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. 2023 Jun 22;12(13):4213.
doi: 10.3390/jcm12134213.

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

Jonathan Halim  1 , Maxim Rooijakkers  2 , Peter den Heijer  1 , Milad El Haddad  3 , Ben van den Branden  1 , Jeroen Vos  1 , Bas Schölzel  1 , Martijn Meuwissen  1 , Menno van Gameren  1 , Saloua El Messaoudi  2 , Niels van Royen  2 , Sander IJsselmuiden  1
Affiliations

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

Jonathan Halim et al. J Clin Med. .

Abstract

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%, p = 0.56), stroke (2% vs. 4%, p = 0.41) and myocardial infarction (1% vs. 3%, p = 0.31) was observed. A permanent pacemaker implantation (PPI) was significantly less needed in the Myval group (4% vs. 15%, p = 0.01). At 1 year, cardiac death (2% vs. 4%, p = 0.41) and the stroke rate (7% vs. 5%, p = 0.76) were similar. Moderate-severe paravalvular leakage (PVL) was also comparable in both groups (1% vs. 4%, p = 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.

Keywords: aortic valve stenosis; myval valve; transcatheter aortic valve replacement.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
PPI rate at 30 days. Abbreviation: PPI = Permanent pacemaker implantation.
Figure 2
Figure 2
Distribution of the degree of PVL at 30 days. Abbreviation: PVL= Paravalvular leakage.
Figure 3
Figure 3
Aortic valve mean gradient at baseline compared to 30-day follow-up.
See this image and copyright information in PMC

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