A systematic review and meta-analysis of the hemodynamics and outcomes of the Myval balloon-expandable valve in patients with severe aortic stenosis and with aortic regurgitation

Abstract

Introduction

Transcatheter aortic valve implantation (TAVI) has been growing rapidly. We aim to evaluate the performance and outcomes of the Myval transcatheter heart valve (THV) in patients with severe aortic stenosis and its use in quantitative videodensimetry, transcatheter valve-in-valve (ViV), and non-calcified aortic regurgitation (NCAR).

Methods

A systematic search was done in PubMed, Scopus, Web of Science, Embase, and Cochrane from inception to October 2024. We used the relevant keywords to include studies that reported the outcomes of patients with severe aortic stenosis who underwent TAVI using the Myval THV and off-label usage in transcatheter ViV and NCAR. Data analysis was done using R software.

Results

A total of 29 studies were included in this study. The results of the mean aortic gradient at discharge, 30-day, one-year, and 2-year were 9.25 mmHg (95 % CI [8.20, 10.29]), 8.46 (95 % CI [7.57, 9.34]). 10.63 (95 % CI [9.12, 12.14]), and 7.2 (95 % CI [6.78, 7.63]), respectively. Additionally, the pooled percentages of patients with ≥ moderate aortic regurgitation were found in 1 % (95 % CI [1,2]) at discharge, 3 % (95 % CI [2,4]) at 30-day, 4 % (95 % CI [2,7]) at one-year follow-up and 5 % (95 % CI [3,8]) at 2-year. Furthermore, usage of the Myval THV in transcatheter ViV and NCAR led to a reduction in mean aortic gradient and incidence of aortic regurgitation, respectively.

Conclusion

The Myval THV showed good safety and efficacy outcomes in short- and long-term follow-ups following the TAVI. Also, it showed promising results during transcatheter ViV and NCAR.