscarriage, which is a violation of the Emergency Medical Treatment and Labor Act (EMTALA).

“CMS is committed to investigating allegations of noncompliance with EMTALA. The agency acted promptly to investigate and identify the violations at Freeman Health System in Joplin, Missouri, and the University of Kansas hospitals in Kansas City, Kansas,” according to a CMS spokesperson. Abortion is largely illegal in Missouri except in cases of medical emergency. In Kansas, abortion is legal up to 22 weeks of pregnancy.

The patient experienced preterm premature rupture of membranes (PPROM) at 18 weeks and was advised that her pregnancy was no longer viable, according to a statement from the US Department of Health and Human Services (HHS). Doctors at both hospitals she presented at said that hospital policies prohibited treatment that could be considered an abortion, yet advised her that her condition could rapidly deteriorate and lead to infection, hemorrhage, and potentially death.

“This was a violation of the EMTALA protections that were designed to protect patients like her,” HHS Secretary Xavier Becerra wrote in a letter to hospital and provider associations. “We will use the full extent of our legal authority, consistent with orders from the courts, to enforce protections for individuals who seek emergency care — including when that care is an abortion.”

“During her visits to 2 different hospitals, the patient was not offered the care that her doctors determined was necessary to stabilize those emergency medical conditions — not because of the clinical judgment of her providers, but because the hospital policies would not allow an abortion to be performed,” Becerra said.

American Hospital Association Responds

“Hospitals and health systems across the United States take seriously their obligations under EMTALA. While we cannot comment on the specifics of any case, the American Hospital Association [AHA] routinely provides advice to our members about EMTALA requirements,” said AHA General Counsel and Secretary Melinda Hatton.

Last July, HHS issued an updated guidance explaining that the EMTALA law applies to patients who are pregnant or experiencing pregnancy loss. AHA shared this advice with their membership and, in August, the association filed an amicus brief “in support of the Department of Justice’s case seeking to enforce EMTALA in Idaho,” where the abortion law made it a felony to terminate a pregnancy with few exceptions, Hatton said. “As we explained in that brief, it is critical that providers have clarity across state and federal law about what care they may — and, in the context of EMTALA, must — provide, and the AHA will continue to work to obtain that necessary clarity.”

Battle Over EMTALA in Texas

A case in Texas is under appeal after the US District Court for the Northern District of Texas issued an injunction prohibiting certain applications of the EMTALA guidance issued on July 11, 2022. Based on that initial court case, a revision to the July HSS guidance now states that:

  • HHS may not enforce the Guidance and Letter’s interpretation that Texas abortion laws are preempted by EMTALA
  • HHS may not enforce the Guidance and Letter’s interpretation of EMTALA — both as to when an abortion is required and EMTALA’s effect on state laws governing abortion — within the State of Texas or against the members of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and the Christian Medical and Dental Association (CMDA)

“The Texas case puts both patients and doctors in a terrible, untenable situation,” said Ann W. Latner, JD, a former criminal defense attorney. “It essentially prevents clinicians from treating patients who require abortion services as part of their emergency care. It defeats the whole purpose of EMTALA, which was to ensure that patients get treatment for emergency medical conditions. It leaves women experiencing pregnancy loss in a no-win situation when they can’t access appropriate medical care, as in the situation that CMS is investigating.”

“Moreover, this will certainly lead to future lawsuits when a patient is harmed as a result of not being properly treated,” Latner said. “Clinicians are being put in a position where they have to weigh their Hippocratic Oath against conflicting state and Federal laws — an incredibly challenging situation, and one in which the patient can sometimes be the loser. Clinicians, in Texas and beyond, should strive to treat patients in the most appropriate manner, within the law, keeping in mind that EMTALA requires medical stabilization.”

Similar Reports About Confusion Regarding Abortion Care and EMTALA

Becerra noted that news reports describe similar experiences among other patients with pregnancy-related emergencies and said these cases may be related to uncertainty among facility administrators on whether providers can use reasonable medical judgment to care for these emergencies in states where abortion care is not legal.

“While many state laws have recently changed, it’s important to know that the federal EMTALA requirements have not changed, and continue to require that health care professionals offer treatment, including abortion care, that the provider reasonably determines is necessary to stabilize the patient’s emergency medical condition,” Becerra wrote. 

CMS will make sure that the hospitals come into compliance with federal law so that EMTALA’s guarantees are protected and take additional action as appropriate, according to HHS.  

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Is it Time for a Break? Prioritizing Vacation Time for Physicians https://www.thecardiologyadvisor.com/general-cardiology/is-it-time-for-a-break-prioritizing-vacation-time-for-physicians/ Fri, 05 May 2023 13:37:56 +0000 https://www.thecardiologyadvisor.com/?p=105458

Finding the time to get away and relax should not be treated as a luxury, especially in the high stress work environment that is the medical field.

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Many physicians routinely advise their patients on the importance of reducing psychological stress and taking time to relax, and cardiologists have a unique understanding of the link between stress and heart health in particular.1 However, they may find it difficult to follow their own advice, despite the critical need for downtime and high levels of physician burnout.

Among cardiologists, some findings indicate higher rates of burnout compared to other specialties,2 although results on this point have been mixed overall. Survey-based studies have also found that nearly one-half of cardiologists in the US reported high levels of job stress,3 and more than one-quarter of cardiologists worldwide reported the presence of a mental health condition.4

In addition to the potential value of vacation time for reducing professional burnout, multiple studies have linked adequate vacation time with improvements in various health measures and outcomes, including well-being, heart rate variability, sleep quality,5, incidence of metabolic syndrome,6 and mortality risk.7

One study showed that, even among individuals who diligently engaged in healthy lifestyle behaviors as part of a 5-year cardiovascular risk reduction intervention, those who took shorter vacation time each year had a substantially higher 30-year mortality risk compared with those who took longer vacation time annually (hazard ratio, 1.37; 95% CI, 1.03-1.83; P =.03).7

Taken together, these findings make a strong case for prioritizing personal time off for physicians.

In addition to the potential value of vacation time for reducing professional burnout, multiple studies have linked adequate vacation time with improvements in various health measures and outcomes . . .

To discuss benefits, barriers, and solutions regarding vacation time for cardiologists, we interviewed Laxmi Mehta, MD, cardiologist and professor, chief wellbeing liaison, faculty director of the Gabbe Health and Wellbeing Program, and director of preventative cardiology and Women’s Cardiovascular Health at The Ohio State University Wexner Medical Center in Columbus; and Amanda D. McCormick, MD, pediatric cardiologist and assistant professor of pediatrics, pediatric heart failure, and cardiac transplantation at the University of Michigan Medical School in Ann Arbor.

Both physicians have co-authored papers pertaining to professional burnout in cardiology,3,8,9 and Dr Mehta was an author of the study on mental health conditions among cardiologists.4

Why is it important for clinicians – and cardiologists in particular – to take an adequate amount of vacation or personal time throughout the year? 

Dr Mehta: Burnout rates are higher while work-life integration is lower among physicians compared to the general US working population. The chronic stress and high workloads are taxing, and physicians—just like our patients—need to rest and recharge. Taking time off is an essential component of our physical and mental health and may help reduce burnout. When physicians return from vacation they are rested and have improved performance and productivity.

Dr McCormick: It is well-recognized that employees from all fields benefit from time away from work, and this is no different for clinicians, of course. In particular, clinicians benefit both from being away from the demands of their practice and from the benefits of resilience-building [that comes] from the enjoyment of time away, whether that is time with loved ones, travel, or for other personal enjoyment.

Specific to cardiologists and other high-acuity specialties, vacation may affect 2 specific components of burnout – allowing reprieve from emotional exhaustion and decreasing depersonalization.

What are some of the barriers that may discourage or prevent physicians from taking time off?

Dr Mehta: Some barriers that physicians face are lack of coverage while away, organizational rules on vacation, and compensation models which de-incentivize time away from work.

Dr McCormick: Unfortunately, taking time off can be challenging for physicians. Some contributors may be the need to cancel or find coverage for patient responsibilities or loss of wages for physicians who are on hourly or relative value unite-based compensation models. For physicians in highly specialized careers where there may not be other physicians with their niche, coverage can be a huge challenge.

In addition to these practical things, even for physicians who take time away it may be challenging in the era of email, text message, and the electronic health record (EHR) to actually be “away,” as technology permits communication even when clinicians are on vacation.

What measures are needed on the practice or institutional level to enable and encourage physicians to take adequate personal time? 

Dr Mehta: Organizational culture needs to support and encourage physicians and their teams to take vacation time. Furthermore, adequate staffing and coverage are needed as well as compensation models that more appropriately adjust for time off.

Dr McCormick: Institutions and practices need to set the expectation that vacation is a requirement, not an option. The culture of everyone taking vacation promotes marginalized groups, including early career faculty and potentially those from underrepresented minorities, from feeling like they need to be constantly available to promote their careers.

Additionally, the culture of being truly “unavailable”— away from text, email, portal, and EHR during time off – must come from the top down. Further, there should be explicit expectations for what coverage is needed during time away.

What are recommendations for cardiologists to help them prioritize taking adequate personal time? 

Dr Mehta: Cardiologists need to recognize that self-care and vacation time are important, and they should ensure that vacation time is adequately accounted for in their contracts. In addition, we need to recognize the importance of time off, advocate for it, and be intentional in using our time off.

It is also important to recognize that vacation time doesn’t mean you need to stress about planning an exotic trip. Just being at home or wherever you like, doing things that you enjoy or spending time with family and friends, is critical recharging time. Self-care is not selfish – it is essential to being the best person and cardiologist that we can be.

Dr McCormick: Coping with a high-demand, high-acuity field like cardiology is a learned skill that we should be teaching in training. Residents and fellows should be taught to be intentional about their vacation time, as time away often requires significant planning ahead. They should also be taught to distance themselves from clinical demands while away.

Finally, for most practices, time away is a matter of reciprocity—if one partner is away, the other partners cover, and vice versa. Having a mindset of coverage for clinical demands for the good of the team, so that in turn you can take time away when planned, improves the whole team’s burnout and resilience.

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Telemedicine Continues to Benefit Small Solo Practices https://www.thecardiologyadvisor.com/home/topics/practice-management/telemedicine-continues-to-benefit-small-solo-practices/ Thu, 04 May 2023 12:12:27 +0000 https://www.thecardiologyadvisor.com/?p=105346

Telehealth has the potential to make health care equitable and accessible to almost 90% of US adults, thanks to the use of smartphones. Source: Getty Images

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The COVID-19 pandemic is ushering in a new wave of telemedicine enabling physicians to maintain quality of care without an office visit. Moreover, the widespread use of telemedicine has helped small independent primary care practices (SIPs), which are defined as those with 5 or fewer clinicians. SIPs provide primary care for a substantial proportion of the US population, and SIPs who were early adopters of telemedicine are benefiting significantly.

Up to 42% of smaller clinics switched to telehealth during the height of the pandemic, said Sristi Sharma, MD, a preventive medicine physician at UC Davis in California, who has been tracking telemedicine trends.

“Telehealth practice helped providers in small independent solo practices continue to manage their patients during the pandemic,” Dr Sharma said. Smaller practices were able to adapt quickly to telehealth during this period despite uncertainties about reimbursement and policies during the pandemic.

Solo practitioners are expected to build on their investment in telehealth through improved infrastructure, tools, and training, she said. Telehealth waivers granted by the state and federal agencies have been extended and are being reevaluated for the long-term, Dr Sharma said. In addition, there are significant federal investments being made to improve the broadband capacity in the country via the 2022 Infrastructure Investment and Jobs Act. “All of these are synergistically going to assist the solo practitioners to maintain and expand telehealth services to provide care for their patients,” Dr Sharma said.

Medical schools seem content to permit insurance companies and bean counters to control the business side of medicine.

The rapid transition from in-person care to telemedicine visits at the start of the COVID‑19 pandemic did not adversely affect the quality of care and even improved some aspects of it. Further, telemedicine may help reverse trends over the past 30 years showing a decline in the number of SIPs. Government mandates and advanced alternative payment models have been difficult for SIPS, who have limited resources for implementing the systems changes necessary to meet current quality standards.

Telemedicine Evolving, Improving

During the COVID-19 pandemic, routine blood pressure assessments decreased because of global disruptions to medical care delivery. Telemedicine successfully filled that gap. “I anticipate that the practice of medicine will continue to include widespread use of telehealth in the future, especially for ambulatory care,” Dr Sharma said. “Apart from patient and provider preference, there are other factors. They include supportive state and federal requirements, focus on improving telehealth infrastructure, and continuous innovation in the field that will ensure that telehealth is the future of medicine.”

A new study has found that a remote hypertension program successfully supported patients through the pandemic in achieving their blood pressure goals. The study, published in the Journal of the American Heart Association, demonstrated the potential for remote programs to provide more effective and equitable care for hypertension, as well as other chronic conditions. The program provided care when patients needed it most, and the program demonstrated the efficacy of a team-based approach through an entirely remote management system, according to the researchers.

The study included 1,256 participants with 605 enrolled in the program during the 6 months before the March 2020 pandemic shutdown and another 651 were enrolled during the 6 months after March 2020. Patients received a digitally connected home blood pressure monitor, which enabled them to collect a more complete and accurate set of measurements than those obtained in an office visit.

An evidence-based clinical algorithm analyzed home blood pressure recordings and guided pharmacological decision-making. It included a team approach with trained patient navigators, pharmacists, and supervising physicians working together to implement a therapeutic strategy with each patient. The rates of achieving goal blood pressure improved to 94.6% during the pandemic compared with 75.8% pre-pandemic. “Telehealth has the potential to make health care equitable and accessible to almost 90% of US adults, including those in the medically underserved communities, owing to their use of smartphones,” Dr Sharma said.

The pandemic has offered all practices, large and small, an enormous opportunity in the form of telehealth. Both patients and physicians like the format, said John Machata, MD, a board-certified family physician in Wickford, Rhode Island, who has been in practice for 39 years (12 years as an SIP) and is retiring as of April 1, 2023. He said independent solo practices continue to be gobbled up by large groups, which are usually operated by hospital networks. While telemedicine may help SIPs, even greater efforts are needed to protect solo practitioners.

“Patients deserve choices,” Dr Machata said. “Do we want patients’ only choice to be cared for by overworked doctors seeing as many patients per hour as possible because bean-counter bosses treat medical care like an assembly line? Small practices offer patients the ability to receive personal care at a relaxed pace.”

Both business skills and telemedicine have not been high priorities for medical school training programs. Unless this changes, overall care could be negatively impact, Dr Machata said. “Given that two-thirds of graduates are employed after their education, the incentive to teach business skills continues to fade,” he said. “Medical schools seem content to permit insurance companies and bean counters to control the business side of medicine.”

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The Psychology of Conflict Resolution https://www.thecardiologyadvisor.com/general-medicine/the-psychology-of-conflict-resolution/ Fri, 28 Apr 2023 13:22:19 +0000 https://www.thecardiologyadvisor.com/?p=105153

Health care providers should try not to make the common mistake of assuming that they have not contributed even in a small way to a conflict.

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Most of the time clinical care relationships proceed smoothly. Patients and their doctors work harmoniously together and there is mutual satisfaction. Still, a normal part of clinical care is the occasional occurrence of conflict. By virtue of their clinical training, many physicians are adept problem solvers. Even so, they could benefit from conflict resolution skills that help promote high-quality care. I will illustrate some conflict resolution principles by first presenting a non-health care conflict, and then show how those skills can be applied in a clinical setting.   

Last summer, my second-favorite appliance, a 10-month-old refrigerator, broke. Although I’m responsible for maintaining the appliances in our household, I’m temperamentally not suited for dealing with customer service. My fuse is short but when we have no place to keep our food, it’s even shorter. In spite of my limitations, the helpful customer service representative I spoke to was able to direct me to visit a nearby retail store for a prompt repair. 

When my spouse and I arrived in the store we were immediately greeted by a helpful floor salesperson. As we relayed our problem next to a blaring stereo speaker, he curtly informed us that our problem would have to be managed over the phone with a national customer service representative. I tried to remain outwardly calm when informing him that this was completely contrary to what I’d already been told. At that point, he become annoyed, which made me even angrier. Within 90 seconds, we were already off to a bad start.   

At that point, my wife knew to grab the reins and try to defuse the tension with her calm and reason. As she continued to patiently address the problem, the salesman visibly calmed himself and began to identify a range of solutions to address the problem. I was then able (albeit sheepishly) to rejoin the discussion and attempt to be constructive. In the next 3 minutes, he not only addressed our problem, but went above and beyond to significantly expedite the solution.  We thanked him profusely for his help, which led him to offer an apology for his behavior, which very quickly led me to apologize for my behavior.  We exchanged pleasantries for another minute and then he leaned in to hug me which I happily reciprocated. What began as a contentious argument in an appliance store evolved into apologies and hugs with a stranger in a matter of minutes. 

What went right to resolve this conflict and how we can apply this success to conflicts in clinical medicine? Before we identify some of the principles of conflict resolution, it’s important to identify the vignette’s limitations in this comparison. There is more about this vignette that is different from clinical medicine than what is similar. First, refrigerators are not surgical treatments and a relationship with a salesperson bears no real relation to a physician-patient relationship. But identifying the principles of effective service recovery and how to recognize and manage affect in arguments are useful lessons. Second, this story was told from my perspective. I’ve done my best to be objective, but you the reader are likely to be missing critical information when you haven’t had the opportunity to hear from the other participants and gather information directly. It would be hard for the reader to conclude that one party was clearly deserving of fault without having the input and perspective of the salesperson or my spouse.  

As for the conflict resolution principles, when engaged in conflict, even for the conflict-averse, hang in there. Strong negative emotions don’t last forever and people eventually cool off.  If you forgo the time that occasionally is needed to allow people’s emotions to shift and restore some of their reasoning capacity, you will be missing opportunities to resolve conflicts. 

Second, try to be the first to lower the temperature on the argument. Strong negative emotions inhibit one’s capacity for empathy and problem-solving. After taking some deep breaths and doing your best to modulate the anger and blame you may feel, try to take a step towards resolving the problem (even when you did not create it). When you accept some responsibility for a problem, the other party is likely to respond in kind. The salesman did that by actively shifting from annoyance to being helpful. When he let go of the position that he was right and we were wrong, I was also much more likely to respond in kind. This demonstrates willingness to resolve the problem and helps leads to solutions, or at least a strengthening of the relationship.

Remember that even if you believe yourself blameless, most conflicts “take two to tango.” Try not to make the common mistake of assuming that you have not contributed even in a small way to the conflict. Maybe just being a representative of the health care system makes you responsible in the eyes of the patient – not necessarily to blame, but responsible. My annoyance and short fuse made me responsible for some of the problem in the store.

Allow people grace, especially yourself.  Health care professionals all have bad days in clinic and the hospital that make for a fuse that is shorter than it should be. For sure, our patients come to us with a range of emotions that can make it harder for them to be flexible, collaborative, engaged, or sometimes even civil. Within reason, extend grace to your patients. And don’t fault yourself when you have trouble meeting your high expectations for how you care for patients.

Finally, conflict resolution often requires asking for help. I needed my spouse to take over and manage our conflict. Patients sometimes need their family members to help them navigate their strong feelings. And an ethics consultation service can help clinicians by filling the role of mediator for significantly challenging conflicts. Whatever the case, these principles of effective conflict resolution deserve a place in the toolbox of any practicing clinician.  

David J. Alfandre, MD, MSPH, is a health care ethicist and an Associate Professor in the Department of Population Health at the NYU School of Medicine in New York. The views expressed in this article are those of the author and do not necessarily reflect the position or policy of the VA National Center for Ethics in Health Care or the US Department of Veterans Affairs.

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Updated Guidelines on Optimal Antibiotic Dosing for Patients With Obesity https://www.thecardiologyadvisor.com/home/topics/metabolic/updated-guidelines-on-optimal-antibiotic-dosing-for-patients-with-obesity/ Fri, 21 Apr 2023 12:48:23 +0000 https://www.thecardiologyadvisor.com/?p=104906 intravenous antibiotics

Researchers evaluated clinical trial data and drug databases to provide updated recommendations on antimicrobial dosing for patients with obesity.

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intravenous antibiotics

Updated recommendations for antibiotic dosing in patients with obesity were published in Pharmacotherapy.

Some patients with obesity have sufficiently altered muscle and fat composition to alter the pharmacokinetics (PK) dosing regimens of antimicrobials. In general, the higher total body weight increases the volume of distribution, but this relationship is not always linear and the nonlinearity can affect loading dose calculations. For medications with limited ability to enter adipose tissue, adjusted body weight may be a better way to calculate loading doses.

The previous recommendations on antibiotic dosing in obesity were published in 2017 and covered dosing recommendations for 34 antimicrobial agents.

For these updates, the review authors searched publication databases for studies published between 2017 and 2022. Data from 120 articles were used to update dosing recommendations for 41 antimicrobials. The review authors focused on patients with a BMI equal to or greater than 30 kg/m2 and normal kidney function.

β-lactams

In β-lactams, there were insufficient data to formulate specific obesity-related guidelines for the use of ampicillin, cefazolin, cefpodoxime, ceftriaxone, cephalexin, imipenem, and nafcillin. There also were no updates on the use of avibactam, ceftazidime, ceftolozane, ertapenem, or tazobactam.

The β-lactams-specific updated dosing recommendations were for the use of 2-g intravenous (IV) infusion of cefepime or ceftazidime every 8 hours; a 2-g IV infusion of meropenem every 8 hours; and a 4.5-g IV infusion of piperacillin-tazobactam every 6 or 8 hours.

Monobactams

For monobactams such as aztreonam, there were insufficient data to update dosing recommendations for patients with obesity.

Fluoroquinolones

There were no changes to dosing recommendations for the use of moxifloxacin or delafloxacin. For ciprofloxacin and levofloxacin, updated recommendations included the administration of a 400-mg IV infusion every 8 hours and a 750-mg IV infusion or oral dose every 24 hours, respectively.

Aminoglycosides

In regard to amikacin, gentamicin, and tobramycin, the authors recommended for an area under the curve or minimum inhibitory concentration dosing approach, as well as the use of Cockcroft-Gault adjusted body weight for the calculation of initial the loading dose. No changes were recommended for trough-based dosing.

Polymyxins

There were no updates for colistin methanesulfonate dosing. In regard to polymyxin B, there were limited data to update dosing recommendations. However, the authors recommended that a maximum daily dose of 200 to 249 mg be considered to limit toxicity risk, though this recommendation was not based on clinically validated data.

Anti-Methicillin Resistant Staphylococcus aureus (MRSA) Agents

There were no changes to dosing recommendations for ceftaroline, dalbavancin, daptomycin, eravacycline, linezolid, omadacycline, or tedizolid. In addition, data were insufficient to update dosing recommendations for oritavancin.

Areas for future studies include identification of optimal body size descriptors, dosing weight scalars, estimation method of renal function, and role for cystatin C in obese patients.

Updated recommendations were provided for clindamycin, trimethoprim-sulfamethoxazole, telavancin tigecycline, and vancomycin. For clindamycin, The authors recommended a 600- or 900-mg IV infusion every 6 to 8 hours, respectively; recommendations for oral dosing included 450 to 600 mg every 6 hours or 600 to 900 mg every 8 hours.

For the use of trimethoprim-sulfamethoxazole in the settings of severe or complicated urinary tract infection and skin and soft tissue infection, a dose of up to 320 mg every 12 hours was recommended. For telavancin, a 750-mg dose every 24 hours was recommended. For tigecycline, updated recommendations included a 100-mg dose every 12 hours in the setting of resistant infection due to Gram-negative organisms. For vacomycin, the authors recommended a maximum loading dose of 3 g and an initial dose of 4.5 g.

There were either no or insufficient data to recommend changes for metronidazole, fosfomycin, or lefamulin dosing.

Of note, patients with obesity were either missing or underrepresented in most of the reviewed studies.

In regard to patients with obesity, “Extended infusions of time-dependent antibiotics may provide a safe way to overcome any potential PK variability,” the authors noted. “Areas for future studies include identification of optimal body size descriptors, dosing weight scalars, estimation method of renal function, and role for cystatin C in obese patients,” they concluded.

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Aspirin Use and Bone Health: Unpacking the Controversy https://www.thecardiologyadvisor.com/general-medicine/aspirin-use-and-bone-health-unpacking-the-controversy/ Fri, 14 Apr 2023 12:42:52 +0000 https://www.thecardiologyadvisor.com/?p=104667 Aspirin bottle.

Research on the effect of NSAID use, including aspirin, on bone health, has resulted in conflicting results.

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Aspirin bottle.

For decades, daily low-dose aspirin has been recommended to prevent the development of cardiovascular disease and reduce the risk for myocardial infarction or stroke in middle-aged and older adults. However, the benefits of daily aspirin use are now being questioned as research has revealed potential detriments of the prophylactic treatment, particularly among those at increased risk for falls, bleeding, and fractures.1,2

Aspirin works as a cyclooxygenase (COX) inhibitor via suppression of prostaglandin through both the COX-1 and COX-2 pathways, resulting in anti-inflammatory effects.3,4 This indirectly may impact bone health as low-grade, chronic inflammation has been found to correlate with increased bone loss and fracture risk. Therefore, aspirin use may decrease bone loss and fracture risk by reducing chronic inflammation.5

In addition, prostaglandins are involved in the bone remodeling cycle—either by promoting osteoblastic bone formation or by increasing osteoclastic bone resorption and bone loss.3,4 Logically, given its multiple mechanisms of action on both the COX-1 and COX-2 pathways, aspirin use could either decrease bone density by inhibiting bone formation or promote bone formation and increase bone density by inhibiting bone resorption.4

While aspirin, ibuprofen, and naproxen all are nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), some NSAIDs selectively inhibit only the COX-2 pathway, which, in turn, may decrease osteoclastic bone resorption and promote increased bone mineral density (BMD).6

These conflicting mechanisms of action of nonselective NSAIDs explain the diverse research findings from studies investigating the effect of NSAID use, including aspirin, on bone health.  

Lately, there has been a lot of debate about whether daily aspirin use is contraindicated or should be used with caution, on a case-by-case basis, in certain patient populations, including:

  • older adults who may be at higher risk for life-threatening fractures due to falls,
  • postmenopausal women at risk of developing osteoporosis,
  • individuals healing from bone injuries, and
  • patients with osteopenia or osteoporosis receiving treatment with bisphosphonates to preserve BMD.

Aspirin Use Among Older Adults

Research investigating the effect of daily aspirin use among older adults has reported conflicting results. While some studies have documented that daily low-dose aspirin use was correlated with increased BMD,7 others have suggested that daily low-dose aspirin intake did not significantly or effectively prevent fractures in this patient population.8,9 In addition, a study reported an association between aspirin use and increased risk for falls leading to fractures in healthy, community-dwelling, older adults.8

Aspirin Use Among Postmenopausal Women

According to the Endocrine Society, approximately 1 in 10 women older than 60 years develop osteoporosis, resulting in decreased quality of life and morbidity.10 Postmenopausal women are at increased risk for primary osteoporosis due to naturally declining estrogen levels, usually developing within 10 to 15 years after menopause.11

Daily aspirin use has shown an ability to increase BMD in some studies,7 so researchers have questioned whether daily aspirin use could affect BMD of postmenopausal women at risk for osteoporosis.

In a study, daily aspirin use did not contribute to decreased femoral or vertebral BMD among postmenopausal women.12 Researchers observed that daily aspirin use was associated with between 2.3% and 5.8% increased BMD in the hip and spine. These findings suggested that daily aspirin consumption may exert modest beneficial effects on BMD in this patient subgroup.12,13

However, fracture risk in this patient subgroup remained similar regardless of daily aspirin use. This indicated that increased BMD does not necessarily equate to decreased fracture risk.13

Effect of Aspirin on Fracture Healing

Because aspirin can potentially inhibit bone formation, concerns arose regarding the prolonged use of aspirin for analgesia while healing from a fracture or bony defect.

According to a recent literature review published in 2021, data from 6 randomized controlled trials demonstrated that risk for nonunion in healing fractures was higher among patients receiving treatment with NSAIDs for more than 4 weeks. However, patients with fractures with limited NSAID use of less than 2 weeks did not demonstrate increased risk for nonunion.14

Another review of the published literature echoed these findings, encouraging physicians treating patients with fractures or bony defects to administer COX-2 inhibitors or other NSAIDs for pain management only in the short-term to prevent delayed fracture healing.15

Effect of Aspirin on Bisphosphonate Use

A study published in the Journal of Bone and Mineral Research reported that NSAID use significantly increased risk for osteoporotic fractures in women aged 75 years and older during the 3-year study period (hazard ratio [HR], 1.27; 95% CI, 1.01-1.62; P =.039).16

In addition, women receiving treatment with the bisphosphonate clodronate concurrently with NSAIDs experienced greater bone loss in the femoral neck than those who received treatment with clodronate without NSAIDs (-3.06% vs -1.12% bone loss; P =.028).16 This observation suggests that use of NSAIDs may negate the positive effects of bisphosphonates on preserving BMD in certain patient populations.

Conclusion

Because aspirin is not a selective NSAID and affects various aspects of the bone remodeling process, special consideration must be given to certain patient groups, including older adults at risk for falling, postmenopausal women, individuals healing from bone injuries, and patients receiving bisphosphonates to preserve BMD.

While daily aspirin use may increase BMD in some individuals, it does not translate to decreased fracture risk. Prolonged aspirin or NSAID use may also negate the effect of bisphosphonates, delay fracture healing, and increase risk for falling among older adults.

Overall, clinicians should consider examining the risks and benefits of daily low-dose aspirin use on a case-by-case basis, assessing the individual’s bone health, risk for falling, cardiovascular disease risk factors that may require prophylaxis, and the need for long-term pain management.

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Mobile Stroke Units: The Barriers to Timely tPA Administration in the US https://www.thecardiologyadvisor.com/home/topics/stroke/mobile-stroke-units-barriers-timely-tpa-administration-us/ Fri, 07 Apr 2023 12:29:54 +0000 https://www.thecardiologyadvisor.com/?p=104392 Close-up-of-the-interior-of-furnished-mobile-stroke-unit-with-medical-equipment.

Two neurologists discuss the barriers to timely tPA administration in acute stroke, including the implementation of mobile stroke units.

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Close-up-of-the-interior-of-furnished-mobile-stroke-unit-with-medical-equipment.

Stroke is one of the leading causes of death in the United States, with over 795,000 cases yearly. In particular, ischemic strokes have the highest prevalence, constituting 87% of all stroke cases.1

Early administration of tissue plasminogen activator (tPA) has proven to limit the risk for damage and functional impairment in patients with acute ischemic stroke.2-4 However, one of the most significant barriers to successful stroke management is administering tPA within the recommended window of 3 hours.5

The first mobile stroke unit (MSU) in the US was implemented in 2015 and allowed for earlier tPA administration, leading to significant improvements in functional outcomes for patients with stroke.

Recent pivotal studies, Berlin PRehospital Or Usual Delivery in Stroke Care (B_PROUD; ClinicalTrials.gov Identifier: NCT02869386) and Benefits of Stroke Treatment Delivered by a Mobile Stroke Unit Compared with Standard Management by Emergency Medical Services (BEST-MSU; ClinicalTrials.gov Identifier: NCT02190500), showed significant improvements in 90-day disability scores for patients with acute stroke treated on an MSU compared with emergency medical service (EMS) management in both Germany and the US. The B_PROUD study also showed that the median time from dispatch to initiation of thrombolysis for patients treated with an MSU was 20 minutes shorter than with conventional ambulances. 6,7

Essentially everything you need to do for a stroke is in the MSU.

While early studies show promising results for patients treated with MSUs, there are significant barriers to implementing and standardizing these services in the US. Many MSUs have not fully integrated into the existing EMS systems, making it difficult to streamline treatment processes. Additionally, most MSUs operate in densely populated cities. Research has suggested several methods for adapting these services to nonurban settings, such as air ambulances and various transport strategies, but further studies are necessary to prove these concepts.8,9

As a relatively new addition to EMS, MSUs do not have national clinical guidelines for standardized care. There is a call to action for guideline committees, medical societies, and stroke leadership to update the level of evidence of MSUs to reflect more recent efficacy trials. Another step for MSU expansion is for regulatory bodies to establish a process to accredit MSU programs using standardized quality measures.8

Additionally, MSUs face issues receiving reimbursements from insurance.8 The lack of reimbursements for MSUs in the US increased reliance on grants to support program costs and has limited the expansion of this service across the nation.10 The body of data supporting MSU cost-effectiveness is still in its early stages and additional data is necessary to support the need for reimbursement. Recent data shows that MSU cost-effectiveness is due to the reduction in long-term disability costs and that MSUs yield a gain of 0.591 quality-adjusted life years per dispatch.11

To discuss MSU implementation barriers, we spoke with James Grotta, MD, founder of the first MSU in the US and the director of stroke research at the Clinical Institute for Research and Innovation, Memorial Hermann-Texas Medical Center in Houston. We also spoke with Matthew T. Bender, MD, neurosurgeon and assistant professor in the division of stroke and cerebrovascular disease at the University of Rochester Medical Center in Rochester, New York, to gain insight on current barriers for treating acute ischemic strokes.

How similar is treating someone in an MSU compared with the emergency department? Is there something in the emergency department that’s not in an MSU?

Dr Grotta: For strokes, the answer is no. Everything that we need to treat a patient in the emergency room for a stroke, we can do in the MSU. In a hospital, there are other things we can do for patients with stroke — for example, a thrombectomy. Patients move from the emergency room into an endovascular suite. 

Essentially everything you need to do for a stroke is in the MSU. Now there are a host of other emergency procedures in the emergency room that could be done on an MSU.

Dr Bender: The MSU is essentially a stroke emergency department on wheels. Providers have all the tools needed to evaluate, stabilize, and treat a patient suffering a stroke. They have a narrower focus than emergency department providers and can defer non-neurologic diagnoses to the emergency room.

Could you elaborate on the gaps preventing timely administration and decision-making for tPA?

Dr Grotta: Most of the time, if the physician is on board the MSU, the CT scan comes up on the computer and you can see it right away. However, in some MSUs, often the physician is present through telemedicine. In some systems, the CT scan must be transmitted to a radiologist to be read. That might produce a few minutes of delay.

I think that’s an unnecessary step because you just have to read the CT to ensure there is no blood. That doesn’t usually require a neuroradiologist to read it. You get a more skilled reading from a neuroradiologist, but the neurologist can generally identify when treatment is appropriate.

The biggest thing we have shown is that treatment in the first hour after symptom onset is critically important. In that first hour, every little thing that takes up a few extra seconds makes a difference. 

Dr Bender: Stroke neurologists are making this decision via telemedicine. They need to formulate their own perspective based on the clinical scenario and imaging but then elicit preexisting goals of care and obtain consent from the patient or family.

It requires efficiency and parallel processing. As a result of our study findings, the MSU team has reviewed additional parallel procedures to facilitate faster treatment decision times.12

What is the most significant barrier to treatment for patients with stroke and what do you propose to help address these barriers?

Dr Grotta: The most significant barrier is that patients do not call 911. If everybody called 911 when they had a stroke, we would be treating many more patients right now. 

Only 12% of patients with stroke get treated with tPA. Admittedly, some cannot be treated with tPA because they have contraindications like bleeding problems, the stroke is not severe enough, or some other illness that precludes it.

If everybody called 911 when symptoms came on, we could quadruple the number of patients currently being treated. Our treatment, tPA, is pretty good, so treating more patients with the existing treatment would make the most significant difference. 

We need to figure out how to alert patients that they are experiencing a stroke and there is research on alerting devices that people might wear.

Dr Bender: Early recognition of stroke symptoms and alerting emergency services remains the most significant barrier. 

Through a partnership with the Cabrini Foundation, we are working to increase awareness and recognition of stroke symptoms in underserved communities within the Rochester metropolitan area.

There are currently no clinical guidelines on a national level for MSUs. Based on your experience and research, what massive overhauls and protocols are needed for MSUs? Who would be the decision-makers for these guidelines?

Dr Grotta: In our health care system, it is all about money. I do not mean to say that negatively, but things that are reimbursed get done, and things that are not reimbursed do not get done. In a sense, MSUs are an expensive operation for a hospital to implement, but they are worth it because we have shown that they are quite effective.

It requires an investment upfront, and right now, there is no adequate reimbursement for MSUs because they are a new thing. Insurers and Medicare do not recognize MSUs as a place of service.

The other impediment is that there are 20 or 30 MSUs right now, and you have to take a year between the time you order an MSU before one rolls out. There is no economy of scale because there is not a huge demand.

If and when MSUs get reimbursement with Medicare, then we will be able to scale up our production capability. 

Dr Bender: We are at a stage where the MSU concept is spreading. To foster that growth, MSU-based stroke treatment needs to be recognized by third-party payors and the Centers for Medicare & Medicaid Services, which is reasonable given that randomized prospective data shows MSU care expedites thrombolysis and leads to better clinical outcomes for patients with stroke. 

What additional data or research is needed to help inform future clinical guidelines?

Dr Grotta: One of the things we have yet to show about MSUs is how we can help patients with large vessel occlusion.

Right now, the main benefit of MSUs is to get tPA in faster. However, some patients do not qualify for tPA or need treatment beyond tPA. Those are the patients with large vessel strokes.

Thrombectomy is another treatment for patients who have the biggest strokes where tPA often does not work, and we pull the clot out with a catheter. However, there are only some hospitals that do that. 

What MSUs can do is triage patients more effectively to these thrombectomy centers and get thrombectomy done faster. Nevertheless, that remains to be proven. 

Most importantly, having an MSU be used for just one disease does not make logical sense. We must find other emergency conditions that MSUs can help with.

Editor’s Note: This interview was edited for clarity and length.

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Sex-Based Disparities in Atrial Fibrillation https://www.thecardiologyadvisor.com/home/topics/arrhythmia/sex-based-disparities-in-atrial-fibrillation/ Fri, 31 Mar 2023 13:05:04 +0000 https://www.thecardiologyadvisor.com/?p=104173

Louise Pilote, MD, Annabelle Santos Volgman, MD, and Salvatore Savona, MD, discuss sex-based health disparities in atrial fibrillation.

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Cardiovascular research findings have consistently demonstrated a range of disparities in cardiovascular disease (CVD) risk factors, outcomes, and quality of care among women compared with men.1 Among the ongoing gaps in this area, numerous studies have highlighted various sex-based differences in patients with atrial fibrillation (AF).

In a 2022 retrospective cohort study of 327 patients who presented to the emergency department with AF¸ results showed several differences between women and men in terms of baseline characteristics, treatment strategies, and outcomes. Women were significantly older than men (mean age, 69.30±11.9 [27–91] vs 57.79±14.8 [21–87], respectively; P <.001) and had higher rates of thyroid dysfunction (18.3% vs 1.8%; P <.001) and several other comorbidities including valvular heart disease, hypertension, and diabetes.2

After adjusting for age and comorbidities, women showed higher rates of heart failure hospitalization (odds ratio [OR], 2.73; 95% CI, 1.04–5.89; P <.001) and recurrent AF (OR, 3.86; P =.02) compared with men.2

In terms of treatment differences, antiarrhythmic medications were used less often in women vs men (24.0% vs 42.8%; P <.001), rate control medications were used more often than antiarrhythmic medications in women (P <.001), and catheter ablation was performed at higher rates in men (63.6%) vs women (36.4%).2

For the overall sample, thyroid dysfunction (OR, 5.95; 95% CI, 3.15-9.73; P <.001) and lack of antiarrhythmic therapies (OR 3.42; 95% CI, 1.81-6.46; P <.001) were associated with an increased risk for AF.2 

There might be biological differences in terms of the effect of AF on the heart—for example, it may cause more heart failure in women because of the combined risk of AF and heart failure associated with hypertension.

These results align with those of numerous other studies demonstrating greater morbidity and treatment disparities in women with AF, including less frequent use of cardioversion and catheter ablation and worse outcomes with stroke prevention measures.3,4 In addition, researchers have observed a higher risk for stroke (and more severe strokes) and death, as well as worse symptoms and quality of life, in women vs men with AF.3,5 

Factors Linked to Sex-Based AF Disparities

“There might be biological differences in terms of the effect of AF on the heart—for example, it may cause more heart failure in women because of the combined risk of AF and heart failure associated with hypertension,” said Louise Pilote, MD, MPH, PhD, FRCPC, professor of medicine at McGill University in Montreal, deputy director of the Research Institute of the McGill University Health Centre, and co-author of a 2022 study regarding sex-based disparities in AF research and guidelines.4

Hormonal mechanisms, specifically the impact of changing estrogen levels throughout the reproductive lifespan, have also been implicated in sex-based AF disparities. In a 2022 population-based cohort study of 235,191 women without AF at baseline, the risk for new-onset AF was higher in those with a history of irregular menstrual cycle, early or late menarche, early or delayed menopause, no live births, and 7 or more live births, after adjustment for multiple confounding variables.6

“These results underscored the importance of taking into account the reproductive history of women when developing tailored screening strategies for AF prevention in women,” wrote the study authors.6

Dr Pilote added, “Gender-related factors such as caregiving responsibility also affect women more than men and prevent them from seeking the care they need or adhering to medications for AF.”

Regarding the stroke findings in particular, disparities likely stem from multiple factors. “Since women are older when they get AF, they tend to have more comorbidities such as hypertension, diabetes, and heart failure, which increases their risk for strokes,” explained Annabelle Santos Volgman, MD, FACC, FAHA, theMcMullan-Eybel Endowed Chair of Excellence in Clinical Cardiology and professor of medicine at the Rush University Medical College in Chicago, and medical director of the Rush Heart Center for Women.

Women are also not receiving anticoagulation therapy as often as men “for various reasons such as physicians not prescribing anticoagulants,4 perhaps due to fear of an increased bleeding risk,” she said in an interview with Cardiology Advisor.

Closing the Gap

An overarching factor driving some of the ongoing sex-based disparities in AF is the relative lack of research focused on women with AF. As Dr Pilote and colleagues noted in their study, women are significantly underrepresented in AF studies, especially randomized controlled trials, and thus the evidence that shapes clinical practice guidelines on AF management are insufficient to inform sex-specific recommendations.4 

On a related note, Michos et al recently found that women are also underrepresented in clinical AF trial leadership, and they stated that increasing such representation could ultimately increase the number of women enrolled in these trials as well.7 

There is a clear need to increase participation of women in AF research, Dr Pilote told Cardiology Advisor: “We need to enroll sufficient numbers of women in AF trials to know that results apply to women. For example, do women require a different dose of anticoagulants than men?”

On the clinical level, physicians should “explain the importance of using anticoagulants to decrease the risk of strokes, and they should refer patients to cardiac specialists who can keep them in a normal rhythm instead of letting them stay AF,” Dr Volgman advised. “Additionally, women need to be informed of the importance of measures to prevent AF, such as controlling their blood pressure, being on the right medications for heart failure, and having awareness of potential AF triggers such as alcohol and poor blood pressure control.”

Physician Q&A: Salvatore Savona, MD

To gain further insights into sex-based disparities in AF, we interviewed Salvatore Savona, MD, clinical assistant professor in cardiac electrophysiology at The Ohio State University Wexner Medical Center in Columbus.

What does the available evidence suggest about differences in AF in women compared with men?

AF is the most commonly encountered arrhythmia and can affect men and women differently. Prior studies have shown that women with valve disease may be more likely to develop AF, whereas coronary disease may be more prevalent in men.2 The previously published Women’s Health Study has also shown an increased risk of developing AF with the number of pregnancies.8 Prior large studies including the Euro Heart Study on Atrial Fibrillation and the ORBIT-AF Registries have found that women present with AF later in life, with worse quality of life, and may have less typical symptoms.9,10

Women in these and other studies were also less likely to have received a rhythm control strategy. In regards to stroke prevention, women had lower rates—up to 33% lower—of prescribed anticoagulation in the PINNACLE National Cardiovascular Data Registry.11 Additionally, women prescribed warfarin have higher rates of stroke compared to men, though the rates are similar with direct oral anticoagulation therapy. Regarding catheter ablation, early studies showed a higher rate of complications with procedures, though this seems to have improved with the use of ultrasound-guided access and transeptal puncture.4

What are some of the proposed mechanisms driving these differences?  

There are many proposed mechanisms to explain the differences in AF between men and women. Prior MRI studies have shown that there is a high fibrotic burden in women compared to men.12 Additionally, there are QT differences in men and women at baseline, and studies have also shown QT differences on ECG based on hormone changes, such as during menopause. This may result in less utilization of anti-arrhythmic therapy.13

Additionally, women have been underrepresented in cardiology trials, therefore they may present later in the time course of their disease, with more advanced disease. Regarding higher stroke risk while on warfarin, it is theorized this may be related to less time being therapeutically anticoagulated. Additionally, women appear to have more nonpulmonary vein triggers for AF, which may result in more complicated procedures.12

What are implications for cardiologists in terms of special screening and treatment considerations for women with AF?  

The most feared complication from AF is a stroke, and patients should be thoroughly assessed for stroke risk at the time of AF diagnosis. This should be guided by the CHA2DS2-VASc score as outlined in the current AF guidelines.14 Additionally, there should be an early assessment of symptoms, especially more atypical symptoms such as fatigue and shortness of breath. This may allow for early intervention to prevent adverse remodeling from persistent AF. More data is suggesting that an early rhythm control strategy is helpful to prevent progression to persistent and permanent AF, highlighting the importance of early intervention.

What additional measures are needed to improve the care of women with AF? 

As ablation strategies evolve and new energy delivery techniques—such as pulsed field ablation, for example—become utilized, it will be paramount to ensure women are represented in trials and post-approval studies to ensure procedural risks are mitigated.15 More patient education is also necessary so that patients do not dismiss symptoms that may be related to AF. Additionally, ongoing research into the drivers and mechanisms for AF and fibrosis will continue to be important to understand previously reported sex differences in patients with AF.

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Picking the Best Place to Practice Medicine https://www.thecardiologyadvisor.com/home/topics/practice-management/picking-the-best-place-to-practice-medicine/ Fri, 24 Mar 2023 12:12:38 +0000 https://www.thecardiologyadvisor.com/?p=103838 clinicians doctors PAs physician associates PA job satisfaction

Annual pay, growth potential, and cost of living are among the important considerations of deciding the best place to practice medicine.

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clinicians doctors PAs physician associates PA job satisfaction

When choosing where to set up a practice, physicians must consider much more than average malpractice insurance rates and Geographic Practice Cost Indices (GPCI). Every year, several lists are published picking the top states in which to practice medicine. Malpractice insurance premiums vary significantly between states. What is best for one clinician might not be quite as important for another, however, especially at different stages of their career.

“When comparing factors like annual physician pay, pay growth potential, cost of living, affordability, and access to recreation and entertainment, some cities score dramatically higher than others,” said Christopher R. Friese, PhD, RN, Health Management & Policy Director at the Center for Improving Patient and Population Health at the University of Michigan in Ann Arbor, Michigan.

Recently, WalletHub compared the 50 states and the District of Columbia across 19 key metrics. The data, which were released in March, included the average annual wage for physicians, hospitals per capita, and the quality of the public hospital system. The top 5 states were South Dakota, Minnesota, Wisconsin, Montana, and Idaho. There may be other factors, however, that are not included in these lists of best cities in which to practice medicine.

Support Staff Considerations

While contentious in some circles, Dr Friese said there are major advantages in the states that allow full scope of practice for advanced practice nurses and physician assistants because clinicians can focus on new and complex patients and allow the team to provide all the services needed. Physicians interviewing for positions should ask about the staffing model in the practice. Dr Friese said it is important to look at how many nurses and how many medical and nursing assistants are part of the practice. Has the level of supportive staffing been the same for a steady period of time?

There is a national labor shortage, and supply chain disruptions continue to be compounded in unexpected ways.

If not adequately staffed by a supportive team, the workloads will be significantly higher, he said. An important factor is the percentile of nurse staffing levels compared with benchmark facilities. “For physicians exploring new opportunities, consider your surroundings and what kind of team will be available to support you in delivering the best care for your patients and reducing the likelihood of burnout,” Dr Friese said.

Michael French, MA, practitioner in residence at the University of New Haven’s School of Health Sciences in West Haven, Connecticut, applies philosophical methods for understanding the experiential aspects of mental illness, ethical issues in treatment, and uses of technology and data in healthcare. He said the first criteria should be what is best for the clinician’s family and themselves. “Burnout is prevalent among physicians, and keeping yourself and your family in an area where you can thrive will aid you in keeping your health in order,” French said. “The second criteria I would recommend is that you look for states where you align with the state’s medical politics.”

Medical politics have come to forefront in the last 3 years and some fields of medicine are being highly impacted, French said. Medical politics are playing a major role in areas of reproductive health, with scores of new abortion laws and other restrictions. French said some states and cities were much more politically influenced when it came to mask wearing and other actions required during the COVID-19 pandemic.

If a physician is starting their own practice, he recommends carefully considering whether they are ready for the business management and the accounting departments required. Overall, private practices have been decreasing, with 2021 being the first year the American Medical Association (AMA) recording more doctors working outside of private practice than within. The AMA’s most recent survey showed that 70% of doctors under the age of 40 are working for someone else.

Expansion of Hospital Networks

The economic expansion of hospital networks mirrors the process that has occurred in the corporate world, according to French. Large companies are expanding to include private practices in their network as well as buying other hospitals to include in their systems. “To run a practice within the network of a hospital can be a useful addition for some, as doing so can make many processes more convenient, but for those who want to run their own practice without potential interference, it may be unwelcomed,” French said. “I believe that it can be a great time to run a medical practice, but it is a far different time to run one than it was even a decade ago.”  

Provider Shortage

Jonathan Henderson, MD, immediate past president of LUGPA, an organization that represents urologists in large independent practices, said establishing an independent practice today is more difficult than ever before in the modern era. The reasons are many and apply to all settings, including independent practice, hospital employment, and academic settings. “The patient backlog from 2 years of the pandemic is daunting, and the shortage of providers is more critical than ever and heightens daily,” Dr Henderson said. “There is a national labor shortage, and supply chain disruptions continue to be compounded in unexpected ways.” 

Ron Holder, Chief Operating Officer of the Medical Group Management Association, said currently licensed vocational or licensed practical nurses are being recruited away from practices by health care and nonhealth care organizations. That needs to be considered when looking at different cities to establish a medical practice.

“Retail and restaurants alike are offering starting pay in excess of what some practices pay for front desk, back office, or clinical support staff,” Holder said. “Urology practices have an additional competitive hurdle on top of that. Whereas many practices rely on medical assistants and licensed vocational nurses, urology practices tend to have a greater need for registered nurses due to the procedures and other duties that require a higher level of licensure.”

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Examining Mental Health Within the Field of Cardiology  https://www.thecardiologyadvisor.com/general-cardiology/examining-mental-health-within-the-field-of-cardiology/ Fri, 17 Mar 2023 14:01:48 +0000 https://www.thecardiologyadvisor.com/?p=103544

An examination of professional burnout, depression, and other psychological concerns for medical professionals within the field of cardiology.

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Mental health concerns affecting physicians have received increasing attention recently, including high rates of professional burnout, depression, and other psychological conditions that have further increased since the onset of the COVID-19 pandemic.1,2 New study results from the American College of Cardiology (ACC) shed light on the state of mental health among cardiologists from around the world.3

Noting the dearth of evidence regarding mental health conditions in this population, researchers at The Ohio State University (OSU) Wexner Medical Center in Columbus, Ohio, conducted a survey on the topic and received responses from 5,931 cardiologists (22.6% women and 53.5% White). Two-thirds of respondents were aged 40 years or older.3

The survey results showed that 28% of cardiologists reported a mental health condition, which could indicate the presence of various behaviors, disorders, or types of emotional distress.3

“In our study, we used a broad definition of mental health conditions, which included self-reported experience with alcohol or drug use disorder, suicidal tendencies, psychological distress such as anxiety, irritability, or anger, other psychiatric disorder such as panic disorder, post-traumatic stress disorder, and eating disorders, and major psychiatric disorder such as major depressive disorder, bipolar disorder, or schizophrenia,” explained study co-author Dr Laxmi Mehta, MD, cardiologist and professor, chief well-being liaison, and faculty director of the Gabbe Health and Wellbeing Program at OSU Wexner Medical Center, and chair of the ACC’s Clinician Wellbeing Workgroup.

The survey “asked if respondents had ever had these conditions, so some may have pre-existed prior to becoming a cardiologist,” she noted. It is also unclear whether rates of mental health conditions among cardiologists have changed since the pandemic began, as the ACC survey was conducted in 2019.

…efforts need to be made to address the systemic issues that are contributing to employee burnout.

Women were more likely to have considered suicide within the previous 12 months compared with men (3.8% vs 2.3%). Additionally, women were more likely than men (42.3% vs 31.1%) to seek help for mental health issues. Predictive factors of mental health conditions included a history of experiencing emotional harassment (OR, 2.81; 95% CI, 2.46-3.20) or discrimination (OR, 1.85; 95% CI, 1.61-2.12) and being divorced (OR, 1.85; 95% CI, 1.27-2.36) or aged younger than 55 years (OR, 1.43; 95% CI, 1.24-1.66).3

“The higher rates of mental health conditions observed in women and younger cardiologists is likely related to the higher prevalence of emotional harassment or discrimination in these groups,” Dr Mehta said. These findings highlight the need to ensure “respectful and inclusive environments for both work and learning.”

The results also showed that 44% of respondents reporting a mental health condition had experienced professional dissatisfaction as assessed by metrics such as feeling valued, being treated fairly, and receiving adequate compensation.3

In other research, cardiologists reported higher levels of burnout and longer work hours compared to other physicians, and only 23% of cardiologists struggling with depression or suicidality indicated a willingness to seek professional help. Such findings suggest that “many cardiologists may be suffering silently,” wrote Patel et al in a 2021 paper in Heart.4

Regarding broad measures needed to address mental health among cardiologists, efforts are needed to “reduce barriers to seeking mental health care, including reducing the associated stigma and reducing the fear of reporting mental health conditions to our hospital credentialling committees and state licensing boards,” according to Dr Mehta. “In addition, efforts need to be made to address the systemic issues that are contributing to employee burnout.”5

On the individual level, Arianna Galligher, LISW, director of the Gabbe Health and Well-Being Program and associate director of the STAR Trauma Recovery Center at OSU Wexner Medical Center, offers the following suggestions for physicians who are struggling with mental health concerns:

  • The first step to getting the right support is to acknowledge that something is wrong or out of balance. Next, it’s important to treat that reality with self-compassion rather than judgment. Struggling with a mental health concern doesn’t mean you’re damaged or broken, and it’s okay to reach out for help.
  • For many, accessing peer support can help in regaining a healthy perspective and developing a plan for how best to move forward. Sometimes that plan will involve seeking treatment from a mental health professional, especially if stress and symptoms are impacting more than 1 area of life.
  • Linkage with peer support and mental health care should be quick, simple, and stigma-free. Institutions also have a responsibility to foster and maintain a culture of caring that prioritizes support among colleagues through formal peer support programs. At OSU Wexner Medical Center, for example, staff have access to the Stress, Trauma and Resilience (STAR) Program, which offers fast, free, confidential support for groups and individuals as well as education, training, and guidance for providers who would like to become peer supporters.       

Dr Mehta added, “The Physician Support Line is a resource that provides free, confidential support by psychiatrists for US physicians and medical students.” The phone number is 1-888-409-0171. The peer-to-peer organization – which encourages individuals to “call for any issue, not just a crisis” – does not record personal information, and physicians seeking help are not required to report the calls to their medical board. The 988 Suicide & Crisis Lifeline (formerly the National Suicide Prevention Lifeline) is an all-hours resource for individuals experiencing a mental health or substance abuse crisis.

If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat 988lifeline.org

Resources

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Warning Issued About Online Tracking Technology https://www.thecardiologyadvisor.com/home/topics/practice-management/warning-issued-about-online-tracking-technology/ Thu, 09 Mar 2023 15:29:05 +0000 https://www.thecardiologyadvisor.com/?p=103043 Clinician texting on phone

In a recent bulletin, the federal Office for Civil Rights suggests steps that practices can take to protect patient data.

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Clinician texting on phone

The federal Office for Civil Rights (OCR) is warning physicians about privacy requirements when using online tracking technologies.

In December 2022, OCR issued a bulletin to highlight obligations related to regulated entities under HIPAA when using online tracking technologies such as Google Analytics or Meta Pixel. This is the first time a specific alert has been issued to physicians over the use of technology platforms.

The bulletin addresses potential impermissible disclosures of ePHI by HIPAA regulated entities to online technology tracking vendors. It suggests steps that regulated entities should take to protect ePHI when using tracking technologies.

“We are in for quite a few changes in the coming months with a number of updates,” said Katina Michael, PhD, the director of the Society Policy Engineering Collective at Arizona State University in Tempe. “We always note that technology moves far ahead of regulation, and this can be said particularly for health-related innovations.”

These technologies collect and analyze information about how to interact with a regulated entity’s website or mobile application. Some regulated entities regularly share electronic protected health information (ePHI) with online tracking technology vendors. Some may be doing so in a way that violates HIPAA rules by causing impermissible disclosures of ePHI to tracking technology vendors.

. . . the issue is not laws but consumer awareness that they can now determine whom to share their data with, and should be sure that their apps and services are trusted vendors.

Text-based medicine is gaining significant momentum, a trend fueled by the ongoing COVID-19 pandemic. “People are more willing to entertain the idea of gaining access to a medical professional ‘on demand’,” Dr Michael said. “One of the major changes being witnessed is how to book a doctor or dentist or optometrist in your medical insurer’s network. On top of scheduling apps, we now have the ability to receive phone consultations, especially if we have COVID-like symptoms and need treatment.”

Text-based medicine allows greater access to care options, Dr Michael said. Patients can consult with clinicians over their smartphones, an attractive feature for individuals who do not want to or cannot travel for an in-person visit.

There is a growing concern about new laws that may hamper this trend in medicine. Physicians can answer general questions, and even a transcript of the conversation can be retained for follow-up. “This might be a great method for chronic sufferers and this kind of patient-physician exchange can provide for transparency and accountability. However, privacy issues are fraught. Increasingly we have seen data breaches of not just medical offices, but also major health insurers,” Dr Michael said.

A data breach can allow a cybercriminal the ability to gain access to transcripts of text-based correspondence between a physician and a patient. The data could become available on the dark web. The breach could involve a patient who is a pilot dealing with anxiety or a female physician experiencing postnatal depression but still wishes to practice. “The range of scenarios is endless,” Dr Michael said. “The question becomes, is one’s right to privacy guaranteed through this kind of medical service offering? The answer is no, it cannot be.”

“HIPAA governs how your data are used by providers and health insurers, but does not govern what individuals do with their data,” said Kevin Schulman, MD, Professor of Medicine at the Clinical Excellence Research Center at Stanford University, Palo Alto, California. “To me, the issue is not laws but consumer awareness that they can now determine whom to share their data with, and should be sure that their apps and services are trusted vendors.” For example, sharing personal medical histories and posting medical charts online is common, but consumers may not fully understand their personal implications of these postings.

That said, HIPAA is intended to protect patients from the misuse of their data by provider organizations. “Providers selling our data for advertising, directly or indirectly through trackers is exactly what HIPAA was intended to prohibit,” Dr Schulman said.

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E-Cigarettes and Cardiovascular Health: The Risks of Vaping https://www.thecardiologyadvisor.com/general-cardiology/e-cigarettes-and-cardiovascular-health-risks-of-vaping/ Fri, 03 Mar 2023 14:35:35 +0000 https://www.thecardiologyadvisor.com/?p=102967

Matthew L. Springer, PhD, Sandhya Venugopal, MD, and Kinjan Parikh, MD, discuss the effect of e-cigarettes on cardiovascular health.

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In the 15 years since e-cigarettes became commercially available, there has been ongoing debate about the health risks of using these devices, as well as the potential utility of e-cigarettes in smoking cessation efforts.1 Among the various health effects of e-cigarette use (i.e., vaping), researchers continue to explore the cardiovascular (CV) impact of vaping, with somewhat mixed results.

Following 2 large cross-sectional studies showing no significant association between exclusive e-cigarette use and CV disease (CVD) risk, the authors of recent research aimed to further elucidate the potential effects of these products on heart health.2

In a 2022 study funded in part by the National Institutes of Health (NIH), Berlowitz et al. conducted a longitudinal analysis based on self-reported data from roughly 24,000 adult participants (50% of whom were younger than 35 years) in the national PATH (Population Assessment of Tobacco and Health) study to examine the link between e-cigarette use and incident CVD.2

After adjusting for covariates including demographic factors, comorbidities, and smoking history, analyses showed no difference in CVD risk between exclusive e-cigarette users and nonusers of combustible cigarettes or e-cigarettes (hazard ratio [HR], 1.00; 95% CI, 0.69-1.45) in up to 4 years of follow-up.

In addition, the results revealed a 30% to 40% lower risk for the outcome of “any CVD” in association with e-cigarette users compared with combustible cigarette users.

Even though the use of cigarettes may have decreased in the last few years, nicotine addiction has continued secondary to e-cigarettes in the market.

Among individuals who identified as dual users of both e-cigarettes and combustible cigarettes, no difference in risk was observed for any CVD (HR, 1.01; 95% CI, 0.81–1.26) or for myocardial infarction (MI), heart failure (HF), or stroke (HR, 0.94; 95% CI, 0.65–1.36) compared with exclusive users of combustible cigarettes.

However, dual users demonstrated a significantly higher CVD risk compared with nonusers in any CVD outcome (HR, 1.54; 95% CI, 1.21-1.96) and in MI, HF, or stroke outcomes (HR, 2.08; 95% CI, 1.40-3.09).

The authors noted several limitations of their study, such as the use of self-reported data and the short follow-up period which may be inadequate to capture the development of CVD.2

Meanwhile, their results suggest that using e-cigarettes while attempting to taper the use of combustible cigarettes does not reduce CVD risk compared to the exclusive use of combustible cigarettes.3

On a related note, the authors of a study published in August 2022 in BMC Medicine conducted a single-center, 3-arm randomized controlled trial to investigate CV effects in 248 individuals attempting to quit smoking with the aid of e-cigarettes or prescription nicotine replacement therapy (NRT).4

Participants were assigned to 1 of 3 groups consisting of the following intervention along with behavioral support: e-cigarettes containing nicotine (18 mg/ml), e-cigarettes with no nicotine, or NRT.

Compared with baseline measures, all 3 groups demonstrated improvements in flow-mediated dilation at 3 months (β=3.33; 95% CI, 2.61-4.05; P <.0001) and 6 months (β=2.69; 95% CI, 2.02-3.35; P <.0001), with no significant difference between groups.

Improvements in the secondary outcomes of mean arterial pressure and peak cutaneous vascular conductance responses to acetylcholine and sodium nitroprusside were also noted after 3 and 6 months, with no significant between-group differences.

All approaches were associated with positive CV effects, and none of the interventions were associated with superior comparative CV outcomes.

Matthew L. Springer, PhD, professor of medicine in the division of cardiology at the University of California, San Francisco, School of Medicine and researcher in the UCSF Cardiovascular Research Institute and the UCSF Center for Tobacco Control Research and Education, has conducted numerous studies on the CV effects of e-cigarettes.

In a NIH-funded study published in October 2022, he and colleagues observed lower flow-mediated dilation as well as blood changes inhibiting endothelial nitric oxide (NO) release in both chronic smokers and chronic e-cigarette users compared to nonusers. The findings also revealed vaping-specific changes associated with increased microvascular endothelial permeability and greater intracellular oxidative stress.5

Other researchers have found increased acute or long-term arterial stiffness, blood pressure, heart rate, and sympathetic tone in e-cigarette users, with evidence indicating that some of these effects may result from nicotine exposure specifically.1

To clarify the evidence and clinical implications regarding the effects of e-cigarettes on cardiac health, we interviewed Dr Springer along with Sandhya Venugopal, MD, clinical professor of health sciences in the division of cardiovascular medicine, director of the ECG Lab, and associate dean of continuing medical education at the University of California Davis School of Medicine in Sacramento, and Kinjan Parikh, MD, cardiologist and clinical instructor in the Leon H. Charney Division of Cardiology at the New York University Grossman School of Medicine. 

What does the latest evidence suggest about the CV effects of e-cigarette use in general and as compared to combustible cigarettes?

Dr Venugopal: Even though the use of cigarettes may have decreased in the last few years, nicotine addiction has continued secondary to e-cigarettes in the market. Because nicotine in any form is highly addictive, vaping with nicotine-containing substances can become habitual. Michael Blaha, MD, at the Johns Hopkins University School of Medicine, points to evidence suggesting that vaping by young people increases the probability of subsequent use of illicit drugs and tobacco products.6 E-cigarettes were the most commonly used smoking products among youth in 2015, with a more than 9‐fold increase in usage from 2011 to 2015.7

Although e-cigarettes have the potential to be less harmful than conventional cigarettes due to their reduced number of harmful chemicals, the effects of e-cigarettes on the CV system are not well-known. One of the complexities of studying the CV effects of e-cigarettes is the large variety of devices and chemical compositions of e-liquids.

Many constituents of e-cigarette aerosols, including nicotine, carbonyl compounds, delicate particulate matter, and metals are associated with substantial toxicity. Inhalation of e-cigarette aerosols among young, healthy adults induces inflammation and oxidative stress. Cross-sectional analysis of CV symptoms showed that e-cigarette users have a higher risk of coronary heart disease, arrhythmia, chest pain, and palpitations.8

The literature on the consequences of second-hand e-cigarette vaping is limited.

Dr Parikh: Recent research funded by the NIH shows likely similar long-term CV risk from e-cigarettes as from traditional combustible cigarettes.2 The constituents of e-cigarette – which include many of the same components from classic cigarettes – increase inflammation in the body and oxidative stress directly to the blood vessels, including the coronary arteries supplying the heart.

Through intermediaries such as a decrease in NO and an increase in hydrogen peroxide and permeability, direct damage is caused to the blood vessels, creating the substrate for long term CVD. Notably, e-cigarettes are relatively new, thus more data is needed to fully understand their long-term health effects.  

Dr Springer: It’s pretty clear from our work and that of several other research groups that e-cigarette use involves some of the same risks as combustible cigarette smoking. Adverse effects of acute exposure to e-cigarette aerosol on vascular endothelial function have been demonstrated in humans and rats, using standard freebase nicotine e-cigarettes, nicotine salt e-cigarettes like JUUL, and e-cigarettes using only the proplyene glycol and vegetable glycerin (PG/VG) vehicle with no nicotine.

We’ve shown that chronic e-cigarette users also have impaired endothelial function relative to nonusers and comparable to that of chronic smokers, and that both the chronic e-cigarette users and chronic smokers have serum that blunts the production of NO by cultured endothelial cells relative to non-user serum.5

Recent work out of the University of West Virginia shows that rats exposed to e-cigarette aerosol only while in utero have persistent vascular problems into adulthood, such as vascular stiffness and impaired aortic relaxation.9

In rat experiments that we recently published, we saw that a daily realistic vaping session for 8 weeks caused a decrease in cardiac function and adverse effects on heart rate variability, susceptibility to arrhythmias, cardiac fibrosis, cardiac microvessel density, and remodeling of cardiac nerves to a more sympathetic balance.10

Since e-cigarette aerosol contains far fewer chemicals than combustion smoke, it’s presumably less harmful than cigarette smoke overall. However, the aerosol contains not just the components initially present in the e-liquid, but also toxic chemical reaction products that occur in the liquid upon storage for many months, reaction products that occur during heating at the heating coil, and metals and particles that come off the coil and wick.

In fact, some of the adverse effects of smoking and vaping on endothelial function appear to be not specific to individual chemicals and instead to derive from airway irritation, as we have recently found that severing the vagus nerve in anesthetized rats completely protects them from tobacco smoke-induced vascular dysfunction.11

So, there are a number of reasons to expect that vaping involves some of the same adverse effects as smoking and presumably lacks other adverse effects of smoking. However, vaping also caused adverse effects that smoking does not cause. For example, in our recent study of chronic e-cigarette users and smokers, serum from the chronic e-cigarette users caused an increase in microvascular endothelial cell permeability in culture that was not caused by serum from chronic smokers or from non-users.5 

Furthermore, serum samples from smokers and from vapers contain elevated levels of circulating inflammatory biomarkers, but the 2 groups have elevated levels of different subsets of these markers.5

The takeaway from all of this is that vaping causes some harmful effects of smoking, vaping lacks other harmful effects of smoking, and vaping causes harmful effects that smoking does not cause. Therefore, while it’s likely that someone who completely switches from smoking cigarettes to vaping will experience a reduction in overall risk, the vaping is not harmless. What’s more, incompletely switching so that someone who used to exclusively smoke now vapes but still smokes a little, may result in experiencing the adverse effects of both behaviors.

How should physicians advise patients on the risks of e-cigarettes?

Dr Venugopal: Doctors should convey the information about e-cigarettes in a nonjudgmental way and let patients know that further data is still needed to clarify their effects.

Dr Parikh: I counsel my patients to refrain from e-cigarettes the same as I would for combustible cigarettes. While we are continuing to collect data supporting the potential health risks and damage these agents can cause, we have little to no data showing any benefit with their use.  

Dr Springer: If you don’t smoke or vape, don’t start vaping. If you smoke, it’s best to completely quit. If a quitting smoker feels the need to vape and can’t be convinced not to, then they should be strongly encouraged to switch completely and not still smoke.

Is there a role for e-cigarettes in smoking cessation? If so, which patients seem to be good candidates?

Dr Venugopal: There are no current evidence-based guidelines for physicians to follow on the use of e-cigarettes. The US Preventive Services Task Force and American College of Physicians recommended against the use of them as a smoking cessation tool given the conflicting and limited evidence.12

In previously published studies, the percentage of healthcare providers who prescribed e-cigarettes to help quit smoking ranged from 4% to 35%, implying a significant variation in clinical practice.13,14

A meta-analysis of CV outcomes of smokers switching from traditional cigarettes to e-cigarettes did not show any improvement in stroke, MI, or coronary heart disease outcomes. However, this work showed reduced adverse respiratory effects in smokers who switched to e-cigarettes.15 Additionally, more extensive studies have shown that smokers who do not stop smoking often use both conventional cigarettes and e-cigarettes, and these dual users have a higher CV risk compared to those who only smoke conventional cigarettes.15

Dr Parikh: No. E-cigarettes are just as addictive as traditional cigarettes, and there is also the recent data supporting a likely additive harm to using both types of cigarettes. The proposed mechanism is that they may activate different pathways that compound one another’s harmful effects.  

Dr Springer: Possibly. Studies have shown that e-cigarettes can be part of an effective smoking cessation program when the program includes other aspects like counseling. Other studies indicate that vaping without the other aspects of the program isn’t a clearly effective cessation tool, although I’m sure for some individuals, it has worked.

What are the top priorities in terms of research and education regarding e-cigarette use? 

Dr Venugopal: One of the complexities of studying the CV effects of e-cigarettes is the large variety of devices and chemical compositions of e-liquids. There is a need for continued FDA regulation and safety testing of new flavors and devices. In addition, more data is still needed regarding the long-term effects of e-cigarettes, especially their impact on CVD in susceptible populations. 

Dr Parikh: Studies to improve our understanding of the long-term effects of e-cigarettes are needed. There is also an ongoing need for education, particularly to the younger population, that e-cigarettes are not a safer alternative to combustible smoking but rather have similar dangerous effects.

Dr Springer: I’m very concerned about the “anything goes” nature of e-cigarettes. Some of the ingredients can be regulated to minimize those that have specific harmful effects, but people can and do put anything in an e-cigarette that they want to. Many ingredients in your kitchen are fine to eat but may be harmful if inhaled; the buttery popcorn flavoring agent is one of the earliest examples of this, tasted great but causes permanent lung disease.17 

I think people need to be very careful of what they put into their lungs. We should do our best to prevent kids from starting to vape, and if adults want to vape, it should be an informed decision with the knowledge that this is not a harmless activity – that is, it’s not “harmless water vapor.”

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American Heart Month: A Spotlight on the Cardiovascular Effects of Eating Disorders https://www.thecardiologyadvisor.com/general-cardiology/american-heart-month-spotlight-on-the-cardiovascular-effects-of-eating-disorders/ Wed, 01 Mar 2023 12:30:10 +0000 https://www.thecardiologyadvisor.com/?p=102806

Physicians in the United States should be alert to the rise in eating disorders, as well as cardiovascular outcomes related to eating disorders.

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As American Heart Month comes to a close, Cardiology Advisor would like to bring attention to recent studies highlighting a growing prevalence of eating disorders in the United States, with increasing rates of inpatient and outpatient treatment seeking noted among people of all age groups with these illnesses since the start of the COVID-19 pandemic.1

Along with the associated psychological effects, eating disorders are linked to increased morbidity and mortality due to medical sequelae including cardiovascular dysfunction. The cardiovascular risks associated with eating disorders are especially concerning for girls and women, given the higher risk of both eating disorders and cardiovascular death in women compared to men.1,2

Data on Cardiac Impairment in Eating Disorders

In anorexia nervosa, cardiovascular complications such as QTc prolongation, arrhythmias, hypotension, and sinus bradycardia affect up to 80% of patients and represent a leading cause of death in this group.3 In bulimia nervosa, repeated purging through self-induced vomiting, laxative or diuretic abuse, or other methods can lead to severe electrolyte imbalance and resulting cardiovascular complications such as conduction disturbances.4

Additionally, a range of structural cardiac abnormalities have been observed in patients with eating disorders. “In individuals with longer-standing illness, there can be cardiac muscle weakness resulting in reduced left ventricular mass index, left ventricular atrophy, and possible mitral valve prolapse,” explained Jeff Hopkins, MD, a pediatrician providing medical management in eating disorders treatment at the Atlanta Center for Wellness in Georgia.1 “Pericardial effusions are also a common finding in almost 25% of chronic eating disorder patients.”

While cardiac dysfunction has been reported in patients with binge eating disorder and avoidant/restrictive food intake disorder, further research is needed to elucidate the complications associated with these relatively new diagnoses and other types of disordered eating.1

When encountering a patient with a possible eating disorder, it is crucial to take the needed time to obtain a detailed history in a non-judgmental manner to increase the probability that the patient will share their thoughts and habits with the provider, and it is critical to keep a wide differential diagnosis in mind when evaluating patients.

Various studies have found that structural cardiac abnormalities may be partially or fully reversed with weight restoration and cessation of eating disorder-related behaviors in individuals recovering from anorexia nervosa.3,5,6 In a 2022 study of 29 adult women who had received treatment for adolescent-onset anorexia nervosa more than 20 years earlier, those with normal weight at follow-up demonstrated echocardiographic and EKG parameters that were similar to those of control patients with no eating disorder history.6

Conversely, participants with low weight who still met diagnostic criteria for anorexia nervosa showed significant reductions in left ventricular end-diastolic dimensions, left ventricular mass, and left atrium dimensions when compared to the restored weight group and healthy controls.6

However, another study found persistent cardiac impairment, including increased vagal tone and endothelial dysfunction, in 46% of adult patients who had received treatment for anorexia nervosa as adolescents, with a mean time of 7.4 years from recovery to follow-up.3 Such findings underscore the important role of cardiovascular monitoring for patients with or in recovery from eating disorders. 

Clinical Recommendations and Next Steps

Dr Hopkins provided several clinical recommendations regarding the recognition and management of eating disorders. For all patients with known or suspected eating disorders, he recommends a thorough cardiac history and examination, to include resting heart rate and orthostatic blood pressure measurements, baseline ECG, and chemistry panels to assess electrolyte levels.

“When encountering a patient with a possible eating disorder, it is crucial to take the needed time to obtain a detailed history in a nonjudgmental manner to increase the probability that the patient will share their thoughts and habits with the provider, and it is critical to keep a wide differential diagnosis in mind when evaluating patients,” he advised.

Dr Hopkins notes that many patients and some health care providers may attribute bradycardia to “athletic heart,” which can be a dangerous mistake in patients with eating disorders. “Those with a true ‘athletic’ heart will not see a significant increase in heart rate with brief in-office exercise—because they are indeed in good shape, while patients who have bradycardia due to an eating disorder will see a brisk increase in heart rate in response to minimal activity, as they are deconditioned and have weak baseline muscle stamina,” he said.

He adds that anecdotal reports have also indicated an increase in POTS among individuals with anorexia nervosa.1

He recommends that providers become familiar with the resources available in their local community, including nutritionists and mental health therapists specializing in eating disorders, to whom they can refer patients for detailed evaluation and evidence-based nutritional and psychological treatment if indicated. Some patients will also require ongoing consultation with a cardiologist throughout their treatment and recovery.

“Cardiologists need to be a part of the treatment team along with mental health professionals, nutritionists, and primary care providers when there is a known cardiac manifestation of a patient’s eating disorder or a pre-existing cardiac diagnosis,” Dr Hopkins explained. “There are many moving parts as a patient’s weight fluctuates, mental health changes occur, and medications are stopped and started. If a patient has had or develops cardiac abnormalities, the cardiologist will need to provide consultation and advice to the patient and other members of the team in during the care of this complicated, chronic, and potentially deadly disease.”

For providers treating patients with or at risk of eating disorders, he strongly recommends a review of the chapter on cardiac abnormalities in the book Eating Disorders: A Comprehensive Guide to Medical Care and Complications,7 which he cites as one of the most respected sources of information in the medical treatment of this patient population.

With greater awareness of the potential signs of eating disorders, Dr Hopkins notes that “cardiologists may be able to take a more active role in helping to identify these disorders in the early stages of illness when evaluating patients for bradycardia or orthostatic changes.”

Among remaining research gaps in this area, he points to the need for further investigation to determine the causes of some of the cardiac changes observed in individuals with eating disorders, with the aim of developing preventive strategies for these complications.

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Americans With Trouble Sleeping Report Their Sleep Affects Their Relationships https://www.thecardiologyadvisor.com/general-medicine/americans-trouble-sleeping-report-sleep-affects-relationships/ Fri, 24 Feb 2023 14:07:04 +0000 https://www.thecardiologyadvisor.com/?p=102650 sleepless-couple-laying-on-opposite-sides-of-a-bed

The Wake Up America Survey is an annual online survey conducted in partnership with The Harris Poll.

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sleepless-couple-laying-on-opposite-sides-of-a-bed

Many people with trouble sleeping (PWTS) report that their insomnia causes strain on their romantic relationships, according to results reported by the Wake Up America Survey.

In 2021, Idorsia Pharmaceuticals US, Inc, launched the Alliance for Sleep, which is a multidisciplinary committee with the goals of researching and promoting awareness about sleep and sleep disorders in the United States (US). The Wake Up America Survey is an annual online survey conducted in partnership with The Harris Poll. Adults and health care providers living in the US were invited to participate. The second annual survey, conducted between August and September 2022 comprised 1098 adults with insomnia or trouble sleeping without sleep apnea or substance abuse, 1005 adults who are partners of a person with trouble sleeping, 301 primary care providers (PCPs), and 301 sleep specialists.

In general, PWTS report being inundated with suggestions on how to improve their sleep. These strategies include using melatonin, over-the-counter sleep aids, cannabidiol or marijuana, avoiding alcohol or caffeine, sleep hygiene, using a noise machine, and meditating, among others. However, none of these strategies are monotherapies for insomnia recommended by the American Academy of Sleep Medicine (AASM).

Even though current guidelines do not recommend using these strategies for treating insomnia, most PCPs and PWTS thought melatonin (~70%) and sleep hygiene (>66%) were recommended to treat insomnia.

As we learn more about sleep and understand the impact of sleep problems on people, we can start to dispel myths and create more awareness.

Investigators also found a disconnect between PWTS and their health care providers (HCPs), in which most PCPs reported asking patients about sleep quality during routine clinical care (67%) but only a third of PWTS reported being asked (36%).

Some of the discrepancy between PWTS and HCPs may be due to bias, in which almost half of PWTS thought there was stigma about medication for sleep, 45% reported a reluctance to seek medication treatment, and 30% a hesitance in talking about sleep with their clinician because of stigma.

Trouble sleeping has long-reaching effects outside the health care setting. Most PWTS (53%) reported that their poor sleep contributed to stress on their relationship, by causing arguments (41%) in general, at least once a month (31%), or constantly (23%). According to both PWTS and their partners, approximately 33% said they argued about how sleep affected the troubled sleeper’s mental or physical health, their partner’s sleep, or their relationship.

In addition, trouble sleeping often caused their partners to “pick up the slack” of the troubled sleeper’s household duties (41%) or to sleep in separate beds (31%).

Overall, researchers found that the results of this survey indicated that PWTS are often misinformed about appropriate treatment strategies and available resources for improving sleep. The lack of focused conversation between patient and HCP likely contributes to a perpetual cycle of misinformation and poor sleep outcomes.

We spoke with Ruth Banca, MD, who is board certified in sleep medicine and psychiatry and is the chair of Behavioral Medicine at Wake Forest Medical School and serves as the co-chair of the Alliance for Sleep.

What were the motivations behind the Wake Up America Survey?

Those of us in the sleep field have known for a long time that insomnia is a serious problem. Insomnia is a difficulty falling asleep or staying asleep and having the perception that the quality of your sleep is generally not good. We know from lots of research that it leads to significant problems both with mental and physical health, yet, in general, I think there’s a sense that insomnia is not really very important. It’s something you should just be able to take care of yourself, that it’s not a serious health problem. I think a big issue for us in the sleep field is to make the public and other HCP colleagues aware that this really is a significant medical issue.

What were the aspects of the survey results that you found most surprising?

Surprising in a good way, to me, was how many people attributed their relationship problems to sleep problems. We know that insomnia has a significant impact on your mental health and your mood. Certainly, if you’re irritable and out of sorts, that’s going to really impact your relationship with your significant other and the people around you. People really attributed some of the difficulties they were having in interpersonal interactions with their sleep.

Some of the things that were surprising in not such a good way were things like how many, not only PWTS, but also HCPs, felt like melatonin was an appropriate treatment for insomnia. There are some things that melatonin can be helpful with, particularly sleep scheduling problems, like if you can’t fall asleep at the right times of day, melatonin is something that sort of helps train your rhythms. But it’s not really an effective treatment for insomnia.

What do you think the disconnect is between the perception of HCPs who thinks that they are asking about sleep and the PWTS who think that they’re not being asked?

It really highlights that we’re not doing a good job in health care asking people about their sleep and doing appropriate things to help them with their sleep. One thing to keep in mind is that the PWTS and the HCPs were not the providers of the PWTS. They were 2 different groups. It might be that the HCPs we assessed maybe are providers who asked more about sleep than the providers the PWTS saw. But I think there actually is more to it than just that. Sometimes we think we ask our patients about aspects of their health, but maybe we’re not really listening, or we think we’re asking about things, but they’re not hearing us.

What do you think needs to be done to start addressing the large unmet need about insomnia in the United States?

First of all, getting the message out to both, PWTS as well as HCPs, that insomnia is a significant health issue and that there are effective treatments. The other thing is trying to get people to understand that addressing sleep problems is a comprehensive lifestyle treatment. It’s not just about good sleep hygiene rules or taking melatonin, it’s really about comprehensive lifestyle treatments and behavioral therapy. We know that cognitive behavioral therapy is an effective treatment for insomnia, yet most people don’t know how to do it or have access to it. There’s also appropriate use of medications, in cases where that’s needed, and identifying other factors that are contributing to sleep problems.

Do you have any specific advice for the partners of someone who has trouble sleeping?

That was another interesting thing from this survey. I’m not sure that there’s ever been a survey of partners of PWTS, outside of the field of geriatrics. I think it’s very frustrating for partners living with someone who’s having a sleep problem, particularly if the partner doesn’t have a sleep problem, they can’t always understand why their partner is having trouble. That can lead to frustration because the partners don’t know what to do to help the person. I think what’s important for people to understand is that if you have a partner with a sleep problem, it’s really no different than having a partner with some other medical problem. We don’t blame people if they have diabetes, heart disease, or high blood pressure, because it is a medical problem. I think, if we can raise awareness that this isn’t just something your partner is doing on purpose or that they should just be able to fix it by themselves, it can be an important first step in supporting the person with trouble sleeping.

What are your plans for the future of the survey?

We’re going to try to keep doing yearly surveys. As we learn more about sleep and understand the impact of sleep problems on people, we can start to dispel myths and create more awareness. I think the other thing to do, in our professional organizations and academically, is to do a better job training future HCPs about how to diagnose and treat a whole range of sleep disorders. Insomnia can be a disorder in and of itself, but it can also be a symptom of many other sleep disorders that have other types of specific treatments.

The Alliance for Sleep has lots of great ideas and we’re already starting to think about what kinds of things we want to ask in next year’s survey.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

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Strategies for Addressing Physician Burnout and Stress-Related Illness https://www.thecardiologyadvisor.com/home/topics/practice-management/strategies-for-addressing-physician-burnout-and-stress-related-illness/ Fri, 10 Feb 2023 13:45:56 +0000 https://www.thecardiologyadvisor.com/?p=102042 Physician burnout

Robyn Tiger, MD, radiologist and founder of StressFreeMD, talks about physician burnout and strategies for addressing stress-related illness.

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Physician burnout

The daily demands of practicing medicine can amount to “’an ongoing assault,’” noted  a 2022 article published by the American Medical Association.1

Physician burnout and the number of physicians intending to leave their jobs — already at high levels before the COVID-19 pandemic — has increased in the pandemic’s wake. A survey of more than 20,000 US physicians and advanced practice clinicians found that burnout increased from 45% in 2019 to 60% in late 2021, and that intent to leave medicine increased from 24% to more than 40% during the same period.2 Forbes has reported that by 2025, 47% of all health care professionals will have left the profession,3 while the Association of American Medical Colleges predicts a potential shortage of up to 48,000 primary care physicians and 77,100 specialists in the US by 2034.4

Fueling these projected mass retirements and physician shortages is “a broken health care system” that stresses quantity of patients seen over the quality of care provided, which has created “a lack of self-worth” among many physicians, said Robyn Tiger, MD, DipABLM. Dr Tiger, a radiologist who practiced medicine for 15 years before moving into lifestyle medicine, is the founder of StressFreeMD, which offers the CME-accredited course, Rx Inner Peace: A Physician’s Guide for Self-Care.

“With physician stress, anxiety, depression, and burnout on the rise, and having personally lost 3 medical colleagues to suicide, I am deeply passionate about sharing what I have learned with as many physicians as I can,” said Dr Tiger, who began working with physicians and others on stress relief and self-care after overcoming her own stress-related illnesses. She now serves as a subject matter expert in stress management for the American College of Lifestyle Medicine, in addition to serving on the Wellness and Resilience Committee of the North Carolina Medical Society and with the Healthy Healer Program of the Western Carolina Medical Society.

In the following indepth interview, Dr Tiger discusses the impact of burnout and stress on clinicians and what can be done to address this problem.

What kinds of issues do you see among the physicians you work with?

They are exhausted emotionally and physically, they lack self-worth, and they’re not sure what the meaning of their own life is anymore. They are even concerned that they made a wrong choice in going into medicine. Burnout is described as 3 components: emotional exhaustion, cynicism, and lack of self-worth. Physicians are describing all of that and more. They are anxious, reactive, and saying and doing things they wish they could take back. They feel unfulfilled, many report low libido — I hear that a lot. It’s also affecting their family life — their kids don’t want to be around them, and many are on the brink of or getting divorced. It’s disrupting everything, and it’s extremely hard.

There are those who say that physician burnout is a systemic problem that can’t be addressed simply through self-care.5 What are your thoughts about that?

There are 2 important components here: First, the health care system needs to change. I know that some major organizations and even our government is working to do that….[through] a national agenda for physician well-being.6 Beyond that, clinicians, as humans, need to be educated on how to be the healthiest version of themselves, so they don’t get sick from chronic stress, and so they can take care of other people and live the life they deserve to live.

I’m not at the level where I can make changes nationally throughout the health care system, I’m coming from the side of how we can educate the human. I created a CME-accredited program called Rx Inner Peace, [which is supported by] 10 pages of referenced literature. The program is not just telling you to “go do yoga”; it’s teaching you what you need to learn to become the healthiest version of yourself, so that you can prevent or reverse disease.

What led you to transition from practicing medicine to working with burned-out physicians?

Dr Tiger: Several years in[to my medical practice], I found myself developing lots of illnesses and symptoms that I couldn’t really put together. They seemed very disconnected, and they didn’t all happen at one time. I had things like really bad vertigo,… tinnitus, difficulty sleeping, and bleeding gums. I also had really bad reflux, horrible chest pain, and migraine headaches with really violent vomiting.

I developed pain in my body — my joints, muscles, you name it. Every day I just felt like I couldn’t move, like I was like trapped in this tense body. No trauma, just pain. I had paresthesia that would develop at the most inopportune times in my hands, feet, and back. I’d be doing a breast biopsy and couldn’t feel the biopsy gun in my hand.

I went to gastroenterologists, and they put me on pills. I went to a neurologist, and they put me on pills. I went to the periodontist, and they were injecting antibiotics into my gums. I took so much medication and had lots of imaging studies. Being a radiologist, I was getting everything imaged and the results were all negative. All of my blood tests were negative too, and nobody could figure out was the matter with me. Every doctor saw me as a symptom that they gave a pill to. I also went to a physical therapist, and I saw a physiatrist for all the pain. Nobody could figure it out.

The suffering was just so intense that I just didn’t want to feel it anymore, and I had lost 3 physician friends to suicide…2 of them overdosed and 1 jumped off a bridge. I didn’t want that to happen to me. My own family and friends didn’t know completely what was going on with me because I kept it all inside. I did see a mental health care professional, and it really didn’t help.

That’s when I decided I could either go down the path I’m on and end up like those colleagues, or I could try and figure out if I could make myself better. I kept hearing more and more about things like yoga and meditation, and I thought they were weird. Even so, I went to a yoga class after working an entire day, totally exhausted and having all kinds of preconceived notions, and at the end of the first session, I felt calm, grounded, and clear, and I was awake — I wasn’t even tired anymore. That was my first “aha” moment.

My left brain wanted to unpack the physiology as to what led to this 180-degree shift so quickly, so I kept going to the classes to learn more. I decided to go into yoga teacher training to learn more. As I continued with classes and teacher training, the symptoms I described started to get better. Then I learned about the field of yoga therapy, [where] I could take the principles I learned in yoga and study them more deeply to help people with many types of symptoms and illnesses and diseases. Through that training and continuing with yoga therapy, all my symptoms went away 100%. I went on to become certified in meditation and life coaching. I’m also certified through iRest, a specific type of meditation that was originally created for Walter Reed Army Hospital to help our military relieve their suffering from post-traumatic stress disorder.

I realized that the diagnosis that nobody made was that I was suffering from chronic stress. When I learned how to relieve that stress and work with my own physiology and mind, I was able to relieve what I was experiencing, which is in the spectrum of what we may call burnout now.

How long have you been working with other physicians on stress and burnout relief, and what kind of results have you seen?

I stopped practicing medicine in 2012 and have been in this space for a decade now. I had been working with several populations — people with cancer, first responders, military veterans, health care professionals, and anyone else who wanted help. Then, in 2020 when the pandemic hit, I decided that I needed to help my colleagues [and] pivoted to focus my attention specifically on physicians. I don’t know exactly how many I’ve worked with, but it’s in the thousands.

The results have been pretty amazing. Physicians say things like, “I’m sleeping well for the first time in decades,” and “My body no longer feels like the tin man.” I’ve had them say to me, “Because of you, my marriage was saved,” and “I found joy in medicine again because of you,” and “My kids want to spend time with me again.”

I basically teach what we were never taught in medical school, which is how to regulate your nervous system and how to work with your thoughts; for me, it’s a 2-part, mind-body approach. My job really is to help [physicians] help themselves. I give them the education and they’re the ones experiencing the transformation.

Is there any evidence to support the efficacy of this approach to dealing with stress and burnout?   

There’s lots of literature out there. That’s actually how I got into yoga therapy to begin with, because when I started to feel better, I dove into the medical literature to find out why. I was surprised to find so many articles published in our own medical literature about the benefits and changes that disciplines such as yoga therapy and meditation can create for many types of symptoms and illnesses and diseases.7-9

There also have been randomized clinical trials on coaching and lots of literature on the topic. For example, Cleveland Clinic recently reported they saved $133 million dollars in retention [through a peer-based coaching and mentoring program promoting clinician well-being], because with every physician that leaves, it costs the medical system as much as a million dollars.10,11

Is there anything else physicians should be aware of in dealing with stress and burnout?

I would like physicians to know that they’re not alone if they’re feeling anything or everything that I described. It’s not okay, but it’s normal.

Also, if someone is having any type of suicidal thoughts, please seek help. To reach the 988 Suicide & Crisis Lifeline, they can call or text 988 or chat 988lifeline.org. [This was formerly the National Suicide Prevention Lifeline.] There is also a phone number (1-888-409-0141), a hotline for physician-to-physician mental health help that doctors and medical students can call and speak to another doctor. There are no notes and nothing is kept where they have to be concerned that their mental health issues could be recorded and held against them.

If you or someone you know is struggling or in crisis, help is available. Call or text 988 or chat 988lifeline.org

Resources

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The Impact of Psychological Stress on Cardiovascular Disease Risk https://www.thecardiologyadvisor.com/general-cardiology/impact-of-psychological-stress-on-cardiovascular-disease-cvd-risk/ Fri, 03 Feb 2023 15:42:08 +0000 https://www.thecardiologyadvisor.com/?p=101706

Glenn N. Levine, MD, Viola Vaccarino, MD, and Allison E. Gaffey, PhD, discuss the effects of psychological stress on cardiovascular disease risk.

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A substantial body of research highlights the association between psychological stress and mental health disorders such as depression and anxiety. Additionally, extensive research points to a significant link between stress and physical illness, with the bulk of these studies focused on cardiovascular risk.1

The term “stress” generally represents “experiences in which the environmental demands of a situation outweigh the individual’s perceived psychological and physiological ability to cope with it effectively,” according to Crosswell et al.1 In research exploring the relationship between stress and heart health, the concept of stress may refer to acute or chronic stress or exposure to daily stressors, stressful life events, or traumatic experiences.1

Recent Evidence Linking Stress and CVD

A 2021 cohort study published in JAMA Network Open examined associations between a composite measure of psychological distress (based on assessments of self-perceived stress, life events, and financial stress) and the risk for cardiovascular disease (CVD), stroke, and death in 118,706 individuals (58.8% women) from 21 countries. Participants had a mean age of 50.4 years and no history of CVD at baseline.2

The results showed that high stress was linked to an increased risk for CVD (hazard ratio [HR], 1.22; 95% CI, 1.08-1.37) and stroke (HR, 1.30; 95% CI, 1.09-1.56) after adjustment for demographic variables and traditional CVD risk factors. Increasing stress levels were associated with an increasing risk for coronary heart disease (low stress: HR, 1.09; 95% CI, 1.01-1.18; high stress: HR, 1.24; 95% CI, 1.08-1.42) and death (low stress: HR, 1.09; 95% CI, 1.03-1.16; high stress: 1.17; 95% CI, 1.06-1.29).

…there are many well-done reports that catastrophic events, such as earthquakes, are associated with a short-term rise in heart attack, arrhythmias, and cardiac death.

In a 2021 study described in JAMA, researchers conducted a pooled analysis of data from 2 cohort studies to determine the association between mental stress-induced myocardial ischemia and cardiovascular events in 918 patients (mean age, 60 years; 34% women) with stable coronary heart disease. Investigators used myocardial perfusion single-photon emission computed tomography to compare the effects of myocardial ischemia provoked by mental stress (via a public speaking task) and conventional stress (via exercise stress testing or a pharmacological stress test with regadenoson).3

The findings revealed a higher risk for cardiovascular death or nonfatal myocardial infarction in patients with vs without mental stress-induced ischemia, after adjustment for a range of confounding variables (HR, 2.5; 95% CI, 1.8-3.5), with an event rate of 4.8 vs 2.3 per 100 patient-years, respectively), while those with conventional stress ischemia alone showed no significant increase in CVD risk.

Patients with both mental and conventional stress ischemia also demonstrated a substantially higher CVD risk than those with no ischemia (event rate, 8.1 per 100 patient-years; HR, 3.8; 95% CI, 2.6-5.6) and those with conventional stress ischemia only (HR, 2.7; 95% CI, 1.7-4.3).

Hospitalizations for heart failure were also higher among patients with vs without mental stress-induced ischemia (event rate, 12.6 vs 5.6 per 100 patient-years; HR, 2.0; 95% CI, 1.5-2.5).

This study and others showing associations between acute stress and myocardial ischemia seem to align with frequent patient reports of angina precipitated by stressful events, according to a 2022 review by Glenn N. Levine, MD, FACC, FAHA, master clinician and professor of medicine at Baylor College of Medicine and chief of cardiology at the Michael E. DeBakey VA Medical Center in Houston, Texas. In his paper published in the American Journal of Medicine, Dr Levine also examined evidence regarding the relationship between acute and chronic psychological stress and other types of cardiovascular dysfunction such as myocardial infarction.4

Proposed Mechanisms and Expert Insights

Regarding potential mechanisms driving the effects of psychological stress on CVD risk, Osborne et al wrote that chronic stress increases activity in the hypothalamic-pituitary-adrenocortical axis and the sympathetic nervous system, which increases inflammation and CVD risk factors including hypertension and insulin resistance. These processes lead to “increased arterial inflammation and noncalcified coronary plaque burden, resulting in higher CVD risk independent of traditional risk factors,” they explained.5

In addition, Dr Levine wrote that acute stress “leads to acute increases in sympathetic activity and increased circulating and local levels of catecholamines, prothrombotic effects, epicardial coronary arterial vasoconstriction in areas of pre-existing atherosclerotic disease, and impaired microvascular function, all in the setting of increased myocardial oxygen demand.”4

We interviewed Dr Levine as well as the following experts to learn more about the stress-CVD link: Viola Vaccarino, MD, PhD, the Wilton Looney Distinguished Professor of Cardiovascular Research in the Rollins School of Public Health at Emory University in Atlanta and professor in the division of cardiology at the Emory University School of Medicine; and Allison E. Gaffey, PhD, clinical psychologist and instructor in the section of cardiovascular medicine at Yale University School of Medicine in New Haven, Connecticut, and clinical investigator at the VA Connecticut Healthcare System.

Dr Vaccarino is the lead author of the 2021 study on stress-induced myocardial ischemia described above, and Dr Gaffey is the lead author of a 2022 meta-analysis of 15 studies indicating that psychological stress assessed by brief screening measures (such as the Patient Health Questionnaire and the Perceived Stress Scale) was associated with an increased risk for first-onset CVD.3,6

What does the strongest evidence suggest about the impact of psychological stress on CVD risk? 

Dr Levine: The strongest evidence that psychological stress can affect the heart comes from 2 areas. One, psychological stress is the major cause of what is called Takotsubo cardiomyopathy, or “stress cardiomyopathy,” in which it seems like the patient is having a heart attack and major dysfunction of the left ventricle can be observed.4 

Second, there are many well-done reports that catastrophic events, such as earthquakes, are associated with a short-term rise in heart attack, arrhythmias, and cardiac death. There is also a growing body of data that seems to suggest that psychological stress is associated with an increased long-term risk of developing heart disease.4

Dr Vaccarino: There are many studies that have described an association between various forms of stress exposure and CVD risk, despite different study designs, different populations, and differences in the definition of “stress.” Although this evidence applies to many different types of populations, the harmful effects appear stronger in high-risk groups, such as people who already have CVD. This evidence, however, is mostly based on perceived or self-reported stress, which could be imprecise or biased.

Our study used an objective way to provoke stress, with a laboratory stressor, and examined the prognostic significance of developing ischemia with mental stress. Those who developed ischemia with mental stress had a more than 2-fold increased risk of adverse events during a 5-year follow-up period, an association that was not explained by other factors. We believe these results provide possibly the strongest evidence linking psychological stress to CVD risk.3

Dr Gaffey: Over 40 years of evidence indicates that experiencing psychological stress, especially chronically, and related psychological distress, is associated with a greater risk for CVD. The strongest evidence in this area pertains to symptoms of depression and anxiety. In our recent study collapsing across different types of distress, there was a 28% greater risk of CVD onset for adults who reported high distress compared to those who reported no or low distress.6

What are the current implications for clinicians? For example, are there any specific recommendations about screening, prevention, or discussing this issue with certain patients?

Dr Levine: While the field has not advanced enough to strongly recommend psychological stress screening and treatment as an intervention that definitively decreases future risk, it is reasonable and prudent to at least be alert to increased psychological stress in patients at risk for or with heart disease, and in those who do seem to suffer from this, consider referral to a mental health expert.

Dr Vaccarino: The implications are that emotional factors are very important for the clinical course and outcome of patients with heart disease. There is a compelling need to include stress and mental health indicators in the risk assessment of patients with CVD. The current practice is mainly focused on addressing conventional risk factors and atherosclerotic disease. This is important because stress and mental health factors can be intervened upon—for example, using stress management training and, in some cases, medications.

Dr Gaffey: Using brief screeners to regularly assess psychological distress—as part of primary and secondary cardiovascular prevention—is advantageous for CVD risk stratification, and any distress screening is really more ethical than not screening. High distress captured via screening should be followed by connection with mental health, social work, or other supportive resources, depending on the needs of the patient.

What should be the focus of future research in this area? 

Dr Levine: Future research should include more prospective studies on the impact of psychological health on cardiac risk and further well-designed randomized trials of psychological stress reduction interventions and their impact on cardiovascular risk.

Dr Vaccarino: Further studies are needed to prove the utility of recognizing and treating myocardial ischemia provoked by psychological stress in the clinical setting. Also, we need to investigate alternative ways to identify the people who are most vulnerable to the harmful effects of stress on the cardiovascular system. This is because cardiac imaging, as we have done in this study, is expensive and carries radiation, and the protocol is time-consuming. If we can identify ways that are more practical in the clinical setting, such as vascular reactivity testing for stress, or even a blood panel of “stress biomarkers,” that would be extremely useful.

Dr Gaffey: There are socially- and biologically-based differences in the types of stressors experienced and impact of those stressors on men and women, respectively. Understanding associations between psychological distress and CVD risk by sex may help clarify the benefits of psychological distress screening and psychological care needed for each group.

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Teachers Reported Greater Mental Health Distress Than Health Care Workers in COVID-19 Pandemic https://www.thecardiologyadvisor.com/home/news/teachers-greater-mental-health-distress-than-health-care-workers-covid-19-pandemic/ Fri, 27 Jan 2023 14:24:36 +0000 https://www.thecardiologyadvisor.com/?p=101410 tired-teacher-at-desk

Random Facebook users were invited to respond to a questionnaire about physical and mental health symptoms. Differences in anxiety, depression, and isolation were evaluated on the basis of profession and whether the individual worked in-person or remotely.

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Teachers in the United States reported greater levels of anxiety, depression, and isolation during the COVID-19 pandemic than health care workers. These findings were published in the Educational Researcher.

Investigators from the Johns Hopkins Bloomberg School of Public Health sourced data for this study from the US COVID-19 Trends and Impact Survey, which was a large online survey conducted by Carnegie Mellon University in collaboration with Facebook.

Random Facebook users were invited to respond to a questionnaire about physical and mental health symptoms between September 2020 and March 2021. Differences in anxiety, depression, and isolation were evaluated on the basis of profession and whether the individual worked in-person or remotely.

The study population comprised 135,488 teachers and 2,640,486 individuals employed in other sectors. The teacher and comparator cohorts comprised 84.1% and 63.9% women, 26.3% and 22.6% of participants were aged 35 to 44 years, 26.7% and 23.1% were aged 45 to 54 years, and 45.1% and 44.9% lived in an area with a population of ≥1 million, respectively.

There’s research showing that when teachers are included in decision making processes, they feel more of a sense of community at their workplace. This is so important because there are such strong outcomes when teachers are negatively impacted.

In the entire study cohort, men reported less anxiety (odds ratio [OR], 0.525; P <.001), depression (OR, 0.708; P <.001), and isolation (OR, 0.814; P <.001) than women; older participant groups reported less anxiety (OR range, 0.126-0.697; all P <.001), depression (OR range, 0.132-0.634; all P <.001), and anxiety (OR range, 0.217-0.697; all P <.001) than individuals aged 18 to 24 years; and individuals with a college degree, professional degree, or graduate degree reported more anxiety (OR range, 1.096-1.115; both P <.001) and isolation (OR range, 1.134-1.293; both P <.001) but less depression (OR range, 0.770-0.816; both P <.001) than individuals with less than a high school education.

Stratified by profession, health care workers reported significantly less anxiety (OR, 0.696; P <.001), depression (OR, 0.952; P <.01), and isolation (OR, 0.957; P <.01) and office workers reported less anxiety (OR, 0.807; P <.001) but more depression (OR, 1.041; P <.05) and isolation (OR, 1.198; P <.001) compared with teachers.

Among the teachers, 106,000 worked in-person and 28,693 worked remotely.

In a teacher-specific analysis, remote workers reported significantly greater depression (OR, 1.122; P <.01) and isolation (OR, 1.563; P <.001) but similar levels of anxiety. Consistent with the main analysis, men reported less anxiety (OR, 0.600; P <.001) and depression (OR, 0.880; P <.01) than women and older age groups reported less anxiety (all P <.001), depression (all P <.001), and isolation (all P <.001) than teachers aged 18 to 24 years.

The results of this study may have been biased by the reliance on self-reported data.

These data indicated that during the pandemic, teachers in the US reported more anxiety, depression, and isolation than health care workers. In general, negative mental health effects were more common among women and younger individuals.

We spoke about this study with 1 of the authors, Joseph M Kush, PhD, of James Madison University and formally of Johns Hopkins Bloomberg School of Public Health.

What was the motivation of this study?

“We were interested in looking at teachers and how they were doing in relation to their mental health throughout the pandemic. A lot of educational research looking at the pandemic has focused on student achievement, or more pure public health questions, like mask usage in schools. But we were curious to know how teachers are doing.

There were 2 primary research questions. The first was looking at the health outcomes among teachers and comparing those rates to professionals in other occupations. The second was to look at teachers specifically and see if there are any differences between in-person vs remote working.”

Were you surprised by any of your results?

“Overall, the results were unfortunate, shall we say? We saw high anxiety symptoms, high depression symptoms, and isolation among everyone. We saw some differences between teachers teaching remote and in-person. Basically, those teaching in person had lower rates of these problematic mental health outcomes. That makes some intuitive sense, if you’re working remote, you’re by yourself and you might feel isolated and have some anxiety symptoms as compared to those that are put together as a community.”

Do you know of any similar study that looked at the mental health of teachers compared with other professions prior to COVID-19? Is it possible that teachers have higher levels of mental distress in general?

“The short answer is yes, it is possible. To your point, we don’t have that kind of pre- postpandemic data. There have been some studies from the past that looked at occupational stress among some 30 different occupations, and teachers were some of the highest. But what is occupational distress? That may be different than anxiety symptoms or feelings of isolation. There’s been a lot of research into teacher burnout or stress globally, but less is known about specific mental health outcomes.”

The results of this study suggest there is a great unmet need for mental health care among teachers. What do you think these results mean for society?

“One thing that motivated us when we [conducted this research] is that we really want teachers to have more of a voice. Unfortunately, a lot of decisions that are made are done so excluding teachers. I understand the pandemic occurred and there was a rapid response, I understand the urgency, but in many cases, teachers were excluded, and that seems problematic. There’s research showing that when teachers are included in decision making processes, they feel more of a sense of community at their workplace. This is so important because there are such strong outcomes when teachers are negatively impacted.”

Do you have plans to expand this research?

“Yes. I do plan on continuing to work in this area. These data are really cool and unique, and I want to continue working on it. There are still these follow-up questions that are going to be really illuminating, such as, why do we see such differences? Do we have other variables that can explain these trends? We’ve taken a snapshot and documented anxiety and depression levels during the pandemic, but we are thinking about ways in which we can link these data to pre-COVID-19 data, which would be really exciting. Then we can talk about longitudinal effects. How are things progressing over time?”

What is the big take-home message of this work?

“I think it is important to document and to see where teachers are. [These results can be] a call for action. Excluding teachers from decision making is not the best approach. We really just want to give teachers a voice and use data to do that.”

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Expert Roundtable: Addressing the Rural Cardiology Shortage  https://www.thecardiologyadvisor.com/home/topics/practice-management/expert-roundtable-addressing-the-rural-cardiology-shortage/ Fri, 20 Jan 2023 15:47:36 +0000 https://www.thecardiologyadvisor.com/?p=100784

Health care shortages in rural areas in the United States affect an estimated 60 million people.

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An estimated 60 million people comprising one-fifth of the United States (US) population, reside in areas defined as rural.1 These individuals face numerous disparities in both health outcomes and health care access compared to those living in urban areas. The prevalence of cardiovascular disease (CVD) is 40% higher among rural vs urban residents, and mortality rates associated with all types of CVD and stroke are also higher in rural areas.1-3

The availability of specialists, including cardiologists, is especially sparse in the rural US, and researchers have found significant inequities between patients receiving cardiology treatment in rural vs urban hospitals.4,5 In a retrospective study published in January 2022 in the Journal of the American College of Cardiology, Loccoh et al examined differences in outcomes between Medicare beneficiaries (n=2,182,903) presenting to rural or urban hospitals with acute cardiovascular conditions.5

Patients receiving treatment for acute myocardial infarction (AMI) at rural hospitals showed lower rates of cardiac catheterization (49.7% vs 63.6%; P <.001), percutaneous coronary intervention (42.1% vs 45.7%; P <.001), and coronary artery bypass graft (9.0% vs 10.2%; P <.001) compared with those treated at urban hospitals.5

Among patients with ischemic stroke, rates of thrombolysis (3.1% vs 10.1%; P <.001) and endovascular therapy (1.8% vs 3.6%; P <.001) were also lower at rural vs urban hospitals.5

In addition, 30-day mortality was higher among rural vs urban patients with AMI (HR, 1.10; 95% CI, 1.08-1.12), heart failure (HR, 1.15; 95% CI, 1.13-1.16), and ischemic stroke (HR, 1.20; 95% CI, 1.18-1.22) after adjustment for demographic factors and comorbidities. The most pronounced differences in mortality were observed among patients receiving treatment at critical access hospitals in remote rural areas.5 

Access to cardiology care, like other types of health care, is determined by many different factors including the supply of health care providers, availability of emergency departments and hospitals, as well as health insurance coverage.

Improving cardiology care and outcomes in the rural US will require a range of efforts from various stakeholders. “Governmental or health care systems that incentivize physician practices in these areas are needed – such as programs that pay down student loans and provide loan forgiveness, for example,” Deirdre Mattina, MD, FACC, general cardiologist in the section of regional cardiovascular medicine at the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic in Ohio, told Cardiology Advisor.

Additionally, she noted, “Medicaid services are often reimbursed at lower rates than commercial insurance plans, which creates disparities in health care delivery by disincentivizing physicians to offer care to this vulnerable population.”

Along with better reimbursement models and programs that provide benefits to physicians practicing in underserved locations including the rural US, the further integration of telehealth into cardiology practices is needed to provide a “bridge to infrequent in-person care,” Dr Mattina said.6

To learn more about these regional disparities in access to cardiology care, we interviewed Laxmi Mehta, MD, clinical professor of internal medicine and section director of preventative cardiology and women’s cardiovascular health at The Ohio State University Wexner Medical Center in Columbus; Sameed Khatana MD, MPH, senior fellow and assistant professor of cardiovascular medicine in the Perelman School of Medicine at the University of Pennsylvania, and staff cardiologist at the Philadelphia VA Medical Center; and Basera Sabharwal, MD, chief cardiology fellow at Mount Sinai Morningside in New York.

What factors are driving the shortage in access to cardiology care in the rural US? 

Dr Mehta: Transportation issues including lack of vehicle access, long travel distances, high costs of transportation, and inadequate infrastructure in transportation means can contribute to poor access to care. Rural hospitals are often designated as critical access hospitals, which are typically smaller and have less capacity for intensive care or rehabilitation services. As rural hospitals continue to close nationwide, access is even more challenging for rural patients. Furthermore, workforce shortages also impact staffing in rural areas and in turn limit access to adequate care. High rates of uninsurance amongst rural populations also result in financial strain and impact access to care.

Dr Khatana: Access to cardiology care, like other types of health care, is determined by many different factors including the supply of health care providers, availability of emergency departments and hospitals, as well as health insurance coverage. The number of physicians in rural areas has been declining for decades. Rural hospitals have also been closing at a greater rate than urban hospitals due to factors such as low reimbursement, staffing shortages, and low patient volume. Additionally, we know that many states with large rural populations in the South and Midwest have not expanded Medicaid health insurance, therefore depriving many rural low-income individuals of health insurance.

Dr Sabharwal: Battling health care disparities between rural and urban areas has been ongoing for over a decade now. In general, life expectancy in urban populations is about 3 to 4 years higher than in rural areas, with some indigenous populations having a life expectancy that is 5 to 6 years lower than people living in urban areas.1 Multiple factors are responsible for this, including higher rates of common but treatable risk factors such as high blood pressure, diabetes, smoking, and high cholesterol.

Another primary reason for health care disparities is social determinants of health including income, education, employment, housing, distance from a health care center, transportation, food insecurity, and limited or no health insurance. All of these factors, as well as scarcity of primary care providers for screening and treatment of common conditions like high blood pressure, and less favorable mental and behavioral health care availability, lead to an increase CVD and stroke. 

Regarding acute care, distance to a hospital center is extremely important. On average, rural residents live more than 10 miles from a hospital, which is twice as far than those living in urban locations. Moreover, hospitals in rural areas see a lower volume of complex and critical diseases, leading to lack of experience in these areas and thus differential disease outcomes between urban and rural hospitals. This gap becomes even wider for complex CVDs. Health practitioners in urban areas are super-specialized, and the high volumes they deal with lead to improved health metrics of those diseases. On the other hand, care in rural areas is less specialized and practitioners practice more widely.

Data shows that less than 10% of US physicians practice in rural areas, and even fewer have more specialized training.7 Health care centers including both clinics and hospitals are finding it tougher to retain specialized physicians in these communities. There’s even a shortage of nurses and support staff in these regions, which adds tremendously to the problem.

What are some of the measures needed to help reduce these gaps? 

Dr Mehta: New models and site of care delivery are essential, including expanding telehealth services and digital technology, as well as training of the entire care team so that community health care workers and other care team members can provide care and expand access for patients. Flexible payment and funding models are necessary to support rural delivery of care. Expanding affordable health care insurance may also be impactful.

Dr Khatana: Shoring up the financial health of rural hospitals so that they can continue to operate is an important step. In Pennsylvania, the state is testing a model called the Pennsylvania Rural Health Model, which will provide hospitals with a “global budget” in which CMS and other participating health insurance payers will pay certain rural hospitals a fixed amount of money to cover all costs of hospital-based care. The goal of this program is to provide more predictable finances to rural hospitals.8 

Additionally, training programs need to be set up in rural areas with a focus on providing for the needs of rural programs. Expanding the scope of practice of advanced practice providers such as nurse practitioners and physician assistants to provide cardiovascular care may also address the issue of the shortage of providers.

Dr Sabharwal: Access to health care has changed in the last few years with the rise in telehealth since the pandemic began. This is extremely important and useful, especially in rural areas where long distance travel for routine care is a barrier. With telehealth, these patients can get regular screening, monitoring, and treatment of diseases including CVDs, and they must travel to specialized centers only when necessary. If we can improve primary prevention of heart disease by treating the risk factors, there will be less heart disease requiring treatment. This requires routine health checks and follow-ups, which can be easily done via telehealth.

Another helpful measure would be to include mandatory rotations in rural outreach centers during residency and fellowship training. This will increase care at those centers with a probable increase in physicians ultimately staying at those practices.9

Other measures would be to make rural practices more attractive to physicians at the end of their training, such as through loan forgiveness programs to those willing to work in rural areas, or by combining practices with urban centers wherein physicians agreeing to practice with the majority of their time in rural centers are still able to rotate monthly or every 3 months, for example, through urban centers with exposure to complex diseases.

Churches and other faith-based organizations are cornerstones of rural communities. Collaboration with these organizations for routine health care workshops with cardiologists and other specialists from urban areas would improve care provided in rural populations. Economic development in rural areas as well as improvement in insurance availability for policies like Medicaid would also decrease the health care disparity gap between rural and urban areas.

What are your recommendations for clinicians interested in providing and advocating for increased access to cardiology care in rural areas? 

Dr Mehta: Clinicians should work on expanding their virtual care of patients and be creative in utilizing technology to address health equity. Development of a diverse workforce that incorporates people with differing training will help expand the reach of care for rural patients. Community education is mandatory regarding cardiovascular risk factors, and healthy lifestyle may be beneficial in improving overall cardiovascular health.

The AHA is committed to bringing equitable care to rural communities through its Rural Health Care Outcomes Accelerator, which includes the Get with the Guidelines Quality Program at no cost for rural hospitals, as well as access to participate in rural learning collaboratives and access to the AHA’s Lifelong Learning Center.11

Dr Khatana: Clinicians interested in providing care in rural areas need to form connections with providers already in these areas. Specialty care, including cardiology, is hard to access, so having formal and informal relationships with rural health care providers can help.

Clinicians can also advocate to health system leaders to partner with rural hospitals to help coordinate necessary cardiovascular care when needed. They should also advocate for the expansion of health insurance coverage for low-income patients in rural areas in states that have not yet expanded Medicaid health insurance.

Dr Sabharwal: Caring for these medically underserved patients can be challenging. For those interested in providing cardiovascular care in this high-risk population, they should begin in their early years of training so they can understand the needs of the community and learn to navigate their practice and the system to provide optimal care in these areas. There are multiple organizations within the health care system that are focusing on such efforts, including the American Heart Association (AHA) as well as community groups. Getting involved with such organizations will help achieve the goal of improving cardiovascular care in these communities.  

What are remaining research needs regarding this topic?

Dr Mehta: Research is necessary to determine optimal delivery of care models, including how best to leverage digital technology. Research on effective rural-based quality measures and how to best support community-centered approaches to care is also needed.

Dr Khatana: Unanswered questions include whether improving the finances of rural hospitals will prevent such hospitals from closing. A study by my colleagues and I, published in JAMA in 2021, showed that cardiovascular health was associated with economic prosperity of an area.10 Future research needs to study whether improving the economic prospects of an area can lead to improvement in health outcomes, including for CVD.

Dr Sabharwal: Health care centers in rural areas lack patient volume and quality metrics. Some metrics require a large sample size to be reliable. These 2 factors combined make data from rural centers difficult to interpret. Further research in this area is needed to better understand the needs of rural communities. In addition, research to analyze how telemedicine performs in these populations would help to better strategize care in these communities. 

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Insomnia and Sleep Apnea Is a Challenging Co-Occurrence: Here’s What We Know https://www.thecardiologyadvisor.com/general-medicine/insomnia-sleep-apnea-challenging-co-occurrence-danny-eckert-phd/ Fri, 06 Jan 2023 13:28:18 +0000 https://www.thecardiologyadvisor.com/?p=100240

Danny Eckert, PhD, a researcher on human sleep and respiratory physiology, explains the potential bidirectional relationship and the clinical complications of COMISA, comorbid insomnia and sleep apnea.

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The co-occurrence of insomnia and obstructive sleep apnea (OSA), two of the most common sleep disorders, was first documented in 1973.1 Yet, clinicians and researchers alike have tended to characterize these disorders as distinct, with independent symptoms, pathways, and treatments. More recently, evidence of a bidirectional relationship between OSA and insomnia has been uncovered, spurring increased interest in the field.

In a 2016 study published in Sleep Medicine Reviews, researchers at the Adelaide Institute for Sleep Health, Flinders University, in Adelaide, Australia, coined the term COMISA (comorbid insomnia and sleep apnea) to describe these co-occurring disorders.2 COMISA appears to be more prevalent than previously thought, with 30-50% of patients diagnosed with OSA also reporting chronic insomnia. In contrast, in patients first diagnosed with insomnia, at least 30-40% have comorbid OSA. 3,4

The Impact of Comorbid Insomnia and Sleep Apnea

Both insomnia and sleep apnea are characterized by dysfunctions in sleep, mood, and social and workplace functioning. However, the co-occurrence of these disorders may lead to the exacerbation of these symptoms.5

“By definition, people with OSA and insomnia may suffer the adverse consequences associated with both conditions,” explained Danny Eckert, PhD, director, Adelaide Institute for Sleep Health at Flinders University. “This includes aggravated fatigue, sleepiness, irritability, poor mood, mental health issues such as anxiety and depression, poor concentration, and headaches,” said Dr Eckert, who has done extensive research on human sleep and respiratory physiology.

COMISA is associated with poorer cardiovascular and metabolic health, often co-occurring with cardiovascular disorders, hypertension, and diabetes.6 Patients with COMISA report an average pain intensity 20 points higher than individuals with just insomnia or OSA, indicating a link between COMISA and chronic pain.7 COMISA is also associated with suicidal ideation and an increased risk for self-harm.5

Subsequently, healthy lifestyle measures such as a healthy diet, exercise, regular schedules, and weight loss strategies can help promote optimal sleep health and well-being.

Researchers at the Adelaide Institute for Sleep Health demonstrated a 47-56% increase in the risk for all-cause mortality in patients with COMISA.5,8 “Social determinants of health play a major role in influencing health outcomes. Yet, the co-relationship between COMISA and mortality persisted after controlling for sociodemographic factors, behavioral factors, and chronic conditions, and remained consistent across diverse insomnia and OSA diagnostic criteria,” explained Dr Eckert.

A Bidirectional Relationship

Although comorbid insomnia and sleep apnea is prevalent in the general population, it’s only recently that researchers started to explore in-depth its causes and consequences, said Dr Eckert. Researchers have proposed several bidirectional causal relationships in pathophysiological mechanisms and clinical manifestations that could contribute to the development and progression of COMISA.

One proposed mechanism, from a May 2022 study published in Sleep Breath, is that OSA is a precursor and risk factor for the development of insomnia. Since patients with insomnia often misconstrue prior sleep as wakefulness, it has been hypothesized that patients with COMISA associate post-respiratory event awakening with wakefulness, resulting in a prolonged time to fall asleep through the night.9 

“Another major potential cause is the presence of a ‘low arousal threshold’ endotype, whereby approximately 30% of people with sleep apnea simply wake up too easily with only minor upper airway narrowing episodes,” explained Dr Eckert. He added, “These frequent awakenings may trigger insomnia episodes and periods of wakefulness throughout the night. Insomnia and light sleep may then further worsen sleep apnea, and so the cycle continues/worsens.”

This hypothesis is supported by the fact that patients with COMISA treated with continuous positive airway pressure (CPAP) therapy experience a reduction in insomnia symptoms.2

Conversely, some researchers have suggested insomnia could develop first as a precursor for OSA. Sleep deprivation resulting from insomnia can reduce upper airway muscle tone, leading to reduced minimum oxygen saturation in patients with mild OSA. However, this hypothesis is not supported by empirical evidence, according to a 2018 study published in the Journal of Clinical Sleep Medicine.10

A third potential linkage between OSA and insomnia implicates the hypothalamic-pituitary-adrenal (HPA) axis. HPA activation via stress can lead to sleep fragmentation and insomnia. Concurrently, OSA-associated respiratory events can also autonomically activate HPA. HPA activation, in turn, results in metabolic and cardiovascular dysfunction, which could explain the comorbidities associated with COMISA.3

Clinical Implications of Insomnia and OSA

Although the relationship between insomnia and OSA has not been fully elucidated, diagnostic, therapeutic, and preventative implications of this relationship cannot be ignored. While early diagnosis is vital to treatment success, the shared symptoms of insomnia and OSA can complicate the diagnosis and measurement of each disorder. Additional research is necessary to define effective diagnostic criteria for COMISA, but clinicians should consider enriching their evaluation with complete patient medical histories, physical examinations, sleep diaries, polysomnography, and actigraphy.11

The multifactorial pathology of COMISA also influences treatment approaches for these sleep disorders. “Comorbidities are common in COMISA and thus, ideally, any treatment management approach is tailored to the individual to account for comorbidities,” Dr Eckert advised.

Cognitive behavioral therapy for insomnia (CBTi), the first-line treatment for insomnia, also appears to be effective in the treatment of COMISA. COMISA-associated complications such as depression, anxiety, and stress do not dampen the effectiveness of CBTi.12

CPAP therapy is the most effective treatment for OSA. However, many studies have suggested that insomnia can negatively impact CPAP use among patients. “Thus, treating insomnia first (or in parallel to sleep apnea) can reduce the severity of sleep apnea,”13 said Dr Eckert. “When insomnia is treated first, it improves patient compliance with CPAP therapy.”14

A combinatorial approach in which CBTi is commenced prior to CPAP therapy has also shown greater potential for improving daytime functioning and sleep compared to individual therapies.15 Non-CPAP-based therapies, including oral appliance devices, upper airway surgery, and nasal dilator strips, have also been explored for COMISA treatment. However, further research is warranted before the efficacy of these techniques can be established.6

Given the significant impact of COMISA on mortality and quality of life, clinicians are beginning to consider ways in which COMISA risk can be identified and mitigated.

“Awareness is step one,” said Dr Eckert. “Simple questionnaires for insomnia, such as the Insomnia Severity Index (ISI), and sleep apnea screening questionnaires, such as the OSA50 and STOP-BANG, can help identify those with a high risk for either condition alone or both.” He added, “Subsequently, healthy lifestyle measures such as a healthy diet, exercise, regular schedules, and weight loss strategies can help promote optimal sleep health and well-being. Physicians should also promptly consider onward referrals to sleep specialists if required.” 

Unanswered Questions Remain

Multifaceted molecular and clinical underpinnings of insomnia and OSA appear to work in concordance, prompting debilitating complications in patients. With COMISA research only in its infancy, several questions regarding its development, multi-organ impact, night-to-night variability, treatment, and physiology remain unanswered. Nevertheless, recent evidence merits more comprehensive efforts by clinicians to investigate and diagnose the potential co-occurrence of these disorders to improve the quality of life of patients.

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How an Ethics Consultant Can Help Resolve Conflicts https://www.thecardiologyadvisor.com/home/topics/practice-management/how-an-ethics-consultant-can-help-resolve-conflicts/ Fri, 16 Dec 2022 14:07:09 +0000 https://www.thecardiologyadvisor.com/?p=99718 Office discussion

Ethics consultants begin by identifying and clarifying the conflict to ensure it is related to ethics.

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Office discussion

“That’s unethical!”  So begins many a conversation (or sometimes maybe just an accusation) that prompts the input of an ethics consultant to help manage an ethical conflict in patient care.  This month’s column will review what an ethics consultant does, when an ethics consultation can be of assistance to the health care professional, when consultation from another resource would be more useful, and how to optimize the input of an ethics consultant.

An ethics consultant is an individual trained in resolving conflicts over values in a health care setting, with values being deeply held beliefs, standards, or principles that guide decision-making. These consultants are often trained in varying professional backgrounds of law, social work, philosophy, nursing, chaplaincy, or medicine among others, but they share an expertise in ethics theory and analysis. Consultants are most often called to assist with a conflict in patient care, but people in health care management, research, and administration also can seek their input.

Ethics consultants begin by identifying and clarifying the conflict to ensure it is related to ethics.  It is not uncommon for them to be called on a legal or clinical matter which is outside the scope of their function.1 Nonetheless, clinicians who are struggling with a challenging case may mistake a legal question for an ethical one. For example, a clinician may ask an ethics consultant about their legal liability if they prescribe a medication that a patient is demanding but that they do not think is medically indicated? Clearly, an ethics consultant cannot provide expert legal advice about risk of liability for patient care questions. In such a case, the consultant will refer the clinician to their counsel for an authoritative legal response. 

Sometimes though, the legal question may lead to a related ethics question. In the example above, if the lawyer indicates that a clinician can provide the requested treatment as the liability for doing so is low, but the clinician is still not sure if they should accede to the patient’s request, the clinician can request further advice from the ethics consultant.  The consultant can then help gather more information from the various stakeholders, in this case, the physician and patient, to resolve the ethics conflict. Speaking with the stakeholders directly, as any medical consultant, helps elucidate and amplify what those specific values are. In this case, the first value could be the clinician’s professional responsibility to provide patient-centered care; that is, providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions.2 The second value could be that the clinician also has a professional obligation as part of their licensure to only provide treatments that adhere to generally accepted standards of care. 

This example points out an important aspect of ethics consultation: that it does not always represent a conflict over one position that is clearly right and another that is clearly wrong.  Rather, the ethics questions are often between one position that is “right” and another one that is “right” in a different way. Thus, the process is often about managing equally reasonable positions that need to be balanced to resolve the problem.

Returning to the example, it becomes clearer how the ethics consultation process can be uniquely helpful in approaching a resolution. By first explicitly identifying the conflicting values, it helps to create a resolution that is responsive to those values, even when one of those values should be prioritized. In other words, even if there is strong ethical justification for the clinician to deny the patient’s request for the requested treatment because doing so is not consistent with generally accepted standards of treatment, the ethics consultation process helps to promote and honor the other relevant values. This might mean recommending to the clinician that they try to identify the patient’s interests behind their request. Does the patient have mistaken ideas about the utility of the requested medication? Is there a reason behind their request that has not yet been articulated? This approach then creates space for honoring both values: patient-centeredness and professional obligations. 

What should clinicians do when they believe they have an ethical concern and need assistance?  First, clinicians should be aware of how to contact their local ethics resources. The threshold to contact them should be low: It is better to contact them and not need them rather than make an assumption that they may not be helpful. Second, they should expect that the ethics consultant can help with ethical dilemmas in patient care, but that the consultant may first recommend another resource to find the definitive answer to the problem, which might include another clinical service, legal, risk management, or chaplaincy. However, even when that additional service is needed, ethics may be helpful as the issue develops or related ethics questions need to be answered. Finally, as clinicians begin to work more with ethics consultants over time, they will likely develop a heightened sensitivity to when ethics can be helpful in the course of clinical care. As some like to say, be aware when your ethics antennae go up, and when they do, you can get help.

David J. Alfandre, MD, MSPH, is a health care ethicist and an Associate Professor in the Department of Population Health at the NYU School of Medicine in New York. The views expressed in this article are those of the author and do not necessarily reflect the position or policy of the VA National Center for Ethics in Health Care or the US Department of Veterans Affairs.

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Cybercriminals Step Up Attacks on Health Care Payment Processors https://www.thecardiologyadvisor.com/home/topics/practice-management/cybercriminals-step-up-attacks-on-health-care-payment-processors/ Thu, 15 Dec 2022 13:43:40 +0000 https://www.thecardiologyadvisor.com/?p=99674 Cyber security firewall interface protection concept. Businesswoman protecting herself from cyber attacks. Personal data security and banking.

Criminals are compromising user login credentials of health care payment processors to divert payments from medical practices to themselves, the FBI warns.

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Cyber security firewall interface protection concept. Businesswoman protecting herself from cyber attacks. Personal data security and banking.

The Federal Bureau of Investigation in September warned that it has received multiple reports of cybercriminals increasingly targeting health care payment processors to redirect payments to themselves. Typically, this involves a cybercriminal obtaining employees’ publicly-available personal identifiable information and other data to impersonate victims and gain access to files, health care portals, payment information, and websites to then redirect payments to the cybercriminal’s bank account.

“The FBI issues these warnings regularly, so it is not surprising,” said Paul Hales, a HIPAA compliance attorney based in St. Louis, Missouri. “The payment processor is to blame, but not solely. It is both. Medical practices must follow HIPAA rules for hiring payment processing business associates.”

From June 2018 to January 2019, cybercriminals targeted and accessed at least 65 health care payment processors throughout the United States to replace legitimate customer banking and contact information with accounts controlled by the cybercriminals, according to the FBI. One victim reported a loss of approximately $1.5 million.

In February 2022, a cybercriminal obtained credentials from a major health care company and changed direct deposit banking information from a hospital to a consumer checking account belonging to the cybercriminal, resulting in a $3.1 million loss. In April 2022, a health care company with more than 175 medical providers discovered that a cybercriminal posing as an employee had changed Automated Clearing House instructions of one of their payment processing vendors to direct payments to the cybercriminal rather than the intended providers.

Health care payment processors are HIPAA business associates and must comply with the HIPAA rules governing their interconnected relationship with medical practices and how each uses and discloses protected health information.

In highly secure situations, such as the CIA, hard tokens are probably widely used. But for the average doctor, it is one additional thing you need to carry around and secure.

The FBI recommends all medical practices ensure antivirus software and anti-malware are enabled and security protocols are updated regularly. It also recommends conducting regular network security assessments to stay up to date on compliance standards and regulations. These types of security checks should include performing penetration tests and vulnerability scans. Practices should create protocols for employees to report suspicious emails, and changes to email exchange server configurations. The FDA also recommended that any direct request for account actions “needs to be verified through the appropriate, previously established channels before a request is sanctioned.”

Medical practices are being told to train all their employees on how to identify and report phishing, social engineering, and spoofing attempts. Some practices may want to consider pursuing options in authentication or barrier layers to decrease or eliminate the viability of phishing.

“Risk analysis is fundamental to HIPAA compliance. Federal auditors found over 80% of business associates failed this Security Rule requirement. Physician due diligence is essential before engaging a business associate,” Hales said. “And they must have an updated business associate agreement in place.”

Physicians may want to work with their legal counsel to protect against business associate negligence. Cyber insurance and risk-shifting contract language are prospective defensive measures, Hales said.

Another approach would be to use hard tokens that permit access to software and verify identity with a physical device instead of authentication codes.

“This kind of token allows software access through verification of a physical device rather than codes or passwords. Although cost can be a concern for using hard tokens compared with other authentication types, such as SMS authentications, hard tokens have an advantage in protecting confidential data,” said cybersecurity specialist Soumitra Bhuyan, PhD, an associate professor at Rutgers University in New Brunswick, New Jersey.

The individual with the hard token needs to be present to access data. Consequently, systems based on hard tokens are difficult to breach remotely. However, hard tokens come with some limitations. They are costly for a large organization to implement and, with any physical devices, they can be lost, Dr Bhuyan said.

Steve Akers, Chief Security Officer for TECH LOCK, a division of Clearwater that provides managed threat detection and response services, said the reason health care payment processors now are under attack is because they are the lowest hanging fruit. “Hitting the supply chain, or in the case of [health care business associates], has proven to be a more lucrative path than targeting the bigger companies, as they typically have fewer resources and less investment in cybersecurity but may have access to many of the same data sets,” Akers said.  

One way to mitigate vulnerabilities related to third-party vendors may be to put special alerts with email banners warning employees of communications originating outside of the organization. It is also suggested that all medical practices require a special verification of any changes to existing invoices, bank deposits, and contact information for interactions with third-party vendors and organizational collaborations.

A hard token could be a special USB stick that must be plugged into the computer or it could be some personal aspect, such as fingerprints or face identification, said Stuart Madnick, PhD, of the Massachusetts Institute of Technology in Boston, where he is the John Norris Maguire Professor of Information Technology in the Sloan School of Management and Professor of Information Technology and Engineering Systems in the School of Engineering. “All of these make it much harder for a hacker to break into your account even if he or she has stolen your ID and password,” Dr Madnick said. “In highly secure situations, such as the CIA, hard tokens are probably widely used. But for the average doctor, it is one additional thing you need to carry around and secure.”

Cybersecurity specialists agree no method is 100% fool-proof. There is always a way that a determined attacker can get through. “We promote the need for resilience,” Dr Madnick said. “If the attacker gets in, how do you minimize the amount of damage that can be done? For example, keep the data encrypted, so even if stolen, it is useless to the hacker.”

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Is Blue Light Causing Skin Damage? https://www.thecardiologyadvisor.com/general-medicine/is-blue-light-causing-skin-damage/ Wed, 14 Dec 2022 15:01:45 +0000 https://www.thecardiologyadvisor.com/?p=99612 computer typing

Angela Casey, MD, relates her experiences addressing patients’ concerns about skin damage caused by blue light.

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computer typing

The significant changes in lifestyle and workstyle of the past few years have people spending more and more time in front of screens and under artificial lights. As time in these environments has increased, so has the number of patients expressing concern about the possible damage of blue light irradiance on their skin.

For an in-depth discussion about the influence of blue light on skin and how to protect oneself, we interviewed Angela S. Casey, MD, who, with colleague, Amy E. Ramser, MD, coauthored a paper on the topic. A board-certified dermatologist, Dr Casey practices at the Center for Surgical Dermatology & Dermatology Associates in Westerville, Ohio. She provided insights as to how and when she advises her patients about the effects of blue light.

What is the typical profile of the patient who is concerned about blue light and their skin?

Dr Casey: Typically, these patients are women of the millennial and Gen X generations. They are well-educated, professional individuals who are discerning their skincare regimens and live a generally healthy lifestyle. Many of them have job flexibility and they are working from home part of the time; in turn, they are in front of a computer for a significant portion of their workday. They are active consumers of information and have read or heard about blue light in media/blogs focused on health, wellness, or beauty.

How has this level of concern increased during the pandemic?

Dr Casey: We have undoubtedly seen concern about blue light rise since the pandemic. As individuals transitioned from the office to working in front of the computer at home, the awareness of blue light and its effects on the skin became top of mind. Prior to the pandemic, I very rarely had patients asking about blue light; now, it seems to come up at least once a week. Additionally, as I am a mother of 3, fellow parents ask about blue light regularly — their children are on devices for a large percentage of their waking hours, and this has parents concerned about long-term consequences of blue light exposure.

Prevention is the best medicine: the large majority of skin damage from blue light, and other factors, is preventable by employing simple, daily habits.

Do you ever bring up the subject of blue light with your patients first, and if so, under what circumstances?

Dr Casey: Yes. During most patient visits, we discuss sunscreen options. As I talk about sunscreens with patients, I remind them to seek broad-spectrum sunscreens that protect against both UVA and UVB radiation. As part of this discussion, I remind them that many sunscreens do not provide comprehensive protection against blue light; sunscreens that are tinted with iron oxide pigments provide blue light protection in addition to UV protection. My preferred sunscreen for the face/neck is a tinted formulation that contains iron oxide, zinc oxide, and titanium dioxide as the active ingredients.

I counsel patients that many makeup foundations and concealers contain iron oxide pigments. And I also remind them that they shouldn’t depend on the foundation or concealer to work as their primary modality of blue light protection (or UV protection for those that are SPF rated) because most individuals are not applying the quantities of foundation needed to achieve the SPF rating noted on the package — they are typically applying much less product than the 2 mg per square centimeter needed.

Although the extent of blue light’s effect on skin is unknown, what would be your estimate?

Dr Casey: Blue light is one small factor in a much larger equation of our daily exposures and the impact on our skin. We have clear evidence that blue light can induce pigmentation, inflammation, and oxidative stress. What’s difficult to tease out is what percentage of skin damage is directly related to blue light when we have all of these other factors (UV exposure, pollution, stress, hormones, diet, movement) that are actively intertwined. I counsel patients to take a holistic approach to skin health: get plenty of sleep, manage stress, exercise, and eat a healthy diet. Wear sunscreen every single day. Apply a retinol or retinoid every night to help repair skin damage sustained during the day.

Just as some patients are aware of blue-light blocking and reducing eyewear, how willing are patients to employ methods to protect their skin from blue light?

Dr Casey: In my practice, most patients are not specifically seeking blue light protection recommendations; rather, they are focused on a comprehensive approach to skin health, and blue light protection is part of the overall equation. My patient population prefers streamlined, simple skincare regimens, and most are not willing to purchase an additional product that specifically protects against blue light. However, almost all of them wear sunscreen daily, and many of use antioxidant serums that contain actives such as vitamin C and vitamin E. We know that antioxidants play an important role in reducing the skin inflammation that results from blue light exposure.

Most of my patients are very willing to transition to tinted sunscreens that contain the iron oxides and antioxidants; the specific product that I recommend contains zinc oxide, titanium dioxide, hyaluronic acid, and vitamin E. By using this, patients are getting an all-in-one product that keeps their morning skincare routine simple. They don’t have to add anything to their regimen, but are swapping out their current sunscreen for a sunscreen product that provides a broader range of protection, including blue light protection.

Any interesting or unexpected findings in your study or practice, regarding blue light?

Dr Casey: Most dermatologists are aware, but it is worth repeating, that the large majority of blue light that we encounter on a daily comes from sun exposure/UV radiation, and not from artificial sources such as computers, screens, or overhead lights. The intensity (or irradiance) of blue light that is emitted from devices is 100 to 1000 times less than the intensity of blue light emitted from the sun.

In darker-skinned patients, blue light can induce pigmentation that is darker and more sustained than pigmentation caused by UVA-1.

The benefits of a healthy lifestyle on achieving clear, glowing skin cannot be overemphasized. Skincare products are one piece of the larger puzzle.

Prevention is the best medicine: the large majority of skin damage from blue light, and other factors, is preventable by employing simple, daily habits. Sunscreen should be a mandatory part of every morning skincare routine, and using a tinted sunscreen with antioxidants is a simple way to arm your skin with the protection that it needs as you face the day.

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A Look at the Effect of Sleep Patterns on Cardiovascular Health https://www.thecardiologyadvisor.com/general-cardiology/a-look-at-the-effect-of-sleep-patterns-on-cardiovascular-health/ Fri, 09 Dec 2022 12:57:53 +0000 https://www.thecardiologyadvisor.com/?p=99401

Findings published in 2020 suggest that irregular sleep schedules may increase CVD risk independent of sleep quality or duration.

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Studies have increasingly shown that short and excessively long sleep durations are linked to worse cardiovascular outcomes,1 and accumulating research has begun to shed light on the deleterious effects of other components of poor sleep patterns, such as nighttime waking and increased sleep latency. In light of these findings, the American Heart Association (AHA) has made sleep health 1 of the “Essential 8” factors in reducing cardiovascular disease (CVD) risk, in an update to the previous “Essential 7” list.2

“Poor sleep quality or decreased amounts of sleep can elevate insulin resistance, trigger inflammation, throw off circadian rhythms, and elevate sympathetic nervous system activity,” explained Dr Tamara Horwich, MD, MS, attending cardiologist, clinical professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles, and medical director of UCLA’s Cardiac Rehabilitation Program.

In a study published in August 2022 in the Journal of the American Heart Association (JAHA), Wang et al examined associations between sleep patterns and CVD risk in 12,268 individuals (mean age, 70.3 years) in the Swedish Twin Registry who were free of CVD at baseline.3 In a follow-up period of up to 18 years, hazard ratios (HRs) for CVDs were 1.14 for less than 7 hours of sleep per night (95% CI, 1.01-1.28) and 1.10 for 10 or more hours per night (95% CI, 1.00-1.21) compared to 7 to 9 hours per night.

Another 2022 study investigated the CVD-sleep connection based on data from 7,850 US adults in the National Health and Nutrition Examination Survey (NHANES).4 According to the results, sleep problems (defined as frequent trouble falling or staying asleep) were associated with an increase in CVD risk (OR, 1.75; 95% CI, 1.41-2.16) after adjustment for confounding variables, with a stronger association noted for individuals younger than 60 years (P =.019).

Chronically sleep-deprived people who regularly sleep less than 6 hours face a greater risk of hypertension, heart attack, arrhythmias, congestive heart failure, stroke, and death.

Prolonged sleep-onset latency was associated with increased risk for CVD (OR, 1.59; 95% CI, 1.17-2.15), congestive heart failure (OR, 2.08; 95% CI, 1.33-3.23), and myocardial infarction (OR, 1.76; 95% CI, 1.29-2.41), while short sleep-onset latency was linked to a reduction in the risk for stroke (OR, 0.64; 95% CI, 0.45-0.90).4

Compared to sufficient sleep, inadequate sleep was associated with greater odds of CVD (OR, 1.42; 95% CI, 1.13-1.78) and myocardial infarction (OR, 1.59; 95% CI, 1.19-2.13).4

In a 2021 cross-sectional study of 521,364 adults, poor self-reported sleep was associated with higher odds of having each CVD risk factor, especially physical inactivity.5 Compared to participants reporting difficulty falling asleep, unrestful sleep, and sleep duration of less than 6 hours per night, those with no difficulty falling asleep, restful sleep, and sleep duration of 6 to 9 hours per night showed a lower CVD risk score (all P < .001).

Findings published in 2020 suggest that irregular sleep schedules may increase CVD risk independently of sleep quality and or duration or traditional CVD risk factors.6 The odds of CVD were as much as roughly 2-fold higher among participants with high variability in the duration or timing of sleep compared with those with less variability. Similar results were found after shift workers were excluded from the analyses.

A 2021 study of 873 patients in China demonstrated that going to bed at 12:00AM or later (OR, 4.005; P <.001), waking at 7:00AM or later (OR, 2.544; P =.011), and sleeping less than 6 hours per night (OR, 2.968; P <.001), were associated with an elevated risk for acute myocardial infarction.7 Additionally, frequent nighttime waking was associated with greater acute myocardial infarction risk among participants older than 65 years.

Short sleep duration was also associated with a higher risk for coronary artery disease as indicated by a high Gensini score (OR, 2.374; P <.001).7

Daytime napping was linked to lower acute myocardial infarction risk (OR, 0.645; P =.046) in participants 65 years or younger, suggesting that regular naps may represent a protective CVD factor in young and middle-aged individuals.7 However, in the 2022 JAHA study, napping 1 to 30 minutes (HR, 1.11; 95% CI, 1.03-1.18) and longer than 30 minutes (HR, 1.23; 95% CI, 1.14-1.33) were associated with an increased risk of CVD compared to no napping.3

In research published in 2021 in Circulation, a lower risk for heart failure was associated with healthy sleep patterns, including early chronotype, sleeping 7 to 8 hours per night, and no frequent insomnia or daytime sleepiness (8%, 12%, 17%, and 34% lower for each component, respectively) in more than 400,000 patients in the UK Blood Biobank.8

In 2 studies drawing from the same cohort, a similar healthy sleep pattern was linked to reduced risk for atrial fibrillation/flutter (HR comparing extreme categories, 0.71; 95% CI, 0.64-0.80) and bradyarrhythmia (HR, 0.65; 95% CI, 0.54-0.77), as well as lower risk of all-cause mortality (HR, 0.94; 95% CI, 0.92–0.96), CVD-related mortality (HR, 0.89; 95% CI, 0.83–0.95), and cancer-related mortality (HR, 0.96; 95% CI, 0.93–0.99).9,10

In other recent research aiming to further elucidate the sleep-CVD connection, lower physical activity was associated with more pronounced associations between poor sleep and all-cause mortality as well as CVD-related and cancer-related mortality.11 In the 2021 cross-sectional study described above, poor sleep was linked to higher odds (approximately 3-fold) of physical inactivity compared to normal sleep.5

In addition, a laboratory study of 20 healthy adults found that moderate light exposure (100 lx) during sleep increased nighttime heart rate, sympathovagal balance (as indicated by decreased heart rate variability), and next-morning insulin resistance compared to dim light exposure (<3 lx) during sleep.12 In the 2021 study linking sleep patterns to increased acute myocardial infarction risk, lower nighttime light exposure was associated with reduced acute myocardial infarction risk (OR, 0.243; P =.009).7

Dr Horwich emphasizes the need to educate patients on ways to improve sleep quality and quantity, especially those at risk of CVD. “We can advise patients to prioritize sleep, keep consistent sleep hours, avoid smartphones and other light before bedtime,” she said. “Sleep consultation and sleep studies are important next steps when sleep disorders are suspected.”

To glean further insights regarding sleep patterns and CVD risk, we interviewed Bishnu Subedi, MD, FACC, board-certified cardiologist at the University of Pittsburgh Medical College Heart and Vascular Institute and director of cardiac imaging at UPMC Carlisle, and Steven Holfinger, MD, sleep medicine physician and clinical assistant professor of internal medicine The Ohio State University Wexner Medical Center in Columbus.

What does the current evidence suggest about associations between sleep patterns and CV risk?  


Dr Subedi: Chronically sleep-deprived people who regularly sleep less than 6 hours face a greater risk of hypertension, heart attack, arrhythmias, congestive heart failure, stroke, and death. Various sleep patterns like chronotype, sleep duration, insomnia, snoring, and daytime sleepiness are important indicators for future outcomes.   

Dr Holfinger: The lowest CV risk is at 7 hours sleep duration, with both decreased and increased sleep need increasing risk.13

Healthy sleep patterns have a nocturnal dip in blood pressure, while those without dipping will have higher CV risk and risk for obstructive sleep apnea (OSA).

CVDs including arrhythmias and MI incidence are linked to circadian rhythms. For example, 20% of MI occur between 12:00AM and 6:00AM.14

Patients with CVD are both more likely to have sleep disorders and may have worsening of their CVD by the untreated sleep disorder.

When patients have sleep disorders that cause circadian misalignment – such as shift work, jet lag, or shifts in daylight savings time – there is a higher risk of CVD.

What are some of the proposed mechanisms underlying this connection? 


Dr Subedi: Sleep disorders can cause repeated episodes of nocturnal hypoxemia, oxidative stress, sympathetic nervous system activation, cortical arousal, and endothelial dysfunction, all of which are mediators of CVD. 

Lower sleep times and fragmented sleep are independently associated with subclinical atherosclerosis, as determined by vascular ultrasonography and calcium scoring, and higher atherosclerotic biomarkers like high-sensitivity C-reactive protein.  

Poor sleep can, independent of primary sleep disorders, contribute to several molecular, immune, and neural changes that play a role in disease development. 

Dr Holfinger: For healthy people, during non-REM sleep, parasympathetic activity predominates with reduction in arrhythmias, and this is generally thought to be a restorative state for the heart and body. During REM sleep, CV risk is elevated due to relatively extreme swings in sympathetic and parasympathetic tone compared to wakefulness.

The overall circadian rhythmicity of CVDs is likely related to swings in sympathetic activity, but also related to variations in the peripheral circadian clocks, as peripheral clocks have been linked with platelet aggregation changes and ventricular repolarization abnormalities in animal models.15

A well-studied link is between OSA and systemic hypertension.16 This is likely due to a combination of mechanisms related to the repetitive intrathoracic pressure swings and intermittent hypoxia, with the largest factor being the effect of increased sympathetic activity on hypertension. This is primarily mediated by the peripheral chemoreceptors at the carotid body leading to the increase in sympathetic activity.

What are recommendations for clinicians in terms of advising patients on these issues and screening for sleep problems?  


Dr Subedi: Patients with or at risk of sleep problems should be advised to engage in at least moderate exercise, quit smoking, avoid alcohol and stimulant or sedative medications before bedtime, and to optimize their sleep habits. 

The AHA’s checklist to measure CV health has added healthy sleep as essential for optimal CV health.2 The new sleep metric suggests 7-9 hours of sleep daily for optimal CV health for adults, and more for children depending on age. 

Patients at higher risk for OSA should undergo polysomnography to test for sleep apnea to see if they may benefit from positive airway pressure (PAP) therapy. 

Dr Holfinger: The most pressing issue would be that in patients with CVD the prevalence of sleep apnea is high, and it is underrecognized both in the general population and in those with CVD. This may be in part because there are many ways sleep apnea can present, and those with CVD tend to report less sleepiness than other groups with sleep apnea.

Clinicians should keep an eye out for other clues that the patient may have sleep apnea, such as snoring, witnessed apneas, fragmented sleep, morning headaches, or nocturia. If sleep apnea is suspected, they should either be referred for a sleep study or to a sleep specialist for evaluation.

If patients have reasons for circadian misalignment, they should be addressed if possible. For example, ICU settings should strive to mimic circadian signaling by limiting light and disruptions at night, limiting 24-hour parenteral feeding, and increasing daytime light and activity levels.

For healthy patients, the recommendation should be to allow adequate sleep time to not force sleep restriction, in addition to maintaining a regular sleep schedule. Avoidance of bright light for the couple of hours when winding down before bed is also beneficial.

What should be the focus of future research pertaining to this topic?

Dr Subedi: Although sleep disorders have been linked to CVDs, the association between sleep characteristics – such as REM vs non-REM – and CVDs remains inconclusive. 

Experts are proposing that a transdisciplinary research framework that integrates knowledge, methods, and measures from the fields of psychology and sleep research may be used to catalyze advances in the prevention and treatment of CVD. 

Dr Holfinger: The impact on CV outcomes related to treating OSA using continuous PAP (CPAP) have been negative in large randomized studies, with most positive effects on CVD being reported in observational studies. Many sleep researchers cite methodological flaws in these RCTs – for example, low adherence to CPAP and exclusion of high-risk groups.

The evidence currently shows that use of CPAP can lead to a modest (2 mm Hg) reduction in systemic hypertension. And instead of CV risk, the aggregate evidence from the RCTs would suggest that CPAP reduces cerebrovascular risk.17

Specific strategies to reduce the effects of circadian misalignment are lacking in long-term studies evaluating the impact on CVD.

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Caution Urged About Ageism in Patient Care https://www.thecardiologyadvisor.com/home/topics/practice-management/caution-urged-about-ageism-in-patient-care/ Tue, 06 Dec 2022 12:35:27 +0000 https://www.thecardiologyadvisor.com/?p=99223 Doctor and patient in conversation, looking at digital tablet

Clinicians need to be aware of their assumptions about patients based on age.

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Doctor and patient in conversation, looking at digital tablet

Clinicians should not allow their own preconceptions about aging to prevent them from providing optimal care to their older patients, according to the lead author of a study linking everyday ageism to a higher prevalence of physical and mental health problems.

“Take the time to get to know older patients as individuals and ask questions about their needs and preferences, rather than make assumptions based on age,” said Julie Ober Allen, PhD, MPH, of the University of Oklahoma in Norman. “Clinicians who are more aware of their assumptions and stereotypes about aging and older adults, which we have all been socialized to have, are better able to monitor their behavior to make sure they don’t act on ageist beliefs.”

Dr Allen recommends that clinicians discuss aging-related cognitive and physical change as a part of human development across the life course rather than inherently representing decline, loss, or something to mourn. While older adults often are resilient, they also may be less likely to adapt successfully or ask for support from others if they believe these efforts will not make a difference. “There’s other research indicating that negative beliefs about aging may serve as a self-fulfilling prophecy,” Dr Allen said.

She and her colleagues surveyed 2035 individuals aged 50 to 80 years from the National Poll on Healthy Aging. The higher a person’s score on a scale of everyday ageism experiences, the more likely they were to be in poor physical or mental health, to have more chronic health conditions, or to show signs of depression. In this cross-sectional study, which was published online in JAMA Network Open, everyday ageism was found to be highly prevalent and associated with multiple indicators of poor physical and mental health.

Assuming that technology is an aging issue is ageist in itself. Asking the patient how they prefer to communicate is best practice.

While the study does not show cause and effect, the investigators noted that the linkages between ageism and health need to be explored further and taken into account when designing programs to encourage good health and well-being among older adults.

The researchers used the Everyday Ageism Scale, which calculates a score based on an individual’s answers to 10 questions about their own experiences and beliefs regarding aging. In the current study, 93.4% of the older adults surveyed said they regularly experienced at least one of the 10 forms of ageism. Approximately 80% agreed with the statement that “having health problems is part of getting older,” even though 83% described their own health as good or very good. This kind of internalized ageism also included agreeing with the statements that feeling lonely, depressed, or sad is part of aging.

In this study, 65% of the older adults said they regularly see, hear, or read jokes about older people, or messages that older adults are unattractive or undesirable. Interpersonal ageism was reported as a regular occurrence by 45% of the respondents. Interpersonal ageism was defined as older persons believing that others assume they have problems using technology, seeing, hearing, understanding, remembering, or acting independently, or they do not contribute anything of value.

“Everyday ageism is often subtle and may or may not be intentionally discriminatory,” the investigators wrote. They added that the “microaggressions” that that define everyday ageism “may communicate that older adults are not fully accepted and respected, appreciated for their individuality, or deserving of the rights and privileges afforded other members of society.”

Geriatrician John Morley, MD, of Saint Louis University School of Medicine in Missouri, said physicians need to treat older persons the same as other adults and avoid ageism in patient care. “Be careful not to use ageist language,” Dr Morley said. “Be respectful. Technology has a great future for geriatric care as the average physician has poor understanding of geriatric syndromes. Health care professionals need to know the computer literacy of their older patients. When it’s poor, they need to work with a family member if the patient agrees.”

While portals can greatly enhance care, physician interaction with patients remains central to ensuring communication barriers are address. Dr Morley said office staff should have protocols to address older patients’ communication capabilities and prevent ageism in patient care. “In persons with poor digital skills, the physician and his staff need to work directly with the patient,” he said. “The digital testing can be done in the office by an office staff. We are in a large digital divide and health care professionals need to assess how the patient wishes to interact.” 

Dr Allen agrees. Having options and asking patients how they prefer to communicate is an important, perhaps under-recognized, aspect of healthcare provision, she said. Addressing the issue of digital skills could also benefit other groups who are affected by the digital divide, such as low-income individuals, rural patients, and those who are simply less tech savvy, she said.

Wanda Jirau-Rosaly, MD, a geriatrician at the Medical College of Georgia at Augusta University, said there is a great deal of societal misinformation and preconceived notions about aging. “Without conscious knowledge, physicians may be the ones giving older adults ageist messages and having ageist assumptions about our patients,” Dr Jirau-Rosaly said. “We must remember, older adults have lived life [and] have lots of living knowledge and experiences that they can even teach us about.”

Although younger individuals have grown up with technology, Dr Jirau-Rosaly said many of her older adults spend hours on the internet browsing instead of watching TV. “To me, more than technology causing a divide due to age is the fact that we do not communicate as well. We write a couple of sentences through a portal,” Dr Jirau-Rosaly said. “Technology feels impersonal and that is what may create the age divide. Some of my patients show me how to use different applications on my phone. Assuming that technology is an aging issue is ageist in itself. Asking the patient how they prefer to communicate is best practice.”

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Issues in Cardiac Procedures for Drug Use-Associated Infective Endocarditis  https://www.thecardiologyadvisor.com/general-cardiology/issues-in-cardiac-procedures-for-drug-use-associated-infective-endocarditis/ Fri, 02 Dec 2022 13:02:01 +0000 https://www.thecardiologyadvisor.com/?p=99072

As the opioid epidemic worsens, rates of drug use-related infective endocarditis and associated procedures have grown substantially.

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Rates of infective endocarditis (IE) and associated procedures have grown substantially in the United States (US) in recent years due to increasing intravenous drug use (IVDU) in the setting of the worsening opioid epidemic. Studies have shown a 681% increase in hospital admissions for drug use-associated IE (DUA-IE) in West Virginia between 2014 and 2018, for example, and a 12-fold increase in such admissions in North Carolina hospitals between 2007 and 2017.1,2

Other findings suggest that 1 in 10 patients receiving cardiac care in the intensive care unit (ICU) uses illicit drugs.3 This trend presents various challenges to cardiac surgeons, including risk assessment and resource allocation issues for patients who are known to have worse outcomes and high rates of reinfection after a procedure compared to patients whose disease is not associated with drug use.4 

Outcomes in DUA-IE vs Non-DUA-IE

In a 2018 retrospective cohort study, researchers used propensity matching to compare cardiac procedure outcomes between US patients with opioid use disorder (OUD; n=11,359) and without OUD (n=5,707,193) from the Nationwide Inpatient Sample database.5 Procedures included coronary artery bypass graft, valve surgery, and aortic surgery, with higher rates of valve and aortic surgeries noted among patients with OUD (49.8% vs 16.4%; P <.001).

While similar mortality rates were observed in patients with and without OUD (3.1% vs 4.0%; P =.12), the overall incidence of major complications was significantly higher among those with OUD (67.6% vs 59.2%; P <.001), including blood transfusion (30.4% vs 25.9%; P =.002), pulmonary embolism (7.3% vs 3.8%; P <.001), mechanical ventilation (18.4% vs 15.7%; P =.02), and prolonged pain (2.0% vs 1.2%; P =.048).5

The main challenges relate to the patient population itself. IVDU patients are typically not very compliant and have high rates of recurrent infection because of continued drug use after surgery.

A study published in 2020 analyzed 228 valve procedures performed at a single US tertiary hospital between 2002 and 2016, of which 35% were DUA-IE cases.6 The results demonstrated higher overall mortality (48% vs 32%; P =.025) and a higher risk of overall mortality (adjusted hazard ratio, 2.41; 95% CI, 1.38-4.20; P =.002) in patients with DUA-IE compared with those with non-DUA-IE. The findings further showed that DUA-IE was linked to higher mortality rates during the midterm postoperative period (53% vs 31%; P =.003).

In addition, patients with DUA-IE were found to have longer (median, 27 vs 17 days) and more expensive (median, $250,994 vs $198,764) hospital stays compared to patients with non-DUA-IE.2

Following cardiac procedures, studies have reported readmission rates of 22% to 49% in DUA-IE patients and continued injection drug use in at least one-third of cases.7 In research published in 2020, the number of reoperative valve surgeries for DUA-IE at 8 US centers increased from 19% in 2012 to 28% in 2017 (P <.001), and these patients demonstrated higher 30-day mortality rates (8.1% vs 4.8%; P =.049).compared to those receiving first-time valve surgery.8

An Ethical Dilemma

In an ongoing ethical debate, some experts have even wondered if people who inject drugs should receive a second valve replacement surgery in the context of continued drug use.9 According to results of several surveys, up to one-half of cardiothoracic surgeons indicated reluctance to provide surgery for native valve DUA-IE, while approximately 25% to 36% of surgeons indicated willingness to reoperate on DUA-IE in patients with prosthetic valve DUA-IE and continuing drug use following the previous surgery.10

Additionally, two-thirds of surgeons reported that they had previously refused surgery for DUA-IE for reasons related to the “personal choice to use drugs, ‘recidivism,’ and inappropriate spending of medical dollars as contraindications to surgical therapy,” wrote the authors of a 2022 review published in the Journal of Cardiac Surgery.10

However, other experts note that despite the poor outcomes associated with persistent postoperative drug use in individuals with DUA-IE, these patients may have lacked access to adequate substance use treatment at the time of the initial surgery. Thus, it is inappropriate to deny surgery to those with recurrent disease based on anticipated relapse risk.10

To gauge clinician perspectives on the topic, we interviewed Ismail El-Hamamsy, MD, PhD, FRCSC, the Randall B. Griepp Endowed Professor of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai and director of aortic surgery for Mount Sinai Health System in New York; Harold L. Lazar, MD, cardiothoracic surgeon at Boston Medical Center and professor of cardiothoracic surgery at Boston University School of Medicine; and Hamza Aziz, MD, assistant professor of surgery in the division of cardiac surgery at Johns Hopkins University School of Medicine in Baltimore.

What are some of the top challenges in cardiac surgery for DUA-IE compared to non-DUA-IE?

Dr El-Hamamsy: The main challenges relate to the patient population itself. IVDU patients are typically not very compliant and have high rates of recurrent infection because of continued drug use after surgery. Additionally, infections can more often occur in IVDU patients than in non-IVDU patients and be caused by drug-resistant organisms or fungi, which are more invasive and harder to eradicate. 

Dr Lazar: There are several challenges for patients with DUA-IE, including a higher chance of developing recurrent IE after surgery and significantly higher mortality if they require a reoperation. One-third of these patients die from drug overdose or recurrent IE following their initial surgery. Recidivism is the strongest predictor of mortality in DUA-IE patients and is the biggest challenge faced in treating these patients.11

Dr Aziz: The biggest challenge for me in DUA-IE is knowing I am not treating the disease but a symptom of the disease, whereas in non-DUA IE, I am eliminating the disease by removing the infection and making patients better. 

The second aspect is that DUA-IE patients are in the hospital for 6 weeks while they get their IV antibiotics. As I get to know their life stories and circumstances, I gain insight into how challenging these people’s lives have been and the fact that the odds of success in life were not in their favor from the time they were kids. Oftentimes, their parents were the ones who introduced them to drugs. 

Lastly, I have had patients who had tremendous recovery in the hospital and show so much promise only to relapse once they go “home,” wherever that may be, and re-infect the valve.

What are recommendations for clinicians in addressing these challenges?

Dr El-Hamamsy: The approach in patients with DUA-IE must be more holistic. Treating the infection alone is unlikely to cure the patient because of the high risk of recurrence due to continued drug use. Instead, a multidisciplinary approach which includes addiction medicine, social workers, and close monitoring after discharge are key to limit the risks of recurrence and to avoid surgical futility.

Dr Lazar: An in-house endocarditis heart team is currently recommended for DUA-IE patients.11 Along with participation from cardiac surgeons, infectious disease, addiction medicine, psychiatry, and nursing, social workers can help with initiating inpatient addiction programs and facilitating discharge to inpatient facilities that can manage IV antibiotics and provide drug addiction treatment. This model could decrease recidivism as well as morbidity and mortality in these high-risk patients.

In a 2020 paper, Ahmed and Safdar discuss an ethical dilemma about whether patients with DUA-IE who receive valve replacement surgery and continue to use drugs should receive a second surgery.9 What are your thoughts about this issue?

Dr El-Hamamsy: This continues to be a great ethical and practical dilemma. On paper, it is easy to argue against major resource mobilization if the patient continues their drug abuse, as these treatments are often futile and consume huge resources. In practice, however, it is very difficult as a surgeon to deny these—often young—patients their only chance of surviving their current infection. 

This highlights the importance of a multidisciplinary team, which includes an ethicist to help make some of these difficult decisions. Ultimately, these are always case-by-case decisions. There are no blanket rules.

Dr Aziz: I do believe in giving patients who relapse a second chance. Most surgeons who have been doing it long enough have had success stories with patients who went clean after their second or even third valve intervention. In the end, it’s an individualized case-by-case decision.

What are the most pressing remaining needs in this area?

Dr El-Hamamsy: The most pressing needs are the realization that DUA-IE is far more than a pure cardiac surgical problem. It requires the creation and implementation of a multidisciplinary team aimed at accompanying the patient after discharge through a journey to rehab and drug cessation. This requires dedicated resources and specific expertise.

Dr Lazar: Many DUA-IE patients lack stable housing and face barriers in access to outpatient drug and rehab programs due to lack of medical insurance and transportation. They may live in areas with a scarcity of options for drug addiction treatment, and some hospitals lack inpatient or outpatient programs for the treatment of drug addiction to prevent recidivism in these patients. 

Addressing these issues involves proper inpatient and outpatient therapy to treat IVDU and prevent recidivism following surgery. Increasing access to these options will require the support of hospital and government resources and third-party payers.

Dr Aziz: In terms of advancements in treatment strategies, I think percutaneous technologies that can “debulk” vegetations safely, not only on the tricuspid valve but also on the mitral and aortic valve, will be quite helpful.

The post Issues in Cardiac Procedures for Drug Use-Associated Infective Endocarditis  appeared first on The Cardiology Advisor.

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HIPAA May Not Cover Personal Health Data Patients Disclose Online https://www.thecardiologyadvisor.com/home/topics/practice-management/hipaa-may-not-cover-personal-health-data-patients-disclose-online/ Fri, 04 Nov 2022 12:08:42 +0000 https://www.thecardiologyadvisor.com/?p=96282 A young woman scans drugs with her mobile phone at a pharmacy

HIPAA protects patients from unauthorized disclosure of personal information by covered entities such as medical practices and hospitals, but out from under the HIPAA umbrella, patients are mostly on their own, according to the authors of a recent report.

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A young woman scans drugs with her mobile phone at a pharmacy

Many patients share personal health data when they sign up for and use medical apps and websites or share details of their health issues with others on social media. Digital medicine companies and social media platforms may be tracking this information and using it to develop targeted ads aimed at individuals with specific medical problems or generate leads for future marketing purposes. The authors of a recent study published in the journal Patterns say most individuals are not fully aware of how they are being followed and manipulated by digital medicine companies and social media platforms.

HIPAA rules bar “covered entities” such as medical practices and hospitals from disclosing protected health information without patients’ consent. But for data generated outside of “the digital walls” of these covered entities, “patients are mostly on their own with respect to understanding how companies utilize their personal and health data, especially when asking questions about their health conditions on social media,” wrote investigators Andrea Downing of The Light Collective, an advocacy group based in Eugene, Oregon, and Eric Perakslis, PhD, Chief Science and Digital Officer at the Duke Clinical Research Institute in Durham, North Carolina.

The team explored this issue in a study of health-advertising tactics of 5 digital medicine companies, with a focus on 5 clinical services. They recruited 10 patient advocates in the hereditary cancer community and asked them to share data on how their online activities were being tracked. The participants downloaded and shared their JavaScript Object Notation (JSON) files, which reveal how data are shared between web servers and web apps. The investigators used these files to determine how information flows from health-related websites and apps to Facebook to target advertising.

Downing and Dr Perakslis reviewed the companies’ websites for third-party ad trackers and looked at whether use of these ad trackers complied with the companies’ own privacy policies. They also looked at Facebook’s ad library for each participant to determine whether health data obtained through these companies influenced the types of ads that the participants were seeing.

Technology has advanced, real problems are manifesting, and it is time for policymakers to act. Passing new comprehensive health privacy legislation that addresses these critical issues by closing privacy loopholes is an important next step.

“We demonstrated that personal data and personal health data can be easily obtained without the aid of highly sophisticated cyberattack techniques but with rather commonplace third-party advertising tools,” the authors wrote in a paper published in the journal Patterns.

They also observed, “While tools we identified are not inherently good or bad, applying commonplace advertising tolls designed for social media marketing can expose sensitive health information in the form of leads. These marketing tools reveal a dark pattern used to track vulnerable patient journeys across platforms as they browse online, in some ways unclear to the companies and patient populations who are engaging through Facebook.”

The authors say they hope these new data trigger an overdue dialogue about health privacy and how it affects specific patient populations.

In an interview, Dr Perakslis pointed out that physicians’ role regarding protected health information is spelled out under HIPAA, but this is not the case for marketing software designed to spread data as prolifically as possible. “Everyone needs to be really careful about what software they use,” Dr Perakslis said. “Most people don’t know what the apps do, and many people have hundreds [of apps].”

The 5 companies included in the analysis provide information or services (including genetic testing) related to inherited cancer risk. The investigators determined that 2 of the companies’ targeted ads were consistent with their own privacy policies. The other 3 did not comply with their own policies and claims of privacy.  

Angie Raymond, JD, PhD, Director of the Program on Data Management and Information Governance at Indiana University and with the Department of Business Law and Ethics at Kelley School of Business, Bloomington, Indiana, said the privacy community did a great job of moving HIPAA into the common vernacular. However, it did a rather poor job of explaining the limitations of the key terms “health” and “covered-entity.” Dr Raymond said this is where things begin to fall down. “It is really leaving people and their health data very vulnerable. We need to do much better,” Dr Raymond said.

Dr Raymond believes privacy protections need to be designed into the technologies that people use. “We do need to move existing protections into a digital world,” he said. “We may need to consider building protections in some new areas that have emerged because of the ubiquitous nature of the digital world and aggregation of data. But, without design we will likely keep chasing our tails.”

Michael S. Sinha, MD, JD, MPH, Assistant Professor in the Center for Health Law Studies at Saint Louis University School of Law in Missouri, said when HIPAA was established, Congress had not contemplated the issue of “mining” PHI from a patient’s online portal or other PHI platform—often without their knowledge or consent—for advertising purposes. Dr Sinha would like to see new federal legislation passed that specifically addresses patient privacy rights.

“This is an emerging problem in health privacy,” Dr Sinha said. “Technology has advanced, real problems are manifesting, and it is time for policymakers to act. Passing new comprehensive health privacy legislation that addresses these critical issues by closing privacy loopholes is an important next step.”

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