Effectiveness and Safety of Myval Versus Other Transcatheter Valves in Patients Undergoing TAVI: A Meta-Analysis

Abstract

Transcatheter aortic valve implantation (TAVI) has changed the treatment of aortic stenosis. The Myval transcatheter heart valve (THV), a novel balloon-expandable THV, has shown promising outcomes. Our aim is to compare the comparative safety and effectiveness of Myval THV against established THVs, such as Sapien and Evolut. A systematic review and meta-analysis was conducted, comparing the Myval THV with other contemporary THVs. Primary endpoints were periprocedural, 30-day and 1-year all-cause mortality. Seven studies involving 3106 patients (1027 Myval; 2079 other THVs) were included. No significant differences were observed in the primary endpoints. Myval demonstrated higher procedural success (RR: 1.04, 95% CI: 1.01-1.07, I² = 29%) and lower rates of permanent pacemaker implantation (PPI) during the index hospitalization (RR: 0.57, 95% CI: 0.36-0.92, I² = 23%) and 30-days (RR: 0.60, 95% CI: 0.40-0.89, I² = 43%), compared to other THV. At 30-day, Myval was associated with lower rates of moderate or severe transvalvular aortic regurgitation (RR: 0.33, 95% CI: 0.11-0.98, I² = 57%) and minor vascular complications (RR: 0.45, 95% CI: 0.23-0.90, I² = 0%). When compared to self-expandable THV, Myval was associated with higher procedural and device success, higher early safety, lower risk for PPI, minor vascular complications and at least moderate transvalvular AR. When compared to Sapien, procedural success and risk for in-hospital PPI was borderline higher and lower in favor of Myval, respectively. The Myval THV demonstrates comparable safety and effectiveness to contemporary THVs, with advantages in procedural success, PPI, and vascular complications.

Keywords: TAVR; aortic valve; balloon‐expandable; self‐expandable; transcatheter aortic valve replacement.

Figure 1

Forest plot showing (A) periprocedural mortality, (B) 30‐day, all‐cause mortality and (C) 1‐year, all‐cause mortality between Myval and other contemporary valves, with risk ratio and 95% CIs. CI, confidence interval, M−H, Mantel−Haenszel. [Color figure can be viewed at wileyonlinelibrary.com]

Figure 2

Forest plot showing (A) in‐hospital and (B) 30‐day permanent pacemaker implantation incidence between Myval and other contemporary valves, with risk ratio and 95% CIs. CI, confidence interval; M−H, Mantel−Haenszel. [Color figure can be viewed at wileyonlinelibrary.com]

Central Illustration 1

This figure illustrates key clinical outcomes comparing transcatheter aortic valve implantation (TAVI) using Myval THV with other THVs. AR, aortic regurgitation; PPI, permanent pacemaker implantation; SEV, self‐expandable valve. [Color figure can be viewed at wileyonlinelibrary.com]