Novartis has voluntarily recalled 1 lot of Sandimmune^® Oral Solution (cyclosporine oral solution, USP), 100mg/mL due to crystal formation observed in certain bottles that may lead to incorrect dosing.

Sandimmune^® Oral Solution is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants, in combination with corticosteroids. It is also indicated for the treatment of chronic rejection in patients previously treated with other immunosuppressants. 

The recalled product, packaged in 50mL bottles, was distributed nationwide to wholesalers across the United States starting in April 2023, and includes lot number FX001691 (expiration date 12/2025). 

Use of the affected product can potentially lead to underdosing or overdosing due to non-uniform distribution of cyclosporine. To date, the Company has not received any reports of adverse events related to this recall.

Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.

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The Solid Organ Transplantation on Prevention of Influenza was a double-blind, multicenter, randomized, superiority clinical trial that ran for 2 consecutive influenza seasons (2018-2020) in Switzerland and Spain. Researchers randomly assigned SOT recipients 1:1:1 by transplanted organ and time since transplantation to 3 cohorts. Patients in the first cohort (n=204) received the standard influenza vaccine, those in the second cohort (n=209) received the MF59-adjuvanted vaccine, and those in the third cohort (n=203) received the high-dose vaccine. All patients were enrolled at least 3 months post-transplantation. The researchers performed immunogenicity and anti-human leucocyte antigen (HLA) antibodies analysis on days 28 and 180 after vaccination.

The primary outcome was the rate of seroconversion (ie, vaccine response) for at least 1 viral influenza strain on day 28, defined as a 4-fold increase in hemagglutination-inhibition titers from baseline. Bonferroni-Holm adjustment was used to compare the vaccines.

Patients in the MF59-adjuvanted and high-dose vaccine cohorts had higher median post-transplantation times (49 and 57 months, respectively) compared with those in the standard vaccine cohort (50 months). Overall, most patients were men, the median age was 58 years, and the most common transplanted organs were the kidney (range, 67%-69%) and liver (range, 14%-22%).

At day 28, the vaccine response rate was highest among patients in the high-dose vaccine cohort (66%), followed by those in the MF59-adjuvanted (60%) and standard dose (42%) vaccine cohorts. Response rates were not significantly different between patients in the intervention cohorts (difference, 0.07; 95% CI, -0.01 to 1; P =.085).

Patients in the MF59-adjuvanted and high-dose vaccine cohorts had higher rates of adverse events (AEs; 84% and 86%, respectively) compared with those in the standard vaccine cohort (59%). However, most AEs were mild and self-limited. There was only 1 vaccine-related severe AE, which occurred in a high-dose vaccine recipient The most common localized events were pain and edema at the injection site, whereas the most common systemic AEs were fatigue and headache.

Low rates of de novo anti-HLA antibodies and biopsy-confirmed acute rejection were noted among all patients.

Limitations of the study include the researchers not measuring influenza specific cell-mediated immunity, the small sample size, and an overrepresented sample of kidney transplant recipients.

According to the researchers, “Our results provide evidence suggesting that these vaccines are preferable to the standard vaccine for preventing influenza in SOT recipients.”

Disclosure: Multiple 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 assess predictors of early CAV progression by characterizing first-year posttransplant anatomic-physiologic changes in the coronary vasculature.

They conducted a prospective study (ClinicalTrials.gov Identifier: NCT03217786) from January 2018 to March 2021 at the University of Ottawa Heart Institute, Ottawa, Canada, and the University Health Network, Toronto, Canada. The study included 82 adult heart transplant (HT) patients (mean age, 51 years; 40% women). Participants received index microcirculatory resistance measurements, coronary flow reserve measurements, fractional flow reserve measurements, optical coherence tomography, angiography, and left anterior descending artery intravascular ultrasound prospective assessment at 3 months (mean 13.8 weeks posttransplant) and 12 months (mean 56.3 weeks) posttransplant.

Intravascular ultrasound change in percentage intimal volume from baseline to 12-month follow-up was used to evaluate CAV progression. Most common indications for transplant were ischemic cardiomyopathy (23%) and dilated cardiomyopathy (28%). Patients with difficult arterial vascular access, allergy to iodinated contrast, contraindications to invasive coronary evaluation, or who died within 3 months of transplant were excluded.

The investigators found that in 50% of patients, donor atherosclerosis (baseline intravascular ultrasound maximal intimal thickness, ≥0.5 mm) was present. Rapidly progressive CAV (maximal intimal thickness, ≥0.5-mm increase from baseline) developed in 13% of patients. De novo CAV (follow-up maximal intimal thickness, ≥0.5mm) developed in 24% of patients.

Lumen volume decreased 9% (-1.02 mm³/mm), vessel volume decreased 4% (-0.50 mm³/mm), percentage intimal volume increased 44% (4.6%), and baseline to follow-up median intimal volume increased 42% (0.58 mm³/mm) on optical coherence tomography. Between baseline and follow-up, there was no significant change in median coronary flow reserve, index of microcirculatory resistance, or fractional flow reserve.

At baseline angiographic disease was found in 11% of patients and, at follow-up, in 22% of patients. Investigators noted 18% median maximum vessel stenosis at baseline and 21% at follow-up. Between the 3 major coronary artery territories, they found no significant difference in disease progression (P =.52).

Predominant morphology was fibrotic plaque (baseline, 29%; follow-up, 50%). One in 5 patients had microvascular dysfunction (index of microcirculatory resistance, ≥25), with 41% of patients at baseline and 45% at follow-up with abnormal coronary physiology. Independent predictors of coronary disease progression included index of microcirculatory resistance, fibrotic plaque, and recipient male sex on multivariable linear regression analysis.

Study limitations include the underpowered sample size, and that baseline assessment at 3 months does not compare with baseline in most other posttransplant studies. The intracoronary assessment is only in the left anterior descending artery, and the follow-up range is too short.

“Fibrotic plaque on optical coherence tomography and index of microcirculatory resistance early posttransplant predict CAV progression in the first year of transplantation,” the investigators wrote. “Serial intracoronary imaging and physiologic assessment in the first year of heart transplantation demonstrate proportionally greater intimal plaque expansion than vessel constriction and lumen reduction, predominant fibrotic plaque morphology, and microvascular dysfunction affecting 1 in 5 patients.” The investigators believe that following heart transplantation, patients with microvascular dysfunction and fibrotic plaque at risk of early cardiac allograft vasculopathy progression can be identified with early examination using measurement of index of  microcirculatory resistance and optical coherence tomography.

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 compared the effects of statin use and nonuse among 57,699 kidney transplant recipients on Medicare from the United States Renal Data System. Post-transplant diabetes mellitus occurred within 5 years in 43% of statin users and 35% of nonusers, Mara A. McAdams-DeMarco, PhD, of the NYU Grossman School of Medicine in New York, New York, and colleagues reported in the Clinical Journal of the American Society of Nephrology. The incidence rates of cataracts (22% vs 12%), hemorrhagic stroke (1.9% vs 1.4%), and rhabdomyolysis (1.5% vs 0.9%) were also higher among statin users. Liver injury occurred in a lower proportion of statin users (2% vs 3%), the investigators reported.

In multivariable analysis, statin use was significantly associated with a 12% higher risk of post-transplant diabetes mellitus, a 22% higher risk of cataracts, and a 37% higher risk of rhabdomyolysis. Statin use was significantly associated with an 18% lower risk of liver injury. Use of the drugs was not associated with hemorrhagic stroke. These associations did not differ by statin type.

The investigators adjusted the models for induction and maintenance immunosuppression agents.

“Although statins seem to be generally well tolerated in kidney transplant recipients with a safety profile similar to that in the general population, the potential effect of statins on post-transplant diabetes mellitus may warrant caution in recipients with high diabetes risk,” Dr McAdams-DeMarco’s team wrote.

Statins included atorvastatin, pravastatin, simvastatin, rosuvastatin, lovastatin, pitavastatin, and fluvastatin. Recipients who used multiple statins or other lipid-lowering agents were excluded from the study.

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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Tarek Alhamad, MD, MS, of Washington University School of Medicine in St Louis, Missouri, and colleagues studied national trends using 2020-2023 US transplant registry data from 35,851 deceased donors (71,334 kidneys) and 45,912 adult recipients. Active COVID-19 was defined as a positive donor SARS-CoV-2 nucleic acid amplification test (NAT) result within 7 days of procurement and resolved COVID-19 as any COVID-19 positive test more than 7 days before procurement.

The risks for graft failure and death within 2 years of transplantation were no higher for recipients of kidneys from deceased donors with active or resolved COVID-19 than for recipients of kidneys without COVID-19 infection, the investigators reported in JAMA Network Open. Donor COVID-19 positivity also was not significantly associated with greater risk of delayed graft function, acute rejection, or longer hospital stay.

Nonuse of kidneys from COVID-19-positive donors decreased over time, the team reported. Overall, the likelihood of kidney nonuse was 1.6- and 1.3-fold higher for active and resolved COVID-19-positive donors than for negative donors. For active COVID-19 donor kidneys, the odds of nonuse significantly decreased from 11.3-fold in 2020 to 2.1-fold in 2021 to 1.5-fold in 2022. For resolved COVID-19 donor kidneys, the odds of nonuse significantly decreased from 3.9-fold in 2020 to 1.9-fold in 2021. By 2023, use of kidneys from active and resolved COVID-19 donors was similar to that of negative donors, the investigators reported.

“Our findings offer robust evidence suggesting that the use of kidneys from COVID-19–positive donors is safe during medium-term follow-up; however, longer-term follow-up is necessary to further validate this practice,” according to Dr Alhamad’s team.

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Shivank Madan, M.D., from Montefiore Medical Center and Albert Einstein College of Medicine in Bronx, New York, and colleagues examined data for HT using COVID-19 donors. A total of 27,892 donors were identified between May 2020 and June 2022 with 60,699 COVID-19 nucleic acid amplification tests (NAT). Donors were considered COVID-19 donors if they were NAT-positive at any time during hospitalization and were further classified as active-COVID-19 (aCOV) if NAT-positive within two days of organ procurement and recently resolved COVID-19 (rrCOV) if initially NAT-positive but became NAT-negative before procurement. A total of 1,445 COVID-19 NAT-positive donors were identified: 1,017 aCOV and 428 rrCOV. Overall, 239 adult-HT recipients from COVID-19 donors met the inclusion criteria (150 aCOV; 89 rrCOV).

COVID-19 donors were younger and mostly male compared with non-COVID-19 donors. The researchers found that HTs from aCOV donors had increased mortality at six months and one year compared with HTs from non-COVID-19 donors (hazard ratios, 1.74 and 1.98, respectively). Similar six-month and one-year mortality was seen for rrCOV and non-COVID-19 donors. In propensity-matched cohorts, the results were similar.

“These early trends should be concerning enough such that heart transplantation centers need to thoroughly evaluate and continue to weigh the risks/benefits of using hearts from active COVID-19 donors,” Madan said in a statement.

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

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“We determined that during the COVID-19 pandemic, financial burden was prevalent among adult BMT survivors and high out-of-pocket medical costs were associated with high financial burden,” the study investigators wrote in their report. The investigators had sought to determine how survivors of BMT have been impacted financially during the COVID-19 pandemic.

The study included adult participants of a survey of the BMT Survivor Study (BMTSS), which had been a retrospective cohort study that included prospective follow-up. The BMTSS evaluated numerous characteristics and outcomes in survivors of BMT.

The current study involved a survey to evaluate out-of-pocket medical costs and financial burden in BMTSS participants during the COVID-19 pandemic, as well as these factors for a sibling comparison group. High out-of-pocket medical costs were characterized by having medical expenses that totaled 10% or more of annual household income.

The current analysis involved 2370 survivors of BMT and 750 of their siblings. Among survivors of BMT, it was reported that 11.3% had high out-of-pocket medical costs, compared with 3.1% of siblings (adjusted odds ratio [aOR], 2.88; 95% CI, 1.84-4.50). Among survivors, several factors were linked to having high out-of-pocket medical costs, such as demographic and clinical characteristics, chronic health conditions, employment status during the pandemic, and others.  

High out-of-pocket medical costs in BMT survivors were linked to several indicators of financial challenge. Some of these included having difficulty with paying medical bills (aOR, 10.57; 95% CI, 7.39-15.11), taking a lower medication dose than prescribed (aOR, 4.99; 95%CI, 3.23-7.70), deferring medical care (aOR, 4.93; 95% CI, 3.71-6.55), thinking about filing bankruptcy (aOR, 3.80; 95% CI, 2.14-6.73), and others.

The investigators concluded that financial burden in association with high out-of-pocket medical costs has appeared common in BMT survivors of this study during the COVID-19 pandemic, and these costs could lead to choices with negative impacts on health. “The protracted nature of financial stress in patients with cancer makes it critical to follow this vulnerable population for long-term consequences,” the study investigators wrote in their report.

Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.

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Bronchiolitis obliterans syndrome, a subtype of chronic graft vs host disease (GVHD), is noted in about 10% of ASCT attempts, and is linked with poor clinical outcomes. Although azithromycin has been used to prevent bronchiolitis obliterans post-lung transplantation, a randomized phase 3 trial linked this treatment with a greater risk of relapse-related mortality.

Samples from the randomized ALLOZITHRO trial (ClinicalTrials.gov Identifier: NCT01959100), however, present the opportunity to evaluate the biochemical mechanisms through which azithromycin promotes relapse. For this study, researchers evaluated immune and metabolic function from samples of patients enrolled to ALLOZITHRO to determine how azithromycin increases relapse risk after ASCT.

The authors relied on multi-omics to evaluate 240 patient samples, of whom 123 were randomly assigned to receive azithromycin whereas 117 received placebo. Other characteristics were balanced on randomization between the 2 groups in the ALLOZITHRO study.

The analysis showed that, compared with placebo, azithromycin was linked with altered energy metabolism pathways and altered immune subsets; these included T cells that exhibited exhausted profiles.

In an in vitro study, azithromycin was also linked with exposure inhibited-T cell cytotoxicity, specifically against tumor cells, as well as glycolysis inhibition with consequently impaired T cell metabolism.

Up-regulation of immunomodulatory genes, including SOCS1, was also noted. “Our results raise the question of the safety of using this treatment in patients at risk of cancer, such as patients with chronic obstructive pulmonary disease,” the authors wrote in their report.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of authors’ disclosures. 

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Focusing on Organ Procurement Organization performance at individual hospitals could eliminate the shortage of heart, liver, and lungs and increase the kidney supply, according to Seth J. Karp, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, and colleagues.

The investigators compared donor potential to actual donors in a cross-sectional study of 2 Organ Procurement Organizations representing 13 hospitals in 2 donor service areas. They reviewed 2008 medical records of deceased patients from 2017-2018 to estimate 8925 total individual inpatient deaths. Based on their estimates, they identified 931 potential donors at these hospitals with ventilation or causes of deaths consistent with donation. The actual number of donors was 242.

The rate of conversion of potential donors into actual donors among the 13 hospitals ranged from 0% to 51%. One of the Organ Procurement Organization obtained organs from 48.2% of potential donors, whereas the other organization obtained organs from only 18.8% of potential donors.

“The performance of the OPOs was moderately related to referrals of ventilated patients and not related to [transplant] center acceptance practices,” Dr Karp’s team noted.

“We therefore conclude that the vast majority of missing donors arise in the space between the [OPO] referral and [transplant] center acceptance.”

According to the investigators, these findings support Centers for Medicare & Medicaid Services’ Organ Procurement Organization oversight measures and congressional calls for OPO process data to increase transparency.

In an accompanying editorial, Jayme E. Locke, MD, MPH, and Robert M. Cannon, MD, MS, of the University of Alabama at Birmingham Heersink School of Medicine, commented:

“This important study by Johnson and colleagues shines some light in only a very small corner of the OPO world. The time for the sun to shine on the whole world of organ donation through the development of a comprehensive, mandatory, and publicly available data source relevant to OPO performance is long past overdue.”

Disclosure: One study author 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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Among 79,334 adult first-time kidney transplant recipients during 2012 to 2014 in the US Renal Data System, 4604 (5.8%) experienced the primary composite outcome of death or acute myocardial infarction within 30 days of transplantation.

Varying proportions of patients underwent nonurgent CHD testing (invasive or noninvasive) during the 12 months before kidney transplantation. Examples of testing included stress electrocardiogram or echocardiogram or coronary angiography. During the most recent era studied, 2012-2014, the pretransplant CHD testing rate was 56% vs 24% among transplant programs in the top and bottom quintiles of testing intensity, respectively. Investigators observed similar testing patterns in the earlier eras.

Analyses revealed that pretransplant CHD testing did not significantly reduce the rate of the primary outcome during 2012-2014, 2008-2011, or 2004-2007, Xingxing S. Cheng, MD, MS, of Stanford University School of Medicine in Palo Alto, California, and colleagues reported in JAMA Internal Medicine. In 2000-2003, the investigators found a slight increase in the primary outcome with CHD testing. The finding might be attributable to use of bare metal stents. The FDA approved the first drug-eluting stent in 2003.

Some members of the nephrology and transplant community have suggested de-escalating CHD screening in asymptomatic kidney transplant candidates. In a JAMA interview, Dr Cheng supported risk stratification.

“The study findings potentially challenge the ubiquity of CHD testing before kidney transplant and should be confirmed in interventional studies,” according Dr Cheng’s team.

The ISCHEMIA-CKD trial similarly found that invasive CHD testing involving coronary angiography followed by revascularization did not benefit asymptomatic patients with advanced chronic kidney disease and stable coronary heart disease.

The post Coronary Heart Disease Testing Before Kidney Transplantation May Be Unwarranted appeared first on The Cardiology Advisor.

Researchers sought to evaluate the first genetically modified porcine-to-human cardiac xenotransplantation to take place worldwide.

In January 2022, at the University of Maryland, a recipient received the first ever genetically modified porcine-to-human cardiac xenotransplantation. The researchers collected daily 12-lead ECGs during the post-operative period, and the recipient survived for 61 days.

“Pig heart-in-pig body” accepted parameters included a short pulse rate (PR) interval (50-120 milliseconds [ms]), short QRS duration (70-90 ms), and short QT interval for repolarization (260-380 ms). In the genetically modified heart xenotransplant (“pig heart-in-human body”) the first ever ECG showed a longer PR interval (190 ms), QRS duration (138 ms), and QT interval (538 ms) in the setting of sinus bradycardia, interventricular conduction dela,y and inferior/antero-lateral T wave inversions.

The researchers noted that during the post-operative period, the prolonged PR intervals remained stable (210±22 ms; range, 142-246 ms). Decremental intra-atrial conduction delay/AV-conduction delay was observed in atrial pacing, most pronounced on day 12 (PR, 380ms).

They found that, during the post-operative course, the QRS duration had remained prolonged with 145±16 ms (range, 116-192 ms) shortened (day 21-40 [148±14 ms] vs day 41-60 [132±11 ms]; P <.001). They noted the persistence of the increased QT 509±54 ms (range, 384-650 ms) with dynamic fluctuations (QT low-point) around day 14 (428±22 ms vs 533±36 ms; P <.001). 

“ECG parameters of the first genetically modified porcine-to-human cardiac xenotransplant (‘pig heart-in-human body’) demonstrated prolongation over the usually encountered ECG measurements in the donor (‘pig heart-in-pig body’) including changes in cardiac depolarization and repolarization,” the researchers wrote.  “Prolonged ECG parameters persisted but showed dynamic changes during post-operative period.” Their results suggest a multifaceted relationship between porcine denervation and interspecies physiology.

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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Researchers conducted a retrospective study to evaluate the prevalence of long-term complications following COVID-19 infection among adults who were SOT recipients. Included patients were hospitalized with COVID-19 infection at a single center between March and May 2020. Outcomes assessed included mortality, allograft rejection, allograft failure, secondary infection, COVID-19 reinfection, complications post-COVID-19 infection, and long COVID-19 symptoms. The follow-up period was 2 years.

Among 117 patients hospitalized with COVID-19 infection during the first wave of the pandemic, 94 were included in the analysis. Of these patients, the median age was 57 (IQR, 48.25-68) years, 62 were men, 39 were White, and the median duration of follow-up after COVID-19 diagnosis was 751 (IQR, 742-760) days.

Following receipt of COVID-19 diagnosis, mortality occurred among 9 patients within 1 year and 14 patients within 2 years. In addition, 21 patients experienced at least 1 episode of allograft rejection and 21 experienced allograft failure.

Secondary infections were observed among 43 patients, of whom 18 were infected with multidrug-resistant organisms and 12 were infected with cytomegalovirus. Other complications following COVID-19 infection observed among the patients included the need for prolonged supplemental oxygen (n=8), new cardiovascular disease (n=25), and new chronic kidney disease or end-stage kidney disease (n=32).

Of 11 patients who were reinfected with COVID-19, the median duration between initial infection and reinfection was 603 (IQR, 389-642) days. The most likely causative variant of reinfection was the Omicron variant (n=5), followed by the Delta (n=3) and Alpha (n=3) variants.

The most commonly reported long COVID-19 symptoms included fatigue in 26 patients, dyspnea in 18, and cough in 11. During the study period, 45 patients received 3 or more COVID-19 vaccine doses, 21 received 2 vaccine doses, and 1 patient received 1 vaccine dose. COVID-19 vaccination history was unknown for the remaining 14 patients.

In regard to complications following COVID-19 infection, “Ongoing study of the impact of these complications will be crucial to improving outcomes in SOT recipients,” the researchers concluded.

Disclosures: Some authors reported affiliations with the pharmaceutical industry. Please see the reference for a full list of disclosures.

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Researchers aimed to characterize the development of skin cancers among organ transplant recipients, evaluating patterns of additional skin cancer development by transplanted organ type and patient age. The main outcomes were represented by the differences in rates of skin cancer development in first and subsequent skin cancers and a comparison based on transplant organ type and patient age for rates of skin cancer development.

Researchers conducted a single-center retrospective cohort study using electronic health record data at Vanderbilt University Medical Center, Nashville, Tennessee, a tertiary care academic medical center, to identify 5129 adult (>18 years of age) organ transplant recipients (mean 51.3±12.9 years of age) who underwent transplant surgery from 1992 through 2017. Only White patients (35.9% women) were included in this study as, according to researchers, based on phenotype, White patients have the greatest skin cancer risk. Additional inclusion criteria included patients with at least 25 billing codes in electronic records and those with data on immunosuppressants.

Researchers observed at least 1 skin cancer developed in 695 patients (13.6%) and overall, 6842 skin cancers were identified in this cohort. They found patients with skin cancer vs patients without skin cancer to be older (64.8 years vs 57.2 years), transplanted at an older age (53.7 vs 50.9), and have a longer follow-up after transplant (11.0 years vs 5.9 years) and all P <.001.

They noted at least 1 skin cancer was more likely to develop in lung (17.7%), kidney (16.5%), or heart (16.1%) recipients than in liver transplant (6.8%) recipients (χ² test, 25.6; degrees of freedom [df], 4; P <.001). Among patients developing skin cancers the mean number of cancers per person was 9.8±15.1 and varied by transplant organ (kidney 11.9±17.6; heart 9.9±13.6; liver 5.2±6.5; lung 4.6±4.8 [P <.001]).

In the rate of developing a second or third skin cancer, researchers found no significant difference by transplanted organ type. They noted age at transplant was associated with time to developing a second skin cancer (χ² test, 20.4; df, 4; P <.001) and a third skin cancer (χ² test, 10.9; df, 4; P <.02).

Significant study limitations include using population and outcome definitions based on International Classification of Diseases and Current Procedural Terminology codes in the electronic health record instead of patient transplant registries, which may have led to a miscount of skin cancers, not including important variables (medications associated with differential skin cancer risks) in models, single-center design, retrospective design, and lack of generalizability.

They concluded that additional skin cancers developed at high rates following initial skin cancer among recipients of all organ types and “all patients had similar rates of development of subsequent skin cancers, whereas increasing age at transplant was associated with an increased risk of subsequent skin cancer.”

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By mid-December 2021, the Omicron variant was the predominant source of COVID-19 infections in New York City. Researchers with the Lung Transplant Program at Columbia University analyzed clinical and mortality outcomes among patients who had received lung transplants and had confirmed SARS-CoV-2 between December 19, 2021, and January 31, 2022, and compared this data with that of patients who had received lung transplants and were infected with COVID-19 during the first and second waves of the pandemic — between March 19, 2020, and May 29, 2020, and November 1, 2020, to February 28, 2021, respectively.

Cases were identified through electronic health records and patient reported information. Overall, 98 patients who had received lung transplants tested positive during the Omicron surge while 32 and 47 patients tested positive during the first and second waves of COVID-19 infection, respectively. Among the patients infected during the Omicron surge, 50% were female (vs 16% and 25% during the first and second waves, respectively) and the median patient age was 58 years (vs a median age of 65 years for both the first and second wave cohorts).

Within the Omicron cohort, 14% of patients had been previously infected with COVID-19; 11% were unvaccinated; 89% had received 2 doses of the mRNA COVID-19 vaccines or 1 dose of a viral vector vaccine; and 72% had received a booster. Notably, more than 70% of the entire Omicron cohort contracted COVID-19 after receiving a COVID-19 vaccine booster, a finding that lends “support to the observed suboptimal vaccine immunogenicity response to the Omicron variant among immunocompromised patients described in early studies,” said authors of the research letter.

In comparing outcomes among the Omicron, first wave, and second wave cohorts, the investigators found that: 90-day mortality rates were 12%, 34%, and 17%, respectively; severe disease rates were 14%, 41%, and 28%, respectively; hospitalization rates were 39%, 84%, and 66% respectively; and mechanical ventilation rates were 7%, 31%, and 15%, respectively.

Study authors also noted that in the Omicron cohort: (1) among the 31% of patients who required supplemental oxygen, 91% received dexamethasone or equivalent corticosteroids; and (2) among the 60% of patients with mild disease, 78% received monoclonal antibody or oral antiviral medications.

This research was limited by the unequal number of patients in the study cohorts and by the retrospective nature of the analysis.

The research letter authors concluded that “despite major improvements in outcomes in the last 2 years, COVID-19 continues to be associated with significant mortality among [lung transplant recipients].” The authors further noted that “Continued research for more effective pre- and post- exposure prophylactic therapies is also needed for this population.”

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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

The post Spotlight on Increasing Myocardial Infarction Disparities in Young Women appeared first on The Cardiology Advisor.

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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Among patients older than 55 years undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), relying on donations from a human leukocyte antigen (HLA)-matched unrelated donor (UD) or haploidentical donor (HaploD) may yield similar outcomes, according to research presented at the EHA 2022 Hybrid Congress.

The ideal scenario in allo-HSCT is the presence of a matched sibling donor, but such donors are not frequently available. It was, however, previously unclear whether using a UD or HaploD would yield superior outcomes among older patients.

The relative outcomes of these donations have important implications for the process of identifying potential donors. For this randomized phase 3 study (ClinicalTrials.gov Identifier: NCT02623309), researchers evaluated, in the case of unavailability of matched sibling donor, the relative safety and efficacy of allo-HSCT using HaploD or UD among patients older than 55 years. The study’s primary endpoint was chronic graft-vs-host disease-free relapse-free survival (GRFS).

Overall, 108 patients were enrolled and 106 patients were included in the analysis; 55 and 51 patients, respectively, were randomly assigned to the HaploD and UD groups. The median patient age was 65 years (range, 55-70), and 79% of patients had a myeloid malignancy.

The median follow-up was 27 months. In the analysis cohort, 73% of patients proceeded to transplant in both groups. The median time from randomization to transplantation was 76 days in the HaploD group vs 95 days in the UD group. Nine (16%) patients in the UD group and 11 (22%) patients in the HaploD group received an allo-HSCT donation from an individual in the HaploD and UD search groups, respectively.

Analysis of the intent-to-treat population showed that the 2-year GRFS rate was 29% in the HaploD group vs 37% in the UD group (P = .22); the 2-year progression-free survival (45% vs 49%; P = .56) and overall survival (50% vs 59%; P = .47) rates were also similar.

An overall analysis of 42 patients treated from a haploidentical donor and 35 patients from a UD confirmed that the primary endpoint was not significantly different (2-year GRFS, 40% vs 34%, respectively; P = .66).

No differences were noted in rates of grade 2 to 4 acute graft-versus-host disease, non-relapse mortality, or relapse risk.

Disclosures are not available for this presentation.

Reference

Harbi S, Boher J-M, Forcade E, et al. Randomized multicenter phase III study of haplo versus HLA-matched unrelated donor (UD) allogeneic hematopoietic stem cell transplantation (ALLO HSCT) for patients older than 55 years. Presented at EHA 2022; June 9-12, 2022. Abstract S236.

The post Allo-HSCT: Unrelated, Haploidentical Donations May Yield Similar Outcomes appeared first on The Cardiology Advisor.

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.

A study found that patients who receive a heart transplant with Paragonix SherpaPak Cardiac Transport System (SHRP) tended to have improved 1-year survival compared with patients who received conventional transplant methods. These findings were published in The Journal of Heart and Lung Transplantation.

Data for this study were sourced from the Global Utilization And Registry Database for Improved heArt preservatioN (GUARDIAN; ClinicalTrials.gov identifier: NCT04141605). The GUARDIAN database is a retrospective, mulit-institution registry which collects data from 11 heart transplant centers in the United States.

According to Dr Andreas Zuckermann, the EU Principal GUARDIAN Investigator, Director of Cardiac Transplantation, and Associate Professor of Surgery Medical University of Vienna, “The lack of research into preservation methods during transport for organ transplant surgery, specifically heart transplant, led me and a group of similar minded investigators to come together in the creation of the GUARDIAN-Heart Registry in 2019. Utilizing the Paragonix SherpaPak in direct comparison to the standard of care ice transport method, we could see from early results a trend to a reduction of primary graft dysfunction and some positive effects in post-transplant outcomes, utilizing advanced organ preservation with the SherpaPak. With each additional analysis we conduct, including the truly remarkable results, presented by Dr. Marzia Leacche at ISHLT 2022, highlighting not only statistically reductions in Severe PGD, and need for Post-Transplant Mechanically Circulatory Support, but an 8.7% increase in 1-year Survival, the evidence continues to mount pointing towards a significant positive clinical impact utilizing advanced organ preservation. ”

For this study, 1-year survival outcomes were evaluated among patients (N=383) who received SHRP or conventional transplant between 2015 and 2021. Patients received a heart transplant using SHRP (n=227) or conventional methods (n=156). The patient cohorts were well balanced, except that fewer patients in the SHRP cohort received implantable left ventricular assist device (35.2% vs 55.1%; P <.001), more patients received pretransplant temporary intra-aortic balloon pump (29.6% vs 13.0%; P <.001) and pre-transplant extracorporeal membrane oxygenation (17.2% vs 7.8%; P =.01), they had longer distances to the donor organ (mean, 463 vs 274 miles; P <.001), and longer ischemic times (mean, 217 vs 195 min; P <.001).

The SHRP cohort tended to have increased 30-day (97.8% vs 95.5%; P =.22) and 1-year (91.1% vs 86.0%; P =.21) survival.

In addition, SHRP associated with significantly reduced severe primary graft dysfunction (5.3% vs 13.0%; P =.01) and a trend for reduced placement of extracorporeal membrane oxygenation post-transplant (8.8% vs 14.7%; P =.07).

The major limitation of this study was the retrospective design.

This study found that despite preoperative risk factors, heart transplant with SHRP associated with numerically reduced mortality up to 1 year after transplant compared with patients who received transplant using conventional methods. These trends were observed even though patients who received SHRP implants had more known risk factors, such as more acute support.

“The potential impact of this research on clinical outcomes and patient’s lives cannot be understated. The GUARDIAN-Heart 1-year Survival Analysis we presented…at the ISHLT 2022 Annual Meeting showed a clear trend to increased 1-year survival for heart transplants utilizing the Paragonix SherpaPak, and is just 1 of many clinical analyses we are researching in the ongoing study,” said Dr Marzia Leacche, Richard DeVos Endowed Chair for Heart Transplant and MCS, Surgical Director, at Spectrum Health, MI. “With over 1100 enrolled heart transplant patients, this one-of-a-kind registry has provided exceptional insight into how transplant centers can effectively improve organ preservation methods to the benefit of all patients.”

Reference

Leacche M, Philpott J, Pham S, et al. US multi-center analysis of the global utilization and registry database for improved heart preservation (GUARDIAN) registry: 1-Year transplant survival analysis. J Heart Lung Tranplant. Published online April 7, 2022. doi:10.1016/j.healun.2022.01.067

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HealthDay News — Neither sex nor parity of blood donors affects mortality in patients who receive red blood cell transfusions, according to a study published online June 13 in the JAMA Internal Medicine.

Jingcheng Zhao, M.D., Ph.D., from the Karolinska Institutet in Stockholm, and colleagues examined whether blood donor sex and parity affect mortality of patients undergoing transfusion with red blood cells in a cohort study using nationwide blood bank and health register data in Sweden. Data were included for 368,778 participants aged 18 to 90 years who received a transfusion between Jan. 1, 2010, and Dec. 31, 2017.

The researchers found that comparing red blood cell transfusions from female and parous donors to male donors, the two-year survival differences were −0.1 and 0.3%, respectively. There were no significant survival differences observed, irrespective of patient sex or age. The median hemoglobin counts were lower for female than male donors (13.5 versus 14.9 g/dL). The relative risk was 1.12 (95% confidence interval, 1.08 to 1.17) for additional transfusions within 24 hours in association with red blood cell transfusions from female donors; after adjustment for donor hemoglobin counts, the association was no longer significant (relative risk, 1.03; 95% confidence interval, 0.98 to 1.08).

“When we take into account the lower hemoglobin levels in blood from women, we see no difference in survival among patients who received a blood transfusion from women compared with from men, regardless of how many times the female donors had been pregnant and of the patients’ sex and age,” Zhao said in a statement.

Abstract/Full Text

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A recent study examined responses to varicella-zoster virus (VZV) vaccination with a recombinant vaccine in patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT). The study results were published in the journal Vaccines (Basel).

The vaccine used in this study was an adjuvanted, recombinant vaccine containing VZV glycoprotein E as the antigen. Patients who have undergone HSCT show a high risk of infection with or reactivation of VZV. The researchers who conducted this study evaluated the response to VZV vaccination in patients who have undergone HSCT.

The study included adults in Germany who had undergone HSCT. The vaccine contained 50 mg of the glycoprotein E antigen was given in 2 doses. After vaccination against VZV with the adjuvanted, recombinant vaccine, VZV-related cellular immunity was tested in peripheral blood mononuclear cells of vaccine recipients using an interferon-gamma Enzyme-Linked Immunospot (ELISpot) assay.

For the ELISpot assay, responses were evaluated to any of the following: whole VZV antigen, a native glycoprotein, and a glycoprotein E peptide pool. Responses were additionally evaluated based on the presence or absence of prior shingles, and 4 age-matched, control individuals who did not receive HSCT were also evaluated for some comparisons.

The study included 34 female patients and 45 males who underwent VZV vaccination. A total of 36 patients had previously had shingles, compared with 43 who had not. In an ELISpot assay, responses were greatest with whole VZV antigen, compared with the other tested antigens.

Participants’ responses were evaluated prior to and after receipt of the second vaccine dose. This assay showed no significant difference in response to whole VZV antigen, but responses to the VZV glycoprotein E peptide pool rose to between 3.2- and 5.7-fold higher with the second vaccination, depending on the antigen concentration used in this test (P =.02 or P =.004, respectively).

In patients who had undergone HSCT, immune responses based on the ELISpot assay using the glycoprotein E peptide pool at a concentration of 1 mg/mL showed significant elevations after receipt of the second vaccine dose (P <.005). HSCT recipients and control individuals who did not receive HSCT showed similar levels of immune responses to the glycoprotein E protein pool prior to vaccination. However, the control population showed a 4.8-fold higher median vaccine response with the first vaccination and a 1.8-fold higher median cellular response after the second vaccination.

Responses varied in assays of different antigen based on prior shingles history. A multivariate analysis showed prior shingles history and male sex to be factors associated with greater response to the vaccine used in this study.

The study investigators considered this study to indicate that in patients who have received allogeneic HSCT, cellular immunity against VZV glycoprotein E was produced, and with prior shingles history and male sex as factors that may contribute to immunity to VZV.

Reference

Koldehoff M, Horn PA, Lindemann M. Cellular immune response after vaccination with an adjuvanted, recombinant zoster vaccine in allogeneic hematopoietic stem cell transplant recipients. Vaccines (Basel). 2022;10(5):809. doi:10.3390/vaccines10050809

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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

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HealthDay News — Among orthotopic heart transplant (OHT) recipients, COVID-19 vaccination is associated with fewer COVID-19 infections, hospitalizations, and deaths and no heart transplant-specific adverse events, according to a study published online April 27 in JAMA Cardiology.

Laura L. Peters, D.N.P., from the University of Colorado Anschutz Medical Campus in Aurora, and colleagues used data from all adult recipients of OHT at a single U.S. heart transplant program to assess the safety and effectiveness of COVID-19 vaccination in OHT recipients.

The researchers found that of the 436 OHT patients, 106 were infected with COVID-19. Among the 366 vaccinated patients, 19.7% had COVID-19 infections, 4.1% required hospitalizations (including four intensive care unit [ICU] admissions), and 3 patients died (0.8%). Among the 70 unvaccinated patients, 48.6% were infected, 14.3% were hospitalized, 3 required ICU admission, and three died (4.3%). There was a lower risk for all outcomes with COVID-19 vaccination (risk ratios: infection, 0.41; hospitalization, 0.29; death, 0.19). 6 months after COVID-19 vaccination, there was no echocardiographic evidence of graft dysfunction, clinically significant rejection, or allosensitization among the vaccinated OHT recipients.

“Even though the immunogenic response to COVID-19 vaccination is lower in patients who receive a heart transplant, the vaccine appears to be safe and is associated with a lower risk of COVID-19 infection, hospitalization, and death, suggesting it is imperative that all heart transplant recipients obtain the COVID-19 vaccine,” the authors write.

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

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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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HealthDay News — Adolescent and young adult (AYA) solid organ transplant recipients should be supported after transfer to adult health care, with improved clinical outcomes in association with successful retention in adult health care, according to a study published online April 7 in Pediatric Transplantation.

Kelly E. Rea, from the University of Georgia in Athens, and colleagues examined health care utilization, medical outcomes, and transition success among 49 AYA recipients of heart, kidney, or liver transplants who had recently been transferred to adult health care. Differences in outcomes were examined for two transition success criteria: initial engagement in adult health care within six or 12 months of the last pediatric appointment and retention in adult health care over three years after the last pediatric appointment.

The researchers found that compared with initial engagement, successful retention in adult health care related significantly to more improved clinical outcomes, including reduced number and duration of hospitalizations and greater adherence to medications. There were significant decreases observed in appointment attendance over three years; age at transfer and time since transplant did not account for individual differences in these decreases.

“Findings underscore the importance of supporting AYAs after transfer. It is not enough to only focus on preparation prior to the transfer event,” the authors write.

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

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In a review published in the Journal of Clinical Medicine, researchers described sexual and emotional health impacts following allogeneic hematopoietic stem cell transplantation (allo-HCT), and they summarized recommendations from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC). The review was authored by Tamim Alsuliman, MD, MSc, of Sorbonne Université in Paris, France, and colleagues.

The authors explained in their review that allo-HCT is associated with impacts on sexual and emotional health, with sexual problems reported in 50% of men and 80% of women following allo-HCT. Additionally, when chronic graft vs host disease (GVHD) is present, sexual health is further impacted. The authors reported that recovery from sexual dysfunction typically happens within 2 years, but some complications may persist for 5 to 10 years after allo-HCT. The authors also described research indicating that many patients have felt that information regarding allo-HCT-related effects on fertility or sexuality was not fully addressed with them.

Effects on sexuality are complex and mixed with psychological or physiological health, Dr Alsuliman and colleagues explained. Hormonal and GVHD-related factors can be associated with sexual and emotional complications. Physical aspects of sexual function in patients after allo-HCT may be affected by such factors as premature ovarian failure (in women), genital GVHD in either sex or nonspecific conditions, such as those affecting libido or mood.

Endocrine dysfunction after allo-HCT can affect ovarian function and family planning. The authors described a study in which hypoestrogenism was seen in 86% of female patients who underwent allo-HCT before they were 35 years of age, and premature ovarian failure was seen in 74%. Hypogonadism in male patients has been described in association with allo-HCT in childhood, but impacts in adulthood are not as well understood. However, research described by the authors suggests impacts on sexual health in adult males after childhood allo-HCT, as well as potentially with allo-HCT performed in adulthood.

The SFGM-TC guidelines, the authors explained, indicate that patients should receive pretransplant and follow-up consultations to evaluate clinical and other aspects of health. The guidelines also provide potential questions patients may ask, as well as possible answers. For example, a patient may ask when it is possible to resume intercourse, and an answer may indicate that sexual intercourse can occur as soon as the patient returns home.

“If patients respect the hygiene instructions and the standard antibacterial, antiviral and antifungal prophylaxis that have been provided to them at the end of the transplant, and if there are no active infections in the partner, there is no justification for a restriction on physical contact, nor is there any specific time limit to be observed,” the researchers wrote.

Some other possible questions related to specific fears and requests for information, such as how a female patient may know if she is menopausal or what to do if there is pain during intercourse. “A multidisciplinary approach should be favored to treat the different aspects of the sexual and emotional life of allo-HCT patients,” the authors concluded in their review.

Reference

Alsuliman T, Jondreville L, Baylet C, et al. Sexual and emotional health after allogeneic hematopoietic cell transplantation: a comprehensive review and guidelines from the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC). J Clin Med. 2022;11(5):1196. doi:10.3390/jcm11051196

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Among heart donors with brain death due to stroke, the effect on recipient and allograft survival rate is dependent on the age of the donor, with the strongest negative association at a young age, decreasing until the increased risk disappears for donors approximately aged 40 years. These study findings were published in the Journal of the American College of Cardiology.

Of the many risk factors in heart transplantation, cause of donor brain death has not been thought of as one of them. Previous studies have offered conflicting results about brain death due to stroke affecting heart transplant outcomes. Researchers sought to examine if stroke as the cause of donor brain death should be considered a risk for a heart recipient.

To accomplish this, researchers conducted a nationwide retrospective cohort study in the United States, with prospective data from the United Network for Organ Sharing (UNOS) registry. This included 18,438 multicenter heart transplant recipients from 2005 to 2018. Of the transplants, 3761 were from donors who died from stroke and 14,677 were donors who died from other causes. Donors less than 15 years of age, recipients less than 18 years of age, and multiorgan transplantation were excluded. The primary outcome for this study was all-cause mortality.

Donors who died from stroke were more likely to be women and older, with histories of smoking, cancer, and hypertension. Researchers noted that recipients from these donors were also more likely to be women, spent less time on the organ waiting list, have inotrope use at transplantation, and were less likely to have a ventricular-assist device before transplantation.

Follow-up was median 4.0 years (IQR, 2.0-5.0 years). In donors aged 40 years or younger, stroke as the cause of death was associated with increased risk of death in recipients at 5 years (stroke, 23%, vs other cause, 19%; HR, 1.17; 95% CI, 1.02-1.35) and allograft failure (HR 1.30; 95% CI, 1.04-1.63). The cause of brain death was not associated with heart transplant outcomes when donors were older than 40 years.

Study limitations included residual confounding and that the UNOS registry didn’t differentiate between hemorrhagic or ischemic stroke. There was missing data for hemodynamic parameters and right ventricular function.

“The detrimental effect of stroke as the cause of brain death might partially offset the benefit of younger donor ages, but this does not necessarily suggest that this particular donor group should be avoided as allografts from this group still have a better quality and result in better survival than those from most of the older donor groups,” the researchers wrote. “These results suggest an opportunity to identify modifiable factors that mediate this association so that changes in donor candidate management of this younger cohort could lead to improved transplantation outcomes.”

Reference

Mikami T, Itagaki S, Fujisaki T, et al. Association of donor brain death due to stroke with prognosis after heart transplantation. J Am Coll Cardiol. Published online March 14, 2022. doi:10.1016/j.jacc.2021.12.031

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A systematic review and meta-analysis found that coronary revascularization was not superior to optimal medical therapy among patients with coronary artery disease (CAD) who were waitlisted for kidney transplant. These findings were published in the Journal of the American Heart Association.

Researchers from the Thomas Jefferson University Hospital searched publication databases through June 2021 for studies of CAD treatment among patients awaiting kidney transplant. A total of 8 studies met the inclusion criteria.

This analysis comprised data from 945 patients, 35.9% of whom were women. Patients who underwent revascularization were aged mean 56.5 years and those who received optimal medical therapy were aged mean 56.1 years.

At an average follow-up of 3.1 years, revascularization was not associated with decreased risk for all-cause mortality (risk ratio [RR], 1.16; 95% CI, 0.63-2.12; P =.63; I², 68%), cardiovascular mortality (RR, 0.75; 95% CI, 0.29-1.89; P =.54; I², 35%), or major adverse cardiovascular events (MACE; RR, 0.78; 95% CI, 0.30-2.07; P =.62; I², 67%).

In a sensitivity analysis using data from 2 studies that were unadjusted, revascularization was favored for reducing MACE (RR, 0.07; 95% CI, 0.01-0.55; P =.01; I², 0%). Neither the analysis which considered data from the 4 adjusted studies (RR, 1.23; 95% CI, 0.53-2.88; P =.63; I², 62%) nor the pooled analysis (RR, 0.78; 95% CI, 0.30-2.07; P =.62; I², 67%) confirmed these findings. In addition, the pooled analysis found significant subgroup variation (c², 6.39; P =.01).

This study was limited by the baseline heterogeneity among study populations and the short follow-up duration. Additional study would be needed to assess long-term outcomes.

This study found no evidence to support revascularization over optimal medical therapy among patients with CAD awaiting renal transplant. As no protocols have been established for CAD therapy among this patient population, further research is needed to establish evidence-based guidelines for effective CAD interventions. “Therefore, initiating aggressive [optimal medical therapy] and conducting vigorous cardiac risk stratification primarily to exclude left main disease, with close hemodynamic monitoring perioperatively, are essential for optimizing outcomes in this high-risk population,” the study authors wrote.

Reference

Siddiqui MU, Junarta J, Marhefka GD. Coronary revascularization versus optimal medical therapy in renal transplant candidates with coronary artery disease: A systematic review and meta-analysis. J Am Heart Assoc. Published online February 8, 2022. doi:10.1161/JAHA.121.023548

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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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Over the past 2 decades, the rate of heart transplantation among patients with pretransplant malignancy (PTM) has increased dramatically. Although heart transplant recipients with a prior malignancy may be at an increased risk for early mortality, particularly those with a hematologic cancer, death rates after the first posttransplant year are comparable between patients with and without PTM. Results of an analysis of this patient population were published in the journal Circulation: Heart Failure.

A contemporary retrospective analysis of adults in the United Network for Organ Sharing registry was conducted among patients with PTM who had received heart transplantation between January 1, 2010, and December 31, 2020. Outcomes of interest in the study included mortality at 1 year following heart transplantation, mortality at 5 years for those who survived the first year after heart transplantation, and development of recurrent or de novo malignancy at 5 years post-heart transplantation. Among patients who developed more than 1 malignancy following heart transplantation, the date of the first occurrence was used in the analysis. The researchers examined patient characteristics, trends, and post-heart transplantation outcomes among the study population.

The percentage of patients with PTM who underwent heart transplantation increased significantly from 3.2% in 2000 to 8.2% in 2020 (P <.001). Additionally, the number of transplant centers that performed heart transplantations in patients with PTM more than doubled in the same time period, from 31.1% in 2000 to 71.3% in 2020 (P <.001). Among a total of 27,344 patients who underwent heart transplantation between 2010 and 2020, a history of PTM was reported in 7.7% of them.

PTM was associated with significantly higher rates of 1-year mortality following heart transplantation (11.9% vs 9.2% in those without PTM; adjusted hazard ratio [aHR], 1.25; 95% CI, 1.09-1.44; P =.001), which was driven by increased mortality in patients with hematologic PTM (aHR, 2.00; 95% CI, 1.61-2.48; P <.001). Among transplant recipients who survived the first year, 5-year survival was similar between those with and without PTM. At 5 years post-heart transplantation, rates of malignancy were higher in the PTM group than in patients without PTM (20.4% vs 13.1%, respectively; aHR, 1.57; 95% CI, 1.38-1.79; P <.001).

Overall, 89% of patients with PTM had a single malignancy prior to transplantation and 12% of them had 2 or more PTMs. Among individuals with PTM, 75% of them had a history of solid organ malignancy. The most common types of PTM were genitourinary/gynecologic/renal (in 28% of patients), hematologic (in 25% of patients), and breast (in 24% of patients). Patients with PTM, compared with those without PTM, were older (60 years vs 56 years, respectively); less likely to be male (56% vs 75%, respectively); and more likely to be White (71% vs 64%, respectively), on average, compared with those without PTM (P <.001 for all).

“Patients with prior hematologic malignancy may be at increased risk for early mortality,” the researchers wrote. “Guidelines which incorporate malignancy-specific characteristics and reflect current standards of oncological care are needed to inform management of this heterogeneous and expanding pool of patients.”

Disclosure: One of the study authors has declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of the author’s disclosures.

Reference  

Batra J, DeFilippis EM, Golob S, et al. Impact of pretransplant malignancy on heart transplantation outcomes: contemporary United Network for Organ Sharing analysis amidst evolving cancer therapies. Circ Heart Fail. Published online January 31. 2022. doi:10.1161/CIRCHEARTFAILURE.121.008968

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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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Cardiovascular disease (CVD) is the leading cause of death for both men and women in the United States.¹ However, CVD awareness has decreased among women, particularly Black, Hispanic, and Asian women.²

Two surveys from the American Heart Association (AHA), 2019 vs 2009, showed a decrease over 10 years in women’s awareness of CVD as their leading cause of death (43.7% vs 64.8%).² The reduced awareness poses a risk for women, for example, who may not know that symptoms of myocardial infarction and coronary artery disease are different in women than in men.^3,4,5

Beyond a lack of awareness, however, what other factors contribute to CVD as the No. 1 cause of death in US women? In honor of American Heart Month, we spoke with 4 women cardiologists from around the US to hear their different perspectives and patient experiences. They answered 2 questions:

1) Why does CVD remain the leading cause of death for women in the US?
2) What guidance can cardiologists provide to women to protect their heart health?

Here’s what they had to say:

Anne B. Riley, MD

1) Unfortunately, CVD in women is frequently overlooked or missed for a variety of reasons. Women’s heart health is sometimes at the bottom of their own priority list. I have seen many women over the years who spend so much of their time and energy being the caregivers for other family members (whether children, spouses, or parents), that they push aside symptoms of heart disease until the situation becomes emergent.

In addition, the general population does not perceive heart disease as a large threat to women in our country, and most are surprised to learn that CVD is the leading cause of death of women in the US. But it is not only the public who needs to be reminded. Many initial pivotal studies of CVD enrolled largely men, and thus results were focused on how men perceived and expressed disease. For many years, symptoms noted by women experiencing heart disease, which are often different from those of men, were deemed “atypical,” because they did not match what men experienced, which was deemed the “typical” experience. Combine these 2 issues, and you create the perfect storm of late/under-detection of CVD in women.

2) Fortunately, national campaigns like the AHA’s “Go Red for Women” movement have begun to move the needle on public awareness of the issues of heart disease in women. It is important for cardiologists to support these public health campaigns to help get the message out about the importance of disease prevention and identification in women. In addition, internal medicine and cardiology training programs have become smarter about teaching differences in symptoms between men and women.

There is also much more research being done on less traditional risk factors, which if present, indicate a higher risk of developing CVD. Most cardiologists now know to ask [about] a history of gestational hypertension, preeclampsia, and gestational diabetes. Similarly, patients with a history of inflammatory disease (like lupus or rheumatoid arthritis), which affect women more than men, also carry a higher risk profile. Finally, as with many things in medicine, the most important tool we have in the identification of disease is a listening ear. Doctors have the best intentions to see the problem, but the rapid-fire environment of health care today can often obstruct our view. Doing what we can to slow down and really hear what the patient is telling us is the best chance we have of picking up CVD in women.

Rachel M. Bond, MD, FACC

1) One reason for this is decreasing awareness and limited screening of sex-specific risk factors, such as complications during pregnancy, along with conditions that impact women’s health more, such as chronic stress, anxiety, [or] depression. Beyond that, women are still being under-diagnosed, untreated, and not provided guideline-suggested management highlighting the ongoing unconscious gender bias, which is the primary culprit for these disparities in care.

2) The first step is to listen to the patients and their concerns, as they know their body better than anyone else. With heart disease preventable 80% of the time, we need to encourage our patients to continue to go for their annual well-woman visit, where their “numbers” are checked, including [blood pressure] BP, cholesterol, blood sugar, and body weight, which are common risk factors for heart disease [that] can be controlled. Lastly, we should encourage our patients to continue to live a heart-healthy lifestyle that follows the AHA’s Life’s Simple 7, including maintaining a heart-healthy diet and at least 150 minutes of moderate exercise per week, which may include brisk walking. 

Ritu Thamman, MD, FASE, FACC

1) Women’s symptoms are not clearly identified as being cardiac by both the physicians and the women. And women wait longer to call for help even if they are experiencing chest pain. Other barriers exist: higher levels of risk for women with [diabetes], obesity, and hypertension, which are not picked up by standard risk assessment tools like the pooled cohort equations.

2) How can cardiologists provide guidance to women to protect their heart health? By asking women patients to know their numbers (BP, weight, sugar, and cholesterol levels) and to exercise in any manner they like!

Nanette Wenger, MD, MACC, MACP, FAHA

1) The fact is that women are not aware that this is their leading cause of death and because they’re not aware, they’re obviously not going to take preventive intervention. Now, back in [2002 and 2004], the National Heart, Lung, and Blood Institute (NHLBI) and the AHA started the awareness campaigns. NHLBI was [the] Heart Truth campaign and AHA was the [Go Red for Women] campaign. And the awareness increased to about 50% from [about 30%]. That did well for a while. But as we examine awareness now, we find that that awareness has dropped. It’s stuck in the [30% to 40% range] again, and the awareness is lowest among young women and women of racial and ethnic minorities.

So, what we have to do [is] bring back the awareness in terms of education, because if women are aware that this is their heart problem, they will listen to what their health care providers say about prevention. …[W]e have to increase the awareness that heart disease is [a] major problem [for women] and increase awareness [on] the symptoms of a heart attack [every woman should know].

2) What we have to do is use the AHA’s Life’s Simple 7, and the important thing for the providers … is that all of this information … is on the Web. They can download any of this for their patients. Really, what we are saying is to have good heart health, you need 4 behaviors and 3 numbers—that makes Life’s Simple 7. The 4 behaviors are: no smoking, maintain ideal weight, eat a heart-healthy diet, and be physically active. …And then you have to know 3 numbers: that your total cholesterol is below 200, that your BP is less than 120 over 80, and that fasting blood sugar is under 100. If we teach Life’s Simple 7, then women can [better] address their heart health.

References

1. Centers for Disease Control and Prevention. Heart Disease in the United States. Updated February 7, 2022. Accessed February 8, 2022. https://www.cdc.gov/heartdisease/facts.htm
2. Cushman M, Shay CM, Howard VJ, et al. 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. Circ. 2021;143:e239–e248. doi:10.1161/CIR.0000000000000907
3. American Heart Association. Heart attack symptoms in women. Updated July 31, 2015. Accessed February 8, 2022. https://www.heart.org/en/health-topics/heart-attack/warning-signs-of-a-heart-attack/heart-attack-symptoms-in-women
4. Cleveland Clinic. 3 Heart attack signs women shouldn’t ignore. Updated October 26, 2021. Accessed February 8, 2022. https://health.clevelandclinic.org/women-dont-ignore-3-subtle-heart-attack-symptoms/
5. Mayo Clinic. Coronary Artery Disease. Updated June 5, 2020. Accessed February 8, 2022. https://www.mayoclinic.org/diseases-conditions/coronary-artery-disease/symptoms-causes/syc-20350613

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HealthDay News — In response to claims that a man was denied a heart transplant because he refused to get vaccinated against COVID-19, Brigham and Women’s Hospital in Boston said Wednesday that its transplant policies mirror those used across the United States.

In a crowdfunding appeal for 31-year-old D.J. Ferguson, a father of two, his family said the hospital told him he was ineligible to receive a new heart because he was not vaccinated, the Associated Press reported. His mother, Tracey Ferguson, said her son is not against vaccinations but has concerns about COVID-19 vaccines because he has atrial fibrillation. “D.J. is an informed patient,” she told the AP. “He wants to be assured by his doctors that his condition would not be worse or fatal with this COVID vaccine.”

Citing patient privacy laws, the hospital would not comment directly on the case. Instead, it noted that its website clearly states that the COVID-19 vaccine is one of several immunizations — including a flu shot and hepatitis B vaccines — required by most U.S. transplant programs, the AP reported. The hospital also said its policies line up with American Society of Transplantation recommendations, and that research shows transplant recipients already have a higher risk for death from COVID-19 than nontransplant patients.

Other U.S. hospitals have faced criticism for denying transplants to patients who were not vaccinated against COVID-19. A Colorado woman suffering late-stage kidney disease said in October that she was denied a kidney transplant because she was unvaccinated. Leilani Lutali, a born-again Christian, said she opposed immunization because of the role that fetal cell lines play in some vaccines’ development.

But any surgery strains a patient’s immune system and can leave them vulnerable to contracting COVID-19, and organ transplant recipients are even more vulnerable because they have to take powerful drugs that suppress their immune system to keep their body from rejecting the new organ, Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association, said in a statement at the time of the Colorado case.

Because there is a shortage of donor organs, transplant centers only place patients on the waiting list whom they deem the most likely to survive with a new organ, experts said.

Associated Press Article

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HealthDay News — A fourth dose of an mRNA-based anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine may increase antispike immunoglobulin (Ig)G titers in kidney transplant recipients, according to a research letter published online Jan. 11 in the Annals of Internal Medicine.

Sophie Caillard, M.D., Ph.D., from the University Hospitals of Strasbourg in France, and colleagues examined whether a fourth dose of an mRNA-based anti-SARS-CoV-2 vaccine would increase antispike IgG titers in 92 kidney transplant recipients (34 received BNT162b2; 58 received mRNA-1273) with antispike IgG titers <143 BAU/mL one month after the third dose.

The researchers found that no safety concerns were observed with the fourth dose. Median antispike IgG levels increased from 16.4 to 145 BAU/mL after a median of 29 days; 50 percent of patients reached the threshold of 143 BAU/mL. Patients who reached this threshold had a longer interval between transplant and fourth vaccine dose and less often received steroids. The percentage of patients with antispike IgG titers above 143 BAU/mL after the fourth dose was 48 and 52 percent for BNT162b2 and mRNA-1273, respectively; patients receiving mRNA-1273 had higher IgG titers (median 150 versus 122 BAU/mL). Only one patient was subsequently diagnosed with mild COVID-19; one month after the fourth dose, the patient’s antispike IgG level was 28 BAU/mL.

“We recognize that an increase in antispike IgG titers does not invariably provide protection from infection and disease, which is why we encourage longitudinal studies with a sufficient duration of follow-up to evaluate the risk for COVID-19 in patients like these after additional vaccine doses,” the authors write.

Two authors disclosed financial ties to the biopharmaceutical industry.

Abstract/Full Text

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HealthDay News — The absolute number of stage 3 acute kidney injury (AKI) kidneys transplanted increased from 2010 to 2020, according to a study recently published online in the American Journal of Transplantation.

Caroline Liu, from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues analyzed U.S. registry data to characterize kidney procurement and discard trends in deceased donors with AKI, defined by ≥50 percent or ≥0.3 mg/dL (≥200 percent or ≥4.0 mg/dL for stage 3 AKI) increase in terminal serum creatinine concentration from admission.

The researchers found that from 2010 to 2020, 172,410 kidneys were procured from 93,341 deceased donors (16 years or older), with 34,984 kidneys discarded (17,559 from AKI donors). During the study period, the proportion of stage 3 AKI donors doubled from 6 percent in 2010 to 12 percent in 2020, while procurement of stage 3 AKI kidneys increased from 51 to 80 percent. The increase in discard of stage 3 AKI kidneys (41 to 44 percent) was not statistically significant.

“Optimistically, you can look at it as we’re transplanting more kidneys because we are harvesting 2,000 more, yet we’re still discarding 44 percent of stage 3 kidneys,” a coauthor said in a statement. “We can do better and wipe out this kidney transplant shortage just by using AKI kidneys.”

Two authors disclosed financial ties to the pharmaceutical and biotechnology industries.

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

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HealthDay News — Including race coefficients in calculations of the estimated glomerular filtration rate (eGFR) contributes to racial disparities in preemptive listing of kidney transplant candidates, according to a study published online Dec. 23 in the Clinical Kidney Journal.

Mersema Abate, M.D., from Norwell Health in Manhasset, New York, and colleagues evaluated differences in racial distribution of preemptive listing before and after application of the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula race coefficients to all preemptively listed non-Black kidney transplant candidates (eGFR modulation) using the Scientific Registry of Transplant Recipients database. The odds of preemptive listing were calculated by race before and after eGFR modulation; Black race was used as the reference.

The researchers found that 30.7 percent of the 385,087 kidney-alone transplant candidates from Jan. 1, 2010, to Dec. 2, 2020, were identified as preemptively listed (71.7 percent White, 19 percent Black, 7.8 percent Asian, 0.6 percent multiracial, 0.6 percent Native American, and 0.3 percent Pacific Islander). The adjusted odds of preemptive listing for White compared with Black candidates decreased from 2.01 before eGFR modulation to 1.18 with the MDRD and 1.37 with the CKD-EPI equations, after adjustment for race coefficients.

“Our data show significant racial disparities derived from the inclusion of race coefficients when calculating eGFR at the time of preemptive listing of Black kidney transplant candidates,” the authors write.

One author disclosed financial ties to the biopharmaceutical and medical technology industries.

Abstract/Full Text

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HealthDay News — For patients with a failed first kidney transplant, a second transplant results in longer average survival time, but the advantage decreases with time spent on the waiting list, according to a study published online Dec. 27 in the Clinical Journal of the American Society of Nephrology.

Alexander Kainz, Ph.D., from the Medical University of Vienna, and colleagues conducted a retrospective study using data from 2,346 patients with a failed first graft to examine the association of time on the waiting list with patient survival among those receiving a second transplantation versus remaining on the waiting list. The difference in restricted mean survival time (RMST) and hazard ratios for all-cause mortality were compared for “retransplant” and “remain wait-listed with maintenance dialysis” for different waiting times after the first graft loss.

The researchers found that RMST at 10 years of follow-up was longer with a second kidney transplantation versus remaining on the waiting list (5.8 life-months gained). In patients with longer waiting time after loss of the first allograft, this survival difference was attenuated: RMST differences at 10 years were 8.0 and 0.1 life-months gained with a waiting time for retransplantation of less than one year and eight years, respectively.

“If these results are reproduced in imitated trials from other countries, it would signify the importance of decreasing time on the waiting list for second kidney transplant candidates by measures such as expedited workup and enlistment of patients with failing first kidney transplants before they require dialysis,” write the authors of an accompanying editorial.

Several authors disclosed financial ties to the pharmaceutical industry.

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

Editorial (subscription or payment may be required)

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Early outcomes appear favorable for heart transplants (HT) using donation after circulatory death (DCD) organs, according to study findings published in the Journal of the American College of Cardiology.

Researchers analyzed patient records from the Organ Procurement and Transplant Network, managed by the United Network for Organ Sharing (UNOS). Adult DCD donors (n= 3611) between 2020 and February 2021 were assessed for characteristics and whether or not their hearts were used for transplant. Patients (n=3088) who received a transplant from DCD or donation after brain death (DBD) donors during the study period were assessed for outcomes through July 2021.

All DCD donors had a median age of 46 (IQR, 35-56) years; 33.7% were women; 77.85% were White; 47.94% had blood type O; left ventricular ejection fraction (LVEF) was 60% (IQR, 54%-65%); cause of death was brain anoxia (51.95%); head trauma (21.38%); cerebrovascular accident or stroke (21.32%); and central nervous system or other tumor (5.34%).

The DCD donor organs that were used for HT (n=136) were from donors who were younger, had higher LVEF, lower body mass index (BMI), more had type O blood, fewer were women, had diabetes, hypertension, any coronary artery disease, a history of smoking, or died due to brain anoxia (all P <.001).

DCD-HT (n=127) and DBD-HT (n=2961) recipients had a median age of 54 (IQR, 43-61) and 57 (IQR, 47-64) years; 28.35% and 25.80% were women; BMI was 29.4 (IQR, 25.7-33.5) and 27.5 (IQR, 24.3-31.4); 1.57% and 11.82% had gender mismatch with their donor; and 7.87% and 12.06% a size mismatch, respectively.

Compared with the DBD recipients, the DCD group was younger (P =.015), fewer had gender mismatch (P <.001), were on life support with inotropes (P =.005), more had type O blood (P <.001), they had more advanced UNOS status (P <.001), and higher BMI (P <.001).

Among a propensity-matched subset (DCD-HT: n=126; DBD-HT: n=252), the 30-day mortality was 0.8% for DCD-HT and 3.3% for DBD-HT (adjusted hazard ratio [aHR], 0.14; 95% CI, 0.02-1.13; P =.069) and 5.4% and 7.6% at 6 months (aHR, 0.49; 95% CI, 0.18-1.32; P =.158), respectively.

In addition, no significant differences were observed for primary graft failure at 30 days (0.00% vs 1.01%; P =.634), stroke before discharge (5.51% vs 3.94%; P =.352), hemodialysis before discharge (16.54% vs 13.52%; P =.354), permanent pacemaker before discharge (0.79% vs 1.87%; P =.729), or post-transplant length of hospital stay (median, 16 vs 16 days; P =.214) for the DCD-HT and DBD-HT recipients, respectively.

This study was limited by its short-term follow-up. Additional study will be needed to determine long-term outcomes of DCD-HT.

“This analysis of the UNOS database suggests favorable early outcomes of adult HT performed with the use of carefully selected DCD donors in the United States,” the study authors wrote. “In addition, we estimate a substantial increase in HT numbers with widespread use and adoption of DCD donors.”

Reference

Madan S, Saeed O, Forest SJ, Goldstein DJ, Jorde UP, Patel SR. Feasibility and potential impact of heart transplantation from adult donors after circulatory death. J Am Coll Cardiol. Published online December 15, 2021. doi:10.1016/j.jacc.2021.10.042

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Anthracyclines, a mainstay of cancer chemotherapy, have been known to induce cardiotoxicity.^1,2 However, data are lacking on anthracycline cardiotoxicity in racially and ethnically diverse populations.  

A research team at the American Heart Association (AHA) Scientific Sessions 2021, held virtually from November 13 to 15, 2021, presented new data on anthracycline cardiotoxicity in a multiracial community. In the study, “Racial and Ethnic Differences in Anthracycline Cardiotoxicity,” researchers examined Black, Hispanic, Asian, and White cancer survivors with incident heart failure, who had received anthracycline-based chemotherapy for any type of cancer in 2016 and 2019.³

Notably, a majority of the patient population was from the Bronx, New York, which has a predominantly Hispanic (54.8%) and Black (28.5%) population, according to 2020 US Census Bureau data for NYC boroughs.⁴ As recent research indicates, Black and Hispanic individuals are still underrepresented in cancer clinical trials.⁵

To gain more insights on the AHA research indicating racial and ethnic disparities in anthracycline cardiotoxicity, we spoke with one of the study authors, Carlos J Rodriguez, MD, MPH, FACC, FAHA, a professor of medicine and epidemiology and population health, vice chair of academic affairs, and director of clinical cardiovascular research and cardiovascular epidemiology at Albert Einstein College of Medicine and Montefiore-Einstein Center for Heart & Vascular Care.

What data were available on anthracycline cardiotoxicity in racially and ethnically diverse populations before your team’s research?

Dr Rodriguez: There’s some prior data suggesting that there are racial and ethnic differences in cardiotoxicity, but they’re very limited. ^6,7 Some of that prior data did suggest that there were higher cardiotoxicity rates among Black cancer patients⁷… But, as I said, most of that data was from older studies. One of the studies was almost 2 decades old. The sample sizes were small. The databases did not have important characteristics, such as socioeconomic factors, and the data in those studies was mostly inclusive of [Black and White individuals] with little to no data on [Hispanic and Asian individuals]. So we, obviously, wanted to do a larger, more diverse and contemporaneous study to look at this issue.

Per your study data, the cumulative incidence of heart failure was 23% in Asian cancer survivors treated with anthracycline — the highest among all racial and ethnic groups. What may be contributing to this statistic?

Dr Rodriguez: So, obviously the problem is that when cancer patients are exposed to some cancer drugs and, in this case, particularly, anthracycline, those drugs even though they’re treating the cancer, they could affect the heart and lead to the heart getting weaker and for heart failure to be manifested. It can happen with different types of cancers, since different cancer drugs are used to treat [various] types of cancer, and different cancer drugs have [varying] levels of risk. Some have higher risks [that] affect the heart. We chose to study anthracycline for this study. That’s one of the cancer drugs that has known cardiac effects, or can weaken the heart. What we found is that Black and Hispanic patients had a higher incidence of heart failure at any point following anthracycline treatment. We did see that there was a higher incidence when it came to all of the groups.

There was a higher incidence, even among Asian cancer survivors, and those findings were interesting and intriguing, but not really conclusive in any way. The Asian receptive group in this study — and our sample was very small — was 10-fold smaller than any of the other groups. So, we cannot be fully confident in the validity of the signal, but the higher incidence of heart failure among Asian cancer survivors — and it was higher than what was seen in [Black, Hispanic, or White individuals] — does highlight an important point: That is that Asian individuals are underrepresented in this field of study, and this group needs to be further studied in this regard.

Since the study’s sample size of Asian participants was very small, should we be more focused on the data regarding Black and Hispanic individuals?

Dr Rodriguez: Yes, I think that that is the main result, the main point of this study. We show higher risk factors, lower socioeconomic status among [Black and Hispanic patients] compared to [White patients]. And even after adjusting for these factors, [Black and Hispanic patients] had a higher incidence of heart failure at any point following treatment with anthracycline chemotherapy.

I think that’s the main finding. Again, the signal among Asian individuals was surprising … , but I think the main purpose of that signal, even though we cannot be fully confident in [its] validity, … is that this group needs to be further studied.

In the study, hypertension, diabetes, and hyperlipidemia were highlighted as being more prevalent in Black, Hispanic, and Asian patients, but not in White patients. Do you believe that cultural differences in daily habits may play a role?

Dr Rodriguez: Yes, I think that there could be some cultural differences. Some of the main cultural differences would be in diet. …[I]t’s already known that [Black and Hispanic individuals] carry a higher burden of heart failure risk factors than [White individuals]. [Black and Hispanic individuals] have higher rates of hypertension, diabetes, dyslipidemia, and obesity. This has been shown in … multiple other works of literature by other researchers. So, I think that we already know that these differences exist and the higher prevalence of these risk factors among [Black and Hispanic patients] is due to a multitude of factors that happen at a patient level, at the healthcare system level, and at the environmental level.

So, it’s not just at the cultural level. You have different factors, different social determinants of health, and factors of structural racism … that have led to these cardiovascular health disparities that you see manifested in our dataset of our inner city population.

 Could you please elaborate on the social and environmental factors that contribute to cardiovascular health disparities?

Dr Rodriguez: Well, you have structural racism and social determinants of health that are the fundamental drivers of some of the health inequities that we see in this dataset. These health inequities can impact some of the results that we see with anthracycline cardiotoxicity in many ways. You have health inequities that are linked to an increased prevalence of heart failure risk factors and poor control of these heart failure risk factors, so poor hypertension, blood pressure control, or worse control of diabetes among [Black and Hispanic patients], predisposing these groups to cardiotoxicity. You have health inequities in access to care, in access to specialized care. You have lack of insurance … and also health inequities that lead to a more stressful experience among cancer patients. Cancer is already a stressful experience enough, but when you have factors like poverty, lower household income, financial and food insecurity, lack of health literacy, and worse quality of patient-provider interactions, all of these things lead to the heart effects that we’re seeing.

There may be also differential treatment, which we have not yet explored in this dataset. Also, when you talk about environmental aspects and social determinants of health, there [are] food deserts, or the lack of healthy food available in poor inner city neighborhoods, which is one of the main factors contributing to some of the cardiac effects that we see.

What can cardiologists do to increase awareness about these racial and ethnic disparities in anthracycline cardiotoxicity?

Dr Rodriguez: I think it starts with awareness and acceptance, being cognizant that these racial and ethnic differences and inequities do exist throughout other areas of medicine. It’s documented already … , but I think understanding that these differences and inequities extend into the cardio-oncology arena [is also important]. AHA has published a statement on the role of structural racism in cardiovascular disease.⁸ I think that statement … is a great starting point for us all to become more aware of these inequities. Increasing awareness is the first part. And then once awareness is increased, then we have to act accordingly to try to do our part in addressing these inequities.  

Should physicians —­­ specifically cardiologists, primary care physicians, and oncologists — be managing these patients differently? If so, how?

Dr Rodriguez: Well, our work highlights that the Black, Hispanic, and Asian population are at a higher risk for these cardiovascular adverse events from chemotherapy, particularly anthracycline. So yes, these populations, in my opinion, need more attention in this regard. As physicians, we should give special attention to these populations with more aggressive optimization and control of these risk factors, possibly more frequent cardiac monitoring during cancer treatment, and also the understanding that there’s a higher risk. So, it should … further emphasize that cardiologists and oncologists along with primary care providers need to work together as a team [in the] cancer treatment [care] process of these patients to avoid or at least minimize the cardiotoxicity complications that we’re seeing in these populations.

What steps have you taken in your practice to help address these racial and ethnic disparities?

Dr Rodriguez: My practice is predominantly Black and Hispanic. In my patients, I make it a point to make sure that cardiac risk factors are optimized and aggressively controlled, particularly before these patients undergo cancer treatment [and] definitely during cancer treatment — anything that can be done from a preventative [standpoint] to avoid the manifestation of cardiotoxicity or heart failure. I think monitoring is also important [in these high-risk populations]. So, if monitoring and then treating accordingly, we’ll be able to see signs of cardiotoxicity or heart failure develop in this group.

Also, among the Asian population and the Hispanic population, there may be increased use of certain complementary and alternative medicines that can interact with cancer therapies that can affect some of the results we’ve seen. So, I think an honest discussion with these [patient groups] about what other alternative treatments or medicines they may be using during the cancer process is important to have because these types of practices are common among the Hispanic and Asian population.

References

1. Cardinale D, Iacopo F, Cipolla CM. Cardiotoxicity of anthracyclines. Front Cardiovasc Med. Published online March 18, 2020. doi:10.3389/fcvm.2020.00026
2. Gabani M, Castañeda D, Nguyen QM, et al. Association of cardiotoxicity with doxorubicin and trastuzumab: a double-edged sword in chemotherapy. Cureus. Published online September 22, 2021. doi:10.7759/cureus.18194
3. Zhang L, Song J, Clark R, et al. Racial and ethnic differences in anthracycline cardiotoxicity. Presented at: AHA Scientific Sessions 2021; November 13-15, 2021. Abstract 13090
4. US Census Bureau. NYC Decennial Census Data: City & Boroughs, Community Districts, 2020 NTAs, 2020 Census Tracts. Accessed November 30, 2021. https://www1.nyc.gov/assets/planning/download/office/planning-level/nyc-population/census2020/nyc_decennialcensusdata_2020_2010.xlsx
5. Javier-DesLoges J, Nelson TJ, Murphy JD, et al. Disparities and trends in the participation of minorities, women, and the elderly in breast, colorectal, lung, and prostate cancer clinical trials. Cancer. Published online November 22, 2021. doi:10.1002/cncr.33991
6. Al-Sadawi M, Hussain Y, Copeland-Halperin RS, Steingart RM, Johnson MN, Yu AF. Racial and socioeconomic disparities in cardiotoxicity among women with HER2-positive breast cancer. Am J Cardiol. Published online February 19, 2021. doi:10.1016/j.amjcard.2021.02.013
7. Litvak A, Batukbhai B, Russell SD, et al. Racial disparities in the rate of cardiotoxicity of HER2-targeted therapies among women with early breast cancer. Cancer. Published online January 30, 2018. doi:10.1002/cncr.31260
8. Churchwell K, Elkind MSV, Benjamin RM, et al. Call to action: structural racism as a fundamental driver of health disparities: a presidential advisory from the American Heart Association. Circ. Published online November 10, 2020. doi:10.1161/CIR.0000000000000936

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HealthDay News — A clinical risk model can predict the risk of death and unplanned cardiac hospitalization for patients waiting for cardiac surgery, according to a study published in the Aug. 30 issue of CMAJ, the journal of the Canadian Medical Association.

Louise Y. Sun, M.D., from the University of Ottawa in Canada, and colleagues derived and validated a clinical risk model to predict the composite outcome of death and cardiac hospitalization of patients on the waitlist for cardiac surgery between 2008 and 2019. The patients were randomly divided into derivation and validation data sets (two-thirds [41,729 patients] and one-third [20,583 patients], respectively). The model was derived using a multivariable Cox proportional hazard model with backward stepwise variable selection.

The researchers found that 4.9 percent of the patients died or had an unplanned cardiac hospitalization while waiting for surgery. At 15, 30, 60, and 89 days, the area under the curve of the model was 0.85, 0.82, 0.81, and 0.80, respectively, in the derivation cohort, and 0.83, 0.80, 0.78, and 0.78, respectively, in the validation cohort. At all time points the model calibrated well.

“Our model can be used to provide decision support for referring physicians and the surgery-anesthesiology team, as well as health care administrators, through time-dependent, individualized risk prediction,” the authors write. “It could also be used in quality benchmarking and to compare wait-time metrics across centers.”

Abstract/Full Text

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HealthDay News — Survival up to five years after a heart transplant is similar for patients aged 70 years and older and those younger than 70 years, according to a study published online June 9 in the Journal of the American Geriatrics Society.

Abhishek Jaiswal, M.D., from the Hartford Hospital in Connecticut, and colleagues compared characteristics and outcomes for adults aged 70 years and older and younger than 70 years in a retrospective cohort analysis involving 57,285 adults listed for heart transplantation between 2000 and 2018. Overall, 37,135 patients underwent heart transplantation, of whom 2.2 percent were aged 70 years and older.

The researchers observed an increase in the yearly listing of those aged 70 years and older, from 2.5 to 11 percent in 2000 and 2017. Those aged 70 years and older had a similar risk for death while waiting as those younger than 70 years (subhazard ratio, 0.86; 95 percent confidence interval, 0.68 to 1.08; P = 0.19), but they had an increased likelihood of being transplanted (subhazard ratio, 1.36; 95 percent confidence interval, 1.26 to 1.48; P < 0.01). The overall posttransplant one- and five-year mortality rates were 10.4 and 19.2 percent, respectively, among the older patients. Compared with younger recipients, older recipients had lower unadjusted survival. After adjustment for relevant confounding variables, no significant between-group difference was seen in five-year mortality (hazard ratio, 1.06; 95 percent confidence interval, 0.91 to 1.254; P = 0.43).

“Our data suggest that advanced age by itself should not be considered an ineligibility criteria for heart transplantation; however, careful selection of such patients is warranted,” Jaiswal said in a statement.

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

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HealthDay News — Young Black heart recipients have an increased risk for mortality in the first year after transplant, according to a study published online Feb. 2 in Circulation: Heart Failure.

Hasina Maredia, M.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues studied 22,997 adult heart transplant recipients using data the Scientific Registry of Transplant Recipients data from January 2005 to 2017 to examine the disparity associated with Black race in heart transplant outcomes.

The researchers found that among recipients aged 18 to 30 years, mortality was increased 2.05-fold for Black versus non-Black recipients (95 percent confidence interval [CI], 1.67 to 2.51; P < 0.001); the risk was only significant in the first year after transplant (first year: adjusted hazard ratio [aHR], 2.30; 95 percent CI, 1.60 to 3.31; P < 0.001; after first year: aHR, 0.84; 95 percent CI, 0.54 to 1.29; P = 0.4). Among recipients aged 31 to 40 and 41 to 60 years, the association was attenuated, with mortality increased 1.53-fold (95 percent CI, 1.25 to 1.89; P < 0.001) and 1.20-fold (95 percent CI, 1.09 to 1.33; P < 0.001), respectively, among Blacks. No significant association with Black race was seen among recipients aged 61 to 80 years (aHR, 1.12; 95 percent CI, 0.97 to 1.29; P = 0.1).

“Clinical research moving forward should focus attention on young, Black recipients during this high-risk period so that longstanding racial disparities seen in heart transplant survival can be improved,” Maredia said in a statement.

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HealthDay News — A blood biomarker, percent donor-derived cell-free DNA (%ddcfDNA), is promising for the early detection of acute rejection (AR) after heart transplant, according to a study published online Jan. 13 in Circulation.

Sean Agbor-Enoh, M.D., Ph.D., from the Genomic Research Alliance for Transplantation in Bethesda, Maryland, and colleagues examined the performance of %ddcfDNA for the detection of AR in heart transplant patients. AR, including acute cellular rejection (ACR) and antibody-mediated rejection (AMR), was defined using histopathology data. Data were included for 171 patients followed for a median of 17.7 months posttransplant.

The researchers found that after surgery, median %ddcfDNA levels decayed to 0.13 percent by 28 days and then increased for patients with AR versus those without AR (0.38 versus 0.03, respectively). The increase was detected 0.5 and 3.2 months prior to the histopathological diagnosis of ACR and AMR, respectively. For AR, the area under the receiver operator characteristics curve (AUROC) was 0.92. The negative predictive value for AR was 99 percent with a 0.25 %ddcfDNA threshold and would have safely eliminated 81 percent of endomyocardial biopsy. Comparing AMR to ACR, %ddcfDNA showed distinctive characteristics, including fivefold higher levels, higher AUROC (0.95 versus 0.85), higher guanosine-cytosine content, and a higher percentage of short ddcfDNA fragments.

“Our data supports the use of %ddcfDNA as a ‘liquid biopsy,’ to monitor allograft health in heart transplant patients. %ddcfDNA is reliable and reproducible, varies both quantitatively and qualitatively in AMR and ACR, has excellent biomarker performance characteristics, and unmasks pathology earlier than existing tools,” the authors write.

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The American College of Cardiology (ACC) Summit Team released recommendations regarding the use of coronary computed tomography angiography (CTA) as an initial tool for the diagnosis of stable coronary artery disease, which were published in the Journal of the American College of Cardiology.

The standard diagnostic tool for patients with stable chest pain in the United States is functional imaging. However, results from recent randomized clinical trials suggest a coronary CTA-first approach may be superior.

Current evidence indicates that CTA does not cause more cardiac catherization or revascularization, and that it is not associated with increased 5-year invasive interventions. In addition, CTA is associated with lower healthcare cost, leading the United Kingdom and European societies to recommend CTA first y for the diagnosis and management of chronic coronary syndromes.

Despite the most up-to-date evidence, and recent guideline shifts in other countries, adoption of this policy may be particularly challenging in the United States due to concerns related to equipment, education, and funding.

Equipment

Nuclear medicine cameras and stress echocardiography laboratories are not widespread in the United States.

Despite this fact, the ACC Summit Team does highlight that CT scanners are ubiquitous across the US. They cite recent trials (eg, PROMISE) which have established that CTA may be feasible at nonexpert sites.

Education

American educational programs have focused on functional over anatomic testing, leading to a scarcity of required technical expertise to integrate such practices country-wide.

Transitioning to a CTA-first policy will require revising training programs, the ACC Summit Team cautions, which should include continuing education programs for practicing clinicians. Revised programs will need to feature expanded certification of imaging skills. Furthermore, all cardiologists and primary care physicians require education on when coronary CTA should be considered over other techniques and how to interpret and integrate results into patient care.

The authors of the document also recommend the implementation of a national registry which would ensure consistent quality for patients.

Funding

The American insurance system causes reimbursement disparities between testing modalities despite similar costs.

To address this issue, the ACC summit Team recommends that a CTA procedure should be reclassified to the Ambulatory Payment Classification group for increased reimbursement. The assessment of value-based and shared-savings models should be investigated to reduce more costly diagnostic procedures and to justify a CTA-first policy results in long-term cost reduction. Direct advocacy will be needed with both public and private payers to establish equitable payment and to eliminate the need for pre-approval permission before a CTA procedure.

Regardless of potential implementation difficulties, the most current research indicates a clear benefit of a CTA-first policy for patients. Therefore, the ACC Summit Team recommends CTA as the default evaluation tool for patients with stable chest pain and for the assessment of obstructive coronary artery disease.

They further stress that collaborations between the United States and the leadership responsible for the roll-out of the CTA-first policy in Europe may allow for enhanced learning and a more rapid adoption of this practice throughout the United States.

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

Reference

Poon M, Lesser J R, Biga C, et al. Current evidence and recommendations for coronary CTA first in evaluation of stable coronary artery disease. J Am Coll Cardiol. 2020;76(11):1358-1362. doi:10.1016/j.jacc.2020.06.078

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HealthDay News — Severe obesity in organ donors is not associated with adverse heart transplant outcomes, according to a study published online Sept. 16 in Circulation: Heart Failure.

Elizabeth D. Krebs, M.D., from the University of Virginia Health System in Charlottesville, and colleagues stratified single-organ first-time adult heart transplants from 2003 to 2017 from the United Network for Organ Sharing database by donor severe obesity status (body mass index [BMI], ≥40 kg/m²). The association between severe obesity and outcomes was assessed.

The researchers found that 3.5 percent of the 26,532 donors had a BMI ≥40 kg/m², with prevalence increasing over time (2.2 and 5.3 percent in 2003 and 2017, respectively). Severely obese donors more often had diabetes mellitus and hypertension; 67.4 percent were size-mismatched (donor weight >130 percent of recipient). Similar short-term outcomes were seen, including one-year survival (10.6 versus 10.7 percent); unadjusted and risk-adjusted long-term survival were not significantly different (hazard ratio, 0.928). Over time, there was an increase in severe obesity in the pool of organ donation candidates, from 3.5 to 6.8 percent in 2003 to 2017, with a lower proportion of hearts from severely obese donors transplanted (19.5 versus 31.6 percent of donors without severe obesity).

“Given the continued increase in obesity in the United States, this research has the potential to expand the critically low donor pool by increasing the number of donors and improving outcomes for the growing list of patients with end-stage heart failure,” a coauthor said in a statement.

One author disclosed financial ties to the pharmaceutical and medical device industries.

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HealthDay News — In the COVID-19 era, there has been a decrease in heart transplant (HT) volumes, according to a study published online July 22 in JAMA Cardiology.

Ersilia M. DeFilippis, M.D., from the Columbia University Irving Medical Center in New York City, and colleagues describe trends in waitlist inactivations, waitlist additions, donor recovery, and HT volume during COVID-19 in a descriptive cross-sectional study. Changes were examined from the pre-COVID-19 (Jan. 19 to March 15, 2020) to the COVID-19 era (March 15 to May 9, 2020).

The researchers identified 600 waitlist inactivations during the COVID-19 era compared with 343 during the pre-COVID-19 era (75 percent increase); there was a 37 percent decrease in waitlist additions, from 637 to 395. The most profound changes were seen in the Northeast and Great Lakes regions, with high COVID-19 rates. There was a 26 percent decrease in deceased donor recovery from 1,878 to 1,395; despite low COVID-19 prevalence, the most significant decrease occurred in the North Midwest. Across all regions, except the Northwest, there were significant reductions noted in HT volumes. There was significant regional variation seen in waitlist additions and deceased donor recovery from the pre-COVID-19 to the COVID-19 era.

“We must be prepared for more inactivations and fewer transplants if and when future surges of COVID-19 cases occur,” the authors write. “In the coming months, the consequences of these waitlist inactivations and decreased transplant volumes on waitlist mortality must be surveilled.”

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