Comparing two-year outcomes of balloon-expandable Myval and self-expanding Evolut R in severe aortic valve stenosis

Elisabetta Moscarella; Alfonso Ielasi; Carolina Montonati; Dario Pellegrini; Mariano Pellicano; Daniele Briguglia; Valentina D'Alessandro; Francesco Giannini; Marco Gamardella; Massimo Medda; Giulio Guagliumi; Carlo Banfi; Mattia Glauber; Maurizio Tespili

doi:10.1016/j.ijcard.2023.131701

Comparing two-year outcomes of balloon-expandable Myval and self-expanding Evolut R in severe aortic valve stenosis

Int J Cardiol. 2024 Apr 1:400:131701. doi: 10.1016/j.ijcard.2023.131701. Epub 2023 Dec 31.

Affiliations

¹ Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
² U.O. Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy. Electronic address: alielasi@hotmail.com.
³ U.O. Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy.
⁴ U.O. Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy; Università Vita Salute San Raffaele, Milan, Italy.
⁵ U.O. Cardiochirurgia Universitaria, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy; Geneva Hemodynamic Research Group, Geneva, Switzerland.
⁶ Faculty of Medicine, University of Geneva, Switzerland; U.O. Cardiochirurgia Mini-Invasiva, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy.

PMID: 38168557
DOI: 10.1016/j.ijcard.2023.131701

Abstract

Background: The new balloon-expandable (BE) Myval transcatheter heart valves (THV) has shown promising early results with low paravalvular leak (PVL) and permanent pacemaker implantation (PPI) rates. Limited data are available regarding its long-term performance. We aimed to compare the 2-year clinical and echocardiographic outcomes of transcatheter aortic valve replacement (TAVR) using the self-expanding (SE) Evolut R and the BE Myval THVs.

Methods: The EVAL study included 166 patients with severe aortic valve stenosis who underwent TAVR either with SE Evolut R (n = 108) or BE Myval (n = 58) THV. Primary objectives include comparison on clinical efficacy (freedom from all-cause mortality, stroke, and cardiovascular hospitalization), echocardiographic performance and PPI rates between the two THVs.

Results: At 2-year the BE Myval group showed higher clinical efficacy (86% vs. 66%,HR:2.62, 95%CI 2.2-5.1;p = 0.006), with fewer cardiac hospitalizations (3.4% vs. 13.9%,p = 0.03). No significant differences in all-cause mortality, cardiovascular mortality, or stroke rates were observed. The proportion of patients with ≥moderate PVL was significantly lower in the BE Myval compared to the SE Evolut R group (4%vs. 22%,p = 0.008). The mean transvalvular gradient was significantly higher in the SE group compared to the BE group (9.5 ± 4.3 vs. 6.9 ± 2.2 mmHg,p < 0.001), however there was no difference in the percentage of patients with a mean gradient ≥20 mmHg between the two groups.

Conclusions: Both THVs offer similar 2-year clinical outcomes. The BE Myval THV demonstrated advantages with higher clinical efficacy and lower PVL incidence. Longer follow-up and randomized trials are needed to validate these results and assess Myval's sustained performance and durability.

Keywords: Aortic stenosis; Balloon-expandable Myval; Self-expanding Evolut R; Transcatheter aortic valve replacement; Transcatheter heart valves.

MeSH terms

Aortic Valve / diagnostic imaging
Aortic Valve / surgery
Aortic Valve Stenosis* / diagnostic imaging
Aortic Valve Stenosis* / surgery
Heart Valve Prosthesis*
Humans
Prosthesis Design
Stroke* / surgery
Transcatheter Aortic Valve Replacement*
Treatment Outcome