Updated systematic review and meta-analysis comparing Myval versus Sapien 3 transcatheter heart valves in severe aortic stenosis: focus on early and one-year mortality.

Abstract

Background: Transcatheter aortic valve implantation (TAVI) is a guideline-recommended treatment for severe aortic stenosis (AS). While the balloon-expandable Edwards Sapien 3 valve has long been the benchmark, the newer Myval valve has emerged as a potential alternative. Comparative data on mid-term survival, specifically one-year all-cause mortality, are lacking but crucial for clinical evaluation.

Methods: This systematic review and meta-analysis synthesised direct comparative evidence on the Myval versus Sapien 3 valves in patients undergoing TAVI, searching PubMed, Embase, and Cochrane Central up to November 2025. The primary outcomes included all-cause mortality within 30 days and 1 year. Secondary outcomes were 30-day safety events and hemodynamic parameters.

Results: Five studies (n = 2771) were included. The pooled analysis indicated no statistical difference in 30-day mortality (RR: 1.05, 95% CI: 0.53-2.07; p = 0.89; I²=0%) or in one-year all-cause mortality (RR: 0.93, 95% CI: 0.64-1.35; p = 0.70; I²=0%). Rates of stroke, major bleeding, pacemaker implantation, and other 30-day complications were also comparable (all p > 0.05). Hemodynamically, the Myval valve was superior at 30 days, with a lower mean gradient (MD: -2.37, 95% CI: -3.45 to -1.30; p < 0.0001) and larger effective orifice area (MD: 0.26, 95% CI: 0.17-0.35; p < 0.00001). Available one-year data from two randomised trials indicated this hemodynamic benefit was sustained.

Conclusion: This updated meta-analysis demonstrates that the newer Myval valve offers comparable early safety and one-year survival to the established Sapien 3 valve, with superior and sustained hemodynamic performance. These findings support its role as a safe and effective alternative in the TAVI landscape.