Original Research

DOI: 10.4244/EIJ-D-24-01112

Four-year durability of the Myval balloon-expandable transcatheter aortic valve

Akash Jain1, MD, DM; John Jose2, MD; Matteo Montorfano3, MD; Henrik Nissen4, MD; Pedro Martin5, MD; Ashok Seth6, MD; Kresimir Stambuk7, MD; Gunasekaran Sengottuvelu8, MD, DM, DNB; Mussayev Abdurashid9, MD; Mario García-Gómez1, MD; Clara Fernandez-Cordón1, MD; Marcelo Rodriguez1, MD; Mathias D. Jorgensen4, MD; Alberto Campo1, MD; Ana Serrador1, MD, PhD; Silvia Vallinas-Hernandez1, MD; Manuel Carrasco-Moraleja1,10, MSc; Alberto San Román1,10, MD, PhD; Ignacio J. Amat-Santos1,10, MD, PhD

Abstract

Background: The Myval series is the first commercially available balloon-expandable transcatheter aortic valve implantation (TAVI) system designed as an alternative to the SAPIEN series. The LANDMARK trial recently demonstrated its non-inferiority compared to contemporary systems. However, the long-term durability of the Myval series remains unknown.

Aims: We aimed to evaluate the 4-year durability of the Myval series using Valve Academic Research Consortium (VARC)-3-defined endpoints.

Methods: We carried out a multicentre ambispective study of patients with severe aortic stenosis who underwent TAVI with the Myval series between December 2017 and April 2020. Baseline characteristics were prospectively recorded in a dedicated database. Clinical and echocardiographic follow-up was performed at 4 years. Outcomes included haemodynamic valve deterioration (HVD), bioprosthetic valve failure (BVF), and patient-prosthesis mismatch (PPM) as defined by the VARC-3 criteria, assessed at a central echocardiography laboratory.

Results: A total of 366 patients from 9 institutions were included, all of whom completed 4-year follow-up or were followed up until death. The 4-year survival rate was 81.8%, with residual ≥moderate aortic regurgitation observed in 9.2% of patients. BVF criterion 1 (symptomatic valve failure) occurred in 3.3%, while no cases of BVF criteria 2 or 3 were reported. Stage 2 HVD was observed in 9.7% of patients and stage 3 HVD in 0.7% at 4 years. Moderate and severe PPM were identified in 3.6% and 2.1% of patients at 1 year, respectively.

Conclusions: In a real-world cohort, 4-year outcomes with the balloon-expandable Myval series demonstrated acceptable valve durability, low haemodynamic deterioration, and comparable performance to contemporary TAVI systems.

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Volume 21 Number 13
Jul 7, 2025
Volume 21 Number 13
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