Sex-related differences in survival and safety outcomes after transcatheter aortic valve replacement: a meta-analysis of reconstructed time-to-event data.

Aims: The impact of sex-related differences on outcomes following transcatheter aortic valve replacement (TAVR) remains inconclusive. This study investigates sex-related differences in survival and safety outcomes in patients with aortic stenosis undergoing TAVR.

Methods and results: We systematically searched PubMed, Embase, Scopus, and Cochrane Library until November 2024. Individual patient data (IPD) were reconstructed from published Kaplan-Meier curves and compared using Cox-proportional hazards model for overall survival and cardiovascular mortality. Pooled risk ratios (RR) for safety outcomes at 30-days and 1 year were estimated using a random-effects model. A total of 48 studies (69 355 women and 65 580 men) were included. Meta-analysis of reconstructed IPD showed that men were at higher risk of all-cause mortality at 5 years [hazard ratio (HR): 1.24, 95% confidence interval (CI): 1.20-1.28, P < 0.001] and cardiovascular mortality at 4 years (HR: 1.34, 95% CI: 1.21-1.49, P < 0.001) compared with women. In random-effects meta-analysis, men faced a higher risk of permanent pacemaker implantation (RR: 1.29, 95% CI: 1.16-1.44, P < 0.001) during the first year. Men experienced a lower risk of stroke (RR: 0.75, 95% CI: 0.64-0.87, P < 0.001) and major vascular complications (RR: 0.58, 95% CI: 0.49-0.69, P < 0.001) at 30 days, and a lower risk of major bleeding (RR: 0.77, 95% CI: 0.70-0.84, P < 0.001) as well as major vascular complications (RR: 0.54, 95% CI: 0.43-0.68, P < 0.001) within the first year.

Conclusion: Men demonstrated poorer 5-year overall survival and 4-year cardiovascular survival following TAVR compared with women. Future research with extended follow-up is needed to understand the mechanism underlying sex-specific TAVR outcomes.