Four-year durability of the Myval balloon-expandable transcatheter aortic valve
Jain A. Jose J. Montorfano M. Nissen H. Martin P. Seth A. Stambuk K. Sengottuvelu G. Abdurashid M. García-Gómez M. Fernandez-Cordón C. Rodriguez M. Jorgensen M.D. Campo A. Serrador A. Vallinas-Hernandez S. Carrasco-Moraleja M. Román A.S. Amat-Santos I.J.
7 July 2025Europa Group
EuroIntervention
2025#21Issue 13e758 - e765 pp.
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.
durability , Myval series , TAVI , transcatheter aortic valve implantation
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Cardiology Department, University Clinic Hospital of Valladolid, Valladolid, Spain
Christian Medical College, Vellore, India
School of Medicine, Vita-Salute San Raffaele University, Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy
Odense University Hospital, Odense, Denmark
Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria, Spain
Fortis Escorts Heart Institute, New Delhi, India
Magdalena Clinic for Cardiovascular Diseases, Zagreb, Croatia
Apollo Hospital, Chennai, India
National Research Cardiac Surgery Center, Astana, Kazakhstan
Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain
Cardiology Department
Christian Medical College
School of Medicine
Odense University Hospital
Hospital Universitario de Gran Canaria Dr Negrin
Fortis Escorts Heart Institute
Magdalena Clinic for Cardiovascular Diseases
Apollo Hospital
National Research Cardiac Surgery Center
Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV)
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