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

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.