Publications by Year: 2025

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.

Most of the 800 000 people living with end-stage kidney disease in the United States rely on a functioning vascular access to provide life-sustaining hemodialysis, yet one-third of arteriovenous fistulas experience early failures. Determining the safety and effectiveness of systemic heparin during fistula creation could improve the quality and quantity of life for these vulnerable patients. In this article, a pragmatic randomized trial was emulated to assess the effect of systemic heparin administration (vs none) during radiocephalic arteriovenous fistula creation on early bleeding and thrombosis, using data from 2 international, multicenter, randomized trials performed between 2014 and 2019. Marginal risks were estimated using inverse probability weighted parametric survival analysis and CIs were generated with bootstrapping. A total of 914 patients were enrolled and 61% received systemic heparin; their median (IQR) age was 58 (49, 67) years and 45% were on hemodialysis at enrollment. No difference in the risk of bleeding events was observed, with a risk difference (95% CI) at 14 days of -0.1% (-1.6 to 1.4). The risk of access thrombosis was lower in the heparin group, with a risk of 3.7% (2.6-4.8) after heparin and 5.3% (3.4-7.4) without heparin at 14 days (risk ratio = 0.72; 95% CI, 0.50-0.98). Trial registration: ClinicalTrials.gov. Identifiers: NCT02110901 and NCT02414841.

A global treatment algorithm was developed for the endovascular revascularization of femoropopliteal lesions and chronic total occlusions, aiming toward a more standardized approach to endovascular treatment in patients with peripheral artery disease. The following steps are proposed. 1) Evaluation of lesion morphology based on preprocedural imaging by Duplex sonography and intravenous ultrasound for selection of lesion preparation tools. Lesion characteristics are mainly defined by calcification, lesion length, and the presence of total occlusion and in-stent restenosis. 2) Selection of vessel preparation strategies, which encompass plain old balloon angioplasty, atherectomy, thrombectomy, intravascular lithotripsy and specialty balloons, or a combination of the preceding, based on lesion and patient-specific characteristics. In addition, a Delphi consensus was applied for the appropriateness of lesion preparation strategies, depending on lesion anatomy, length, plaque morphology, and subintimal versus intraluminal guidewire crossing. 3) Definitive lesion treatment strategies using drug-coated balloons, bare-metal stents, drug-eluting stents, and/or covered stents or a combination. By establishing this treatment algorithm in routine practice, improvements in vessel- and patient-specific outcomes are anticipated, which will be further enhanced by continuous collaboration among experts from different countries and disciplines and by randomized controlled trials.

OBJECTIVE: Routine imaging surveillance following endovascular aortic aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) is critical for the timely diagnosis of late post-operative complications. Compliance with recommended EVAR surveillance is variable, and disparities in post-EVAR surveillance remain unclear. This study examines variability in EVAR surveillance and emergency health service utilization across several sociodemographic populations.

METHODS: All Medicare fee-for-service beneficiaries who underwent infrarenal EVAR for intact AAA between January 2011 and December 2019 were included. Patients were stratified by several sociodemographic characteristics: age category (66-74, 75-84, >85 years), sex (male, female), race (White, Black, Asian, Other), dual-enrollment in Medicare and Medicaid (dual-enrolled, Medicare-only), and distressed communities index (distressed >80th percentile, non-distressed ≤80th percentile). The following post-operative healthcare utilization metrics were assessed: EVAR-related office visits, imaging studies, emergency department (ED) visits, and hospital readmissions. Annual incidence rates were calculated for each healthcare utilization metric at 2 and 5 years after EVAR and compared across groups using Poisson regression models, adjusting for sociodemographic and hospital characteristics and comorbidities.

RESULTS: In 111,381 Medicare beneficiaries who underwent EVAR, post-operative healthcare utilization varied substantially across sociodemographic groups. After adjustment, annual incidence rates of EVAR-related office visits at 2 years post-EVAR were lower in patients who were >85 years vs 66-75 years (adjusted rate ratio [aRR]: 0.95 [95% confidence interval: 0.93-0.97]), female vs male (0.94 [0.93-0.95]), dual-enrolled vs Medicare-only (0.83 [0.81-0.85]), and residing in distressed vs non-distressed communities (0.95 [0.93-0.96]). Rates of imaging studies were lower in patients who were >85 years (0.98 [0.96-0.99]), dual-enrolled (0.97 [0.95-0.98]), and residing in distressed communities (0.97 [0.96-0.98]). There was higher use of hospital services in patients who were >85 years (ED: aRR 1.37 [1.33-1.41]; Readmission: aRR 1.23 [1.19, 1.28]), female (ED: 1.19 [1.16-1.22]; Readmission: 1.15 [1.12-1.19]), Black (ED: 1.10 [1.05-1.15]; Readmission: 1.15 [1.09-1.22]), dual-enrolled (ED: 1.29 [1.26-1.33]; Readmission: 1.14 [1.09-1.18]), and residing in distressed communities (ED: 1.03 [1.01-1.06]; Readmission 1.02 [0.99-1.05]). At 5 years post-EVAR, similar trends across sociodemographic groups were observed, with the added finding of lower rates of EVAR-related office visits in Black vs White patients.

CONCLUSIONS: Significant variation in post-EVAR healthcare utilization exists among Medicare beneficiaries. Patients who were older age, female sex, Black race, or socioeconomically-disadvantaged had lower rates of EVAR-specific follow up and higher use of emergency health service. Barriers in access to care are apparent, underscoring the need for targeted interventions to enhance post-EVAR surveillance and improve outcomes in these populations.