2All India Institute of Medical Sciences, Guwahati, India
3Calicut Medical College, Government Medical College, Kozhikode, India
4Rawalpindi Medical University, Rawalpindi, Pakistan
5Shifa College of Medicine, Islamabad, Pakistan
6Faculdade de Ciências Médicas da Santa Casa de São Paulo-SP, Brazil
Abstract
Background: Myval is a balloon-expandable valve (BEV) used in transcatheter aortic valve implantation (TAVI) with distinguished features. Data comparing Myval with contemporary transcatheter heart valves (THVs) is limited. The authors performed a meta-analysis of studies comparing Myval with contemporary THVs (Sapien series and Evolut series).
Methods: The authors searched PubMed, EMBASE, and Cochrane databases. The primary composite endpoint of early safety (freedom from death and major complications) and other outcomes were extracted as defined by the Valve Academic Research Consortium 3 (VARC 3). The authors computed risk ratios (RRs) with 95% CIs using a Mantel−Haenszel method with a random-effects model with Review Manager (Cochrane Collaboration).
Results: Six studies with 2084 patients were included. Myval had better early safety at 30 days as per VARC 3 (RR 1.12; 95% CI: 1.02-1.22; P = .01) and lower need for permanent pacemaker implantation (PPI) (RR 0.62; 95% CI: 0.45-0.86; P = .004). Other outcomes were comparable in both groups. Vis-à-vis Evolut, Myval had better 30-day device success and lower rates of moderate or severe paravalvular leak (PVL) in addition to better early safety and lower need for PPI. Subgroup analyses of Myval with Sapien showed non-inferiority of Myval.
Conclusion: Myval showed better safety and lower need for PPI and may become a promising alternative for concurrent THVs.