Advancing Health Equity in the Cardiovascular Device Life Cycle.

Abstract

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.