Abstract 13349: Inclusion and Enrollment of Women and Minorities in Left Atrial Appendage Occlusion Clinical Trials: A Meta-Analysis

Introduction: Retrospective studies suggest that women undergoing left atrial appendage occlusion may have worse outcomes and population-based studies suggest racial variations in appendage anatomy and risk of stroke. Hypothesis: Randomized controlled trials of LAAO for atrial fibrillation will have low rates of inclusion of women and racial minorities. Methods: Databases were queried for all randomized clinical trials of LAAO from inception until May 2022 and included in the analysis (Figure 1) . Results: The search strategy identified 10 trials for inclusion in the study. Most studies reported rates of participation of women (9/10, 90 percent Figure 2a ). The inclusion of women in these trials were low and constituted 34% of included patients (29-42%) with high heterogeneity ( Figure 3a). Among these reports, only two studies (2/10, 20 percent, Figure 2b ) reported details of the race and ethnicity of participants and 1031 / 1114 (93%) were Caucasians. Meta-analysis showed low heterogeneity Figure 3b). Conclusions: In trials of LAAO for atrial fibrillation, rates of inclusion of women remain low relative to population prevalence. Reporting of participation of ethnic minorities also remains low. Improvement in these areas in future studies may help support the generalizability of the existing literature.