Assessing the Novel Myval Balloon-Expandable Valve with the Evolut Valve: A Propensity-Matched Study

Background: The Myval balloon-expandable (BE) valve has shown encouraging early clinical data in terms of safety and efficacy. Comparative data with other well-established contemporary valves are nonetheless still scarce. This study aims to compare the performance of the Myval BE valve with the Evol...

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Main Authors: Jonathan Halim, Maxim Rooijakkers, Peter den Heijer, Milad El Haddad, Ben van den Branden, Jeroen Vos, Bas Schölzel, Martijn Meuwissen, Menno van Gameren, Saloua El Messaoudi, Niels van Royen, Sander IJsselmuiden
Format: Article
Language:English
Published: MDPI AG 2023-06-01
Series:Journal of Clinical Medicine
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Online Access:https://www.mdpi.com/2077-0383/12/13/4213
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Summary:Background: The Myval balloon-expandable (BE) valve has shown encouraging early clinical data in terms of safety and efficacy. Comparative data with other well-established contemporary valves are nonetheless still scarce. This study aims to compare the performance of the Myval BE valve with the Evolut self-expanding (SE) valve. Methods: In this retrospective single-center study, 223 patients with symptomatic severe aortic stenosis (AS) were included and treated with the Myval BE valve (n = 120) or with the Evolut SE valve (n = 103). Then, 91 pairs were compared after matching. Clinical outcomes were evaluated at 30 days and 1 year. Echocardiographic follow-up was performed at 30 days. Results: Procedural complications were rare in both groups. At the 30-day follow-up, no significant difference in cardiac death (Myval: 1% vs. Evolut: 2%, <i>p</i> = 0.56), stroke (2% vs. 4%, <i>p</i> = 0.41) and myocardial infarction (1% vs. 3%, <i>p</i> = 0.31) was observed. A permanent pacemaker implantation (PPI) was significantly less needed in the Myval group (4% vs. 15%, <i>p</i> = 0.01). At 1 year, cardiac death (2% vs. 4%, <i>p</i> = 0.41) and the stroke rate (7% vs. 5%, <i>p</i> = 0.76) were similar. Moderate–severe paravalvular leakage (PVL) was also comparable in both groups (1% vs. 4%, <i>p</i> = 0.17). Conclusion: Safety and efficacy outcomes were comparable between the two valves, except for a higher PPI rate for the Evolut SE valve. Up to 1-year follow-up, clinical outcomes showed acceptable rates of stroke and cardiac death with both valves. Valve hemodynamics were excellent with a low rate of moderate–severe PVL in both groups.
ISSN:2077-0383