Abstract Body (Do not enter title and authors here): Introduction:
Transcatheter aortic valve implantation (TAVI) has been growing rapidly. The Myval balloon-expandable (BE) valve is a novel valve used for treating patients with severe aortic stenosis. No previous meta-analysis has assessed the different outcomes of TAVR using the Myval. We aim to evaluate the performance and outcomes of the Myval BE valve in patients with aortic stenosis.
Methodology:
A systematic search was done in PubMed, Scopus, Web of Science, Embase, and Cochrane from inception to June 2024. We used the relevant keywords to include studies that reported the outcomes of people who underwent a Myval balloon-expandable procedure for Aortic stenosis. 30-day and one-year outcomes were extracted across the studies. Device success of Myval was identified using Valve Academic Research Consortium (VARC)-2 and VARC-3 criteria.
Results:
Thirteen studies comprising 1256 patients of aortic valve stenosis were included. Of those, 679/1198 (56.7%) were males. The device success of Myval reached 97% CI [0.95, 0.98] across in included studies (Figure 1). Following TAVI, the procedural death and life-threatening bleeding with Myval were 1.3%, CI [0.6, 2.8], and 0.6%, CI [0.2, 2.5], respectively. Stroke cases following Myval were noticed in 3.6%, CI [2.2, 5.6] of total participants.
After following for 30-days, all-cause mortality and moderate or severe aortic regurgitation cases were 1.8%, CI [1.0, 3.2], and 2.3%, CI [1.0, 5.0], respectively. Also, the transvalvular mean pressure gradient was found to be 7.7 mmHg, CI [7.5, 8.0]. One year follow-up showed that all-cause mortality slightly increased, reaching 8.4% CI [6.1, 11.4] and stroke cases were noticed in 5.2%, CI [3.4, 7.9]
Conclusion:
Myval showed good safety and efficacy outcomes after 30 days and one-year following the TAVI.