Faisal A Al-Harbi, Ahmad Khalaf Alanazi, Norah Abdullah Algoblan, Sayer Samawi Aldhafeeri, Layan Bader Alrashoodi, Mohammed Ahmad Alamer, Ola Fozan Alquraishi, Alhanouf Abdalmahsn Alresaini, Norah Mohammed Almutiq, Mohammad Saad Aljibreen, Lamis Faisal Alwabili, Naser Kolko
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.