The randomized, open-label, noninferiority TAVR-CMR (Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement; ClinicalTrials.gov Identifier: NCT03831087) trial was conducted at 2 heart centers in Austria and assessed the noninferiority of CMR vs CT for guiding TAVR.

Potential TAVR candidates were randomly assigned in a 1:1 fashion to have a predefined TAVR-CMR protocol or a standard contrast-enhanced TAVR-CT protocol to evaluate anatomic characteristics of the aortic annulus and access route. Eligible participants had severe aortic stenosis diagnosed based on guidelines of the European Society of Cardiology/European Association for Cardiothoracic Surgery and had typical symptoms of severe aortic stenosis.

The primary outcome was defined per the Valve Academic Research Consortium (VARC)-2 criteria as device success at discharge including absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomic location, and proper intended performance of the prosthetic heart valve.

A total of 380 potential TAVR candidates were randomly assigned to CMR-guided (191 patients) or CT-guided (189 patients) TAVR planning from September 11, 2017, to December 16, 2022. Among the cohort, 138 participants in the CMR-guided group and 129 patients in the CT-guided group had TAVR (modified intention-to-treat [mITT] population). The per-protocol cohort included 248 patients (121 in the CMR group, 127 in the CT group). The median age for both populations was 82 years, and 50% were women.

For the mITT cohort, device implantation success occurred in 93.5% of patients in the CMR group and in 90.7% of patients in the CT group (between-group difference, 2.8%; 90% CI, -2.7 to 8.2%; P <.01 for noninferiority). In the per-protocol cohort, device implantation success occurred in 92.6% of the CMR-guided patients and in 90.6% of the CT-guided patients (between-group difference, 2.0%; 90% CI, -3.8 to 7.8%; P <.01 for noninferiority).

Stroke or transient ischemic attack (TIA) and the need for permanent pacemaker implantation occurred more frequently in the CT-guided group (stroke/TIA: 5.4% vs 0.7%; P =.02 in the mITT population; 5.5% vs 0.8%; P =.04 in the per-protocol population; permanent pacemaker: 11.6% vs 3.6%; P =.01; 11.8% vs 3.3%; P =.01, respectively).

The CMR and CT groups had comparable all-cause mortality at a median of 6 months (8.7% vs 7.0%, respectively; P =.60 in the mITT population; 8.3% vs 7.1%, respectively; P =.73 in the per-protocol population).

Sensitivity analyses with use of VARC-3 device success criteria were consistent with the primary outcome (mITT: 88.4% vs 85.3%; P =.01 for noninferiority; per-protocol: 90.1% vs 85.0%; P <.01 for noninferiority).

Among several limitations, the prespecified noninferiority margin of 9% absolute risk difference is liberal for an expected failure rate of 8%, the investigators noted. Also, the use of an alpha of 0.10 instead of 0.05 for nominal significance is different from convention. Other limitations included the open-label design, and contrast volume was not systematically evaluated.

“…CMR-guided TAVR was noninferior to CT-guided TAVR in terms of device implantation success at hospital discharge, with no difference between the groups in the proportion undergoing the TAVR procedure,” the study authors wrote.

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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

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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The systematic review and meta-analysis evaluated the effect of TV repair in modifying the prognosis of patients with HLHS, the risk for TVR recurrence, and the need for reintervention.

A literature search was conducted in the PubMed, Web of Science, and Scopus databases in January 2023. Eligible studies included patients affected by HLHS with TVR receiving TV repair; reported survival, and/or TVR recurrence, and/or risk for reoperation for TVR displayed as Kaplan-Meier curves; and were published in English after 1970. A random-effect meta-analysis was performed on the study outcomes.

A total of 9 articles with 203 patients who received surgical repair of TVR were included. Participants’ median/mean age at TV repair ranged from 0.02 to 1.9 years, and the median/mean follow-up ranged from 0.4 to 7.9 years. The most common surgical technique for TV repair was commissuroplasty (139/191 patients, 72.8%), followed by annuloplasty (113/191, 59.2%).

Pooled analysis showed that in-hospital mortality after TV repair was 9% (95% CI, 1%-21%; I²= 76.9%; P <.001). The pooled risk for early (in-hospital) TV reoperation was 1% (95% CI, 0%-5%; I²= 32.9%; P =.15).

Based on 5 studies, the transplant-free survival rates at 1, 2, 5, and 10 years of follow-up were 75.5% (95% CI, 67.6%-84.3%), 69.4% (95% CI, 60.9%-79%), 63.6% (95% CI, 54.6%-73.9%), and 61.9% (95% CI, 52.7%-72.6%), respectively. The pooled transplant-free survival rate of patients who had TV repair was not different vs the 323 patients with HLHS without TVR (control group; P =.59).

In pooled analysis of 4 studies with 91 patients, freedom from TVR recurrence at 1, 2, 5, and 10 years of follow-up was 65.9% (95% CI, 56.7%-76.7%), 63.2% (95% CI, 53.8%-74.3%), 57% (95% CI, 46.7%-69.7%), and 48.7% (95% CI, 37.3%-63.7%), respectively.

Pooled analysis from 5 studies with 115 patients showed that rates of freedom from TV reoperation at 1, 2, 5, and 10 years of follow-up were 77% (95% CI, 69.4%-85.4%), 71.4% (95% CI, 63.1%-80.7%), 63.6% (95% CI, 54.5%-74.3%), and 63.6% (95% CI, 54.5%-74.3%), respectively.

Age at surgery was an effect modifier (hazard ratio [HR], 0.05; 95% CI, 0.01-0.25; P <.001), and younger patients had an increased risk for TV reoperation. The rate of patients who needed TV repair during a Norwood operation had a modifier effect on the freedom from TV reoperation (HR, 1.02; 95% CI, 1.01-1.02; P <.001).

Limitations of the study include the use of observational studies in the meta-analysis, and comparing outcomes of cases vs controls from different populations may result in a selection bias. Also, the relatively short mean follow-up times did not allow reliable inferences on the long-term fate of TV and patient survival after TV repair.

“At a medium-term follow-up, TV repair can effectively modify the prognosis of patients with HLHS and loss of systemic TV competence, re-establishing a comparable transplant-free survival to HLHS peers without TVR,” wrote the study authors. “However, the durability of surgery seems to be time-dependent and a significant quota of patients will experience TVR recurrence, requiring more than 1 surgical procedure on the TV.”

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Raj R. Makkar, M.D., from Cedars-Sinai Medical Center in Los Angeles, and colleagues assessed the safety and efficacy of redo TAVR in a national registry. The analysis included all consecutive patients in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (Nov. 9, 2011, to Dec. 30, 2022) who underwent TAVR with balloon-expandable valves in either failed transcatheter heart valves (redo TAVR; 1,320 patients) or native aortic valves (native TAVR; 349,271 patients).

Researchers found that the rates of procedural complications of redo TAVR were low (coronary compression or obstruction: 0.3%; intraprocedural death: 0.6%; conversion to open heart surgery: 0.5%) and overall similar to native TAVR. For death at 30 days (4.7 vs 4.0%) or 1 year (17.5 vs 19.0%) and stroke at 30 days (2.0 vs 1.9%) or 1 year (3.2 vs 3.5%), there were no significant differences between redo-TAVR and native-TAVR populations, respectively. At 1 year, redo TAVR reduced aortic valve gradients, although they were higher in the redo-TAVR group vs the native-TAVR group (15 vs 12 mm Hg). Rates of moderate or severe aortic regurgitation did not differ significantly between the redo-TAVR and native-TAVR groups at 1 year (1.8 vs 3.3%). Timing of redo TAVR (before or after 1 year of index TAVR) and index transcatheter valve type (balloon-expandable or non-balloon-expandable) did not significantly affect death or stroke after redo TAVR.

“Redo-TAVR with balloon-expandable valves might be a reasonable treatment for failed TAVR in selected patients,” the authors write.

Edwards Lifesciences funded the study.

Abstract/Full Text (subscription or payment may be required)

Editorial (subscription or payment may be required)

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Investigators in Denmark sought to describe patient characteristics, microbiology, and prognosis of IE after TAVI.

They conducted a cohort study using Danish nationwide registries and the Danish Microbiology Database to identify 273 patients with IE after TAVI, 1022 patients with IE after non-TAVI prosthetic valve placement, and 5376 patients with native valve IE from January 2010 to December 2021. Patients were followed from admission for IE until 5 years of follow-up, date of death, emigration, or end of study.

Compared with patients with IE after non-TAVI prosthetic valve placement (median age, 76 years; frail, 56.4%) and patients with native valve IE (median age, 71 years; frail, 45.7%), patients with IE after TAVI were older and more had intermediate or high frailty (median age, 82 years; frail, 61.2%). Frailty was defined using The Hospital Frailty Risk Score that included all hospital contacts up to 10 years prior to IE (0-4 points, low; 5-15 points, intermediate; >15 points, high).

Prescriptions filled within 180 days before IE were used to identify comorbidities (hypertension: at least 2 filled prescriptions for blood pressure lowering drugs; diabetes: at least 1 filled prescription of a glucose lowering drug). Cardiovascular comorbidity was higher for IE after TAVI compared with the other groups, and cancer, diabetes, and chronic obstructive pulmonary disease were comparable between groups.

In sensitivity analysis, patients with IE after TAVI were matched 1:2:3 with patients with IE after non-TAVI prosthetic valve placement and patients with native valve IE (matched for sex, age, and calendar year of endocarditis).

Compared with patients with native valve IE (11.4%), Enterococcus spp. was common in patients with IE after TAVI (27.1%) and IE after non-TAVI prosthetic valve placement (21.2%), as was Streptococcus spp. for patients with IE after TAVI (30.8%) compared with patients with IE after non-TAVI prosthetic valve placement (22.0%) and patients with native valve IE (24.1%). Compared with patients with IE after non-TAVI prosthetic valve placement (15.2%) and patients with native valve IE (13.5%), blood culture negative IE was infrequent in patients with IE after TAVI (5.5%).

Compared with patients with IE after non-TAVI prosthetic valve placement (57.2%) and patients with native valve IE (53.6%), 5-year mortality was highest for patients with IE after TAVI (75.2%). No between-group differences were found for the unadjusted 90-day mortality rate. No significant difference was found in mortality rates between groups at 1 to 90 days and 91 to 365 days using Cox models adjusted for bacterial etiology and patient characteristics. Cardiac procedures were performed on 3.7% of patients with IE after TAVI, 17.8% of patients with non-TAVI prosthetic valve placement, and on 19.5% of patients with native valve IE. In general, and regardless of in-hospital cardiac procedures, patients with Staphylococcus aureus had the highest mortality rate.

Study limitations include the inability to determine the anatomical location of endocarditis and missing data for TAVI group procedural characteristics, as well as data for dental status, long-term catheter use, and type of valve prosthesis.

“Patients with IE after TAVI are older and more comorbid, Enterococcus spp. and Streptococcus spp. are often present, and rarely blood culture negative compared with other groups of IE,” the investigators wrote. “While long-term unadjusted mortality rates were higher for IE after TAVI, the adjusted mortality rates were comparable.”

Disclosure: Some study authors 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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The prospective registry analysis included patients who received TAVR for native valve aortic stenosis between May 2014 and February 2017 from 11 centers in the United States. All participants (N=884) completed pre-TAVR assessments for depression or cognitive function.

Depression was measured with use of the 2-item Patient Health Questionnaire (PHQ-2), and cognitive function was measured with use of the Mini-Cog test.

Mortality was assessed at the last follow-up, and quality of life was evaluated at 30 days and 1 year. The Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) was used to assess disease-specific quality of life, and the EuroQol visual analogue scale (EQ-VAS) was used for generic quality of life.

Depression screening was positive in 171 of 873 (19.6%) patients, and cognitive dysfunction screening was positive in 273 of 859 (31.8%) participants. Overall, the mean age of participants was older than 80 years, and a majority were men. The median follow-up time was 2.88 (IQR, 1.2-3.7) years.

Baseline depression (hazard ratio [HR], 1.45; 95% CI, 1.13-1.86; P <.01) and cognitive dysfunction (HR, 1.27; 95%, 1.02-1.59; P =.04) were each independently associated with increased mortality in separate models and after adjustment. When depression and cognitive dysfunction were combined in 1 model, mortality was highest among participants with both depression and cognitive dysfunction (HR, 2.19; 95% CI, 1.55-3.10; P <.001) vs those without depression and cognitive dysfunction, which remained significant after adjustment (HR, 2.06; 95% CI, 1.44-2.96; P <.001).

In multivariable analyses, depression was associated with scores 6.6 (95% CI, 0.3-13.6; P =.01) points lower on the 1-year KCCQ-OS, and cognitive dysfunction was not associated with KCCQ-OS 1 year after TAVR. Depression and cognitive dysfunction were independently associated with worse generic quality of life per the EQ-VAS 1 year after TAVR (depression, 6.7 points lower [95% CI, 0.5-12.7; P =.01]; cognitive dysfunction, 5.5 points lower [95% CI, 0.9-9.7; P =.01]).

Among 207 patients who had follow-up PHQ-2 assessments at 1 year, 160 (77.3%) were negative for both evaluations, 24 (11.6%) had depression that resolved at 1 year, 13 (6.3%) had new depression, and 10 (4.8%) had persistent depression.

Limitations of the study include the reliance on screening questionnaires for depression and cognitive dysfunction. Aside from a chart diagnosis of dementia, previous diagnoses of mood and cognitive disorders, or medications used for them, were not accounted for. In addition, data on other post-TAVR endpoints and information on causes of death are not available, and the study is not powered to identify a relationship change in depression status at 1 year and subsequent mortality.

“Using simple, validated screening tools in a multicenter study, depression was identified in approximately 20% and CD [cognitive dysfunction] in one-third of patients undergoing TAVR,” wrote the researchers. “Recognition of depression and CD may improve preprocedural risk stratification and inform prognostic discussions.”

Disclosure: Some of the study authors 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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Researchers retrospectively reviewed all patients who received a Ross procedure from 1994 to 2019 at a single center. The participants were categorized into the younger group (aged <50 years) and older group (aged ≥50 years) based on the age when they had the Ross procedure.

The primary endpoint was differences in survival up to 10 and 15 years between the younger and older patients who had the procedure.

A total of 225 patients had the Ross procedure during the study period, with 156 patients aged younger than 50 years and 69 patients aged 50 years or older. The mean age of the younger group was 36±8.1 years vs 55±4.2 years for the older group. A majority of patients were men in both groups (younger, 58.5%; older, 69.6%).

The younger group had a significantly increased rate of aortic insufficiency (51% vs 26.1%; P <.01), and aortic stenosis was significantly more common in the older group (25.6% vs 58.0%; P <.01). Younger patients also had an increased rate of bicuspid aortic valve (81.4% vs 58.0%; P <.01).

The younger group had an operative mortality rate of 1.3% compared with 4.3%  in the older group (P =.15).

The median follow-up was 16.2 (IQR, 9.1-20.4) years in the younger group and 16.1 (IQR, 8.9-19.3) years in the older group. For all-cause mortality, survival up to 10 years was not statistically different in the 2 groups, with a survival rate of 96.2% in the younger group and 91.3% in the older group (log-rank P =.16; hazard ratio [HR], 2.3; 95% CI, 0.7-7.0). In the younger group, 6 patients (3.8%) died within 10 years compared with 6 (8.7%) who died in the older cohort.

Survival up to 15 years was significantly increased among younger patients vs older patients (94.9% vs 85.5%; log-rank P =.04; HR, 2.89; 95% CI, 1.1-7.3). Within 15 years, 8 patients (5.1%) had died in the younger group compared with 10 patients (14.5%) who died in the older group.

For both groups, the survival of patients who had the Ross procedure was not statistically different from the age- and sex-matched US general population (younger log-rank P =.27; older log-rank P =.70).

A competing risk analysis with multivariable subdistribution hazard models showed that being aged 50 years or older was associated with an increased risk of cardiac death in the 15-year follow-up (HR, 8.99; 95% CI, 1.02-79.2; log-rank P =.05) but not in the 10-year follow-up (HR, 6.78; 95% CI, 0.72-64.1; log-rank P =.10).

Limitations of the study include the retrospective design with participants from a single center. Also, the case selection and operative technique of Ross procedures changed over time, and the sample size of patients in the younger group is larger than the older cohort, which increases the risk of type 2 error.

“Our findings suggest that at experienced centers, the Ross procedure can be performed in carefully selected patients who are over 50 years old,” wrote the study authors. “While we hope that this series spurs debate, larger and multicenter studies are needed to update and establish the age range at which Ross procedure is a viable consideration for aortic valve disease.”

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The observational, retrospective study used institutional databases to compare postoperative complications, transvalvular gradients, mortality, and heart failure readmissions after redo SAVR vs ViV TAVR (TAVR within a previous SAVR).

The participants had ViV TAVR from 2013 to 2022 or isolated redo SAVR from 2011 to 2022 at the authors’ center. The primary outcome was mortality.

A total of 4200 TAVRs and 2306 isolated SAVRs were conducted. The cohort included 198 patients (median age, 79.5 [74.0-85.0] years; 42.4% women) who received ViV TAVR and 147 patients (median age, 65.0 [58.0-73.0 years]; 34% women) who had isolated redo SAVR. The ViV TAVR group had significantly increased rates of peripheral vascular disease, chronic lung disease, and New York Heart Association Class III or IV heart failure.

Both groups had an operative mortality of 2.0%, although the observed to expected operative mortality in the redo SAVR group was greater vs the ViV TAVR group (1.2 vs 0.32). The participants who had redo SAVR were significantly more likely to have postoperative renal failure that required dialysis and to need transfusion, reoperation for bleeding, and permanent pacemaker insertion. The ViV group had significantly increased mean gradients at 30 days (13.0 [9.0-18.0] vs 8.0 [5.0-13.0], P <.001) and at 1 year (14.0 [10.0-20.0] vs 7.5 [6.0-11.0], P <.001).

The redo SAVR group had a median follow-up of 4.1 (2.3-6.8) years compared with 1.8 (0.9-2.8) years in the ViV TAVR group (P <.001). The 2 groups had comparable Kaplan-Meier survival estimates at 1 year (redo SAVR, 92.47% vs ViV, 91.30%). Survival estimates were significantly greater at 5 years for patients who had redo SAVR (80.78% vs 56.06% for ViV), although 5-year data were not available for most patients in the ViV cohort.

Univariable analysis demonstrated that ViV TAVR was associated with a significantly higher hazard of death vs redo SAVR (hazard ratio [HR], 2.33; 95% CI, 1.48-3.67; P <.001). In the multivariable model, this finding was no longer significant (HR, 1.39; 95% CI, 0.65-2.99; P =.40). Age (P =.02) and chronic dialysis (P <.001) were significantly associated with mortality in the multivariable analysis.

The ViV TAVR group had significantly greater competing-risk cumulative incidence estimates of heart failure readmissions, although this finding is based on data that were only available in a minority of patients in the ViV group at 5 years (ViV, 30.89% vs redo SAVR, 18.26%).

Limitations of the study include the potential for selection bias and residual confounding. In addition, the follow-up is short, especially in the ViV group, and the relatively small sample size may lead to sampling error, which limits generalizability of the results.

“As indications for TAVR expand, particularly in the ViV era, the lifetime management of aortic valve disease, with all potential reinterventions, must be emphasized during decision-making,” wrote the researchers. “This requires a data-driven understanding of outcomes for each valve reintervention option.”

Disclosure: Some of the study authors 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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Investigators sought to compare the efficacy of DOACs vs VKAs after TAVI in a real-world population. The primary outcomes included all-cause mortality and combined cardiac and cerebrovascular events (aortic prosthesis reintervention, transient ischemic attack [TIA], stroke, myocardial infarction, and all-cause mortality in the first year after TAVI).

The investigators conducted an observational study using the German Aortic Valve Registry to enroll 45,598 patients receiving TAVI from 92 hospitals in Germany from January 2011 to December 2019. Among these patients, 16,974 (mean age [SD], 80.7 [5.7] years; 49.3% men) received an anticoagulant (DOAC, n=5641; VKA, n=11,333). Patients were overwhelmingly White (98.8%). There were similar medical histories and comorbidities between the DOAC and VKA treatment groups, except for previous cardiac surgery (15.7% vs 21.5%), atrial fibrillation (49.3% vs 61.1%), and permanent pacemaker (13.2% vs 17.2%). The most common comorbidities were hypertension (91.2% and 89.1%) and congestive heart failure (42.4% each group).

There was a significant increase in DOAC use from 2011 to 2019 (9.4% vs 69.9%). Procedural and postprocedural in-hospital characteristics for DOAC vs VKA revealed small between-group differences (vascular complications, 3.8% vs 2.9%; new-onset atrial fibrillation, 8.0% vs 7.3%; stroke, 1.1% vs 0.9%). Postinterventional days in ICU (mean [SD], 3.12 [4.04] vs 2.92 [3.79]) were slightly more for DOAC and postinterventional days in hospital (9.10 [6.67] vs 11.21 [8.35]) were slightly less for DOAC. There were no significant between-group differences in mean postinterventional aortic valve gradient.

The absolute event rate per 100 person-years for all-cause mortality was 1.7 for DOAC vs 1.9 for VKA during the 1-year follow-up, and the event rate for the combined cardiac and cerebrovascular events was 1.2 for DOAC vs 1.3 for VKA during the 1-year follow-up.

There were no significant between-group differences in all-cause mortality (hazard ratio [HR], 0.95; 95% CI, 0.88-1.01; P =.114) or cardiac and cerebrovascular event-free survival (HR, 0.93; 95% CI, 0.86-1.01; P =.071) after adjustment for baseline confounders.

Overall survival in 5-year follow-up showed subgroup significance in the beneficial effect of DOAC vs VKA among women (P =.046).

Study limitations include use of retrospective data, missing data on adherence and switching of medications during follow-up, and lack of generalizability to other ethnicities/races.

“This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation,” the investigators concluded. “Comparison of VKA versus DOAC treatment was associated with similar outcomes in terms of all-cause mortality and cardiac and cerebrovascular events including TIA, hemorrhagic/ischemic stroke, myocardial infarction, reintervention on the AV [aortic valve], and all-cause mortality, after multivariate adjustment.”

Disclosure: This research was supported by the German Cardiac Society which receives unrestricted grants by medical device companies.

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The retrospective cohort study included patients with rAAA who received repair at a multihospital integrated regional health care system from 2010 to 2020.

MOF was defined with use of 3 scoring systems: the Denver score, the Sequential Organ Assessment Score (SOFA), and the Marshall Multiple Organ Dysfunction Score (MODS) score. The Denver criteria defined MOF as a score of higher than 3. The SOFA criteria defined MOF as dysfunction in 2 or more organs on a given day. The MODS criteria defined MOF as a score of 8 or higher.

The primary outcome was 30-day mortality.

Among 370 patients with rAAA who received repair, 288 (median age, 72.0; 76.7% men) survived past 2 days. For postoperative days 3 to 5, 14.24% of participants had MOF with the Denver criteria, 9.03% with the SOFA criteria, and 13.54% with the MODS criteria. For MOF with use of any scoring method, 19.4% of patients met the criteria. Patients with MOF were more likely to have had a previous stroke (17.9% MOF+ vs 6.0% MOF-, P =.016).

Pulmonary derangement occurred in 65.9% (Denver), 57.7% (SOFA), and 56.4% (MODS) among patients with MOF. In addition, neurologic derangement was observed in 92.3% (SOFA) and 89.7% (MODS) of patients with MOF, and renal derangement occurred in 26.8% (Denver), 23.1% (SOFA), and 10.3% (MODS) of  patients with MOF.

The 30-day mortality was 16.0% in the 288 patients in the primary cohort and 34.6% in the full cohort of 370 patients. Having MOF for all 3 scoring systems was associated with increased 30-day mortality (11.3% vs 41.5%; P <.01 [Denver]; 12.6% vs 46.2%; P <.01 [SOFA];12.5% vs 35.9%; P <.01 [MODS]), as was having MOF using any criteria (10.8% vs 35.7%, P <.01), in unadjusted Kaplan-Meier survival curves. MOF continued to be an independent predictor of 30-day mortality in the multivariate analysis (odds ratio [OR], 3.42; 95% CI, 1.47-7.96; P =.004).

Chronic kidney disease was associated with an increased incidence of MOF (OR, 2.45; 95% CI, 1.06-5.67; P =.037), and endovascular repair was protective against MOF (OR, 0.19; 95% CI, 0.09-0.39, P <.001) in the logistic regression model.

Nonsurvivors were significantly older vs survivors (82.0 years vs 70.0 years; P <.001).

Limitations of the study include the retrospective design and inability to account for residual confounding and variations in clinical data collection. Also, the number of patients included in the analysis is limited owing to the rare nature of the pathology and decreasing incidence.

“MOF develops in a subset of patients after successful rAAA repair and is associated with considerable short-term mortality,” wrote the study authors. “Endovascular repair may benefit against the high mortality associated with this syndrome. Further prospective efforts with more robust data and follow-up are necessary to truly understand MOF’s natural history and identify potential intervention targets.”

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Compared with SAVR, TAVR with SAPIEN 3 has demonstrated superior efficacy at 2 years among patients with low surgical risk who have severe symptomatic aortic stenosis. However, the comparative cost effectiveness has not been evaluated.

The researchers conducted a prespecified analysis from the Placement of Aortic Transcatheter Valves PARTNER 3 (ClinicalTrials.gov Identifier: NCT02675114) trial. Patients (N=929) with severe symptomatic aortic stenosis who were at low surgical risk were randomly assigned in a 1:1 ratio to receive TAVR with the SAPIEN 3 system (n=485) or SAVR (n=444). Costs were estimated using Medicare claims data and the SAVR and TAVR costs included the average device costs ($5900 and $32,500, respectively). Quality-adjusted life years (QALYs) were defined using the EuroQOL 5-item questionnaire. Economic value was defined as an incremental cost-effectiveness ratio (ICER) of less than $50,000 per QALY gained.

The TAVR and SAVR groups were mean age, 73.6 (SD, 5.8) and 74.0 (SD, 6.1) years; 67.4% and 71.6% were men; they had a Society of Thoracic Surgery risk score of 1.9 (SD, 0.7) and 1.9 (SD, 0.6); and 31.5% and 23.9% had a New York Heart Association class III or IV, respectively.

Compared with SAVR, the TAVR procedure was associated with a significantly shorter procedure time (P <.001), lower stroke incidence (P =.016), lower major bleeding rate (P <.001), shorter total hospital stay (P <.001), and a greater rate of discharge to home with self-care (P <.001).

The TAVR and SAVR index procedures cost an average of $37,370 and $18,327 (P <.001) and an associated hospitalization cost of $7174 and $23,578 (P <.001), physician fees of $2652 and $4702 (P <.001), and total index admission cost of $47,196 and $46,606 (P =.586), respectively.

During the 2-year follow-up, the TAVR and SAVR groups had similar rehospitalization and hospital stay usage, however, the TAVR group spent fewer days in a skilled nursing facility (SNF) or in rehabilitation than the SAVR group (difference, -210 days; P <.001).

During the follow-up, the TAVR procedure was associated with a lower SNF and rehabilitation cost (P =.004). Overall, the total follow-up costs of the TAVR and SAVR procedures was $19,638 and $22,258 (P =.132) and cumulative 2-year costs of $66,834 and $68,864 (P =.306), respectively.

For the base case, the TAVR procedure had a 95% probability of being within the $50,000 cost effective cutoff per QALY gained.

Stratified by subgroup, the groups with the greatest probability of being within the margin for cost-effectiveness were patients with left-ventricular ejection fraction (LVEF) of 65% or less (99%), Kansas City Cardiomyopathy Questionnaire (KCCQ) score of 70 or less (98%), NYHA class III/IV (98%), and men (98%). The lowest probability of cost-effectiveness was observed for patients with LVEF greater than 65% (51%).

The researchers noted that “TAVR remained an economically dominant strategy unless the long-term relative risk of death for patients undergoing TAVR versus SAVR was >1.04.”

“[F]or patients with severe AS [aortic stenosis] and low surgical risk, transfemoral TAVR with the SAPIEN 3 valve is economically dominant compared with SAVR at 2-year follow-up and is projected to be highly cost-effective over a lifetime horizon, as long as there are no differences in late mortality between the 2 strategies,” the researchers concluded.

Disclosures: This research was supported by Edwards Lifesciences Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

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Investigators sought to assess treatment of ATAADs, comparing long-term freedom from reoperation and overall survival in VSRR and CAVGR. They conducted a meta-analysis of reconstructed time-to-event data from 7 studies found in a database search of Cochrane Controlled Trials Register, LILACS, SciELO, EMBASE, and PubMed through December 2022 without language restriction and assessed by 2 independent reviewers.

They included 858 patients (n=367, VSRR; n=491, CAVGR). Included studies had populations who had received TAAD surgical intervention, with an intervention group receiving VSRR, a second intervention group receiving CAVGR, follow-up with survival/mortality rates and/or need for reoperation, and were designed as a randomized controlled or observational trial.

Overall, study population mean ages ranged from 37 to 67 years, were predominantly men, with significant prevalence of additional surgical procedures (total arch replacement, hemi-arch replacement, coronary artery bypass).

Risk of bias was assessed using the Risk of Bias in Non-Randomized Studies of Interventions tool which found overall risk of bias to be moderate-to-high (leaning to the high-side) with the most serious risk of bias due to confounding followed by selection bias.

Between groups, overall survival showed no statistically significant difference (hazard ratio (HR), 0.83; 95% CI, 0.63-1.10; P =.192) over time. The VSRR group vs the CAVGR group had a higher risk of reoperation (HR, 9.99; 95% CI, 2.23-44.73; P =.003).

Age had a modulating effect on the outcome, with a statistically significant positive coefficient in meta-regression (in VSRR vs CAVGR for overall mortality, the higher the mean age, the higher the HR). Outcomes were unaffected by concomitant coronary bypass surgery, concomitant hemi-arch and/or total arch replacement, history of connective tissue disorders, diabetes, hypertension, or female sex.

Limitations of the study include use of data from observational studies susceptible to biases, variations in surgeons’ expertise, incompleteness of follow-up, and poor representation of older patients.

 “VSARR [VSRR] did not confer a better (or worse) survival over time in patients with ATAAD, but it was associated with higher risk of reoperations in the long run,” the study authors wrote.

Disclosure: Some study authors 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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The systematic review and meta-analysis compared short-term results (up to 30 days) of TAVI with the Evolut PRO (Medtronic) and Evolut R (Medtronic) valves in patients with symptomatic severe aortic valve stenosis. Outco.mes included PVL and major vascular complications (MVC), including serious bleeding.

Investigators searched PubMed, Google Scholar, ClinicalKey, and the Web of Science databases through November 2022 for human studies that directly compared strategies for transcatheter aortic valve replacement with the Evolut R and Evolut PRO.

A total of 11 observational studies (7 multicenter registries) with 12,363 patients were included. The studies had a moderate risk of bias.

Participants who received the Evolut PRO (n=3439) and Evolut R (n=8924) substantially differed in age (P <.001), sex (P <.001), and Society of Thoracic Surgeons Predicted Risk of Mortality risk profile (P <.001). Evolut PRO patients, compared with Evolut R patients, were older (80.13±7.65 years vs 77.58±8.79 years) and more were women (62.92% vs 54.71%) but they had a lower risk profile (6.79±6.4 vs 7.34±5.6).

The need for use of more than 1 prosthesis during initial implantation was low in the Evolut PRO (0.87%, 26 of 2973 cases) and Evolut R groups (1.18%, 94 of 7972 cases), with statistical significance in favor of the Evolut PRO (risk ratio [RR], 0.52; 95% CI, 0.30-0.89; P =.02; I²=8%). No difference was observed in the pooled estimate of other TAVI-related complications between the groups, which was 0.45% (13 of 2900 cases) for the Evolut PRO patients vs 0.49% (37 of 7526 cases) for the Evolut R patients.

The analysis of moderate-to-severe and mild PVL included 11 (n=12,363) and 7 (n=10,862) studies, respectively. The researchers found a decrease of about 35% in risk for moderate-to-severe PVL in patients with the Evolut PRO valve (RR, 0.66; 95% CI, 0.52-0.86; P =.002; I²=0%). There were corresponding event rates of 2.41% (83 of 3439) for the Evolut PRO and 3.03% (270 of 8924) for the Evolut R. No difference was observed for mild PVL between devices.

Analysis of serious bleeding and MVC included 9 studies. The Evolut PRO group had a decrease of over 35% in risk for serious bleeding compared with the Evolut R group (RR, 0.63; 95% CI, 0.41-0.96; P =.03; I²=39%). No differences in MVC were found between the 2 devices (RR, 0.77; 95% CI, 0.54-1.08; P =.13; I²=7%).

The risk for other clinical endpoints was similar between the devices, including 30-day mortality (RR, 0.93; 95% CI, 0.69-1.25; P =.63; I²=0%), periprocedural myocardial infarction (RR, 1.31; 95% CI, 0.42-4.05; P =.64; I²=40%), and cerebrovascular accident (RR, 0.81; 95% CI, 0.61-1.08; P =.15; I²=0%).

Among several study limitations, only observational studies are included, and those that have compared the Evolut PRO and Evolut R have reported only short-term outcomes thus far. Furthermore, 2 studies accounted for over 70% of the study population.

“The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in the clinical and procedural endpoints,” wrote the study authors. “Implantation of the Evolut PRO was associated with a statistically significantly lower rate of moderate-to-severe PVL. These benefits might, in consequence, further translate into improved long-term clinical outcomes.”

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Investigators sought to determine if a diagnosis of intraventricular conduction delay (IVCD; RBBB, LBBB, or NIVCD) in patients with ACS is related to long-term prognosis. The primary endpoint was cardiac death.

They conducted a retrospective study of 9749 consecutive patients with an invasive coronary angiography diagnosis of ACS and a recorded electrocardiogram (ECG) who were evaluated from January 2007 through December 2018 at Tays Heart Hospital in Finland. Follow-up for cardiac-related death was through December 2020. The Finnish national register was searched for mortality and cause of death data with no losses to follow-up.

Patients (mean age, 68.3±11.8 years; 32.7% women) had a median follow-up time of 6.1 years (IQR, 3.3-9.4).  In follow-up, there were 3156 deaths, of which 52.9% were cardiac-related. A total of 8681 patients (89.1%) did not have IVCD. There were 239 patients with NIVCD, 288 patients with LBBB, and 539 patients with RBBB. Compared with patients with no observable conduction disorders, patients with IVCD tended to be older at baseline with more comorbidities.

There were 551 deaths among patients with IVCDs. Overall, 76.9% of patients with NIVCD, 67.6% of patients with LBBB, 55.7% of patients with RBBB, and 50.1% of patients with no IVCD died. The investigators noted that in the first 12 years of follow-up, cumulative incidence for cardiac death was 19.6% among patients with no IVCD, 57.0% among patients with NIVCD, 46.2% among patients with LBBB, and 33.2% among patients with RBBB (all P <.001 for comparison). At 12 years, cumulative incidence for other causes of death was 21.9% among patients with no IVCD, 19.7% among patients with NIVCD, 22.6% among patients with LBBB, and 29.1% among patients with RBBB.

Patients in all IVCD groups had a significantly higher risk of cardiac death vs patients with no IVCD (NIVCD subdistribution hazard estimate [SDH], 2.68; 95% CI, 2.19-3.27; LBBB SDH, 1.63; 95% CI, 1.31-2.03; P <.0001; RBBB SDH, 1.37; 95% CI, 1.15-1.64; P <.0001). NIVCD and RBBB remained notable risk factors for cardiac death after adjusting for LVEF (hazard ratio [HR], 1.96; 95% CI, 1.59-2.43; P <.001 for NIVCD; and HR, 1.30; 95% CI, 1.08-1.56; P =.005 for RBBB).

Study limitations include exclusion of noninvasively diagnosed patients and the older age of patients with IVCD.

Among consecutive patients receiving invasive evaluation for ACS, investigators concluded those with NIVCD were a high-risk subgroup compared with other patients. “In contrast to LBBB, the risk associated with NIVCD was not related to LVEF.” Investigators believe NIVCD should be acknowledged in guidelines as a significant predictor of death. They wrote, “Our results support the ESC guidelines describing LBBB in patients as a high-risk feature, but a matter of debate remains in whether RBBB should be considered as a high-risk factor not only in STEMI but also in ACS patients.”

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Investigators assessed rates of reoperation and survival following valve repair compared with the Ross procedure for the unicuspid aortic valve in adults.

The retrospective analysis included patients who received treatment of a unicuspid aortic valve at a university medical center in Germany between December 1998 and April 2022. Overall, 345 patients (mean age, 33.5 [SD, 9.7] years; 74% men) received treatment. Individuals were excluded if they were aged younger than 18 years or older than 54 years at the time of the operation. A total of 258 patients were then categorized into 2 groups: 64% patients received valve repair and 91 (36%) patients had the Ross procedure (pulmonary autograft replacement).

The participants were followed prospectively, clinically and echocardiographically, at discharge, 3 months, 1 year, and yearly afterward. The main indications at the time of operation were isolated aortic stenosis (AS) in 45 patients (repair, 15%; Ross, 22%; P =.114), isolated aortic regurgitation (AR) in 104 patients (repair, 51%; Ross, 21%; P =.001, and combined disease in 103 patients (repair, 34%; Ross, 52%; P =.02). The patients who had valve repair were younger (mean age, 32 years) vs those who had a Ross procedure (mean age, 38 years; P =.061).

The median and mean follow-up were 5.1 years and 5.9 years, respectively. The follow-up was 95% complete, with 1512 patient-years.

Early death after valve repair occurred in 1 patient, and 2 early reoperations also were performed in the repair group. In addition, 3 patients died at 3 months to 4.1 years postoperatively (repair, n=2; Ross, n=1). At 10 years, the overall survival was 98%. The 10-year survival was the same after valve repair (97%) and pulmonary autograft replacement (95%; P =.769).

For the repair group, reoperation-free survival was 77% at 10 years. The cumulative incidence of reoperation was 21% at 10 years and the cumulative mortality incidence was 2%. For the Ross group, reoperation-free survival was 94% at 10 years, with a cumulative incidence of reoperation of 2% and cumulative mortality incidence of 4%.

In analysis of patient age at the time of operation, among participants in the repair group, those aged 18 to 25 years had improved freedom from reoperation of 84% at 10 years vs older patients (ages 26-30 years, 54%; ages 31-40 years, 75%; ages 41-54 years, 66%; P =.347). Freedom from reoperation in the Ross group at 10 years was similar (94-96%) among all age groups (P =.934). Receiver operating characteristic curve analysis indicated a trend toward the best durability occurring in patients aged younger than 26 years.

The main study limitation is the observational design, as the analysis was performed retrospectively and treatment allocation was not randomized. In addition, the reproducibility of the findings may be limited owing to a highly experienced surgeon in a high-volume center performing the procedures.

“The incidence of reoperation after the Ross procedure is low but remains poorly defined for UAVs [unicuspid aortic valves],” wrote the study authors. “Thus, for patients younger than 25, repair may be used as a bridge to pulmonary autograft replacement, reserving Ross for repair failures.”

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This analysis was part of the Rotterdam Study, which is an ongoing, prospective, population-based cohort of adults recruited at age 45 years or older and followed every 3 to 4 years. In this analysis, a random subset of 2348 patients who received computed tomography (CT) between 2003 and 2006 and had follow-up data through 2016 were evaluated for aortic valve calcium and the development of HF.

The study population comprised individuals with a mean age of 68.5±6.6 years, 52% were women, 98% were White, they had a BMI of 27.6±3.9, 74.1% had hypertension, 12.5% had diabetes, and 15.8% were current smokers. At baseline, 747 had aortic valve calcium. The individuals with aortic valve calcium were older, fewer were women, they had higher systolic blood pressure, more had hypertension and a history of coronary heart disease, and more were on blood-pressure-lowering medications and statin therapy (all P <.001) compared with the no aortic valve calcium cohort.

In the multivariate linear regression analysis, left ventricular mass indexed by body surface area was associated with the presence of aortic valve calcium (b, 2.80; P =.001) and log aortic valve calcium per 1-unit increase (b, 1.13; P <.001), left atrium diameter with aortic valve calcium (b, 0.06; P =.020) and log aortic valve calcium per 1-unit increase (b, 0.01; P =.007), and left ventricular ejection fraction with aortic valve calcium (b, -0.68; P =.048).

At a median follow-up of 9.8 years, 182 incident HF events were diagnosed. Stratified by aortic valve calcium at baseline, 12.6% of those with aortic valve calcium and 5.5% without aortic valve calcium were diagnosed with HF.

Stratified by level of aortic valve calcium at baseline, those with aortic valve calcium levels of 800 or higher and aortic valve calcium levels of 300 to 799 had significantly higher rates of HF during follow-up compared with patients with lower levels of aortic valve calcium at baseline (P <.001).

In the fully-adjusted model, incident HF was associated with aortic valve calcium levels of 800 or more (subdistribution hazard ratio [sHR], 2.54; 95% CI, 1.31-4.90; P =.006) and aortic valve calcium levels of 300 to 799 (sHR, 2.36; 95% CI, 1.32-4.19; P =.004) compared with patients with no aortic valve calcium and log aortic valve calcium per 1-unit increase (sHR, 1.10; 95% CI, 1.03-1.18; P =.005).

The overall mortality rate was 23.7% during follow-up. Mortality risk did not depend on aortic valve calcium status.

In sensitivity analyses, the relationship between HF and aortic valve calcium was attenuated after excluding patients with aortic valve stenosis and those who developed coronary heart disease during follow-up.

These findings may not be generalizable to a more diverse population.

“In this prospective study among community-dwelling men and women free of HF, the presence of AVC [aortic valve calcium] and high levels of AVC were associated with left ventricular structure and increased risk of new-onset HF,” the study authors wrote. “Our results suggest that larger CT-assessed AVC could be an indicative of increased risk for development of HF.”

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Investigators sought to evaluate transvalvular hemodynamics and clinical outcomes in patients with small aortic annuli receiving TAVI stratified by sex. The primary outcome was all-cause mortality. The secondary outcome was incidence of predischarge severe prosthesis-patient mismatch and its association with all-cause mortality.

They conducted the retrospective, observational TAVI-SMALL 2 international registry from June 2011 to April 2020. The registry included 1378 patients treated with transfemoral implantation of current-generation self-expanding (Portico, Abbott Vascular, Santa Clara, California; Acurate neo, Boston Scientific, Marlborough, Massachusetts; Evolut R and Evolut Pro, Medtronic, Minneapolis, Minnesota) and balloon-expandable valves (Sapien 3, Edwards Lifesciences, Irvine, California) for severe native aortic valve stenosis and small aortic annuli (annular perimeter <72 mm or area <400 mm²) at 16 high-volume centers. Patients with valve-in-valve procedures, TAVI for pure aortic regurgitation, or lack of preprocedural computed tomography data were excluded.

At baseline there were 1233 women (89.5%) and 145 men (10.5%) with aortic stenosis and small aortic annuli treated with transfemoral TAVI. Women compared with men were older (83.1 years vs 80.9 years; P <.001) and had lower height, weight, and body surface area (all P <.001). Hypertension was more common in women, but comorbidities of coronary artery disease, peripheral artery disease, chronic obstructive pulmonary disease, dyslipidemia, previous myocardial infarction, and percutaneous coronary intervention were more common among men. There were no significant between-group differences in atrial fibrillation, diabetes mellitus, or the Society of Thoracic Surgeons Predicted Risk of Mortality.

Propensity score-matching 1:1, women vs men, resulted in 99 pairs with no significant difference in any baseline characteristic.

At median follow-up of 377 days (IQR, 168-700 days), investigators found no difference between women vs men in incidence of all-cause mortality overall (10.3% vs 9.8%; P =.842) and in propensity score-matched populations (8.5% vs 10.9%; P =.586). They found no between-sex difference in cardiovascular mortality (P =.307), acute kidney injury (P =1.000), transient ischemic attack or stroke (P =.789), myocardial infarction (P =.375), or hospitalization for heart failure (P =.734).

There was no evidence of a difference in predischarge severe prosthesis-patient mismatch after propensity score matching (P =.275) though prosthesis-patient mismatch was numerically higher in women (10.2%) vs men (4.3%). Women in the overall population with severe prosthesis-patient mismatch suffered a higher incidence of all-cause mortality vs women with less-than-severe prosthesis-patient mismatch (log-rank P =.027) and less-than-moderate prosthesis-patient mismatch (log-rank P =.024). In the overall population and after propensity score matching, women were at increased risk for major vascular complications and major bleeding with borderline significance.

Significant study limitations include the possibility of selection or confounding bias, as well as the possibility of missing data. The sample size is also underpowered for men.

“No difference in all-cause mortality at medium-term follow-up was observed between women and men with aortic stenosis and small annuli undergoing TAVI,” the study authors wrote. “Incidence of predischarge severe PPM [prosthesis-patient mismatch] was numerically higher in women than men, and it was associated with increased all-cause mortality in women.”

Disclosure: Some study authors 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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Data for this study were sourced from the CONDUCT (ClinicalTrials.gov Identifier: NCT03497611) registry, which collected data from 4 centers in Europe. In this study, data were collected between 2019 and 2021 and risk factors for receiving PPI after TAVI were evaluated. Valve oversizing was defined as an annulus area smaller than the minimum valve size area range.

The overall study population comprised 75% women and the mean age was 79.9±6.3 years.

Among the 300 included patients, 42 received post-TAVI PPI. Stratified by PPI, more pacemaker recipients had diabetes (42.9% vs 26.0%; P =.024), chronic obstructive pulmonary disease (COPD; 16.7% vs 6.2%; P =.028), decreased left ventricular ejection fraction (47.5% vs 51.2%; P =.014), and higher systolic pulmonary artery pressure (mean, 48.8 vs 39.5 mm Hg; P =.010) compared with nonrecipients, respectively.

During TAVI, the PPI recipients had significantly larger valve sizes (mean, 27.3 vs 26.6 mm; P =.027) and more had valve oversizing (17.6% vs 11.7%; P =.029) compared with nonrecipients, respectively. All other procedural details were similar between groups.

Following TAVI, fewer PPI recipients had no or trace paravalvular regurgitation (64.3% vs 84.7%; P =.004) and they had a longer time to discharge (mean, 8.6 vs 5.0 days; P <.001), lengths of stay in the intensive care unit (mean, 65.7 vs 16.3 hours; P <.001), and time in the general ward (mean, 6.9 vs 5.3 days; P =.004) compared with patients who did not receive PPI, respectively.

In the univariate analyses, predictors for PPI included diabetes, COPD, atrial fibrillation, prolonged QRS duration, complete right bundle branch block (RBBB), aortic annulus calcification, and valve size. In the multivariate analyses, complete RBBB (odds ratio [OR], 6.775; 95% CI, 2.531-18.140; P <.001) and valve size of 29 mm (OR, 3.4; 95% CI, 1.4-8.5; P =.008) remained significant predictors for PPI risk.

The major limitation of this study is the small sample size of patients who received PPI.

 “…only valve sizing persisted to be a major, avoidable risk factor for PPI,” the study authors wrote. “The valve type, implantation depth and postdelivery balloon dilatation all affected PPI rates, but without statistical significance, potentially already reflecting the refined implantation techniques in the participating centers.”

Disclosure: Some study authors 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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Investigators sought to determine the optimal septal reduction therapy (alcohol septal ablation vs septal myectomy) for obstructive hypertrophic cardiomyopathy (HCM). All-cause mortality in studies with at least 1 year of follow-up was the primary outcome. Reoperations of LVOT and LVOT pressure gradient reduction were the secondary outcomes.

They conducted a meta-analysis of 27 observational studies (N=15,968 patients) identified by 2 independent investigators in the Cochrane CENTRAL, EMBASE, and MEDLINE databases from inception through mid-January 2023. Studies in which patients with obstructive HCM received alcohol septal ablation (n=6636) or septal myectomy (n=9332) were included. All of the included studies had low risk of bias determined by the Newcastle-Ottawa Scale for observational studies, and funnel plots showed no evidence of publication bias.

At baseline, proportions of concomitant systolic anterior motion and mitral regurgitation were similar between groups, as were rates of diabetes mellitus, syncope, and hypertension. Patients receiving alcohol septal ablation were older than patients in the septal myectomy group (weighted mean difference, 4.86 years; 95% CI, 2.47-7.24; P <.01). The alcohol septal ablation group vs the septal myectomy group had lower baseline septal thickness (weighted mean difference [MD], -0.74 mm Hg; 95% CI, -1.45 to -0.02; P =.04; I²=62%). Between-group preprocedural LVOT pressure gradients were similar.

Analysis showed similar all-cause mortality rates (hazard ratio [HR], 1.24; 95% CI, 0.88-1.76; P =.21; I²=56%). The alcohol septal ablation group compared with the septal myectomy group had a significantly higher rate of permanent pacemaker implantations (HR, 1.68; 95% CI, 1.28-2.20; P =.0002; I²=35%).

Alcohol septal ablation was associated with a higher reoperation rate (HR, 9.14; 95% CI, 6.55-12.75; P <.001; I²=0%) and less reduction of LVOT pressure gradient (weighted MD, 11.04 mm Hg; 95% CI, 5.60-16.48; P <.01; I²=64%). In subgroup analysis there was higher long-term mortality in the alcohol septal ablation group (HR, 1.50; 95% CI, 1.04-2.15; P =.03; I²=52%) during follow-up of at least 5 years. Both groups had similar 30-day mortality rates and cardiovascular mortality rates. The alcohol septal ablation group had less reduction of LVOT pressure gradients and higher postprocedural LVOT pressure gradients. The 2 groups had similar rates of stroke and the rate of rehospitalization due to heart failure showed no significant between-group difference.

Significant study limitations include the secondary outcomes and subgroup analyses being exploratory only.

“…ASA [alcohol septal ablation] was associated with a significant increase in permanent pacemaker implantations and reoperation rates, and less LVOT PG [pressure gradient] reduction,” the study authors wrote. “Long-term mortality with the data of 5 years [or longer] showed favorable outcome with SM [septal myectomy], although the results from the subgroup analysis and secondary outcomes are exploratory results.”

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Patients with cirrhosis who receive orthotopic liver transplantation evaluation between 2000 and 2020 at Indiana University were eligible for this single-center, retrospective case-control study. A random sample of 88 patients with and 97 patients without obstructive CAD were included in this study. Identification of CAD was evaluated by adding independent variables using a nested logistic regression model. The model that best differentiated between patients with and without CAD was determined.

Patients with CAD were older (P =.003), more were men (P =.001), and more were on insulin (P =.007) than the patients without CAD. Among the CAD group, 64.8% had obstructive CAD.

An abnormal stress echocardiogram was defined as one with chest pain, ischemia, wall motion abnormalities, left ventricular augmentation failure with stress, mitral valve calcification, and/or aortic valve calcification. Abnormal echocardiograms occurred among 72.7% of patients with CAD and 46.4% without CAD (P =.003). An abnormal stress echocardiogram had an area under the curve (AUC) for detecting obstructive CAD of 0.58, sensitivity of 35.2%, specificity of 81.4%, positive predictive value (PPV) of 63.3, and negative predictive value (NPV) of 58.1.

Abdominal calcification was observed among 50% of patients with CAD and 36.1% of patients without CAD (P =.06) and coronary calcification among 28.4% and 22.7% (P =.008), respectively.

By adding aortic valve sclerosis or stenosis data to abnormal stress echocardiography data, the AUC for detecting obstructive CAD increased to 0.69. Adding mitral valve calcification data to aortic valve sclerosis or stenosis data and abnormal stress echocardiography data also had an AUC of 0.69. In each progressive model, adding abdominal calcification (AUC, 0.72), coronary calcium on computed tomography (AUC, 0.73), and age, gender, and diabetes requiring insulin status (AUC, 0.80) data increased the predictive power of the model.

The final model with all predictors was significantly more predictive than abnormal stress alone (P <.001) and had a sensitivity of 58.0%, specificity of 88.7%, PPV of 82.3, and NPV of 69.9 for detecting CAD.

The limitations of this study include the retrospective, single center design.

These data indicated that adding vascular calcification data to stress echo may improve CAD identification in patients with cirrhosis. “Our study should be considered explorative and hypothesis-generating,” the study authors wrote.  “Prospective studies evaluating the impact of vascular and valvular calcification and stress testing on the ability to identify obstructive CAD in patients with cirrhosis before liver transplant are needed.”

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Valvular heart disease, when any heart valve struggles to allow adequate blood flow through and from the heart, can be fatal if not detected and managed in a timely manner. It has been estimated that 2.5% of Americans have valvular heart disease.¹

If caught in time, valvular heart disease can be managed without measures as intensive as surgery. Early detection may help patients avoid severe outcomes resulting from blood flow difficulties and thickening of the heart muscle. For this reason, patients who are at risk for developing valvular heart disease should know the different ways it can occur, how to detect symptoms, and what may be required if the condition is left unmanaged. When discussing valvular heart disease with patients who may not be aware of the risks, how can you break down the basics for them?

What is Valvular Heart Disease?

Valvular heart disease is a general term that encompasses any instance of disease or damage to a heart valve. The four valves of the heart – the mitral, tricuspid, aortic, and pulmonary valves – allow for blood flow through the four chambers of the heart.¹ These valves have flaps (two in the case of the mitral valve, three in the case of all other valves) that open and close to allow for a proper, regulated flow of blood. A damaged valve, however, may have difficulties fully opening or closing. This affects the amount of blood and the direction it can go in.

If a patient’s heart valves are struggling to flow blood through the heart, it will pump harder to get more blood flowing. This can increase their risk for heart failure, stroke, and sudden cardiac arrest.²

There are three general types of valvular heart disease: valvular regurgitation, stenosis, and atresia.

Regurgitation

Regurgitation is when the flaps of the valve do not close properly, which can cause blood to leak and flow backwards into the heart. With some of the blood flowing the wrong way, the heart may have to work harder to pump the correct amount of blood.³ Often, regurgitation can be the result of valve flaps bulge back, known as prolapse.²

Stenosis

In valve stenosis, the opening of the valve struggles to open properly. This could be a result of flaps fusing together, thickening, or stiffening.² Aortic stenosis, where the narrowed opening of the aortic valve struggles to provide enough blood from the left ventricle, is one of the most common forms of valvular heart disease.⁴

Atresia

Atresia is a congenital condition where the valve does not fully form and does not have an opening to allow for blood flow.

Who is at Risk for Valvular Heart Disease?

Certain risk factors for valvular heart disease are similar to those of other cardiovascular conditions, such as advanced age or a family history of heart disease; with valvular heart disease, early history of heart disease particularly increases risk.²

Other forms of heart disease can put a strain on the valves and increase a patient’s risk as well. Endocarditis, an infection in the lining of the heart, can settle into and damage the valves. Heart failure, atherosclerosis, and high blood pressure can also affect heart valves and potentially cause valvular heart disease.

Rheumatic disease can also bring about valve disease. Triggered by the same bacteria that causes strep throat to develop, rheumatic disease can scar the heart valve and increase risk over time. This is more common in older Americans, particular those born before 1943.¹

Other risk factors include:

• Diabetes
• High cholesterol
• Obesity
• Autoimmune disease
• Lack of exercise
• Marfan syndrome

Valvular Heart Disease Symptoms

It is important that at-risk patients know to detect potential symptoms of valvular heart disease. Unfortunately, symptoms are not always readily apparent. In a particularly slow-moving valvular heart disease, it can take years before symptoms appear, at which point the condition may be quite advanced. The disease can also develop and progress rapidly in some cases. Because of this, the best advice you can give your patients is to tend to their cardiovascular health as best they can.

When symptoms do appear, they often include:

• Fatigue
• Chest pain
• Dizziness
• Arrhythmia (irregular heartbeat)
• Shortness of breath
• Swelling or rapid weight gain

Valvular Heart Disease Diagnosis

Clinicians may notice possible valvular heart disease if they hear a heart murmur during a routine physical examination or cardiology appointment. An abnormal sound like that would potentially indicate that a valve is not working correctly, at which point a primary care physician would refer the patient to a cardiologist and a cardiologist would recommend further tests. This may include an echocardiography (using sound waves to create a moving image of the heart and its blood flow).

The location, sound, and rhythm of the heart murmur may also allow a health care professional to determine the affected valve and the type of valvular heart disease.¹

Valvular Heart Disease Management

Upon diagnosis of valvular heart disease, patients may receive immediate treatment in some cases but not others, depending on the severity of the symptoms and the damage to the valve. In mild cases, a patient may be recommended to simply make lifestyle changes to promote good overall health. Simultaneously, they may receive medications to alleviate their symptoms before further, more intensive treatment is needed. They may undergo regular follow-ups to determine how their symptoms are developing and if the valve is worsening.

Valvular Heart Disease Treatment

If the condition is serious enough, surgery may be required to repair or replace the damaged valve. Repair is often preferred to replacement if feasible, as valve replacement has more risks. Depending on the severity of the disease, however, replacement may be necessary.

The two types of replacement valves are biologic valves made of human or animal tissue and mechanical valves.² The type of surgery required will depend on the type of valvular heart disease. For example, in aortic stenosis, the transcatheter aortic valve replacement surgery has become a standard choice, particularly for those who are at a higher surgical risk.⁵ While this procedure is not without risk, it is minimally invasive and can mitigate the risks that come with open-heart surgery.

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Investigators sought to assess early- and mid-term clinical outcomes among patients with left side heart bioprosthetic deterioration treated with transcatheter ViV/ViR implantation using the Myval THV. The primary outcome was postprocedural technical success. Secondary outcomes included death, final mean transprosthetic aortic valve gradient of more than 20 mm Hg, mean transprosthetic mitral valve gradient of more than 10 mm Hg, and need for a second THV.

This was a multicenter observational study conducted from April 2019 to January 2022. The investigators included 97 consecutive patients with severe symptomatic aortic BHVs (n=33; aged 71.6±14.9 years; 30.3% women) and mitral BHVs (n=64; aged 67.3±14.5 years; 60.9% women) or annuloplasty ring failure receiving transcatheter aortic ViV and mitral ViV or ViR implantation with balloon-expandable (BE) Myval implantation. The European consensus statement was used to define BHV/ring failure. Potential candidates for transcatheter ViV or ViR implantation were symptomatic patients considered too high-risk for surgical valve replacement.

Patients receiving mitral ViV vs patients receiving aortic ViV had more history of atrial fibrillation (64.1% vs 24.2%), coronary artery disease (35.9% vs 24.2%), and chronic obstructive pulmonary disease (20.3% vs 12.1%). Patients receiving aortic ViV vs patients receiving mitral ViV had more history of stroke (21.2% vs 14.1%), carotid artery disease (33.3% vs 17.2%), and hypertension (75.8% vs 65.6%). Treatment groups were similar for New York Heart Association (NYHA) class III, peripheral vascular disease, and dyslipidemia. Overall, 84.4% of mitral group patients and 72.7% of aortic group patients had stents.

The percutaneous transfemoral arterial route was used for all aortic ViV procedures. Mitral ViV/ViR procedures were performed either through transapical, or transfemoral vein access, and interatrial septal predilatation in 95.3% of patients.

There were 95 patients who achieved technical success. Acute structural transcatheter mitral ViV/ViR dysfunction requiring a second THV implantation occurred in 2 patients. There were no procedural deaths.

Early-term (30 days following mitral and aortic ViV/ViR implantation) there was an increase in valve areas and a significant reduction in prosthetic transvalvular pressure gradients. Overall, there were 5 hospitalizations (2 among aortic patients).

There was 92% survival at 15 (IQR, 8-21) months. Patients receiving aortic ViV implantation experienced 97% survival compared with 89% survival in patients receiving mitral ViV/ViR (hazard ratio, 2.7; 95% CI, 0.33-22.7; P =.34). There were 3 patients in the mitral group who required hospitalization.

Patients with aortic and mitral ViV/ViR implantation had significant improvement in NYHA functional class I (n=2 at baseline) and II (n=20 at baseline) at the longest available follow-up (93.8% and 92.1%, respectively). The mortality rate at the longest available follow-up time was 11%.

Study limitations include the observational design, underpowered sample size, and the limited follow-up duration.

“…transcatheter ViV (or ViR) implantation for failed left side heart surgical bioprosthesis (or ring) can be safely performed with the use of the new BE Myval THV with a high success rate and minimal early mortality and morbidity,” the study authors wrote. “Particularly, a 100% success rate was observed in aortic ViV procedures, which may reflect the substantial procedural refinements that have been achieved in the past years in transcatheter aortic valve replacement (TAVR) interventions.”

Disclosure: Some study authors 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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Recognizing that inflammation has been implicated in the progressive exacerbation of VAF and thrombogenesis, the researchers sought to examine the link between systemic inflammation, as measured by 6 different indices, and left atrial thrombus in patients with VAF. The 6 indices included the following:

• Neutrophil/lymphocyte ratio
• Monocyte/ lymphocyte ratio (MLR)
• White blood/mean platelet volume ratio
• Neutrophil/mean platelet volume ratio
• Systemic immune inflammation index
• Systemic inflammation response index

A total of 448 individuals with documented VAF who had received transesophageal echocardiography (TEE) at Henan Provincial People’s Hospital, located in Henan Province, China, between January 2015 and September 2022, were retrospectively evaluated. Of these patients, 434 participants were enrolled in the study. The mean patient age was 56.94±9.12 years. Overall, 36.2% of the participants were men.

TEE detected left atrial thrombus in 32.9% of the patients. Compared with individuals without left atrial thrombus, patients with left atrial thrombus were more likely to be men, they were more likely to have heart failure and diabetes, and they were more likely to have a larger left atrial diameter and higher C-reactive protein levels. All 6 inflammatory indices were significantly higher among patients with left atrial thrombus.

Based on correlation analysis, the 6 inflammatory indices were all positively correlated with C-reactive protein levels (P <.001). Neutrophil/lymphocyte ratio had the highest correlation coefficient (r =0.447) and white blood/mean platelet volume ratio had the lowest (r =0.277).

Per multivariate logistic analysis, the 6 inflammatory indices were independent predictors of left atrial thrombus, with MLR appearing to perform the best (odds ratio, 12.006; 95% CI, 3.404-42.347; P <.001) and having the highest area under the curve (0.639; 95% CI, 0.583-0.694; P <.001).

Several limitations of the study should be noted. Due to its retrospective design, the study is not specifically constructed to evaluate the endpoints reported. Prospective studies with larger sample sizes are thus needed to confirm the results of the present analysis. Although many factors, including smoking, alcohol, and mental stress, can generate chronic systemic inflammation, these data were not obtained in this study.

“Elevated inflammatory indices were associated with an increased risk for LAT [left atrial thrombus] in patients with VAF,” the study authors wrote. “Because these indices are extensively used and readily available in the clinical field, we propose that they could be used as cost-effective predictors for thromboembolic risk, which would benefit a large subset of patients with VAF in developing countries.”

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HCM is a genetic disorder characterized by asymmetric left ventricular (LV) hypertrophy, as well as a broad clinical and morphologic spectrum. MV disease is observed frequently in patients with HCM. Data on the prognostic implications of MV disease and its progression in individuals with HCM remain scarce, however. For the study, conducted at Yonsei University College of Medicine in Seoul, Korea, researchers evaluated the prognostic implication of MV disease and its progression in East Asian patients with HCM.

A total of 1193 patients who had been diagnosed with HCM in a single-center HCM registry between January 2005 and December 2016 were identified. An HCM diagnosis was based on “echocardiographic demonstration of a hypertrophied, nondilated LV in the absence of another cardiac or systemic disease that could produce a comparable magnitude of LV hypertrophy.” Following the exclusion of some patients, a total of 1185 individuals were ultimately included in the study. A total of 667 patients who received follow-up echocardiograms after 3 to 5 years were evaluated as well.

The mean age for participants was 60; 67% of the patients were men. The participants were classified into 2 groups, according to the presence of LV outflow tract (LVOT) obstruction: obstructive HCM (group 1; n=104) and nonobstructive HCM
(group 2; n=1081).

In this study, LVOT obstructive was defined as “peak pressure gradient of the LVOT [of] ≥30 mm Hg on continuous-wave Doppler echocardiogram at rest or with physiologic provocation.” The progression of MR was defined as “the increase of at least 1 grade.” Clinical outcomes included a composite of cardiovascular death, heart failure hospitalization, MV surgery or septal myectomy (SM), and heart transplantation.

Overall, 23.5% (278 of 1185) of the participants exhibited at least mild MR on indexed electrocardiograms. Among patients with obstructive HCM, MR, SAM, and MAC all were more often reported. Over 7.0 years of follow-up, the presence of MR was independently associated with poor clinical outcomes (hazard ratio [HR], 1.60; 95% CI, 1.07-2.40; P =.023).

Based on follow-up echocardiograms performed 3 to 5 years later, 10.0% (67 of 667) of individuals in this analysis demonstrated MR progression, which was independently associated with a poor prognosis (HR, 2.46; 95% CI, 1.29-4.71; P =.007).  

Several study limitations warrant mention. There are some situations where it may be a challenge to quantify MR in individuals with HCM — particularly when LVOT obstruction exists. Also, not all of the participants underwent provocation tests for the diagnosis of HCM, which could be linked to the underdiagnosis of obstructive HCM in this analysis. Further, participants with HCM were recruited from a tertiary hospital only, and individuals who had already undergone SM or MV surgery were excluded, which might create selection bias.

The researchers concluded, “The presence and progression of MR is a prognostic factor in the occurrence of poorer clinical outcomes; therefore, careful assessment of MV functional abnormalities and detailed evaluation of MV anatomical features are needed to predict subsequent complications in patients with HCM.”

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Researchers from Brigham and Women’s Hospital in the United States sourced data for this analysis from the Atherosclerosis Risk in Communities (ARIC) study, which was a prospective epidemiological cohort study that recruited participants between 1987 and 1989. The subset of patients (n=6118), who attended visits 5 in 2011-2013 and 7 in 2018-2019 and underwent echocardiography, were staged for aortic and mitral stenosis and regurgitation according to the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines. Prospective trends in VHD were evaluated between visits 5 and 7.

The study participants were mean age, 76 at visit 5; 42% were men; 22% were Black; 62% were ever smokers; and 83% had hypertension.

At visit 5, 2640 had no VHD, 2362 had Stage A VHD, 1010 Stage B VHD, and 66 Stage C/D VHD. In general, age and the prevalence of comorbidities were positively related with advanced VHD stage.

Stratified by valve and disease type, Stages A, B, C, and D aortic stenosis was observed among 15.4%, 4.1%, 0.4%, and 0.4% of participants, respectively. A total of 32 participants had undergone aortic valve replacement. Stage A mitral regurgitation was observed among 38.6% of participants.

At visit 7, 15% of patients presented with no VHD, 20% with Stage A VHD, 10% with Stage B VHD, 4% with Stage C/D VHD, and 1% with a replaced valve. The remaining participants were lost to follow-up (30%) or died (20%).

In general, comparing visits 5 and 7 indicated the rates of no VHD (43.2% vs 23.8%) and Stage A VHD (38.6% vs 31%) decreased, whereas Stage C/D VHD (1.1% vs 7.3%) and valve replacement (1.1% vs 2.2%) increased over time, respectively.

During a median follow-up of 5.5-6.5 years, the following occurred:

• new-onset atrial fibrillation (AF) occurred among 564 patients;
• new-onset heart failure (HF) among 553 patients;
• new-onset coronary heart disease (CHD) among 300 patients;
• incident stroke among 250 patients; and
• mortality among 1295 patients.

In general, risk for all outcomes except stroke increased with VHD stage, in which compared with no VHD, among patients with VHD, risk was increased for:

• mortality (adjusted hazard ratio [aHR] range, 1.2-2.3);
• HF (aHR range, 1.9-4.7);
• AF (aHR range, 1.4-2.4), CHD (aHR range, 1.4-2.9); and
• the composite outcome of events (aHR range, 1.2-2.2).

Findings were similar in a sensitivity analysis including only participants who attended both visits.

A limitation of this study was the loss of study participants to follow-up or death, which may have introduced healthy selection bias.

These data indicated that subclinical VHD was common among the general population as was progression to more severe disease with age. “These findings clarify the burden of VHD in late life and highlight the public health importance of interventions to mitigate VHD progression,” the researchers concluded.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

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Investigators sought to evaluate 2-year clinical outcomes after transcatheter mitral valve replacement (TMVR) among patients enrolled in the MITRAL (Mitral Implantation of Transcatheter Valves; ClinicalTrials.gov Identifier: NCT02370511) trial. The MITRAL trial assessed outcomes in mitral valve-in-valve replacement (MViV), valve-in-mitral annular calcification (ViMAC), and mitral valve-in-ring replacement (MViR). The primary endpoint of the study was mean MV gradient of 10 mm Hg or more and absence of a mitral regurgitation (MR) grade of 2+ or higher at 2 years. The secondary endpoint was all-cause death at 2 years.

The investigators initiated the multicenter prospective study at 13 US sites. Included patients had high surgical risk and severe MAC, prior failed bioprosthetic MV replacement, or prior failed mitral annuloplasty ring repair. Overall, 91 patients were enrolled from February 2015 through December 2017 (30 patients with MViV, 31 ViMAC, 30 MViR).

Patients in the MViV group had a mean age of 76±10 years, 63% were women, 10% used home oxygen, 20% had diabetes, and median left ventricular ejection fraction was 56%. Patients in the ViMAC group had a mean age of 75±8 years, 71% were women, 23% used home oxygen, 39% had diabetes, and median left ventricular ejection fraction was 63%. Patients in the MViR group had a mean age of 72±9 years, 37% were women, 13% used home oxygen, 30% had diabetes, and median left ventricular ejection fraction was 47%.

Two-year all-cause mortality was 6.7% in the MViV group, and 85% of patients were New York Heart Association (NYHA) functional class I to II. Mean MV gradient in this group was 6.9±2.4 mm Hg. Only 1 of the 2 deaths in this group was cardiovascular in etiology. Stroke occurred in 6.7% of patients at 2 years. There was no hospitalization for heart failure between years 1 and 2 of follow-up. There were no cases of endocarditis or valve thrombosis at 2 years.

All-cause mortality was 39.3% in the ViMAC group, and 66.7% of patients were NYHA functional class I to II. Mean MV gradient in this group was 5.6±2.0 mm Hg. Among deaths in this group, 6 of 11 were cardiovascular in etiology. Stroke occurred in 10.7% of patients at 2 years. There were no hospitalizations for heart failure between years 1 and 2 of follow-up. There were no cases of endocarditis and 1 case of prosthetic valve thrombosis at 2 years.

All-cause mortality was 50% in the MViR group. There were 65% of patients who were NYHA functional class I to II, and mean MV gradient in this group was 6.5±2.7 mm Hg. Among deaths in this group, 5 of 30 were cardiovascular in etiology. Stroke occurred in 3.3% of patients at 2 years. There were 27% of patients rehospitalized for heart failure at 2 years.

The investigators noted that all patients had mild mitral regurgitation at 2 years. There was sustained improvement in the Kansas City Cardiomyopathy Questionnaire scores for the survivors in all 3 arms compared with baseline.

Study limitations include the underpowered sample size and lack of randomization and use of a control group. Additionally, there may be survival bias.

“Use of balloon-expandable aortic transcatheter heart valves in selected patients with severe MAC, failed annuloplasty ring, and bioprosthetic MV dysfunction is associated with improvements in symptoms, quality of life, and stable prosthesis function at 2-year follow-up,” the investigators wrote. “The MViR group experienced higher mortality rates between 1 and 2 years compared to the MViV and ViMAC groups.”

Disclosure: This research was supported by Edwards Lifesciences. Some study authors 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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Shuai Yuan, Ph.D., from the Karolinska Institutet in Stockholm, and colleagues examined the associations of sleep duration and daytime napping with PAD risk in a cohort of 53,416 Swedish adults. The analyses were replicated in a case-control study with 28,123 PAD cases and 128,459 controls from the Million Veteran Program (MVP) and in a cohort of 452,028 individuals from the U.K. Biobank (UKB). Causal inference-based analyses of sleep-related traits and PAD were assessed using two-sample Mendelian randomization among 31,307 PAD cases and 211,753 controls.

The researchers identified a U-shaped association between sleep duration and the risk for PAD in observational analyses. Compared with individuals with a sleep duration of seven to less than eight hours per night, the risk for incident PAD was higher in those with short sleep (less than five hours) or long sleep (at least eight hours; hazard ratios, 1.74 and 1.24, respectively). The analyses in the MVP and UKB supported these findings. Positive associations were also identified between daytime napping and PAD (hazard ratio, 1.32) in an observational analysis. An inverse association between sleep duration and PAD (odds ratio, 0.79 per hour increase) and an association between short sleep and increased PAD (odds ratio, 1.20) were supported by a Mendelian randomization analysis.

“More research is needed on how to interrupt the bidirectional link between short sleep and PAD,” Yuan said in a statement. “Lifestyle changes that help people get more sleep, such as being physically active, may lower the risk of developing PAD. For patients with PAD, optimizing pain management could enable them to have a good night’s sleep.”

Abstract/Full Text

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The Trifecta and Trifecta GT valves are heart valve replacement devices designed to treat diseased, damaged, or malfunctioning native or prosthetic aortic heart valves. According to published literature, Trifecta valves appear to be associated with have a higher cumulative incidence of early SVD (5 years or less) and lower freedom from reintervention due to SVD, compared with other commercially available surgical bioprosthetic valves.

Early SVD was also described in medical device reports submitted to the FDA. Peak time to SVD with Trifecta valves was reported to be 3 to 5 years post-implant. Outcomes related to these cases included surgical valve explant/replacement, transcatheter valve-in-valve intervention, and death.

It is recommended that the risks and benefits of all available aortic valve treatment options be discussed with patients prior to surgery. Patients who have received implantation with Trifecta valves should be monitored for signs and symptoms of potential SVD. These patients should also receive lifelong follow-up visits, conducted at least yearly, with a transthoracic echocardiogram assessment beginning 1 year post-implant.

The FDA is evaluating the issue with Abbott and developing additional patient management plans. Health care providers are encouraged to report any adverse events or suspected adverse events with Abbott Trifecta valves to the FDA’s MedWatch program.

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Investigators sought to assess the prevalence of and outcomes in patients with a probable or highly-probable CA diagnosis who subsequently received transcatheter (TAVR) or surgical aortic valve replacement (SAVR). To identify patients with CA, the investigators used echocardiographic “red flags,” defined as the presence of an interventricular septal thickening of 13 mm or more that was associated with at least 1 (probable CA) or 2 (highly-probable CA) of the following criteria: mitral stenosis of less than 6 cm/s, a right ventricular wall thickening of 5 mm or more, a pericardial effusion, or a myocardial granular sparkling.

This retrospective study included 2 cohorts of patients (N=2066; mean age, 74 years; 42% women) with severe AS between 2002 and 2018. Mean follow-up in the TAVR cohort (n=770) was 2.3 years and 2.9 years in the SAVR cohort (n=1296).

The TAVR cohort had 88 patients (11.4%) with probable CA and 67 patients (8.7%) with highly-probable CA. All-cause mortality in this cohort was similar across all groups (probable CA, 35.2%; highly-probable CA, 38.8%; no CA, 33.7%; P =.69).

The SAVR cohort had 167 patients (12.9%) with probable CA and 84 patients (6.5%) with highly-probable CA. All-cause mortality in this cohort was similar across all groups (probable CA, 12.0%; highly-probable CA, 14.3%; no CA, 10.7%; P =.56).

The investigators found no association between suspicion of CA and all-cause mortality in both cohorts, analyzed separately or combined, using Cox regression survival analysis adjusted for covariates.

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Between 2012 and 2019, the National Readmission Database was explored for International Classification of Diseases, Tenth Revision (ICD-10) codes that had been used to identify patients with TAVR. The population obtained was divided into 2 groups, patients with cirrhosis receiving TAVR and patients without cirrhosis receiving TAVR. Chi-square statistics in software Stata v.17 were utilized to evaluate cardiovascular outcomes in both of the cohorts at index admission.

From 2012 to 2019, a total of 308,802 individuals who had received TAVR were identified. Overall, 1.74% of these patients had cirrhosis and 98.3% did not have cirrhosis. The mean patient age was 71.6 years in individuals with cirrhosis and 79.9 years in those without cirrhosis.

Results of the study demonstrated that the prevalence of coagulopathy (55.7%), uncomplicated diabetes (38.4%), fluid and electrolyte disorders (34.5%), and anemia (30.7%) was significantly higher among the group of patients who had received TAVR with cirrhosis compared with those who had received the procedure and did not have cirrhosis (P <.05 for all).  Further, hospital readmission rates at 30 days, 90 days, and 180 days were significantly higher among patients in the TAVR-with-cirrhosis group than in those in the TAVR-without-cirrhosis group (P <.05).

“Outcomes were similar in both TAVR patients with cirrhosis and without cirrhosis,” the study authors wrote. “However, readmission rates were high in TAVR patients with cirrhosis.”

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Investigators sought to assess the influence of psychosocial risk factors on short-term outcomes following SAVR and TAVR in adult patients. Primary endpoints included readmission, 30-day mortality, and composite morbidity (myocardial infarction, new atrial fibrillation, acute kidney injury, bleeding complications, pacemaker implantation, pulmonary embolus, or stroke).

They conducted a nationally representative analysis in the United States using the Nationwide Readmissions Database to identify all adult patients in the database at least 18 years of age who received SAVR (n=74,763) and TAVR (n=87,142) from 2016 to 2018. Patients were stratified as having no psychosocial risk factors or at least 1 psychosocial risk factor. Psychosocial risk factors were defined as low socioeconomic status (SAVR, 22.7%; TAVR, 19.9%), uninsured status (SAVR, 1.7%; TAVR, 0.3%), psychiatric disease (SAVR, 18.1%; TAVR. 13.2%), substance use (SAVR, 14.6%; TAVR, 5.5%), or limited cognitive comprehension (SAVR, 1.0%; TAVR, 4.3%).

The investigators noted that 45.1% of patients in the SAVR group had at least 1 psychosocial risk factor, and 36.4% of patients in the TAVR group had at least 1 psychosocial risk factor. Patients with at least 1 psychosocial risk factor in the SAVR group vs patients with no psychosocial risk factors were more likely to be women (35.0% vs 28.0%; P <.001) and were significantly younger (64.3 vs 67.5 years of age; P <.001). Between these groups, overall comorbidity burden was similar. Patients with at least 1 psychosocial risk factor in the TAVR group showed similar demographics, tending to be younger and women, and they also had similar comorbidity burden between groups.

The investigators found that patients with at least 1 psychosocial risk factor and who received SAVR had significantly higher readmissions vs patients with no psychosocial risk factors (13.1% vs 11.3%; P <.001) and significantly higher 30-day mortality vs patients with no psychosocial risk factors (4.2% vs 3.7%; P =.048). They found no difference in composite morbidity in this study group.

Among patients with at least 1 psychosocial risk factor and who received TAVR, investigators observed a significantly higher 30-day readmission vs patients with no psychosocial risk factors (11.7% vs 10.7%; P =.012). They found no difference in composite morbidity or 30-day mortality in this study group.

Risk-adjusted analysis revealed that psychosocial risk factors were a significant predictor of higher 30-day readmissions in patients who received SAVR (adjusted odds ratio, 1.10; 95% CI, 1.02-1.19).

Study limitations include database billing code inaccuracies and lack of granular clinical or operative details. There are also unaccounted for out-of-hospital events and readmissions out-of-state or across calendar years.

“Together these findings suggest that PSRFs [psychosocial risk factors] are important nontraditional risk factors that contribute to socioeconomic disparities and are important for clinicians to recognize when identifying patients who are at risk for worse postoperative outcomes,” the study authors wrote. “Furthermore, PSRFs should be utilized by the structural heart team as another tool to help guide the decision to proceed with SAVR vs TAVR, as less invasive procedures like TAVR may be beneficial in patients with PSRFs due to its faster and less intensive recovery period, although further research to validate these findings is needed.”

Disclosure: Some study authors 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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Eric M. Isselbacher, M.D., from Massachusetts General Hospital in Boston, and colleagues conducted a comprehensive literature search to develop recommendations on the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease.

The authors note that multidisciplinary aortic team care should be considered in determining the appropriate timing of intervention. To determine the optimal medical, endovascular, and open surgical therapies, shared decision-making involving the patient and multidisciplinary team is encouraged. Shared decision-making is especially important for patients with aortic disease who are contemplating pregnancy or who are pregnant. The threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in selected patients at centers with multidisciplinary aortic teams and experienced surgeons; in specific scenarios among patients with heritable thoracic aortic aneurysms, the threshold can be even lower. Surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to patient body surface area or height, or the aortic cross-sectional area to patient height in patients who are significantly shorter or taller than average.

“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” Isselbacher said in a statement.

Several authors disclosed financial ties to the biopharmaceutical and health care industries.

Abstract/Full Text

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Investigators from the University of Pittsburgh Medical Center in the United States aimed to evaluate whether household income affected risk for readmission following TAVR. Data for this study were sourced from the Nationwide Readmissions Database collected between 2012 and 2018.

The study population comprised 208,363 individuals. Stratified by household income quartiles, 42,679 were in the lowest 25^th percentile, 56,084 in the 26^th to 50^th percentile, 56,843 in the 51^st to 75^th percentile, and 52,757 in the highest 25^th percentile. Patient cohorts were aged median 81 to 83 years and 45.2% to 47.4% were women. Stratified by household income quartile, the groups differed significantly by age, discharge location, insurance type, and all comorbidities except cerebral vascular disease (all P <.001).

At 30 days, the readmission rate was 17.9% and associated mortality rate was 2.7%.

Risk for 30-day readmission was not associated with the lowest quartile (odds ratio [OR], 1.03; 95% CI, 0.98-1.08; P =.17), the 26^th to 50^th percentile (OR, 1.02; 95% CI, 0.97-1.06; P =.35), or the 51^st to 75^th percentile (OR, 1.01, 95% CI, 0.97-1.05; P =.53) compared with the highest quartile.

Risk for 30-day readmission was associated with discharge to a short-term hospital (OR, 2.1; 95% CI, 1.7-2.5; P <.001); discharge to a skilled nursing facility, intermediate care facility, or other type of facility (OR, 1.7; 95% CI, 1.6-1.8; P <.001); discharge to home health care (OR, 1.4; 95% CI, 1.3-1.4; P <.001); chronic kidney disease (OR, 1.33; 95% CI, 1.29-1.38; P <.001); congestive heart failure (OR, 1.23; 95% CI, 1.01-1.51; P <.001); chronic obstructive pulmonary disease (OR, 1.17; 95% CI, 1.13-1.22; P <.001); diabetes (OR, 1.06; 95% CI, 1.02-1.11; P =.002); or hypertension (OR, 0.87; 95% CI, 0.84-0.91; P =.01).

This study did not find a relationship between socioeconomic status, defined by median household income, and risk for readmission following TAVR. Discharge location and preexisting comorbidities were significant predictors for readmission risk.

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Among the many products comprising the booming dietary supplement industry, a growing number of individuals are turning to supplements and drinks containing caffeine and other compounds purported to increase energy. According to some reports, the energy drink market in the United States reached more than $9.7 billion in sales in 2015.¹ While many use these supplements with the aim of reducing fatigue and improving mental focus, people often seek to improve athletic performance by consuming such products.

However, experts have cautioned that, despite their popularity, caffeine-based products and other types of energy-boosting supplements could have adverse effects, especially on cardiovascular health. Because of these risks, the World Health Organization has cited consumption of energy drinks as a significant public health issue.²

While most of these risks are associated with the high levels of caffeine contained in these products, other common ingredients intended to increase energy include taurine, guarana, ginseng, glucuronolactone, and bitter orange.³ In a 2022 position statement, the European Association of Preventive Cardiology notedthat consumption of a formulation containing caffeine, taurine, and glucuronolactone “may increase arterial blood pressure, act as a platelet aggregation enhancing factor and compromise endothelial function in healthy individuals.”³

The authors point to a range of cardiovascular side effects linked to consumption of energy drinks, including coronary disease, heart failure, cardiac arrhythmias, ventricular tachycardia, and aortic dissection, among numerous other potential cardiovascular consequences.³

In addition, in a randomized, double-blind, placebo-controlled trial published in 2019, Shah et al examined the effects of 2 different energy drinks on cardiovascular parameters compared to placebo.⁴ The results showed that that consumption of the energy drinks significantly prolonged participants’ QTc interval (maximum change from baseline in Bazett’s corrected QT interval: +17.9±13.9 ms for drink A, +19.6±15.8 ms for drink B, and +11.9±11.1 ms with placebo; P =.005 for ANOVA; P =.04 and P <.01, respectively, compared to placebo).

Significant increases in peripheral and central systolic and diastolic blood pressure were also observed with the energy drinks compared to placebo (all P <.001).

These risks may be especially elevated among individuals with underlying heart conditions. A 2017 study found that the risk of cardiac arrest increased by 20% in individuals with familial long QT syndrome after drinking 2 cans of an energy drink.³

Along with the cardiovascular hazards associated with these drinks and other energy supplements in general, consuming them before exercise can further compound the risks as cardiovascular demands increase with physical activity. For example, some findings suggest that intake of 200-300 mg of caffeine 1 hour prior to aerobic exercise decreased endothelial cell function in healthy individuals, as indicated by reductions in myocardial blood flow.⁵

To gauge clinician views on the potential cardiovascular risks of consuming caffeine and other energy supplements before exercise, Cardiology Advisor checked in with Gregory M Marcus, MD, MAS, professor of medicine in residence and associate chief of cardiology for research at the University of California, San Francisco, School of Medicine, and  Jeffrey J. Hsu, MD, PhD, assistant clinical professor of medicine in the division of cardiology at the University of California, Los Angeles, School of Medicine.

What is known thus far about the cardiovascular effects of supplements such as energy drinks containing caffeine or other substances before exercising? 

Dr Marcus: The great majority of research in this area has been conducted in artificial environments using small numbers of research participants and usually examining 1 brief moment in time rather than repeated assessments.⁶ Although the data there are conflicting, there is some evidence that caffeine may help bolster athletic performance. However, these studies have generally not been designed to assess the safety of this practice nor longer-term consequences beyond mainly a single workout.

It’s important to emphasize that the possible health benefits of caffeine that have been recently highlighted in the medical literature and lay press stem from large observational studies of predominately regular coffee drinkers rather than the use of high doses of caffeine or caffeine supplements specifically before exercise.⁷

Dr Hsu: Caffeine is a common ingredient in most energy drinks, including those taken prior to exercise. While caffeine in moderate amounts – the equivalent of 2 to 4 cups of coffee – may help to improve endurance, the concern is that higher doses of caffeine may increase the risk of adverse cardiovascular effects, including arrhythmias and severe hypertension, particularly when combined with high-intensity exercise. 

Have you observed any effects related to these drinks or supplements in your own patients?

Dr Hsu: Yes, it is increasingly common for athletes – both at the recreational and elite levels – to use caffeinated “pre-workout” supplements during their training, and I have seen young athletes present with symptoms related to arrhythmias or ectopy. These often improve or completely resolve with cessation of these supplements. 

How should clinicians advise patients regarding the use of these supplements in the context of exercise?

Dr Marcus: While clinicians should, of course, encourage regular exercise, they should likely caution their patients against using supplements or energy drinks to facilitate workouts. There is no strong evidence of clinical benefit and some observational data to demonstrate harm.

These energy drinks may include other constituents, including sugar, that are overall detrimental to health. I generally recommend avoiding supplements, as the concentrations of molecules tends to exceed those in natural foods that our bodies have evolved to consume.

In general, large randomized trials of supplements tend to show either no benefit or harm to health, often with unintended adverse consequences.⁷ For example, while observational studies suggest that caffeine as can be found in commonly consumed beverages like coffee does not have a meaningful negative effect on heart rhythm disturbances and may even protect against some common heart rhythm problems, there are many case reports of young, otherwise healthy individuals experiencing clinically significant heart rhythm disturbances in the context of consuming energy drinks with high levels of caffeine.⁸

Dr Hsu: Clinicians who care for athletes should inquire about supplement use during clinic visits. Clinicians should counsel their patients that there is no “magic bullet” for optimizing their cardiovascular fitness or athletic performance, and athletes should carefully review the components of any exercise supplement they plan to consume. Those who have a history of cardiovascular disease such as arrhythmias, hypertension, or cardiomyopathy should take extra caution and review supplements with their physician prior to use. 

What are the most pressing remaining research needs regarding this topic?

Dr Marcus: Long-term investigations examining actual health-related outcomes beyond simply immediate physical performance are needed to inform clinicians and, in turn, help us to provide the most beneficial guidance to our patients.

Dr Hsu: In my opinion, with the widespread use and marketing of these exercise supplements, we need a better understanding of whether we are clearly seeing adverse cardiovascular effects in people who use these supplements. My concern is that there is little regulation of how these supplements are marketed, and combining high doses of caffeine or other stimulants with vigorous exercise may carry undue cardiovascular risk. 

References

1. Al-Shaar L, Vercammen K, Lu C, Richardson S, Tamez M, Mattei J. Health effects and public health concerns of energy drink consumption in the United States: a mini-review. Front Public Health. 2017;5:225. doi:10.3389/fpubh.2017.00225
2. Breda JJ, Whiting SH, Encarnação R, et al. Energy drink consumption in Europe: a review of the risks, adverse health effects, and policy options to respond. Front Public Health. Published online October 14, 2014. doi:10.3389/fpubh.2014.00134
3. Adami PE, Koutlianos N, Baggish A, et al. Cardiovascular effects of doping substances, commonly prescribed medications and ergogenic aids in relation to sports: a position statement of the sport cardiology and exercise nucleus of the European Association of Preventive Cardiology. Eur J Prev Cardiol. Published online January 27, 2022. doi:10.1093/eurjpc/zwab198
4. Shah SA, Szeto AH, Farewell R, et al. Impact of high volume energy drink consumption on electrocardiographic and blood pressure parameters: a randomized trial. J Am Heart Assoc. Published online May 29, 2019. doi:10.1161/JAHA.118.011318
5. Planning Committee for a Workshop on Potential Health Hazards Associated with Consumption of Caffeine in Food and Dietary Supplements; Food and Nutrition Board; Board on Health Sciences Policy; Institute of Medicine. Caffeine in food and dietary supplements: examining safety: workshop summary. Washington (DC): National Academies Press (US). 2014(5): Caffeine Effects on the Cardiovascular System. 
6. Cameron M, Camic CL, Doberstein S, Erickson JL, Jagim AR. The acute effects of a multi-ingredient pre-workout supplement on resting energy expenditure and exercise performance in recreationally active females. J Int Soc Sports Nutr. 2018;15:1. doi:10.1186/s12970-017-0206-7
7. Poole R, Kennedy OJ, Roderick P, Fallowfield JA, Hayes PC, Parkes J. Coffee consumption and health: umbrella review of meta-analyses of multiple health outcomes. BMJ. Published online November 21, 2017. doi:10.1136/bmj.j5024
8. Mandilaras G, Li P, Dalla-Pozza R, Haas NA, Oberhoffer FS. Energy drinks and their acute effects on heart rhythm and electrocardiographic time intervals in healthy children and teenagers: a randomized trial. Cells. 2022;11(3):498. doi:10.3390/cells11030498

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When the United States (US) Supreme Court overturned the Roe v Wade decision in June 2022, proponents of reproductive choice warned of the wide range of adverse consequences that may result from the decision to end federal protection of abortion access. In addition to the anticipated impact of abortion restrictions on the general population, many medical experts and patient advocacy groups have emphasized the potential dire effects of such restrictions on certain patient populations including those with chronic diseases and disabilities.^1,2

Certain cardiovascular diseases (CVDs), for example, are associated with increased risk for morbidity and mortality in pregnancy.³ Recent findings from the US Centers for Disease Control and Prevention show that cardiac conditions represent the leading cause of maternal mortality, accounting for more than one-third of pregnancy-related deaths.⁴ Thus, it is important that individuals with these conditions retain the option to terminate a pregnancy if it poses risks to the patient.

“Patients with heart disease, including congenital heart disease (CHD), often face increased risks to their health during pregnancy,” said Dr Joseph M Truglio, MD, MPH, assistant professor of medicine, pediatrics, and medical education at the Icahn School of Medicine at Mount Sinai in New York City. “For some, a pregnancy may be life-threatening, while others may be at high risk for complex fetal heart conditions.”

Dr Ali N. Zaidi, MD, associate professor of medicine and pediatrics and director of the Adult Congenital Heart Disease Center at Mount Sinai, noted that an estimated 1% of all live newborns have CHD, and more than 90% of these individuals now reach adulthood.⁵ “This leads to a considerable number of women of childbearing age who have CHD, including those with moderate and severely complex CHD.” An earlier population-based study based in Quebec, Canada, found that the prevalence of severe CHD among adults increased between 1985 and 2000, with a predominance of such cases observed among women.⁶

“As physicians, our primary job remains to the welfare and safety of all our patients, including women with CHD who are already at high risk of adverse maternal outcomes during pregnancy,” Dr Zaidi said. The overturning of Roe v Wade “makes it much harder to safeguard a pregnant woman’s health, especially those with complex CHD.”

The Supreme Court’s ruling “represents a catastrophic barrier to evidence-based care for patients with CHD and other cardiovascular diseases – particularly those from marginalized groups and racialized communities, who already experience marked maternal-fetal health inequities,” Dr Truglio stated. He emphasized that clinicians must continue to heed their ethical obligations to patients and advises that clinicians stay abreast of abortion laws in each state as well as resources for locating abortion providers. He points to resources such as the Abortion Finder and the Planned Parenthood abortion access tool.

For additional discussion regarding the implications of increasing abortion restrictions on these patient groups, we interviewed Dr Monica V. Dragoman, MD, MPH, assistant professor and system director of the complex family planning division in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai; and Dr Linda Cassar, DNP, RNC-OB, CNE, clinical associate professor and program director of the Accelerated BSN program at the George Washington University School of Nursing in Washington, DC.

Regarding the recent Supreme Court decision to overturn Roe v Wade, what are the potential effects of lack of abortion access on patients with CHD and other cardiovascular diseases?

Dr Dragoman: The prevalence of cardiac disease is on the rise among reproductive-age women.⁷ Increasing rates of acquired disease can be linked to increasing rates of obesity, diabetes, and increasing maternal age, while increasing rates of maternal CHD can be attributed to advancements in treatment – allowing women to live longer and start families. 

All women face challenges avoiding unintended pregnancy and planning their families if and when they choose. The stakes can certainly be higher for women living with CVD, especially for those in whom pregnancy can present potentially life-threatening health risks. Restricting access to abortion, an essential health care intervention, is bad for all women’s health. Restricting access to abortion in the context of caring for a person with CVD amplifies impacts in the general population; it exacerbates jeopardy to their life and health, the life and health of their pregnancy, as well as their current or potential future families.

Dr Cassar: Physiologic changes during pregnancy cause significant stress on the heart. Blood volume will increase by approximately 1,500 mL by the end of pregnancy, heart rate will increase by 25%, and cardiac output increases by 30 to 50%, peaking at about 25 weeks of gestation.⁸ Women without cardiac disease, and even some with lower risk cardiac diseases, can compensate for these changes and have relatively healthy pregnancies with positive outcomes.

For those with certain congenital cardiac complications or those with severely limiting acquired cardiac conditions, pregnancy should be avoided, as the risk of maternal morbidity and mortality can be significant. The World Health Organization (WHO) has classified cardiac disorders into 4 risk classifications.⁹ Risk Class 1 patients have no detectable increase in the risk of complications from their cardiac conditions, and the risk increases with each class up to Risk Class 4.

These are patients for whom pregnancy is contraindicated and termination of pregnancy is recommended due to the increased likelihood of severe maternal morbidity and high probability of maternal mortality. According to the CDC, from 2016 to 2018, cardiac conditions (cardiomyopathy, hypertensive disorders, and other cardiovascular complications) accounted for 35.5% of all maternal deaths.⁴

What are the implications specific to your institution, and how is your facility planning to prepare for and address these issues?

Dr Dragoman: We are privileged to live in a state that values bodily autonomy and honors that health care decisions are best made in partnership between patients and their doctors. New York is currently positioned to offer sanctuary for those who have the means to receive care in our state during this evolving medical crisis. 

Unfortunately, we are already dealing with a national epidemic of maternal mortality that disproportionately affects communities of color. According to the Kaiser Family Foundation, 43% of women ages 18-49 living in states where abortion has been banned or likely will be banned are women of color.¹⁰ These women will face higher barriers to accessing abortion care in other states due to less access to financial resources for services, travel, and other logistical needs, exacerbating disparities in maternal morbidity and mortality. People of color also carry a disproportionate burden of CVD. These harmful bans will hurt a lot of people who are unable to access essential reproductive health care services, including abortion.

Mount Sinai’s OB/GYN department is home to world-class experts in complex family planning who work with patients with complex medical conditions to create individualized contraceptive management plans. Some goals include reducing the likelihood of unintended pregnancy and helping patients time any pregnancies to when their conditions are stable or optimized.

For patients who decide not to continue a pregnancy and for whom pregnancy presents an unacceptable health risk in the context of their condition, we offer pregnancy termination. Patients also work with maternal-fetal medicine specialists who provide care during high-risk pregnancies to support the best health outcomes for moms and babies.

How might the ruling on Roe v Wade affect medical education and future generations of clinicians?

Dr Cassar: In higher education, abortion restrictions will impact the way that the curriculum is developed and presented in health education programs, including medical schools, nursing schools, physician assistant programs, and surgical tech training, just to name a few. In states where abortion is not permitted, appropriate training will not be provided to practitioners who would traditionally be providing this type of care.

These clinicians will move into practice unprepared to care for patients who need an abortion or may be suffering from the complications of one performed incorrectly. This does not just impact practitioners in an OB/GYN setting. It will have a ripple effect to emergency rooms, operating rooms, intensive care units, and primary care settings. 

What are your recommendations for other clinicians in terms of providing optimal care and support to these patients in the context of tightened abortion restrictions?

Dr Dragoman: As a first step, it is important for clinicians caring for patients living with CVD to find out if they have a local complex family planning specialist to confer with regarding contraceptive management, pregnancy planning, and pregnancy termination. Complex Family Planning was just recognized by the American Board of Obstetrics and Gynecology as an official subspecialty in 2020, but fellowship training to cultivate physicians with this expertise has existed since the mid-1990s.  

In addition, there are evidence-based guidelines produced by the US Centers for Disease Control and Prevention, the Medical Eligibility Criteria for Contraceptive Use, that offer recommendations on which contraceptive methods a given patient may be eligible to use safely.¹¹ It is important that patients, especially those living with CVD and other medical conditions, are aware of the full range of effective contraceptive options available to best support decision-making and pregnancy planning.

If you live in a state with restrictions on abortion, make sure you are also clear on the limits of the law and whether or not there are health exceptions to accessing the procedure. Support your institution to provide safe and legal services to the full extent possible in your context. Be aware of resources available to connect patients to out-of-state services when necessary. In addition to the Abortion Finder, there is a national network of abortion funds that can assist patients with financial and logistical support, especially with out-of-state care seeking.

Dr Cassar: All patients, but especially those with preexisting cardiac conditions, should receive preconception counseling to ensure an optimal state of health and assess the risks of pregnancy before moving ahead with any plans to conceive. For patients with lower risk cardiac conditions, there will likely be limited, if any restrictions on pregnancy, and their counseling may be as simple as ensuring optimal management of their disease prior to pregnancy and having more frequent doctor visits during the pregnancy to assess the health of the patient and fetus.

Patients with certain congenital cardiac anomalies or higher risk acquired cardiac disease will likely be counseled not to become pregnant, and reliable birth control methods should be discussed. In case of unintended pregnancy for these higher risk patients, a plan should be in place for how to proceed with the option that is safest for the patient and does not violate any laws for their state of residence.

What broader measures are needed to protect patients with CVD and other disabilities in light of the new restrictions? 

Dr Dragoman: Abortion is essential health care. Patients don’t come to us with a political agenda when they are facing a pregnancy crisis – they need help. All clinicians involved in caring for reproductive-age people capable of pregnancy have a stake in reversing these harmful policies restricting comprehensive reproductive health care. Physicians and other clinicians have an important role to play in advocating for necessary policy change.

Dr Cassar: The easiest option here is to amend the laws and allow practitioners to provide abortions to women who are medically in need of them – this would be the most ethical thing for states to do. Unfortunately, this may be a long and arduous uphill battle. In the absence of changes in the laws to allow this, networking between providers will be critical to optimize maternal health and outcomes. Developing networks of resources and practitioners to supplement the care that is allowed to be provided in states with severe restrictions or bans on abortion will be essential to having good outcomes for mothers with preexisting cardiac or other chronic conditions.

References

1. Harris LH. Navigating loss of abortion services – a large academic medical center prepares for the overturn of Roe v. Wade. N Engl J Med. Published online June 2, 2022. doi:10.1056/NEJMp2206246
2. Adams C. Disability rights groups say it’s time to abolish the ableism that dominates abortion activism. NBC News. Published July 21, 2022. Accessed August 14, 2022.
3. Neale T. As US abortion protections are lost, cardiologists brace for impact. TCTMD. Published online June 24, 2022. Accessed August 14, 2022.
4. US Centers for Disease Control and Prevention. Pregnancy mortality surveillance system. Accessed August 14, 2022.
5. Müller MJ, Norozi K, Caroline J, et al. Morbidity and mortality in adults with congenital heart defects in the third and fourth life decade. Clin Res Cardiol. Published online March 1, 2022. doi:10.1007/s00392-022-01989-1
6. Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. Published online January 8, 2007. doi:10.1161/CIRCULATIONAHA.106.627224
7. Lindley KJ, Bairey Merz CN, Davis MB, Madden T, Park K, Bello NA; American College of Cardiology Cardiovascular Disease in Women Committee and the Cardio-Obstetrics Work Group. Contraception and reproductive planning for women with cardiovascular disease: JACC Focus Seminar 5/5. J Am Coll Cardiol. Published online April 5, 2021. doi:10.1016/j.jacc.2021.02.025
8. Ricci SS. Essentials of maternity, newborn, and women’s health nursing. 5^th edition. LWW; 2020.
9. American College of Obstetricians and Gynecologists’ Presidential Task Force on Pregnancy and Heart Disease and Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 212: pregnancy and heart disease. Obstet Gynecol. 2019;133(5):e320-e356. doi:10.1097/AOG.0000000000003243
10. Artiga S, Hill L, Ranii U, Gomez I. What are the implications of the overturning of Roe v. Wade for racial disparities? Published July 15, 2022. Accessed August 14, 2022.
11. US Centers for Disease Control and Prevention. US medical eligibility criteria (US MEC) for contraceptive use, 2016. Accessed August 14, 2022.

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The health of Americans has improved significantly over the past 50 years, as evidenced by an increased lifespan and lower infant and adult mortality rates. However, Black Americans and other racial/ethnic minority groups are still at greater risk for early mortality and morbidity from a range of chronic health conditions such as diabetes, hypertension, obesity, asthma, and heart disease compared with White Americans.^1,2 Evidence suggests that these health disparities stem from structural racism, as well as provider implicit bias or unconscious bias, that factors into judgments and influences clinical decision-making.¹

Moreover, these health disparities cannot be accounted for by socioeconomic factors alone. The COVID-19 pandemic further underscored these health disparities, as minority populations were disproportionately affected by the illness in the first 2 years of the pandemic.¹

Health Disparity: Part of American History

Prior to the Civil War, physicians, scientists, and slave owners perpetuated beliefs in the physical dissimilarities between Black and White populations as a way to justify slavery.³ These beliefs are still held today. A 2016 survey found that almost 50% of White medical students and residents admitted to false beliefs regarding biologic variances between White and Black patients.⁴

It is crucial to understand racial inequalities in medical treatment. The term “racism” refers to a system based on a discriminative mentality that classifies and ranks the human population in stereotypical ways and allocates societal resources accordingly (Table 1).^5,6 At the individual level, this may or may not be accompanied by bias, whether conscious or unconscious. These untrue opinions may influence medical decisions and contribute to racial disparities in health-related outcomes.^3-4

Table 1. Definitions^5,6

Distrust of the medical profession by Black patients can be traced back to when Black individuals were used for experimental procedures, surgeries, and dissections. For example, in the 1800s, James Marion Sims, MD, known as the “father of modern gynecology,” performed gynecologic surgical procedures on unanesthetized Black women.⁵ More recently, the Tuskegee Syphilis Study has contributed to fear and mistrust among patients and vestiges of the belief that Black people are less than human, which is still rooted in America today.⁷

Distrust of medical professionals, false beliefs, social disadvantages, clinician bias, and a discriminative health care system all contribute to ethnic and racial disparities. According to Fiscella and Sanders, “Separate and unequal systems of health care between states, between health care systems, and between clinicians constrain the resources that are available to meet the needs of disadvantaged groups, contribute to unequal outcomes, and reinforce implicit bias.”⁸

To counter implicit and unconscious bias, initiatives beyond diversity and cultural competency training are needed. PAs and nurse practitioners (NPs) can positively impact disparities by building trust and respect while promoting equity and justice in the health care system. Medical students, including PA and nursing students, should be offered courses that promote cultural awareness in patient care and help to develop vital communication and clinical skills related to reducing negative associations, which can affect judgment and behavior.⁹

Health Disparities Related to Implicit Bias

Implicit bias refers to an individual’s unconscious or conscious perceptions, stereotypes, and beliefs of others. Subconscious beliefs can cause one to speak or act in ways contrary to their conscious principles. These biases can be positive or negative and may raise serious concerns in health care. The implicit bias of health care providers can adversely affect their medical decision-making, severely impacting an already underprivileged population.¹⁰

Maina et al found that 8 of 14 studies (57%) that explored the relationship between implicit bias and health care outcomes using clinical scenarios or simulated patients found no statistically significant relationship between implicit bias and patient care.¹⁰ However, 6 studies found that higher implicit bias was correlated with disparities in treatment recommendations, expectations of therapeutic bonds, pain management, and empathy. Half of the studies examined the impact of implicit provider bias on real-world, patient-provider interaction and found that providers with more pronounced implicit bias demonstrated poorer patient-provider communication.¹⁰

A provider’s ability to empathize with a patient can enhance their ability to deliver high-quality and competent care. A positive interaction between clinicians and patients can influence the likelihood of a patient adhering to medical treatments. It also helps these patients understand and participate in their care. However, Roberts et al found that patients with low socioeconomic status rated their clinicians’ empathy scores as lower than those reported by patients not of low socioeconomic status (mean difference, -0.87 [95% CI, -1.72 to -0.02]).¹¹

Moreover, race or ethnicity is also factored into some of the strategies and calculations applied by practitioners when administering treatment and medications. As a result of this implicit bias, Black patients may be less likely to receive specific medicines, transplants, and specialist referrals. For example, study findings show that minorities are less likely to be prescribed pain relief medications by doctors. Specifically, an analysis of data from 350 emergency departments in the US found that non-White patients were 22% to 30% less likely to receive analgesic medication and 17% to 30% less likely to receive opioids compared to their White counterparts.¹²

Another trickle-down effect of implicit bias is that a health care provider might not issue a referral for an uninsured patient to a specialty clinic if there is no system of care for uninsured patients in the local community. In addition, a patient may not visit a specialist if the clinic is too far away from their home or if the out-of-pocket costs are too high. Also, minority populations often have limited access to health care, particularly preventative care, early intervention, and effective management of chronic illness, which play a fundamental role in optimal health-related outcomes. As a result, disparities in the quality and quantity of treatment among different racial and ethnic groups contribute to racial health disparities.

Even among minority patients who do have access to health care, the quality of that care is decreased compared with that among White patients. The 2021 National Healthcare Quality and Disparities Report found worse quality of care among Black vs White patients for 11 out of 29 (38%) patient safety measures, 18 out of 43 (42%) effectiveness of care measures, and 32 out of 72 (44%) healthy living measures (Table 2).¹³

Table 2. Measures With Worse Outcomes for Black Patients

An illustration of health disparity is the disproportionate effects of the COVID-19 pandemic on racial and ethnic minority communities during the early stages of the pandemic when the death rate for Black Americans was almost 2-fold higher than that for White Americans (Figure).^14,15 The death rate among Latino populations was also higher than that for White individuals. The pandemic also showed the effects that concerted outreach efforts can have on balancing out health disparities as this statistic has changed and White Americans now have a 14% higher COVID-19 death rate compared with Black Americans and a 72% higher rate than that among Latino Americas, according to the latest data from the Centers for Disease Control and Prevention. Among the successful outreach efforts were those that lead to an increase in vaccination rates over the 18 months.

Another recent correction of implicit bias in health care is the removal of race from the calculation of estimated glomerular filtration rate (eGFR) recommended by the National Kidney Foundation (NKF)–American Society of Nephrology (ASN) Task Force in 2021.¹⁶ The inclusion of race in eGFR estimations has been linked to disparities in care such as delays in kidney disease diagnosis and the eligibility for kidney transplantation.¹⁷

Thus, negative biases toward marginalized groups give rise to social disadvantages and imbalances and, in some cases, poor health outcomes. Health care disparities signify the failure of this system at many levels. However, change can be made.

What Can Providers Do?

With the knowledge that unconscious bias exists, measuring and mitigating its effect is a new area of focus that is needed for health care professionals.¹⁸ Amazon, Microsoft, and Zillow have announced plans and initiatives to increase Black representation in their boardrooms and CEO positions.¹⁹ In health care, more than “just” diversity training and cultural competency training is needed — organizations like DNPs of Color are calling for more people of color in the C-suites of hospitals and health care systems. Similar to Fortune 500 companies, health care providers need to modernize their approach to understanding cultures that they are not familiar with. Individual strategies of reflection, mentorship, and sponsorship initiatives as well as a commitment to cultural awareness and humility are some of the proposed calls to action.²⁰ In medicine, it is so easy to link a specific behavior or disease pattern to a specific racial/ethnic group and this may lead to negative attitudes toward certain minority populations. Clinicians must commit to the normalcy of treating all patients equally.

Research suggests that biased behaviors increase during medical education in part because of biases shown by professors that are picked up by medical/nursing students.²¹ Medical education is also missing the mark in terms of representation of diverse patients in core medical courses. The Mayo Clinic has targeted bias in medical education by studying the environment and training provided in 49 medical schools in the US and the change in student attitudes and values over time.²² As noted previously, positive interaction with health care providers can improve patients’ attitudes surrounding their medical care and improve communication, trust, and knowledge. Learning to connect with patients by understanding their perspectives begins in the classroom. Through the development of practical and tangible clinical skills and learning exercises, students can practice vital communication skills before using these skills in clinical settings with patients.²³ This type of training may be provided annually instead of as a one-time workshop. In addition to promoting clinicians’ awareness of implicit biases, training also can offer strategies to reduce associations and even control the influence of such associations on judgment and behavior.

For practicing clinicians, the American Medical Association (AMA) and the American Academy of Family Practice (AAFP) have developed strategies for clinicians to address possible bias. These include debiasing techniques through training, taking the perspective of others, emotional expression, counter stereotypical exemplars, and intergroup contact.^24,25

Conclusion

Despite significant advances in the diagnosis and treatment of medical conditions, Black Americans and other minority groups, on average, tend to receive lower-quality health care and have greater morbidity and mortality rates compared with White Americans. This is primarily because of the long-term effects of racism regardless of one’s socioeconomic status. Health disparities can be reversed; however, it will require authentic commitment to remove racial bias and improve training from medical/nursing school through practice.

Recently, the attitudes and biases of health care professionals toward disadvantaged groups have become the focus of research. As the United States becomes more diverse, racial bias and discrimination may increase as well; thus, continued research on implicit bias is required. All providers should be aware of their bias when providing care to patients as this can affect patient outcomes. Mitigating personal bias and improving clinician perceptions are self-directed pursuits and require reflection and commitment to counter stereotypes.

Resources

Leah D. Moss, PA-C, DMSc, MSPAS, is a Navy physician assistant.

References

1. Racism and health. Centers for Disease Control and Prevention. Updated November 24, 2021. Accessed June 15, 2022. https://www.cdc.gov/healthequity/racism-disparities/index.html
2. Kochanek KD, Anderson RN, Arias E. Leading causes of death contributing to decrease in life expectancy gap between black and white populations: United States, 1999-2013. NCHS Data Brief. 2015;(218):1-8.
3. American medicine was built on the backs of slaves. and it still affects how doctors treat patients today. The Washington Post. June 4, 2021. Accessed June 15, 2021. https://www.washingtonpost.com/news/made-by-history/wp/2018/06/04/american-medicine-was-built-on-the-backs-of-slaves-and-it-still-affects-how-doctors-treat-patients-today/
4. (old 4) Hoffman KM, Trawalter S, Axt JR, Oliver MN. Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites. Proc Natl Acad Sci U S A. 2016;113(16):4296-301. doi:10.1073/pnas.1516047113
5. Merriam-Webster’s Collegiate Dictionary. 11th ed. Merriam-Webster Inc; 2003. [continuously updated] https://merriam-webster.com
6. Social justice guide. Howard University School of Law. Accessed June 21, 2022. https://library.law.howard.edu/socialjustice/disparity
7. Thomas SB, Casper E. The burdens of race and history on black people’s health 400 years after Jamestown. Am J Public Health. 2019;109(10):1346-1347. doi:10.2105/AJPH.2019.305290
8. Fiscella K, Sanders MR. Racial and ethnic disparities in the quality of health care. Annu Rev Public Health. 2016;37:375–394. doi:10.1146/annurev-publhealth-032315-021439
9. Dehon E, Weiss N, Jones J, Faulconer W, Hinton E, Sterling S. A systematic review of the impact of physician implicit racial bias on clinical decision making. Acad Emerg Med. 2017;24(8):895-904. doi:10.1111/acem.13214
10. Maina IW, Belton TD, Ginzberg S, Singh A, Johnson TJ. A decade of studying implicit racial/ethnic bias in healthcare providers using the implicit association test. Soc Sci Med. 2018;199:219-229. doi:10.1016/j.socscimed.2017.05.009
11. Roberts BW, Puri NK, Trzeciak CJ, Mazzarelli AJ, Trzeciak S. Socioeconomic, racial and ethnic differences in patient experience of clinician empathy: Results of a systematic review and meta-analysis. PLoS One. 2021;16(3):e0247259. doi:10.1371/journal.pone.0247259
12. Shah AA, Zogg CK, Zafar SN, et al. Analgesic access for acute abdominal pain in the emergency department among racial/ethnic minority patients: a nationwide examination. Med Care. 2015;53(12):1000-1009. doi:10.1097/MLR.0000000000000444
13. 2021 National Healthcare Quality and Disparities Report. Agency for Healthcare Research and Quality. Updated January 2022. Accessed June 21, 2022. https://www.ahrq.gov/research/findings/nhqrdr/nhqdr21/index.html
14. COVID-19 weekly cases and deaths per 100,000 population by age, race/ethnicity, and sex. Centers for Disease Control and Prevention. Accessed June 13, 2022. https://covid.cdc.gov/covid-data-tracker/#demographicsovertime
15. Leonhardt D. Covid and race. New York Times. June 9, 2022. Accessed June 13, 2022. https://www.nytimes.com/2022/06/09/briefing/covid-race-deaths-america.html
16. Delgado C, Baweja M, Crews DC, et al. A unifying approach for GFR estimation: recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. Am J Kidney Dis. 2022;79(2):268-288.e1. doi:10.1053/j.ajkd.2021.08.003
17. Eneanya ND, Yang W, Reese PP. Reconsidering the consequences of using race to estimate kidney function. JAMA. 2019;322(2):113-114. doi:10.1001/jama.2019.5774
18. Blair IV, Steiner JF, Havranek EP. Unconscious (implicit) bias and health disparities: where do we go from here? Perm J. 2011 Spring;15(2):71-78.
19. Amazon, Microsoft, and Zillow are backing an initiative to increase black representation on corporate boards. CNN. October 7, 2021. Accessed June 15, 2021. https://edition.cnn.com/2021/06/03/investing/corporate-diversity-black-boardroom-initiative/index.html
20. Kerner J, McCoy B, Gilbo N, Colavita M, Kim M, Zaval L, Rotter M. Racial disparity in the clinical risk assessment. Community Ment Health J. 2020;56(4):586-591. doi:10.1007/s10597-019-00516-3
21. Nolen L. How medical education is missing the bull’s-eye. N Engl J Med. 2020 25;382(26):2489-2491. doi:10.1056/NEJMp1915891
22. Targeting unconscious bias in health care. Mayo Clinic News Network. April 21, 2015. Accessed June 15, 2022. https://newsnetwork.mayoclinic.org/discussion/targeting-unconscious-bias-in-health-care/
23. Zestcott CA, Blair IV, Stone J. Examining the presence, consequences, and reduction of implicit bias in health care: a narrative review. Group Process Intergroup Relat. 2016;19(4):528-542. doi:10.1177/1368430216642029
24. Implicit bias. American Academy of Family Physicians. Accessed June 6, 2022. https://www.aafp.org/about/policies/all/implicit-bias.html
25. Health equity education center. American Medical Association. Accessed June 6, 2022. https://edhub.ama-assn.org/health-equity-ed-center

The post Provider Implicit Bias: Bringing Awareness to Clinical Practice appeared first on The Cardiology Advisor.

Despite an overall reduction in the incidence of myocardial infarction (MI) and associated mortality in the general population, a growing body of research suggests increasing MI rates and worsening outcomes among individuals younger than 55 years.^1,2 To elucidate these trends, numerous studies have focused specifically on the reported sex-based disparities in MI risk factors and outcomes in this patient population. 

“Myocardial infarction rates are going up in young women, and cardiovascular mortality is no longer improving in young people in the United States,” Viola Vaccarino, MD, PhD, said in an interview with Cardiology Advisor. Dr Vaccarino is the Wilton Looney 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. She published a paper on the increasing acute MI (AMI) rates among young women in a 2019 issue of Circulation.³ 

Study Highlights

A 2019 study analyzed data from the Atherosclerosis Risk in Communities (ARIC) Surveillance study and observed an increase in the annual incidence of AMI hospitalizations among young women (aged 35-54 years) from 1995 to 2014, while AMI incidence decreased among young men.²

Adjusted analyses further demonstrated that young women are less likely than young men to receive coronary revascularization (relative risk [RR], 0.79; 95% CI, 0.71–0.87), nonaspirin antiplatelets (RR, 0.83; 95% CI, 0.75–0.91), lipid-lowering therapies (RR, 0.87; 95% CI, 0.80–0.94), coronary angiography (RR, 0.93; 95% CI, 0.86–0.99), and beta blockers (RR, 0.96; 95% CI, 0.91–0.99).

While this study found comparable rates of 1-year all-cause mortality in women and men (hazard ratio [HR], 1.10; 95% CI, 0.83–1.45), a 2022 study⁴ described in the Journal of Clinical Medicine found an 84.3% higher 3-year all-cause mortality rate in young women (<65 years) vs young men (<55 years) after AMI (adjusted HR [aHR], 1.843; 95% CI, 1.098–3.095). Conversely, elderly women show a 20.4% lower mortality rate compared to elderly men (aHR, 0.796; 95% CI, 0.682–0.929).

Research published in 2020 in the European Heart Journal reported similar disparities in invasive procedures and guideline-based treatment approaches provided to young (<50 years) women vs men. While there was no significant difference in cardiovascular mortality between women and men following discharge, women demonstrate greater all-cause mortality (aHR, 1.63; P =.01) after a median follow-up period of 11.2 years.⁵

In a multicenter prospective study reported in August 2021 in Frontiers in Cardiovascular Medicine, investigators observed a longer duration of time from symptom onset to hospital admission among young (≤45 years) women compared to young men.⁶ Additionally, the risk for in-hospital adverse events is higher for young women vs men (adjusted odds ratio [aOR] for death, 5.767; 95% CI, 1.580–21.049; P =.0080; aOR, for the composite of death, re-infarction, and stroke, 3.981; 95% CI, 1.150–13.784; P =.0292). Among patients who are discharged, the 2-year cumulative incidence of death is higher for women vs men (3.8 vs 1.4%; P =.0412).

Risk Factors

In a matched case-control study published in May 2022 in JAMA Network Open, researchers examined sex-specific risk factors for MI in a sample of 2,264 adults aged younger than 55 years who experienced a first acute MI compared with 2,264 matched control participants.⁷

Most of the factors that collectively contributed to roughly 85% of the total AMI risk showed stronger associations for young women, including:

• diabetes (OR, 3.59; 95% CI, 2.72-4.74 in women vs OR, 1.76; 95% CI,1.19-2.60 in men)
• depression (OR, 3.09; 95% CI, 2.37-4.04 in women vs OR, 1.77; 95% CI, 1.15-2.73 in men)
• hypertension (OR, 2.87; 95% CI, 2.31-3.57 in women vs OR, 2.19; 95% CI, 1.65-2.90 in men)
• currently smoking (OR, 3.28; 95% CI, 2.65-4.07 in women vs OR, 3.28; 95% CI, 2.65-4.07 in men)
• family history of premature MI (OR, 1.48; 95% CI, 1.17-1.88 in women vs OR, 2.42; 95% CI, 1.71-3.41 in men)

Hypercholesterolemia shows a stronger association in young men (OR, 1.02; 95% CI, 0.81-1.29 in women vs OR, 2.16; 95% CI, 1.49-3.15 in men). Low household income represents an additional risk factor in both groups (OR, 1.02; 95% CI, 0.81-1.29 in women vs OR, 2.16; 95% CI, 1.49-3.15 in men).

As many of these risk factors are potentially modifiable, the results point to the need for sex-specific strategies to modify these risk factors to prevent AMI in young adults, according to the authors.

The disparities in MI rates and outcomes are “especially marked in rural communities, suggesting that economic deprivation may be affecting cardiovascular health, especially among young women,” Dr Vaccarino noted.⁸ Related factors may include reduced access to prevention services and affordable health care in general, environmental factors such as lack of access to fresh food and safe places to walk, and psychosocial stress due to the multiple family demands that women often fill.

“Clinicians should offer prevention services to women beginning at a younger age and offer resources that can provide them the support they need to stay healthy or recover if they already developed a myocardial infarction,” she said. “These services are especially needed in low resource settings.”

Expert Q&A

Cardiology Advisor interviewed the lead authors of 2 of the recent studies^7,5 on MI in young women to learn more about the concerning trends observed in this population: Yuan Lu, ScD, researcher and assistant professor in the section of cardiovascular medicine at Yale School of Medicine in New Haven, Connecticut; and Ersilia M. DeFilippis, MD, a specialist in advanced heart failure and transplant cardiology and assistant professor of medicine at Columbia University Irving Medical Center in New York.

What are your thoughts about findings of disparities in MI risk factors and outcomes in young women, and do they align with your observations in practice?

Dr Lu: Our study identified sex differences in AMI risk factors as well as the strength of associations between these risk factors and AMI among young adults. Traditional cardiovascular risk factors such as hypertension and diabetes had stronger associations in women vs men, with significant interactions by sex. This observation is consistent with prior studies, including the INTERHEART study⁹ of older populations, and we provided an independent validation of these findings in young adults.

Moreover, we showed that current smoking and gender-related characteristics including low income and depression were linked to greater risk in women compared to men. These findings align with our observations in practice. In clinical practice, we noticed that young women admitted for AMI are more likely to have depression, which partially contributes to the higher mortality and poorer health status after AMI in young women.

Dr DeFilippis: Unfortunately, sex disparities in outcomes have been demonstrated across a variety of cardiovascular conditions, so while our findings were disappointing, they were not surprising. Although the most common presentation of MI in women is chest pain, they also may have atypical presentations (including shortness of breath, palpitations, and fatigue) that could lead to delayed diagnosis.⁵ I know women who have been told they were having an anxiety attack when in fact they were having manifestations of ischemic heart disease or heart failure.

What are the possible mechanisms driving these disparities?

Dr Lu: We found that socioeconomic and psychological factors have an important role in the development of AMI in young women. Although the mechanisms by which low socioeconomic status and low social support negatively affect patient outcomes remain unclear, numerous psychological, behavioral, and physiological theories have been proposed. These range from poor self-care and negative health behaviors to increased financial strain and elevated stress responses.

Indeed, we found that patients with low socioeconomic status had a higher prevalence of all cardiovascular factors and more financial instability than patients with moderate or high socioeconomic status. Depression also plays an intimate role in the development of AMI in young women, and depression was strongly associated with poorer functional status and mental health status after AMI.

Dr DeFilippis: We do understand that certain traditional cardiovascular risk factors may have a greater risk for future CV events in women than in men. Additionally, the mechanisms underlying ischemic heart disease may be different in women, including microvascular disease, coronary spasm, and spontaneous coronary artery dissection in addition to classic plaque rupture. These may require further testing or imaging modalities. 

Despite this, we know that few women with abnormal stress tests get referred for diagnostic angiography or have a change in medication therapies. Therefore, underdiagnosis and undertreatment likely also result from implicit bias on the part of health care providers.

Additionally, we know that awareness of heart disease as the leading cause of death among women declined from 2009 to 2019, highlighting a need for increased education of women so they can recognize their symptoms and advocate for themselves.¹⁰

What are the relevant recommendations for clinicians?  

Dr Lu: As a first step, clinicians need to be aware of the sex difference in risk factors for AMI in young women and pay attention to screening these risk factors when providing care for young women. Then they can refer the patient to targeted interventions to address these risk factors if indicated.

Dr DeFilippis: To paraphrase William Osler, “Listen to the patient; she is telling you the diagnosis.” Since women may have atypical presentations, it is important to have a high index of suspicion. Additionally, all physicians should take an obstetric and gynecologic history on their female patients. We know that sex-specific risk factors for CVD include a history of pre-eclampsia or premature ovarian failure among others. This can help to risk-stratify women in addition to traditional cardiovascular risk factors. 

What other measures may be needed to reduce these disparities?

Dr Lu: Raising awareness about cardiovascular disease risk in young women is the first necessary step to address these disparities. Then, screening risk factors including family history and psychological factors are needed to further identify high-risk patients for AMI. Documentation of family history and social determinants of health in the electronic health records will help clinicians to better understand and risk-stratify their patients. Finally, the development of more individualized risk prediction will enable more effective application of preventive therapies in young women.

Dr DeFilippis: Needed measures include targeting social determinants of health and development of sex-specific guidelines and sex-specific risk calculators.¹¹

Increased education of women regarding heart disease as the leading cause of death is also needed. Unfortunately, many women with the lowest awareness rates are those with lesser education and low income, and those who are racial and ethnic minorities. Therefore, this education must include partnership with local communities, including in local gyms, schools, and faith-based organizations.

There is also a need to improve the diversity of women in clinical trials of ischemic heart disease. We know that increased diversity of clinical trial leadership is associated with increased recruitment of women into cardiovascular trials, so this represents an additional need.

References

1. Wu WY, Berman AN, Biery DW, Blankstein R. Recent trends in acute myocardial infarction among the young. Curr Opin Cardiol. 2020;35(5):524-530. doi:10.1097/HCO.0000000000000781
2. Arora S, Stouffer GA, Kucharska-Newton AM, et al. Twenty year trends and sex differences in young adults hospitalized with acute myocardial infarction. Circulation. Published online November 11, 2019. doi:10.1161/CIRCULATIONAHA.118.037137
3. Vaccarino V. Myocardial infarction in young women. Circulation. Published online February 19, 2019. doi:10.1161/CIRCULATIONAHA.118.039298
4. Song PS, Kim MJ, Seong SW, et al; Kamir-Nih Investigators. Gender differences in all-cause mortality after acute myocardial infarction: evidence for a gender-age interaction. J Clin Med. 2022;11(3):541. doi:10.3390/jcm11030541
5. DeFilippis EM, Collins BL, Singh A, et al. Women who experience a myocardial infarction at a young age have worse outcomes compared with men: the Mass General Brigham YOUNG-MI registry. Eur Heart J. Published online October 13, 2020. doi:10.1093/eurheartj/ehaa662
6. Lv J, Ni L, Liu K, et al. Clinical characteristics, prognosis, and gender disparities in young patients with acute myocardial infarction. Front Cardiovasc Med. Published online August 22, 2021. doi:10.3389/fcvm.2021.720378
7. Lu Y, Li SX, Liu Y, et al. Sex-specific risk factors associated with first acute myocardial infarction in young adults. JAMA Netw Open. Published online May 3, 2022. doi:10.1001/jamanetworkopen.2022.9953
8. Tran P, Tran L. Influence of rurality on the awareness of myocardial infarction symptoms in the US. Ther Adv Cardiovasc Dis. Published online December 4, 2019. doi:10.1177/1753944719891691
9. Anand SS, Islam S, Rosengren A, et al; INTERHEART Investigators. Risk factors for myocardial infarction in women and men: insights from the INTERHEART study. Eur Heart J. Published online March 10, 2008. doi:10.1093/eurheartj/ehn018
10. Cushman M, Shay CM, Howard VJ, et al; American Heart Association. Ten-year differences in women’s awareness related to coronary heart disease: Results of the 2019 American Heart Association National Survey: A Special Report From the American Heart Association. Circulation. Published online September 19, 2021. doi:10.1161/CIR.0000000000000907
11. DeFilippis EM, Van Spall HGC. Is it time for sex-specific guidelines for cardiovascular disease? J Am Coll Cardiol. Published online July 5, 2021. doi:10.1016/j.jacc.2021.05.012

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The FDA on April 8 posted to its website a draft document proposing recommendations to increase the cybersecurity of medical devices. The document is titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.

“With the increasing integration of wireless, Internet- and network- connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device related health information, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become more important,” the document reads.

Effective cybersecurity relies upon security being “built-in” to a device, and not “bolted-on” after the device is designed because cybersecurity threats to the health care sector have become more frequent and severe, according to the FDA.

Cybersecurity incidents have rendered medical devices and hospital networks inoperable and have disrupted patient care across healthcare facilities in the United States and elsewhere.

In the draft document, which contains nonbinding recommendations, the FDA noted that “the safety and security risks of each device should be assessed within the context of the larger system in which the device operates. In the context of cybersecurity, security risk management processes are critical because, given the evolving nature of cybersecurity threats and risks, no device is, or can be, completely secure.”

The FDA listed the following security objectives: authenticity (including integrity), authorization, availability, confidentiality, and secure and timely updatability and patchability. The agency advises that premarket submissions should include information describing how these security objectives are addressed by an integrated into device design.

“Because exploitation of known vulnerabilities or weak cybersecurity controls should be considered reasonably foreseeable failure modes for systems, these factors should be addressed in the device design,” the FDA wrote.

Michael K. Hamilton, Chief Information Security Officer for Critical Insight, a cybersecurity company in Bremerton, Washington, said the Biden Administration has taken significant steps toward helping to bridge the gap between the public harm done by cyberattacks against the health sector and the private responsibility for security. “Creating security standards for medical device security is another facet of this strategy, and while a bit late to the game, very welcomed as it provides the opportunity to transfer the responsibility for device security to manufacturers rather than continuing to expect that the health sector will provide the resources to do so,” Hamilton said.

“Cyberspace is continuously evolving, and with the growing number of cybercriminals, it is always a cat and mouse game,” said Mohiuddin Ahmed, PhD, a cybersecurity and data analytics expert at Edith Cowan University’s School of Science in Perth, Australia. “I appreciate the new FDA guidance, but it could have been imposed earlier.”

Although cybersecurity has improved significantly in the past few years, there is no room for complacency, Dr Ahmed said. “Cybercrime is a trillion-dollar business. Unless we go back to non-Internet days, there will always be cyber incidents, especially in health care, as the cybercriminals know the pressure points,” he said.

Hamilton said the FDA’s recommendations make sense and have to potential to improve the cybersecurity of medical devices. “Knowing that these devices are confirmed secure when delivered, and with strategies to maintain security through routine vulnerability detection and updates, provides a bit of breathing room for overtaxed technology security professionals working in the health sector.”

Lynne Coventry, PhD, Professor of Human Cybersecurity at Northumbria University in Newcastle upon Tyne, UK, who has studied the fundamental tension between privacy/security goals and the traditional medical goals of utility and safety, said health care systems may be more vulnerable now because of the COVID-19 pandemic, which has increased the workload and contributed to fatigued health care personnel, she noted. The result could be less vigilance regarding cybersecurity as personnel focus their reserves on patient care.

Throughout history, medical professionals have protected public health and responded to health threats. Their ability to do that is being threatened by risks associated with connecting medical devices to computer networks, Prof Coventry said. “Cybersecurity is not just a technical problem to solve. It is a complicated sociotechnical problem. Reducing cybersecurity risks also requires addressing interconnected social, business and legal aspects,” she said.

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Transgender individuals face numerous health disparities compared to the general population, including elevated rates of HIV, mental illness, and substance use disorder.¹ Additionally, various research findings have demonstrated an increased risk for cardiovascular disease (CVD) among transgender patients, although results have been mixed across studies.

In a retrospective single-center study published in September 2021 in the American Journal of Preventive Cardiology, Mahowald et al examined CVD prevalence rates and associated comorbidities in transgender women referred to a women’s heart clinic for management of CVD or cardiac risk factors or for preoperative risk assessment in preparation for gender-affirming surgery.² Of the 52 patients (aged mean, 57±10 years) comprising the sample, 92% were receiving gender-affirming hormone therapy.

The pooled cohort equation demonstrated that the 10-year risk for atherosclerotic CVD was 9.4±7.7% when using a risk calculation for cisgender men, compared with 5.2±5.1% when using a risk calculation for cisgender women (P <.001).

“Older transgender women may have an underestimated prevalence of CVD and its risk factors,” the authors wrote.² “More research is needed to identify cardiovascular health profiles, improve practice consistency, and establish normative values for transgender patients.”

In a 2019 study using data from the Behavioral Risk Factor Surveillance System (BRFSS), Caseres et al found higher rates of any CVD condition (adjusted odd ratio [AOR], 2.98; 95% CI, 1.65-3.06) as well as diabetes (AOR, 1.45; 95% CI, 1.05-1.99), angina and coronary heart disease (AOR, 1.90; 95% CI, 1.34-2.68), stroke (AOR, 1.88; 95% CI, 1.16-3.03), and myocardial infarction (AOR, 2.98; 95% CI, 2.14-4.17) among transgender women compared with cisgender women.³

The results further showed higher rates of myocardial infarction among gender nonconforming individuals compared to cisgender women (AOR, 2.68; 95% CI, 1.14-6.30). Comparisons between transgender women and transgender men yielded no differences in CVD rates.³

In another 2019 study that used BRFSS data, the rate of myocardial infarction was substantially higher in transgender men compared with cisgender men (OR, 2.53; 95% CI, 1.14–5.63; P =.02) and cisgender women (OR, 4.90; 95% CI, 2.21–10.90; P <.01), after adjustment for CVD risk factors such as age, presence of hypertension, exercise, and smoking.⁴ Among transgender women, the rate of myocardial infarction was higher compared to cisgender women (OR, 2.56; 95% CI, 1.78–3.68; P <.01) but not in comparison to cisgender men.⁴

Research published in August 2021 in Transgender Health also used data from the BRFSS to investigate the odds of CVD among transgender individuals compared with cisgender individuals.⁵ Analyses revealed that the odds of CVD were 2.66 times greater (95% CI, 1.60–4.41) among participants assigned female at birth (AFAB) who identify as transgender vs cisgender, while no significant difference in the odds of CVD was noted between transgender vs cisgender participants among those assigned male at birth (AMAB).

In a comparison between gender nonconforming and cisgender participants, the odds of CVD were 2.21 times higher (95% CI, 1.04–4.70) among the gender nonconforming individuals.⁵

Noting a possible link between estrogen-based hormone therapy and CVD in transgender individuals, Getahun et al explored this association in a 2018 cohort study based on electronic medical records of 2,842 transgender women and 2,118 transgender men matched to 48,686 cisgender men and 48,775 cisgender women, respectively.⁶ The results showed a higher incidence of venous thromboembolism (VTE) among transgender women, with more pronounced differences found among those who initiated hormone therapy during the follow-up period.

The differences in VTE risk at 2 and 8 years were 4.1 (95% CI, 1.6-6.7) and 16.7 (95% CI, 6.4-27.5) per 1000 persons compared with cisgender men, and 3.4 (95% CI, 1.1-5.6) and 13.7 (95% CI, 4.1-22.7) compared with cisgender women. There was insufficient evidence to draw conclusions regarding comparative VTE risk among transgender men.⁶

A systematic review published in 2021 in the Journal of Sex Medicine reported a greater incidence of VTE in AMAB patients compared with AFAB patients (42.8 vs 10.8 VTE per 10,000 patient years; P =.02) and a “similar or higher” incidence in AMAB patients compared with cisgender women on hormone replacement therapy.⁷

The key question regarding these findings is, “How important is the impact of exogenous estrogen on VTE risk?” according to study co-author Dr Joshua D. Safer, MD, FACP, FACE, executive director of the Mount Sinai Center for Transgender Medicine and Surgery and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York, and co-author of the 2018 study and other articles on the topic.^6,1,8 “It may be that standard approaches to otherwise high-risk patients – like deep vein thrombosis prophylaxis in surgery – essentially erase the very modest increased risk of VTE suggested in cross-sectional studies.”

The higher body weight and lower frequency of exercise observed in transgender populations may further contribute to an elevated CVD risk, he noted.⁹ Such factors may be attributable to the discomfort these individuals experience in a hostile environment such as the typical fitness center. “It may be that the stigma and discrimination experienced by transgender people are the greatest concerns for CV health, contributing to decreased exercise, more obesity, and delayed medical care,” Dr Safer said.

In addition, psychosocial stressors related to other forms of structural violence including reduced access to affordable housing and health care may contribute to excess CVD and associated mortality in this population, as described in a scientific statement published in 2021 by the American Heart Association.⁹

“At the population level, the largest benefit for transgender people may be to remove stigma in order to better integrate them in exercise programs and athletics and appropriate health care,” Dr Safer stated. On the clinician level, “Physician and medical staff education is important to create safe spaces for transgender people to receive timely care.” These efforts may include the use of medical forms with inclusive language such as questions about the patient’s current gender identity as well as their gender assigned at birth if this information is needed, and use of the term “relationship status” rather than “marital status,” for example.¹⁰

For clinicians who are unsure of how to address the increased CV risk observed among transgender patients, “A major point is not to rush to overemphasize the likely small – if any – contribution from exogenous hormone treatment and to approach transgender people like anyone else,” Dr Safer advises.

References

1. Safer JD, Coleman E, Feldman J, et al. Barriers to healthcare for transgender individuals. Curr Opin Endocrinol Diabetes Obes. 2016;23(2):168-71. doi:10.1097/MED.0000000000000227
2. Mahowald MK, Maheshwari AK, Lara-Breitinger KM, et al. Characteristics of transgender women referred to women’s heart clinic. Am J Prev Cardiol. Published online July 10, 2021. doi: 10.1016/j.ajpc.2021.100223.
3. Caceres BA, Jackman KB, Edmondson D, Bockting WO. Assessing gender identity differences in cardiovascular disease in US adults: an analysis of data from the 2014-2017 BRFSS. J Behav Med. 2020;43(2):329-338. doi:10.1007/s10865-019-00102-8
4. Alzahrani T, Nguyen T, Ryan A, et al. Cardiovascular disease risk factors and myocardial infarction in the transgender population. Circ Cardiovasc Qual Outcomes. Published online April 5, 2019. doi:10.1161/CIRCOUTCOMES.119.005597
5. Howerton I, Harris JK. Transgender identity and cardiovascular disease. Transgender Health. Published online 19, 2021. doi:10.1089/trgh.2020.0188
6. Getahun D, Nash R, Flanders WD, et al. Cross-sex hormones and acute cardiovascular events in transgender persons: A cohort study. Ann Intern Med. Published online August 21, 2018. doi:10.7326/M17-2785
7. Kotamarti VS, Greige N, Heiman AJ, Patel A, Ricci JA. Risk for venous thromboembolism in transgender patients undergoing cross-sex hormone treatment: A systematic review. J Sex Med. Published online June 14, 2021. doi:10.1016/j.jsxm.2021.04.006
8. Slack DJ, Safer JD. Cardiovascular health maintenance in aging individuals: The implications for transgender men and women on hormone therapy. Endocr Pract. Published online December 12, 2021. doi:10.1016/j.eprac.2020.11.001
9. Streed CG Jr, Beach LB, Caceres BA, et al; American Heart Association Council on Peripheral Vascular Disease; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Stroke Council. Assessing and addressing cardiovascular health in people who are transgender and gender diverse: A Scientific statement from the American Heart Association Circulation. Published online July 8, 2021. doi:10.1161/CIR.0000000000001003
10. Schultz G. Making medical forms and doctor visits more inclusive: Creating safe appointments for transgender, nonbinary, and gender diverse individuals. INvisible Project. Accessed online July 1, 2022.

The post Exploring Cardiovascular Risk in Transgender Patients appeared first on The Cardiology Advisor.

HealthDay News — Coronary artery bypass grafting (CABG) may increase long-term survival even in elderly patients, according to a study published online June 20 in Mayo Clinical Proceedings.

Kukbin Choi, M.D., from the Mayo Clinic in Rochester, Minnesota, and colleagues assessed risks, outcomes, and trends in patients ≥80 years undergoing CABG. Analysis included 1,283 older, consecutive patients undergoing primary isolated CABG from Jan. 1, 1993, to Oct. 31, 2019, with a median follow-up of 16.7 years.

The researchers found that operative mortality was overall 4% but showed a significant decrease over the study period. Estimated survival rates were 90.2% at one year, 67.9% at five years, 31.1 at 10 years, and 8.2% at 15 years. Compared to age- and sex-matched octogenarians in the general U.S. population, median survival time was 6.0 and 7.6 years, respectively, with CABG. Significant risk factors of mortality included older age, recent atrial fibrillation or flutter, diabetes mellitus, smoking history, cerebrovascular disease, immunosuppressive status, extreme levels of creatinine, chronic lung disease, peripheral vascular disease, decreased ejection fraction, and increased Society of Thoracic Surgeons predicted risk score.

“Although CABG in octogenarians carries a higher surgical risk, it may be associated with favorable outcomes and increase in long-term survival,” the authors write. “Further studies are warranted to define subgroups benefiting more from surgical revascularization.”

Abstract/Full Text (subscription or payment may be required)

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Although mortality rates associated with venous thromboembolism (VTE) have decreased in recent decades due to earlier diagnosis and anticoagulation, significant gaps remain in addressing the psychological sequelae of the condition. VTE often represents a traumatic event for patients, many of whom report ongoing anxiety, panic, and depression related to the experience.^1-3 However, these issues may go unrecognized and may be inadvertently exacerbated by clinicians.^4,5

Several studies based on patient interviews have shed light on some of the psychological effects associated with VTE. A 2019 longitudinal qualitative study published in BMJ Open included semistructured interviews with 11 patients (64% female) who had experienced VTE within the previous year. Participants “reported being forever changed by the experience,” with “continued high levels of trauma and anxiety symptoms” related to VTE.²

In research described in 2021 in Research and Practice in Thrombosis and Haemostasis (RPTH), Tran et al examined psychological symptoms in 72 individuals (63% female) with a previous diagnosis of pulmonary embolism (PE). Based on self-reported data and semistructured interviews, they found that approximately one-half of participants experienced ongoing psychological distress following PE.

These individuals “often recalled painful symptoms, recalled diagnosis delivery as stressful, worried about PE recurrence, and had anxieties about stopping their anticoagulant medication,” according to the report. However, roughly two-thirds of patients indicated that they had not sought professional mental health treatment for these symptoms.³

A qualitative study published in 2022 in RPTH explored the impact of clinician communication regarding VTE diagnosis among 24 patients (63% female) treated in emergency departments in the midwestern United States. Results of semistructured interviews suggest that providers’ verbal and nonverbal communication can increase the psychological distress that patients experience in this situation.⁴

To further discuss these findings and ways for clinicians to improve communication and support regarding VTE, we interviewed the following experts: Jeffrey Kline, MD, professor and associate chair of research in the department of emergency medicine at Wayne State University School of Medicine in Detroit, and lead author of the 2022 study⁴ described above; and Rachael Hunter, PhD, clinical psychologist, senior lecturer, and researcher at Swansea University in Wales, United Kingdom, and lead author of the aforementioned 2019 study.²

What is known about the psychological effects of receiving a VTE diagnosis? 

Dr Kline: Patients commonly express the question “Why me?” a question that starts at the time of diagnosis and often persists for years afterward. They wonder whether the clot problem itself or the treatment will change aspects of their lives such as work, family, and hobbies. Others have concerns about recurrence or even death. Some want full genetic testing, although studies have shown that, in general, this does not reduce anxiety.⁶

Dr Hunter: Studies show that while some people cope very well with experiencing VTE, for others the experience can be very challenging and have a significant impact for a range of reasons. Firstly, VTE can often happens suddenly and unexpectedly, and for some people, it can be a life-threatening event. As such, it may leave them hypervigilant to future threats, and some may experience heightened anxiety and even post-traumatic symptoms.  

A lot of VTE patients report feeling very anxious in the period following VTE, and this can be problematic because symptoms of anxiety — in particular, panic — can mirror the features of a pulmonary embolism. This leaves some patients feeling unsure if they are experiencing a VTE or a panic attack.¹

Secondly, the risk of future VTE, which is often made very clear to patients, can also be really worrying for people. In particular, we know that once a person experiences a VTE, they are at increased risk of future VTE and that future VTE are likely to increase in severity unless managed appropriately. This can feel really frightening for patients, and it also means that someone who experiences a fairly nebulous DVT may still feel really anxious about the future.

Thirdly, anticoagulation therapy carries its own risks, and so patients must not only adapt to the VTE itself but also the risk associated with the recommended treatment. 

What are some of the factors that contribute to these VTE-related psychological issues? 

Dr Kline: Lack of reliable information plays heavily into this. While in the hospital, many patients with clots can’t even state why they are receiving anticoagulants. Some believe they’ve had a heart attack. Some hear exaggerated language such as, “You almost died,” which contributes to long-lasting ruminations and fear. After discharge, patients seek information from family, friends, and the internet, some of which is misleading.

Dr Hunter: Reminders of the VTE can exacerbate symptoms of anxiety or trauma, keeping the patient stuck in a vicious cycle. For example, taking medication or even being in the environment where the VTE occurred could remind the patient not just of the VTE event, but also the potential for future VTEs. An important reminder for patients were long-term physical symptoms experienced as a result of the VTE, such as pain or breathlessness. Not only did these remind the patient of the VTE and the risk of future VTE, but they could also trigger emotions associated with the diagnosis and management of their condition.

In particular, because of the difficulties in diagnosing VTE, many patients may have experienced misdiagnosis or missed diagnosis. This can lead to feelings of frustration or anger, and long-term physical symptoms may reinforce these feelings as a constant reminder, keeping patients stuck in feelings of anger or resentment.²

Finally, it’s important to emphasize that there is very little public awareness of VTE or blood clots. This lack of awareness can translate into a lack of empathy and support from family and friends, leaving people feeling isolated and contributing further to emotional and psychological effects.

It is also important to consider the individual’s own specific circumstances and history. For example, if a person has experienced mental health difficulties prior to VTE, this may — but not necessarily — make them more vulnerable to difficulties when facing a physical health event. The patient’s social circumstances may also be important to consider. For example, if the individual now has to leave their job or occupation because of the VTE, this could have a big impact emotionally as well as financially.

Finally, if your patient seems worried about their treatment in any way, it’s important to try and discuss this with them, especially in the case of anticoagulation. Sometimes we can dismiss patients’ worries without allowing them to share their concerns about treatments, and this can be detrimental. Some VTE patients feel worried about taking long-term medications or may have fears about the implications of this. An empathic conversation early on, allowing them to share and acknowledging their concerns, can be very reassuring.

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Based on the results of studies conducted over the past 25 years, oral health is increasingly recognized as an important factor in cardiovascular health.¹ Although causal evidence remains elusive, researchers have linked various oral health issues with an elevated risk of cardiovascular disease and myocardial infarction.

“Poor oral health, particularly gingivitis and periodontal disease, have been associated with the development of atherosclerotic cardiovascular disease,” according to Tamara Horwich, MD, MS, health sciences clinical professor of medicine/cardiology at the David Geffen School of Medicine at the University of California, Los Angeles, medical director of the UCLA Cardiac Rehabilitation Program.² “Studies of the general population in different countries have also shown that people with periodontitis are more likely to experience a heart attack.”³

Emerging research on the oral-CV health connection

Results of several recent studies have generated further insights regarding the connection between oral health and cardiovascular disease. A study published in August 2021 in Scientific Reports found that tooth loss, dry mouth, and the presence of 3 or more oral problems were associated with all-cause mortality in a sample of 3075 older adults in the United States.⁴ In addition, periodontal disease was linked to higher rates of cardiovascular disease-related mortality (subdistribution hazard ratio (SHR), 1.49; 95% CI,1.01-2.20).

In a nationwide Korean cohort study published in February 2022 in the Journal of Hypertension, Kim et al investigated the presence of cardiovascular disease in 52,677 patients with hypertension who received oral checkups at baseline, with a mean follow-up period of roughly 11 years.⁵ Analyses revealed an independent association between the presence of 5 or more dental caries and the occurrence of stroke or myocardial infarction (adjusted HR [aOR], 1.37; 95% CI, 1.10–1.72; P =.006], and brushing teeth at least twice daily was associated with a lower risk of these outcomes (aOR, 0.88; 95% CI, 0.81–0.96; P =.002).

A study reported in May 2022 in the Journal of Dental Research analyzed prospective data from 5294 participants in France who underwent full oral and physical examinations and were subsequently assessed every 2 years over a median follow-up period of approximately 8 years.⁶ The authors examined the risk of coronary heart disease (CHD) associated with varying states of oral health status: optimal oral health and preserved masticatory capacity (cluster 1), moderate oral health and moderately impaired masticatory capacity (cluster 2), and poor oral health and severely impaired masticatory capacity (cluster 3).

The findings demonstrated a higher CHD risk in cluster 2 compared to cluster 1(HR, 1.45; 95% CI, 0.98-2.15), and in cluster 3 vs cluster 2 (HR, 2.47; 95% CI, 1.34-4.57; P <.05). “To conclude, middle-aged individuals with poor oral health and severely impaired masticatory capacity have more than twice the risk of incident CHD than those with optimal oral health and preserved masticatory capacity,” as stated in the paper.⁶

Dr Horwich described 2 main hypotheses regarding the proposed mechanisms driving the link between oral health and cardiovascular disease. “When there is infection in the oral cavity, bacteria can translocate from the mouth into the blood and blood vessels, triggering an immune response which may damage the blood vessel lining and initiate the development of atherosclerotic plaque formation,” she explained. “Alternatively, an oral infection such as gingivitis or periodontitis may increase general inflammation in the body, which contributes to the process of plaque formation in the coronary arteries.”

In a 2021 review published in the American Journal of Preventive Cardiology, the authors discuss associations between periodontal disease and atherosclerotic cardiovascular disease, noting that both are inflammatory diseases with overlapping mechanisms and risk factors.² This connection is especially concerning given the high prevalence (46%) of periodontal disease among US adults. They emphasized that the current lack of causal evidence should not impede efforts to promote awareness and prevention of periodontal disease with the aim of reducing the risk of atherosclerotic cardiovascular disease.

Other research has indicated that regular dental screening may reduce the risk of cardiovascular disease, including a 2021 retrospective cohort study described in the Journal of Clinical Periodontology. Investigators followed 478,245 adults for 11 years and observed a lower risk of major adverse cardiovascular events among participants who underwent dental screening compared to those who did not receive dental screening (aHR, 0.90; 95% CI, 0.87–0.93; P <.001).⁷

Clinical implications and remaining needs

“It is important to be aware of all the areas of residual risk that leave patients at risk for cardiovascular disease,” said the lead author of the 2021 review, Eugenia Gianos, MD, director of Women’s Heart Health at Lenox Hill Hospital and director of cardiovascular prevention for Northwell Health in New York.² Notably, research has shown that cardiovascular disease can increase the risk for oral disease as well.⁸ “Making sure to ask patients about their dental health is important for cardiovascular care but also overall health.”

Despite the growing evidence supporting the broader implications of oral health, there remain substantial gaps in access to oral health care in the US.⁹ “One of the most important limitations to optimal oral care is inadequate dental coverage,” according to Dr Gianos, who says that greater legislative support is needed to address this disparity.

Although there is an ongoing need for randomized controlled trials to investigate whether improved dental care can reduce cardiovascular disease, Dr Horwich cites the importance of encouraging regular dental checkups and proper oral hygiene for all patients, such as brushing teeth twice daily and flossing once daily. Clinicians can educate patients about the connection between oral health and cardiovascular health and ask simple oral health screening questions such as, “Do your gums bleed when you brush?” and “How many teeth do you have?” with referral to dental practitioners for further assessment as warranted.⁸

“While more research is necessary to identify mechanisms that link cardiovascular disease and oral health, collaboration between dentists and physicians is recommended to reduce potential risk factors for systemic disease,” said 1 of Gianos’ co-authors, Kenneth Fleisher, DDS, FACS, clinical professor in the department of oral and maxillofacial surgery at the New York University College of Dentistry. Dr Gianos points to the need to integrate medical and dental electronic health records and to develop interdisciplinary conferences to increase collaboration between medical and dental providers.²

References

1. Aldossri M, Farmer J, Saarela O, Rosella L, Quiñonez C. Oral health and cardiovascular disease: Mapping clinical heterogeneity and methodological gaps. JDR Clin Trans Res. Published online September 4, 2020. doi:10.1177/2380084420953121

2. Gianos E, Jackson EA, Tejpal A, et al. Oral health and atherosclerotic cardiovascular disease: A review. Am J Prev Cardiol. 2021;7:100179. doi:10.1016/j.ajpc.2021.100179

3. Xu S, Song M, Xiong Y, Liu X, He Y, Qin Z. The association between periodontal disease and the risk of myocardial infarction: a pooled analysis of observational studies. BMC Cardiovasc Disord. Published online February 1, 2017. doi:10.1186/s12872-017-0480-y

4. Kotronia E, Brown H, Papacosta AO, et al. Oral health and all-cause, cardiovascular disease, and respiratory mortality in older people in the UK and USA. Sci Rep. Published online August 12, 2021. doi:10.1038/s41598-021-95865-z

5. Kim J, Kim HJ, Jeon J, Song TJ. Association between oral health and cardiovascular outcomes in patients with hypertension: a nationwide cohort study. J Hypertens. 2022;40(2):374-381. doi:10.1097/HJH.0000000000003022

6. Deraz O, Rangé H, Boutouyrie P, et al. Oral condition and incident coronary heart disease: A clustering analysis. J Dent Res. Published online December 7, 2022. doi:10.1177/00220345211052507

7. Kim KS, Kim T, Kang SH, Lee JR, Lee HJ, Lee H. Effect of dental screening on cardiovascular risk: A nationwide cohort study. J Clin Periodontol. Published online December 12, 2022. doi:10.1111/jcpe.13584

8. King S, Chow CK, Eberhard J. Oral health and cardiometabolic disease: understanding the relationship. Intern Med J. Published online February 20, 2022. doi:10.1111/imj.15685

9. D’Souza RN, Collins FS, Murthy VH. Oral health for all – Realizing the promise of science. N Engl J Med. Published online March 3, 2022. doi:10.1056/NEJMp2118478

The post Exploring the Link Between Oral Health and Cardiovascular Disease appeared first on The Cardiology Advisor.

Among the many risk factors for poor prognosis following cardiac emergencies, accumulating research points to one that may be overlooked: the time of the week. Research has shown worse outcomes in cardiac patients presenting to the emergency department on the weekend vs during the week, and findings from several studies presented at the annual American College of Cardiology meeting in April 2022 add further support to this observation.^1-3

Altujjar et al analyzed 6,020 records from the National Inpatient Sample (NIS) database to compare outcomes among patients who were hospitalized with aortic dissection on a weekday vs over the weekend.¹ After adjusting for demographic factors and common comorbidities, such as myocardial infarction and heart failure, the authors found that weekend admissions were linked to higher in-hospital mortality (adjusted odds ratio [aOR], 1.27; P =.012) both in patients treated medically (OR, 1.32; P =.023) and in those treated surgically (OR, 1.36; P =.018).

Weekend admissions were also associated with lower odds of receiving surgical intervention (OR, 0.83; P =.003). In addition, patients with aortic dissection type B demonstrated higher mortality (OR, 1.7; P =.015) and longer time to surgery (2.83 vs 1.88 days; P =.0017) if they were admitted on the weekend compared to a weekday, while no such differences were observed in aortic dissection type A patients.¹

The same group conducted a similar study² based on records of 5,535 patients hospitalized for cardiac arrest and observed higher in-hospital mortality in those with weekend vs weekday admission (77.13% vs 73.32%; aOR, 1.20; 95% CI, 1.04-1.39; P =.012).

Munshi et al examined NIS data to identify outcomes in weekday and weekend admissions in nearly 3 million cases of acute new onset non-ST elevation myocardial infarction (NSTEMI). Their analyses revealed higher odds of mortality (aOR, 1.04), longer length of stay (adjusted mean difference, 0.06 days), and numerous complications (aOR, 1.05) including acute renal failure, cardiac arrest, and acute respiratory failure (all P <.05) in patients presenting on the weekend. Odds of mortality (aOR 1.14; P <.05) and complications were further increased among those who were admitted on the weekend and received revascularization.³

Findings on this topic have been mixed overall, however. One recent study, for example, showed no evidence of elevated in-hospital mortality in patients hospitalized for acute myocardial infarction (AMI) on the weekend vs weekdays.⁴

We interviewed the following experts to discuss some of their own study results and thoughts about the weekend effect: Saraschandra Vallabhajosyula, MD, MSc, assistant professor of medicine at the Wake Forest School of Medicine in Winston-Salem, North Carolina, and medical director of the Cardiac Intensive Care Unit at the Congdon Heart and Vascular Center at the Atrium Health Wake Forest Baptist; and Ibrahim Sultan, MD, associate professor of cardiothoracic surgery at the University of Pittsburgh School of Medicine, director of the Center for Thoracic Aortic Disease at the University of Pittsburgh Medical Center, and surgical director of the UPMC Center for Heart Valve Disease.

What does the available evidence suggest thus far about the weekend effect and why it might occur? 

Dr Vallabhajosyula: ​The weekend effect is a complex phenomenon that denotes lower-quality care and potential delays in care for acute conditions on weekends, holidays, and off-hours. It is hypothesized to be due to differences in staffing patterns, emergency-only services with varying definitions of “emergency,” lesser availability of resources, and potentially higher rates of complications.

Dr Sultan: The weekend effect is the idea that outcomes of emergency surgery might be affected by the time when it is performed. Specifically, it is suggested that surgery performed outside of normal “business hours,” especially during the weekend, may result in suboptimal outcomes compared to surgery performed during business hours on a weekday. This is the so-called “weekend effect.” Data is admittedly conflicting, but it likely favors the existence of this phenomenon.

We have examined this phenomenon as it pertains to surgery for acute type A aortic dissection. While some studies suggest that 30-day mortality is higher for aortic surgery performed on the weekend, other studies have not found such a difference. However, a recent systematic review and meta-analysis by Toh et al suggests that pooled data from prior studies supports the existence of higher mortality when aortic surgery is performed on the weekend.⁵

Data explaining why the weekend effect might exist is more sparse. It is postulated that poor outcomes during the weekend may be due to limited staffing or expertise for such complex cases. It is also suggested that available staff are fatigued during the weekend. The latter is difficult to prove, while the former requires further investigation. 

What do you believe your recent study added to our understanding of this topic? ​

Dr Vallabhajosyula: Using a large national database of over 9 million acute myocardial infarction admissions in the United States between 2000 and 2016, we sought to assess if outcomes are truly different between patients admitted on weekends vs weekdays in the contemporary era.⁴ Our study did not demonstrate any differences in in-hospital mortality or rates of coronary angiography or percutaneous coronary interventions (PCI) in AMI. This is truly a tremendous finding since it consolidates the concentrated effort of various national initiatives for prompt care in this critically ill population. 

Dr Sultan: To our knowledge, our study is the largest series examining this effect. [Of 36,399 ED visits for aortic dissection, they found that 13% of patients admitted on the weekend died in the hospital compared to those admitted on a weekday.⁶]

The recent study by Toh suggests that the existing research may be biased.⁵ However, data from a single, large database such as the Nationwide Emergency Department Sample (NEDS) may be an opportune source for providing unbiased estimates of a phenomena such as the weekend effect. Second, existing single-institution studies include highly specialized tertiary academic centers in their analysis, while the NEDS database is far more inclusive in the types of hospitals included in the population. Thus, our study’s findings may be more generalizable to the larger patient population. 

Why is there such ongoing debate regarding the weekend effect? What are the main points of disagreement?​

Dr Vallabhajosyula: Multiple studies prior to ours have shown that the weekend effect is prevalent in acute care, both within and outside of cardiovascular medicine. Specifically in AMI, there has been a perception that revascularization is delayed due to the weekend effect, which adversely effects outcomes. In our longitudinal study over 17 years, these differences were seen more often in the earlier years, but the gap narrowed over time. This is suggestive of higher uptake of national and societal guidelines on early and prompt angiography and revascularization in AMI. 

Dr Sultan: The main point of disagreement stems from interpreting the data in appropriate context. Experts who deny the existence of the weekend effect argue that specialized centers with dedicated staffing 24/7 may be able to achieve similar outcomes whether aortic surgery is performed on the weekend or on a weekday. Conversely, this may not be generalizable to the average patient presenting to the average hospital. Interpreted in this context, both are likely to be true.

As our study suggests, when considering all-comers presenting to any hospital, the weekend effect is likely to be true. But other studies, including a recent study by Arnaoutakis et al of the International Registry of Acute Aortic Dissection, which includes aortic centers of excellence at tertiary and quarternary care hospitals, found no difference in mortality whether surgery was performed on the weekend or during the week.⁷ Again, context matters when interpreting the data. 

What are the key considerations for clinicians regarding this topic? ​

Dr Vallabhajosyula: For STEMI patients, in the absence of significant contraindications, rapid coronary angiography and PCI is the norm and has been widely implemented across all centers in the US. For NSTEMI patients, which are a larger fraction in our practice, we must be careful and diligent in our care. These patients are often dynamic and evolve during their hospital course. We need to have a low threshold to consider early coronary angiography and PCI either on weekdays or weekends to provide optimal care. 

Dr Sultan: It is likely the case that optimal outcomes are attainable only at tertiary or quarternary referral hospitals with centers of excellence for the surgery of interest. However, data regarding the weekend effect highlights the importance of robust referral networks and the need for appropriate staffing and resources “on-call” 24-7, including neurophysiology and perfusion.  

What else is needed to improve outcomes related to this phenomenon? 

Dr Vallabhajosyula: The care provided for these patients needs a strong team of multidisciplinary providers led by the cardiologist/interventional cardiologist. We need a strong and vigilant team of nurses, respiratory therapists, ancillary staff, and caregivers who can provide holistic care. Systems of care need to be strong to rapidly evaluate and treat perturbations prior to clinical or hemodynamic deterioration. Use of best practice guidelines, consistent care independent of time of admission, and development of quality improvement initiatives that target best practices are important next steps to help these acute ill patients. 

Dr Sultan: Three things are likely necessary. First, we need to continue to define the gold standard of aortic surgery – for instance, when and how to repair the aortic root, the appropriate extent of the distal reconstruction, the need for concomitant elephant trunk procedures, the optimal cerebral protection strategy, etc. Once defined, intraoperative decision-making should be streamlined, whether on the weekday or weekend.

Second, hospitals ought to dedicate appropriate staffing and resources to be available 24/7 in order to improve outcomes on the weekend. This may be costly, but it may be necessary for optimizing outcomes. Finally, further research is necessary. In addition to investigating the optimal surgical approach, further data is necessary to clarify whether surgeon fatigue impacts emergent surgery for acute aortic dissection that is performed on the weekend.

References

1.  Altujjar M, Mhanna M, Bhuta S, et al. The weekend effect on outcomes in patients presenting with acute aortic dissection: a nationwide analysis. J Am Coll Cardiol. Published online April 1, 2022. doi:10.1016/S0735-1097(22)02733-4

2.  Altujjar M, Khokher W, Sajdeya O, et al. Weekend effect on patients presenting with cardiac arrest: a nationwide analysis. J Am Coll Cardiol. Published online April 1, 2022. doi:10.1016/S0735-1097(22)02031-9

3.  Munshi R, Pellegrini J, Nehru N, et al. “The weekend effect:” a nationwide analysis of difference in outcomes among patients with NON-ST elevation myocardial infarction admitted during the weekend. J Am Coll Cardiol. Published online April 1, 2022. doi:10.1016/S0735-1097(22)01882-4

4.  Vallabhajosyula S, Patlolla SH, Miller PE, et al. Weekend effect in the management and outcomes of acute myocardial infarction in the United States, 2000-2016. Mayo Clin Proc Innov Qual Outcomes. 2020;4(4):362-372. doi:10.1016/j.mayocpiqo.2020.02.004

5.  Toh S, Yew DCM, Choong JJ, Chong TL, Harky A. Acute type A aortic dissection in-hours versus out-of-hours: A systematic review and meta-analysis. J Card Surg. Published online October 1, 2020. doi:10.1111/jocs.15070

6.  Brown J, Usmani B, Arnaoutakis G, et al. 10-Year trends in aortic dissection: Mortality and weekend effect within the US Nationwide Emergency Department Sample (NEDS). Heart Surg Forum. 2021;24(2):E336-E344. doi:10.1532/hsf.36817.  Arnaoutakis G, Bianco V, Estrera AL, et al. Time of day does not influence outcomes in acute type A aortic dissection: Results from the IRAD. J Card Surg. Published online September 16, 2020. doi:10.1111/jocs.15017

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A retrospective review of health records found that the Ross procedure was associated with improved long-term survival and freedom from valve-related complications compared with prosthetic aortic valve replacement (AVR). These findings were published in the Journal of the American College of Cardiology.

Investigators at the Icahn School of Medicine at Mount Sinai sourced data from the California and New York mandatory reporting databases. To adjust for baseline differences, using a propensity score matching approach, all patients who received primary AVR using the Ross procedure (pulmonary autograft; n=434) or received a prosthetic AVR (biological: n=434; mechanical: n=434) between 1997 and 2014 were assessed for long-term outcomes.

The Ross, biological, and mechanical cohorts were aged mean 35.9±9.2, 36.2±9.4, and 36.7±8.8 years; 75%, 73%, and 78% were men; 74%, 71%, and 71% were White; 18%, 18%, and 19% had hypertension; and 15%, 15%, and 14% had congestive heart failure, respectively.

At 30 days, the mortality rate was 0.23% for Ross, 0.69% for biological AVR, and 0.69% for mechanical AVR (P =.71). At year 15, the survival rates were 93.2%, 87.9%, and 88.4% (P =.005), respectively. Mortality risk was lower for the Ross procedure compared with biological (hazard ratio [HR], 0.42; 95% CI, 0.23-0.75; P =.003) or mechanical (HR, 0.45; 95% CI, 0.26-0.79; P =.006) AVR.

At 15 years, the cumulative stroke incidence was 2.1% for the Ross procedure compared with 3.3% (HR, 0.61; 95% CI, 0.24-1.57; P =.30) for the biological AVR and 4.8% (HR, 0.37; 95% CI, 0.16-0.89; P =.03) for the mechanical AVR.

Major bleeding occurred at a rate of 1.9% for the Ross procedure compared with 3.3% (HR, 0.50; 95% CI, 0.19-1.32; P =.16) and 5.2% (HR, 0.32; 95% CI, 0.13-0.81; P=.016) for the biological and mechanical AVR, respectively.

Cumulative aortic and pulmonary valve reintervention occurred among 17.2% of Ross, 29.8% (HR, 0.63; 95% CI, 0.45-0.88; P =.008) of biological AVR, and 7.4% (HR, 2.4; 95% CI, 1.5-3.8; P =.0002) of mechanical AVR recipients.

For endocarditis, at 15 years, the rate was 2.3% among Ross procedure recipients compared with 8.5% (HR, 0.37; 95% CI, 0.17-0.80; P =.012) for biological AVR and 3.7% (HR, 0.61; 95% CI, 0.25-1.50; P =.61) for mechanical AVR.

These findings may not be generalizable, as patients who were aged 50 years or older or who had important comorbid conditions were excluded from this analysis.

“This study further confirms the notion that a living valve substitute in the aortic position translates into improvements in clinically relevant outcomes in young adults,” the study authors noted. “The Ross procedure should be considered the option of choice for young adults requiring isolated replacement of the aortic valve, provided it is performed in centers with Ross procedure expertise to ensure safety and durability.”

Reference

El-Hamamsy I, Toyoda N, Itagaki S, et al. Propensity-matched comparison of the Ross procedure and prosthetic aortic valve replacement in adultsJ Am Coll Cardiol. Published online March 1, 2022. doi:10.1016/j.jacc.2021.11.057

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A proteomics-based risk model was found to be superior for predicting recurrent atherosclerotic cardiovascular disease (ASCVD) compared with a clinical risk model, according to results of a study published in the European Heart Journal.

Data for this study were sourced from the Second Manifestations of ARTerial disease (SMART) cohort which is an ongoing, prospective, single-center cohort that started in 1996, from University Medical Center Utrecht in the Netherlands. Data from individuals (n=870) who had a 10-year SMART risk score of greater than 15% and had available blood samples were used as the derivation cohort. Data for the validation cohort were sourced from the Athero-Express study, which observed 700 patients who received carotid and femoral endarterectomy in 2002 for 3 years. Using these data, a proteomic-based risk model was developed and tested for its ability to predict risk for recurrent ASCVD.

The derivation and validation cohorts were aged median 65 (IQR, 9) and 70 (IQR, 9) years; 75.5% and 68.4% were men; mean BMI was 26.9±3.9 and 26.2±3.8; and 30.2% and 18.6% of patients had recurrent ASCVD, respectively.

The relative importance of 6 of the 50 assessed proteins (N-terminal pro-brain natriuretic peptide [NT-proBNP], kidney injury molecule-1 [KIM1], matrix metallopeptidase 7 [MMP7], growth/differentiation factor-15 [GDF-15], hydroxyacid oxidase 1 [HAOX1], transforming growth factor b induced [TGFBI]) were found to be greater than 0.4.

Using the importance of these proteins, the developed proteomics model had a receiver operating characteristic (ROC) curve area under the curve (AUC) of 0.810 (95% CI, 0.797-0.823) in the derivation cohort and 0.801 (95% CI, 0.785-0.817) in the validation cohort. These values were superior to the clinical model for both the derivation (AUC, 0.750; 95% CI, 0.734-0.765) and validation (AUC, 0.765; 95% CI, 0.743-0.784) cohorts.

Combining the protein and clinical models improved the prediction among the derivation cohort (AUC, 0.824; 95% CI, 0.812-0.835) but not the validation cohort (AUC, 0.792; 95% CI, 0.771-0.811).

After recalibrating all models, the protein model outperformed the clinical model (D AUC, 0.036; 95% CI, 0.020-0.051; P <.001) and the combined model was not superior (DAUC, -0.007; 95% CI, -0.023 to 0.004; P =.996).

Stratified by low (£2 mg/L) and high (>2 mg/L) C-reactive protein (CRP) status, the top 10 most predictive proteins differed between cohorts, in which a-1-microglobulin/bikunin precursor (AMBP), nidogen 1 (NID1), vasorin (VASN), and transferrin (TF) were found to be important among patients with low CRP but not among those with high CRP.

This study may have been limited by the proteins included in the proteomics panel used.

“We show that a panel of 50 proteins is superior to a clinical risk model in predicting recurrent ASCVD events,” the study authors wrote. “…large prospective studies will have to confirm the value of proteome-based risk scores in secondary prevention before routine clinical implementation can be advocated.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Nurmohamed NS, Periera JPB, Hoogeveen RM, et al. Targeted proteomics improves cardiovascular risk prediction in secondary prevention. Eur Heart J. Published online February 9, 2022. doi:10.1093/eurheartj/ehac055

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Among patients with obstructive prosthetic valve thrombosis, low-dose and slow/ultraslow infusion of tissue plasminogen activator (tPA) were associated with low rates of complication and mortality, according to findings published in the Journal of the American College of Cardiology.

The treatment options of surgery or thrombolytic therapy (TT) for obstructive prosthetic valve thrombosis lack real-world data and randomized controlled trials. This leaves the optimal treatment for this life-threatening complication of prosthetic heart valve replacement unclear. Some major guidelines recommend reoperation for patients with obstructive left-sided prosthetic valve thrombosis, though mortality rates are as high as 18%. Researchers aimed to compare morbidity and mortality short-term outcomes of TT and surgery as the first-line treatment strategy in patients with obstructive prosthetic valve thrombosis.

To accomplish this, researchers conducted a multicenter observational prospective study of 158 adult patients (65.2% women; median age 49 years [IQR, 39-60 years]) diagnosed with prosthetic valve thrombosis in 8 tertiary centers between December 2013 and December 2020. Heart teams considered guidelines and shared decision making with patients. For centers lacking redo-valve surgery experience, TT was opted unless contraindicated. TT was administered using slow (6 hours) or ultraslow (25 hours) infusion of low-dose tPA 25 mg, mostly in repeated sessions. The primary outcome was 3-month mortality following TT or surgery.

TT was performed in 52.5% of patients and 47.5% of patients received surgery. Major criteria for TT success was measured by Doppler documentation of the complete improvement in valve hemodynamics, reduction in major diameter or area of the thrombus by 75%, and symptomatic improvement. The TT success rate was 90.4%, with a median tPA dose of 59 mg (IQR, 37.5-100 mg). Minor complications occurred in 38.7% of patients who underwent surgery and in 8.4% of patients who received TT. Major complications occurred in 41.3% of patients who received surgery and in 6% of patients who received TT. The 3-month mortality rate was 18.7% for surgery and 2.4% for TT.

Study limitations included the non-randomized observational design, that only short-term follow-up data was included, and surgical skills were not standardized. Additionally, more women were in the TT group than the surgery group, which may have led to bias.

 “Slowly administered infusions of tPA are a safe and effective alternative to surgical therapy in selected patients with obstructive mechanical heart valve prostheses,” the researchers wrote. “Surgery has a high mortality rate even in experienced centers; therefore, TT may be considered as a beneficial treatment strategy in patients with obstructive [prosthetic valve thrombosis] in the absence of contraindications.”

Reference

Özkan M, Gündüz S, Güner A, et al. Thrombolysis or surgery in patients with obstructive mechanical valve thrombosis. J Am Coll Cardiol. Published online March 7, 2022. doi:10.1016/j.jacc.2021.12.027

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Mortality among patients who develop infective endocarditis (IE) after receiving transcatheter aortic valve implantation (TAVI) was associated with patient characteristics and pathogen, not treatment strategy. These findings were published in the Journal of the American College of Cardiology.

This study evaluated data collected for the observational, multicenter, international Infections Endocarditis after TAVI International Registry. Patients (N=584) who developed TAVI-IE at 59 centers in 11 countries between 2005 and 2020 were assessed for characteristics, treatment strategy, and outcomes.

Patients were aged median 80.7 (IQR, 75.4-84.7) years, 37.5% were women, BMI was 26.9 (IQR, 24.1-30.7), TAVI implantation occurred in an operating or hybrid room for 59.9%, 88.0% had a transfemoral approach, 52.6% received a balloon-expandable prosthesis, and 93.8% had beta-lactam antibiotic prophylaxis only. Most patients received antibiotic therapy alone (n=473) and a minority underwent cardiac surgery (n=111).

Patients who were treated with surgery had an increased risk for periannular complication (hazard ratio [HR], 2.74; 95% CI, 1.73-4.34; P <.001), TAVI platform involvement (HR, 2.16; 95% CI, 1.36-3.43; P =.001), and echocardiographic vegetation (HR, 2.02; 95% CI, 1.26-3.23; P =.003).

The surgical cohort also had increased risk for IE complications of other systemic embolization (HR, 2.67; 95% CI, 1.50-4.77; P <.001), persistent bacteremia (HR, 2.27; 95% CI, 1.48-3.49; P <.001), any complication (HR, 2.16; 95% CI, 1.27-3.68; P =.004), and heart failure (HR, 2.14; 95% CI, 1.41-3.25; P <.001).

Among the surgical and antibiotic recipients, in-hospital mortality occurred in 29.1% and 32.6% (P =.420); 1-year mortality among 47.1% and 48.2% (P =.448); 2-year mortality among 56.3% and 55.0% (P =.535); and 2-year recurrence rates were 8.9% and 13.0% (P =.312), respectively.

Significant predictors of 1-year mortality were septic shock, acute renal failure, and persistent bacteremia.

Similar trends were observed among the subset of patients who did and did not have TAVI involvement.

This study was limited by the observational nature and could not account for differences in treatment decisions.

This study found that mortality following TAVI-IE was associated with patient characteristics and infectious pathogen rather than treatment received. “Moreover, because both treatment options are associated with an equal worse outcome, prevention and early diagnosis of infective endocarditis are of utmost importance,” the study authors noted.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Mangner N, del Val D, Abdel-Wahab M, et al. Surgical treatment of patients with infective endocarditis after transcatheter aortic valve implantation. J Am Coll Cardiol. Published online March 1, 2022. doi:10.1016/j.jacc.2021.11.056

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February has been designated as American Heart Month since 1964, when it was established by President Lyndon B. Johnson who asked Americans to “give heed to the nationwide problem of the heart and blood-vessel diseases, and to support the programs required to bring about its solution.”¹ 

While research and initiatives have made strides in the ensuing 58 years, cardiovascular disease (CVD) is still the leading cause of death among American men, women, and people of most racial and ethnic groups. One in every 4 deaths each year are because of CVD.²

Examining the Link Between Gout and Cardiac Disease

Gout, the most common inflammatory arthritis in adults,³ is associated with higher CV morbidity and mortality. Hypertension, smoking, diabetes mellitus, dyslipidemia, age, and obesity are risk factors for CVD, which are common comorbidities in patients with gout.⁴

In addition, inflammation has emerged as a risk factor for the development of early coronary artery disease, and possibly, acute CV events, such as myocardial infarction (MI). High uric acid that leads to chronic inflammation can potentially contribute to associated higher CV burden in gout. Evidence supports an increased CVD risk in inflammatory conditions, such as gout.^5,6

The attributable risk proportion of CVD to gout may far exceed any other rheumatic diseases. This is particularly important when considering recent data demonstrating the rising incidence and prevalence of gout.⁷

Increased serum urate (SU) levels, or hyperuricemia, are a precursor to gout. Therefore, ULT use in gout may decrease systemic inflammation, generation of oxidative species, and reverse endothelial dysfunction via hyperuricemia-dependent or -independent pathways.

In a 2019 review, Gupta and colleagues reviewed data to better understand the increased burden of CVD among patients with gout, the potential underlying mechanisms (including hyperuricemia, inflammation, endothelial dysfunction, and oxidative stress) and the effect of ULT on CVD risk reduction.⁸

Untreated gout may be associated with higher CV event and mortality risk than treated gout.⁹ Other systemic markers of inflammation are also associated with increased SU, such as increased levels of C-reactive protein (CRP), tumor necrosis factor, and interleukin (IL)-1, which, in turn, lead to a greater risk for adverse CV outcomes.^6,10 Inflammation results in increased oxidative stress, which is linked to atherogenesis.¹¹ Through this production, oxidative species are reactive in endothelial cells and activation of xanthine oxidase, which further propagates the production of harmful free radicals. These free radicals lead to increased oxidization of low-density lipoproteins in inflammatory conditions, such as gout, and have been associated with CVD. Other inflammatory conditions that bear similarity to gout with regard to chronic inflammation, such as lupus and rheumatoid arthritis, have been linked to incident CVD.

Does Gout Confer Greater Risk for Cardiac Disease? How Can Providers Address This?

The risk may be modifiable. When targeting systemic markers of inflammation, the risk for CV events has been shown to decrease, as seen in the Canakinumab Anti-Inflammatory Thrombosis Outcome Study (CANTOS; ClinicalTrials.gov Identifier: NCT01327846).⁶ Several underlying mechanisms of CVD have been hypothesized in gout, including hyperuricemia-associated endothelial dysfunction by impaired nitric oxide-mediated vasodilation, increased oxidized low-density lipoproteins, dyslipidemia, and/or acute and chronic inflammation. Use of ULT and/or colchicine (anti-inflammatory) has the potential to modify this CV risk.¹⁰

From a study that demonstrated a reduced risk for recurrent MI and a decrease in CV mortality with the use of IL-1 inhibitor canakinumab, the increased risk for fatal infections was a cause for concern.⁶ A further understanding of the risk/benefit of these medications for the improvement of cardiac outcomes in the general population and their appropriate use in gout to improve CV outcomes are needed.

While a diagnosis of hyperuricemia or gout confers a greater risk for CVD, further evidence is necessary to examine whether gout, like smoking and diabetes, is an equivalent risk factor for CVD.⁸ Patients with gout do, however, have higher incidence of CVD, therefore aggressive screening and treatment of gout should occur routinely in primary care settings. With such preventative measures, patients with gout have the potential to see improved outcomes.

Treating gout with allopurinol can include cardioprotective benefits such as potential reduction in the risk for MI, stroke, atrial fibrillation, and other CVDs, as seen in observational studies in select populations. These studies have shown that a longer duration of ULT use (≥2 years) may be needed to decrease CVD-specific morbidity.^12,13 However, randomized controlled trials (RCTs) are required to validate findings of observational studies and determine which subgroup populations of gout are most likely to benefit from appropriate long-term urate lowering with ULTs.

In conclusion, comorbidities associated with gout, chronic and recurrent acute inflammation, as well as oxidative stress, are all likely to contribute to the pathogenesis of CVD. Anti-inflammatory agents may decrease CVD not only in the general population, but also in people with chronic inflammatory conditions.

Once a diagnosis of gout is conferred, care providers should commence gout treatment quickly as inflammation plays an important role in cardiac disease. Well-designed RCTs are needed to test these hypotheses generated from observational studies regarding the higher risk of CV disease in gout.

References

1. Harold JG. The evolution of American Heart Month. American College of Cardiology. Published February 23, 2017. Accessed February 10, 2022. https://www.acc.org/latest-in-cardiology/articles/2017/02/21/12/42/the-evolution-of-american-heart-month
2. Centers for Disease Control and Prevention. Underlying cause of death, 1999-2018. CDC WONDER Online Database. Atlanta, GA. Published online 2018. Accessed February 10, 2022.
3. Bardin T, Richette P. Impact of comorbidities on gout and hyperuricaemia: an update on prevalence and treatment options. BMC Med. 2017;15:123. doi:10.1186/s12916-017-0890-9
4. Choi HK, Curhan G. Independent impact of gout on mortality and risk for coronary heart disease. Circulation. 2007;116:894-900. doi:10.1161/CIRCULATIONAHA.107.703389
5. Krishnan E, Baker JF, Furst DE, Schumacher HR. Gout and the risk of acute myocardial infarction. Arthritis Rheumatol. 2006;54:2688-2696. doi:10.1002/art.22014
6. Ridker PM, Everett BM, Thuren T, et al. Anti-inflammatory therapy with canakinumab for atherosclerotic disease. N Engl J Med. 2017;377:1119-1131. doi:10.1056/NEJMoa1707914
7. Zhu Y, Pandya BJ, Choi HK. Prevalence of gout and hyperuricemia in the US general population: the National Health and Nutrition Examination Survey 2007-2008. Arthritis Rheumatol. 2011;63:3136-3141. doi:10.1002/art.30520
8. Gupta MK, Singh JA. Cardiovascular disease in gout and the protective effect of treatments including urate-lowering therapy. Drugs. 2019;79:531-541. doi:10.1007/s40265-019-01081-5
9. Pérez Ruiz F, Richette P, Stack AG, et al. Failure to reach uric acid target of <0.36 mmol/L in hyperuricaemia of gout is associated with elevated total and cardiovascular mortality. RMD Open. 2019;5. doi:10.1136/rmdopen-2019-001015
10. Jalal DI, Jablonski KL, McFann K, Chonchol MB, Seals DR. Vascular endothelial function is not related to serum uric acid in healthy adults. Am J Hypertens. 2012;25:407-413. doi:10.1038/ajh.2011.237
11. Kotur-Stevuljevic J, Memon L, Stefanovic A, et al. Correlation of oxidative stress parameters and inflammatory markers in coronary artery disease patients. Clin Biochem. 2007;40:181-187. doi:10.1016/j.clinbiochem.2006.09.007
12. Singh JA, Cleveland J. Allopurinol and the risk of incident peripheral arterial disease in the elderly: a US Medicare claims data study. Rheumatology (Oxford). 2018;57(3):451-461. doi:10.1093/rheumatology/kex232
13. Singh JA, Yu S. Allopurinol and the risk of atrial fibrillation in the elderly: a study using Medicare data. Ann Rheum Dis. 2017;76(1):72-78. doi:10.1136/annrheumdis-2015-209008

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Among the various cardiovascular sequalae associated with COVID-19, an increase in the number of cases of stress cardiomyopathy – also referred to as Takotsubo syndrome (TTS) – have been reported since the pandemic began. According to the results of a cohort study (N=1,914) published in July 2020 in JAMA Network Open, the incidence of stress cardiomyopathy increased roughly 4-fold in the early months of the pandemic, from 1.5%-1.8% to 7.8%.¹

Risk Factors and Diagnosis

The growing number of TTS cases has been attributed both to the pathophysiology of COVID-19 infection and the multiple stressors related to the pandemic. In a study by Chang et al, COVID-19 infection was present in 66.7% of patients, while emotional triggers, psychiatric disorders, and neurologic disorders were reported in 33.3%, 12.1%, and 6.1% of patients, respectively.²

“Clearly being infected and its health sequela predominate, but also fear of infection, changes in lifestyle, loss of employment, grief of loss, and social isolation for prolonged periods are all involved,” explained Dr Eduardo de Marchena, MD, FACC, FACP, FSCAI, associate dean for international medicine, professor of medicine and surgery, and director of interventional cardiology at the University of Miami Miler School of Medicine in Miami.

Some findings indicate a slight shift in predisposing factors for TTS during vs before the pandemic. While TTS has traditionally occurred primarily in older women with psychiatric or neurologic disorders, with psychological stress as the triggering factor, it has been “increasingly reported in the setting of physical stress (mostly COVID-19 pneumonia)–triggered male patients without psychiatric/neurologic disorders,” Chang et al stated.²

Nonetheless, the link between TTS and elevated levels of stress and anxiety is well-established. The increase in TTS cases more likely stems from the psychological, social, and economic distress related to the pandemic rather than direct mechanisms of viral involvement.¹

Dr de Marchena notes the importance of remaining vigilant to the possibility of a TTS diagnosis, as the condition may present with nonspecific symptoms. TTS may be misdiagnosed as acute coronary syndrome (ACS) due to shared symptoms, including chest pain and dyspnea, along with signs of myocardial injury or ischemia on ECG and troponin elevations.^3,4 The International Takotsubo (InterTAK) syndrome diagnostic criteria are used in the diagnosis of TTS, with coronary angiography representing the gold standard diagnostic tool in differentiating between TTS and ACS.^5,4

Typical Outcomes

Limited findings have indicated high rates of complications and mortality in patients presenting with TTS among these recent cases. In a 2021 study of 123 patients with TTS, Chang et al found an overall in-hospital mortality rate of 23.3%, with higher mortality observed among men (38.7%) compared with women (13.9%).² The prognosis is generally more favorable in patients with primary TTS (presenting for treatment due to TTS symptoms, usually with a clearly identifiable emotional trigger) compared to those with secondary TTS due to serious underlying illness or injury.⁴

Overall, TTS is “generally a transient disorder that is managed with supportive therapy,” said Dr Ahmad Jabri, MD, a cardiology fellow at MetroHealth in Cleveland, Ohio who served as lead author of the JAMA Network Open study while he was with the Cleveland Clinic.¹ “Conservative treatment and resolution of the physical or emotional stress usually result in rapid resolution of symptoms, although some patients develop acute complications such as shock and acute heart failure that require intensive therapy.”

In February 2021, Dr de Marchena and colleagues published a case report describing 2 elderly women who presented with chest pain and ACS, who were ultimately diagnosed with stress cardiomyopathy triggered by increased pandemic-related emotional stress.⁶ The patients were treated with beta blockers and anxiolytics, and 1-month follow-up showed resolution on ECG, thus confirming these cases to be stress-mediated.

Another group reported a TTS patient who developed the symptoms of chest pain and dyspnea while watching an anxiety-provoking news program about the COVID-19 pandemic. “Symptoms resolved during the first few hours of hospitalization… [and she] was discharged with prescription of metoprolol and apixaban,” the authors wrote.⁴ “A follow-up echocardiogram 1 month later was entirely normal, with left ventricular ejection fraction of 75% and resolution of all previous anomalies including wall motion abnormalities, systolic anterior motion, and dynamic outflow tract gradient.”

A similar case report described a 71-year-old woman with TTS that appeared to be related to social isolation and emotional stressors related to reduced family contact during the pandemic.⁷

Key Considerations and Next Steps

“We should also question our patients about life stressors and encourage socialization either virtually or with safe in-person contact,” Dr de Marchena advised. “Obviously the effect of job loss, family tensions, and other issues are difficult to quantitate but should be discussed with patients, and social workers and community organizations can greatly assist in these areas as well.” 

He pointed to the need for urgent measures to help high-risk patients cope with ongoing stressors and thus potentially prevent the occurrence of TTS. Additional research is warranted to elucidate the mechanisms of TTS, as well as strategies for early recognition and treatment with both pharmacotherapy and psychotherapy.

“Research should also be done to gain insights into potential causes, such as adverse changes in population-scale mental health,” Dr Jabri added. “Such research may document a need for interventions to protect the emotional health of communities during widespread disasters.”

References

1. Jabri A, Kalra A, Kumar A, et al. Incidence of stress cardiomyopathy during the coronavirus disease 2019 pandemic. JAMA Netw Open. Published online July 9, 2020. doi:10.1001/jamanetworkopen.2020.14780
2. Chang A, Wang YG, Jayanna MB, Wu X, Cadaret LM, Liu K. Mortality correlates in patients with Takotsubo syndrome during the COVID-19 pandemic. Mayo Clin Proc Innov Qual Outcomes. 2021;5(6):1050-1055. doi:10.1016/j.mayocpiqo.2021.09.008
3. Casagrande M, Forte G, Favieri F, et al. The broken heart: The role of life events in Takotsubo syndrome. J Clin Med. 2021;10(21):4940. doi:10.3390/jcm10214940
4. O’Keefe EL, Torres-Acosta N, O’Keefe JH, Sturgess JE, Lavie CJ, Bybee KA. Takotsubo syndrome: Cardiotoxic stress in the COVID era. Mayo Clin Proc Innov Qual Outcomes. 2020;4(6):775-785. doi:10.1016/j.mayocpiqo.2020.08.008
5. Ghadri JR, Wittstein IS, Prasad A, et al. International Expert Consensus Document on Takotsubo Syndrome (Part I): Clinical Characteristics, Diagnostic Criteria, and Pathophysiology. Eur Heart J. 2018;39(22):2032-2046. doi:10.1093/eurheartj/ehy076
6. Kir D, Beer N, De Marchena EJ. Takotsubo cardiomyopathy caused by emotional stressors in the coronavirus disease 2019 (COVID-19) pandemic era. J Card Surg. Published online December 18, 2021. doi:10.1111/jocs.15251
7. Rivers J, Ihle JF. COVID-19 social isolation-induced takotsubo cardiomyopathy. Med J Aust. Published online September 9, 2020. doi:10.5694/mja2.50770

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HealthDay News — Neighborhood-level socioeconomic status (SES) significantly predicts mortality and repair rate in patients undergoing isolated mitral valve surgery for degenerative disease, according to a study presented at the annual meeting of The Society of Thoracic Surgeons (STS), held virtually from Jan. 29 to 30.

Amit Iyengar, M.D., from the University of Pennsylvania in Philadelphia, and colleagues used data from the STS Adult Cardiac Surgery Database between 2012 and 2018 to identify 46,183 adults undergoing first-time, isolated mitral valve surgery for degenerative mitral disease. Patients’ SES was estimated utilizing the 2018 Area Deprivation Index (ADI) at a census block group level.

The researchers found that high-SES patients had more elective presentations (88 versus 82 percent) and less urgent surgery (13 versus 21 percent). Patients with higher SES tended to travel farther to receive surgery (33 versus 17 miles) and receive operations from higher-volume surgeons (62 versus 31 cases/year). Furthermore, high SES was associated with a higher repair rate (82.8 versus 65.3 percent), more minimally invasive approach (39 versus 24 percent), lower composite complication rate (40 versus 48 percent), and lower 30-day mortality (1.3 versus 2.9 percent). ADI significantly predicted 30-day mortality and repair rate in an adjusted analysis.

“Neighborhood SES is associated with differing valve pathologies and presentations,” Iyengar said in a statement. “Clinically, the extremes of SES represent two differing patient populations — elective degenerative pathology (high SES) and more urgent, nondegenerative pathology (low SES).”

Press Release

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