One-Year Outcomes of Myval Versus Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: A Systematic Review and Meta-Analysis.

Abstract

The Myval and Myval Octacor transcatheter heart valves (THVs) are newer-generation balloon-expandable devices for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis (AS), but comprehensive synthesis of 1-year outcomes incorporating recent randomized data remains limited. We searched PubMed/MEDLINE, Embase, and CENTRAL through June 2026 for randomized controlled trials and propensity-matched or adjusted observational studies comparing Myval/Myval Octacor with contemporary THVs in adults undergoing transfemoral TAVI for severe symptomatic AS. The primary outcome was 1-year all-cause mortality; secondary outcomes included cardiovascular death, stroke, new permanent pacemaker implantation (PPI), mean transvalvular gradient, effective orifice area, and moderate-to-severe aortic regurgitation. Random-effects meta-analyses generated pooled risk ratios (RRs) and mean differences with 95% confidence intervals. Five studies (2 randomized trials, 3 propensity-matched/adjusted cohorts; 2327 patients: 1107 Myval, 1220 contemporary THV recipients) were included. At 1 year, Myval showed comparable outcomes to contemporary THVs for all-cause mortality (RR 0.89, 0.66-1.21), cardiovascular death (RR 0.92, 0.55-1.55), and stroke (RR 1.41, 0.91-2.18), with similar new PPI rates (RR 0.82, 0.47-1.42). Among randomized trials, Myval had lower mean transvalvular gradients (MD -1.28 mm Hg, -1.73 to -0.82) and larger effective orifice area (mean difference +0.15 cm2, 0.09-0.20) than SAPIEN, with no significant difference in moderate-to-severe aortic regurgitation (RR 1.28, 0.19-8.71). Myval demonstrated comparable all-cause mortality, cardiovascular death, stroke, and PPI rates to contemporary THVs at 1 year, along with favorable hemodynamics versus SAPIEN, supporting Myval as an effective contemporary TAVI platform; longer-term studies are needed to confirm durability and clinical outcomes.