Sex-Specific Outcomes in Cardiovascular Device Evaluations.

Background: Females have historically been underrepresented in cardiovascular device trials. As a result, differences in outcomes for males and females are not possible to be determined in subanalyses. Materials and Methods: Against a backdrop of troubling trends in cardiovascular outcomes for females, we provide a narrative review on the differences in outcomes observed in females undergoing device evaluations in multiple fields of cardiovascular medicine, including coronary revascularization, structural heart disease, and heart failure. We also review predictors of cardiovascular trial nonparticipation as it may provide avenues by which female enrollment in cardiovascular device trials can be improved. Results: Advances have been made in structural heart therapy, where female representation in transcatheter aortic valve replacement studies was nearly 50%. For other indications, coronary revascularization and heart failure, there was clearly a disparity in female recruitment. On average, female representation was 25% in major clinical trials evaluating drug eluting stents, implantable cardioverter defibrillators, cardiac resynchronization defibrillators, and ventricular assist devices. As a result, the best treatment recommendations for females in these fields are currently guided by outcomes evaluated primarily in males. Conclusions: Female enrollment in device clinical trials for coronary revascularization and heart failure has lagged, leaving uncertainty in making benefit/risk assessments of device therapy. The predictors of female nonparticipation in clinical trials can inform a comprehensive strategy to facilitate and enrich the enrollment of females in cardiovascular device trials. This is critical to ensure that sex differences can be considered in treatment selection, so that patients can receive the best available care.