Publications

IMPORTANCE: In the 2020 Bostock v Clayton County decision, the US Supreme Court extended employment nondiscrimination protection to sexual minority adults. The health impacts of this ruling and similar policies related to sexual orientation-based discrimination are not currently known.

OBJECTIVE: To estimate changes in mental health following the Bostock decision among sexual minority adults in states that gained employment nondiscrimination protection (intervention states) compared with those in states with protections already in place (control states).

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study used 2018-2022 data from the Behavioral Risk Factor Surveillance System and a difference-in-differences approach to evaluate changes in mental health after the Bostock decision by comparing sexual minority adults (aged ≥18 years and identifying as lesbian, gay, or bisexual) in 12 intervention states with those residing in 9 control states. Models were estimated for all participants and separately for employed participants. Data were analyzed between February and September 2024.

EXPOSURE: Residing in a state that gained employment nondiscrimination protection after the Bostock decision.

MAIN OUTCOMES AND MEASURES: The primary outcome was number of poor mental health days during the past 30 days, and the secondary outcome was severe mental distress (defined as 14 or more past-month poor mental health days).

RESULTS: Of 597 462 participants (306 365 in intervention states [77.7% aged 18-64 years and 22.3% aged ≥65 years; 51.7% female] and 291 097 in control states [77.5% aged 18-64 years and 22.5% aged ≥65 years; 50.6% female]), 5.1% in intervention states and 6.0% in control states self-identified as sexual minority adults. The mean (SE) number of past-month poor mental health days was unchanged after the Bostock decision among sexual minority adults in both intervention (from 8.70 [0.27] to 9.59 [0.24] days; adjusted difference, 0.57 [95% CI, -1.02 to 2.16] days) and control (from 8.53 [0.21] to 10.15 [0.20] days; adjusted difference, 1.17 [95% CI, -0.46 to 2.79] days) states, resulting in no differential change between the 2 groups (difference-in-differences, -0.60 days; 95% CI, -1.25 to 0.06 days). Among the subset of employed sexual minority adults, the mean (SE) number of poor mental health days did not change in intervention states (from 7.99 [0.38] to 8.83 [0.30] days; adjusted difference, 0.87 [95% CI, -0.49 to 2.22] days) but increased in control states (from 7.75 [0.27] to 9.75 [0.26] days; adjusted difference, 1.84 [95% CI, 0.44-3.24] days). These findings corresponded to a significant relative reduction in poor mental health days among employed sexual minority adults in intervention vs control states (difference-in-differences, -0.97 days; 95% CI, -1.74 to -0.21 days). Mean (SE) rates of severe mental distress increased less among employed sexual minority adults in intervention (from 26.35% [1.59%] to 29.92% [1.46%]; adjusted difference, 6.81% [95% CI, 2.20%-11.42%]) vs control (from 26.53% [1.27%] to 34.26% [1.16%]; adjusted difference, 10.30% [95% CI, 5.99%-14.61%) states, also corresponding to a significant relative reduction among employed sexual minority adults (difference-in-differences, -3.49%; 95% CI, -6.71% to -0.27%).

CONCLUSIONS AND RELEVANCE: These findings show significant relative reductions in past-month poor mental health days and severe mental distress among employed sexual minority adults after the implementation of a federal ban on employment discrimination based on sexual orientation. Larger and more consistent mental health benefits observed among sexual minority adults in the workforce underscore the importance of broadening protections to other social domains.

BACKGROUND: The federal government spends billions of dollars per year on payments to Medicare Advantage (MA) plans based, in part, on beneficiaries' risk scores. Despite this, little is known about the true burden of chronic medical conditions among MA beneficiaries compared with those in fee-for-service (FFS) Medicare.

OBJECTIVE: To determine whether the prevalence of chronic medical conditions is higher among MA compared with FFS beneficiaries.

DESIGN: Cross-sectional.

SETTING: Population based.

PARTICIPANTS: Adults aged 65 years or older enrolled in MA or FFS Medicare.

MEASUREMENTS: Using direct physical examination and laboratory data from the National Health and Nutrition Examination Survey (2015 to 2018), we compared the age- and sex-standardized prevalence of obesity, hypertension, hyperlipidemia, diabetes, and chronic kidney disease between MA and FFS beneficiaries.

RESULTS: The unweighted study population included 2446 respondents corresponding to a weighted total of 45 426 711 adults (34.4% MA, 65.6% FFS Medicare). The prevalence of obesity (41.1% vs. 40.6%; standardized difference [SDiff], 0.48 percentage points [pp] [95% CI, -5.2 to 6.2 pp]), hypertension (70.9% vs. 71.0%; SDiff, -0.05 pp [CI, -5.8 to 5.7 pp]), hyperlipidemia (79.4% vs. 82.3%; SDiff, -2.86 pp [CI, -7.0 to 1.3 pp]), and chronic kidney disease (19.2% vs. 22.8%; SDiff, -3.48 pp [CI, -9.2 to 2.3 pp]) was not higher among MA beneficiaries compared with FFS beneficiaries. However, the prevalence of diabetes was higher in MA (33.3% vs. 26.3%; SDiff, 7.00 pp [CI, 3.3 to 10.7 pp]).

LIMITATION: Differences in the severity of specific medical conditions between groups could not be assessed.

CONCLUSION: In this nationally representative study from 2015 to 2018, the prevalence of obesity, hypertension, hyperlipidemia, and chronic kidney disease was not higher among MA compared with FFS beneficiaries; however, the prevalence of diabetes was higher among MA beneficiaries.

PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute (NHLBI) and American Heart Association (AHA).

Despite advancements in diagnostics and therapeutics for cardiovascular disease, significant health disparities persist among patients from historically marginalized racial and ethnic groups, women, individuals who are socioeconomically under-resourced or underinsured, and those living in rural communities. While transcatheter interventions have revolutionized the treatment landscape in cardiology, populations bearing the greatest burden of disease continue to face inequitable access and poorer outcomes. A notable gap in the literature concerns the role of modern approaches to cardiovascular device innovation in shaping and perpetuating health disparities. Health equity has been declared one of the top strategic initiatives for 2022 to 2025 by the Food and Drug Administration Center for Devices and Radiological Health, underscoring the need for greater attention, dialogue, and targeted interventions in this space. This narrative review uses the cardiovascular device life cycle as a conceptual framework to enhance understanding and guide future efforts to mitigate disparities in the field of interventional cardiology. Drawing on illustrative examples from interventional cardiology, we examine current practices in cardiovascular device regulation and approval, clinical trial evaluation, adoption patterns, and postprocedural outcomes with the aim of uncovering potential mechanisms of disparities and identifying opportunities for targeted interventions.

IMPORTANCE: Improving cardiovascular health in rural areas is a national priority in the US. However, little is known about the current state of rural cardiovascular health and the underlying drivers of any rural-urban disparities.

OBJECTIVE: To compare rates of cardiometabolic risk factors and cardiovascular diseases between rural and urban US adults and to evaluate the extent to which health care access, lifestyle factors, and social risk factors contribute to any rural-urban differences.

DESIGN, SETTING, AND PARTICIPANTS: This nationally representative cross-sectional study analyzed data from US adults aged 20 years or older residing in rural vs urban areas using the 2022 National Health Interview Survey. Data were analyzed between August 2024 and February 2025.

EXPOSURE: County-level rurality.

MAIN OUTCOMES AND MEASURES: The primary outcomes were age-standardized rates of cardiometabolic risk factors (hypertension, hyperlipidemia, obesity, and diabetes) and cardiovascular diseases (coronary heart disease [CHD] and stroke).

RESULTS: The study population consisted of 27 172 adults, including 4256 adults (14.0%) residing in rural areas, 14 741 (54.8%) in small or medium metropolitan areas, and 8175 (31.2%) in urban areas. Mean (SD) participant age was 49.1 (17.8) years, and 4399 participants (50.8%) were female. Compared with their urban counterparts, rural adults were more likely to smoke, be insufficiently physically active, and have more social risk factors. Age-standardized rates of cardiometabolic risk factors were significantly higher in rural areas, including hypertension (37.1% vs 30.9%; rate ratio [RR], 1.20; 95% CI, 1.13-1.27), hyperlipidemia (29.3% vs 26.7%; RR, 1.10; 95% CI, 1.03-1.18), obesity (41.1% vs 30.0%; RR, 1.37; 95% CI, 1.27-1.47), and diabetes (11.2% vs 9.8%; RR, 1.15; 95% CI, 1.02-1.29). The same pattern was observed for CHD (6.7% vs 4.3%; RR, 1.58; 95% CI, 1.35-1.85), but no differences were observed for stroke. The magnitude of rural-urban disparities was largest among young adults (aged 20-39 years) for hypertension (RR, 1.44; 95% CI, 1.12-1.86), obesity (RR, 1.54; 95% CI, 1.34-1.77), and diabetes (RR, 2.59; 95% CI, 1.54-4.38). Rural-urban disparities in cardiovascular health were not meaningfully attenuated after adjustment for measures of health care access (insurance coverage, usual source of care, and recent health care utilization) and lifestyle factors (smoking and physical activity). However, accounting for social risk factors (poverty, education level, food insecurity, and home ownership) completely attenuated rural-urban disparities in hypertension (adjusted RR [aRR], 0.99; 95% CI, 0.93-1.06), diabetes (aRR, 1.02; 95% CI, 0.90-1.15), and CHD (aRR, 1.08; 95% CI, 0.91-1.29), but only partially attenuated disparities in obesity (aRR, 1.29; 95% CI, 1.20-1.39).

CONCLUSIONS AND RELEVANCE: This national cross-sectional study found substantial rural-urban disparities in cardiometabolic risk factors and cardiovascular diseases, which were largest among younger adults and almost entirely explained by social risk factors. These findings suggest that efforts to improve socioeconomic conditions in rural communities may be critical to address the rural-urban gap in cardiovascular health.

BACKGROUND: Food and Drug Administration-mandated postmarket studies for transcatheter aortic valve replacement in low-risk populations plan to use passively collected registry data linked to claims for long-term follow-up out to 10 years. Therefore, it is critically important to understand the validity of these claims-based end points. We sought to evaluate the ability of administrative claims with International Classification of Diseases-Tenth Revision (ICD-10) codes to identify trial-adjudicated end points and reproduce treatment comparisons of aortic valve replacement in the Evolut Low Risk Trial.

METHODS: We linked Evolut Low Risk trial patients to the Medicare Provider Analysis and Review database. We calculated sensitivity, specificity, positive predictive value, negative predictive value, and κ agreement statistic of claims to detect clinical end points through 2 years in trial patients. We additionally compared end points across treatment arms using trial-adjudicated outcomes versus claims-based outcomes.

RESULTS: Trial-adjudicated deaths were perfectly identified by claims. Claims had good performance in identifying trial-adjudicated disabling stroke (sensitivity 68.8%, specificity 99.0%, positive predictive value 64.7%, negative predictive value 99.1%, κ=0.66) and pacemaker placement (sensitivity 85.2%, specificity 98.4%, positive predictive value 90.4%, negative predictive value 97.5%, κ=0.86), but more modest performance in identifying trial-adjudicated myocardial infarction (κ=0.46) and vascular complications (κ=0.45). There was no difference between treatment arms for the primary end point of death or disabling stroke using trial data (hazard ratio, 0.83 [95% CI, 0.41-1.68]) or claims data (hazard ratio, 0.89 [95% CI, 0.43-1.81]; interaction P=0.71).

CONCLUSIONS: Claims-based end points performed well in ascertaining death, disabling stroke, and pacemaker placement and were able to reproduce principal trial findings. These results support the selective use of claims-based end points for transcatheter aortic valve replacement postmarketing surveillance.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

The evidence base evaluating the use of mechanical circulatory support (MCS) devices in complex, high-risk percutaneous coronary intervention is evolving from a small number of randomised clinical trials to incorporate an amassing body of real-world data. Due to both the growing incidence of the procedures and the limitations of the evidence, there is wide variability in the use of MCS, and the benefits are actively debated. The goal of this review is to perform an integrated analysis of randomised and non-randomised studies which have informed clinical and regulatory decision-making in contemporary clinical practice. In addition, we describe forthcoming studies that have been specifically designed to advance the field and resolve ongoing controversies that remain unanswered for this complex, high-risk patient population.

BACKGROUND: Recent data support both surgical-first and endovascular-first revascularization approaches for chronic limb-threatening ischemia (CLTI), but hospital-based practices are poorly described.

OBJECTIVES: This aim of this study was to characterize contemporary variations and outcomes associated with each strategy among U.S. hospitals providing both approaches.

METHODS: Medicare beneficiaries ≥66 years of age with CLTI treated at institutions offering both strategies between October 1, 2015 to December 31, 2021 were analyzed. A marginal Cox regression approach was used, and models were adjusted for patient-level covariates.

RESULTS: Among 196,070 patients at 1,832 institutions, 82.5% underwent endovascular treatment. Patients undergoing endovascular revascularization were older and had a higher comorbidity burden. The adjusted median OR for receiving an endovascular procedure was 2.32 among hospitals (Q1-Q3: 2.24-2.40; P < 0.01), demonstrating high variability in intervention use. Patients undergoing endovascular revascularization at the highest quintile hospitals had a lower rate of major amputation (adjusted HR [aHR]: 0.82; 95% CI: 0.77-0.88; P < 0.01) and a higher rate of repeat procedures (aHR: 1.37; 95% CI: 1.32-1.43; P < 0.01). Patients undergoing surgical bypass at the highest quintile hospitals had a higher rate of major amputation (aHR: 1.21; 95% CI: 1.13-1.29; P < 0.01) and a lower rate of repeat procedures (aHR: 0.73; 95% CI: 0.70-0.76; P < 0.01).

CONCLUSIONS: This study showed large interhospital variability in revascularization strategies, as well as improved outcomes for patients receiving endovascular treatment at higher volume sites. Further work is needed to standardize treatments with the goal of improving limb salvage rates.