Advancing Health Equity in the Cardiovascular Device Life Cycle

Area of Science:

• Cardiovascular Medicine
• Health Equity
• Medical Device Innovation

Background:

• Despite advances, cardiovascular disease (CVD) care disparities persist for marginalized populations, including racial/ethnic minorities, women, and rural residents.
• Transcatheter cardiovascular interventions have improved treatment but access and outcomes remain inequitable for high-burden populations.
• The role of cardiovascular device innovation in perpetuating these disparities is under-examined.

Purpose of the Study:

• To examine how cardiovascular device innovation influences health disparities in interventional cardiology.
• To utilize the cardiovascular device life cycle as a framework for understanding and mitigating inequities.
• To inform targeted interventions by identifying mechanisms of disparity in device regulation, trials, adoption, and outcomes.

Main Methods:

• Narrative review of the cardiovascular device life cycle.
• Analysis of regulatory and approval processes.
• Examination of clinical trial diversity and evaluation.
• Assessment of device adoption patterns and post-procedural outcomes.
• Focus on interventional cardiology examples.

Main Results:

• Cardiovascular device innovation and adoption may inadvertently exacerbate existing health disparities.
• Gaps exist in clinical trial representation and equitable access to novel interventions.
• Regulatory and post-market surveillance may not adequately address equity concerns.

Conclusions:

• A systematic approach is needed to ensure cardiovascular device innovation promotes health equity.
• Interventions targeting the entire device life cycle are necessary to reduce disparities in interventional cardiology.
• Collaboration between regulatory bodies, industry, and clinicians can foster equitable access and outcomes.