Three-Year Follow-Up of the First 100 Patients Treated with the Balloon-Expandable Myval Transcatheter Aortic Valve System: A Single-Centre Experience

Abstract

Background/Objectives: To report our single-centre experience with the first 100 patients who underwent transcatheter aortic valve replacement (TAVR) with the new balloon-expandable Myval system. We report 3-year outcomes in low- to high-risk TAVR patient populations. Methods: From November 2019 to July 2021, 100 consecutive patients underwent TAVR, and their outcomes were classified according to the Valve Academic Research Consortium 3 definitions. Device performance was assessed using transthoracic echocardiography. Data collection was approved by the local ethical committee. Results: Among the 100 patients, most were male (n = 63), the mean age was 74.7 years, the mean EuroSCORE II score was 4.8 ± 4.9, and the mean Society of Thoracic Surgeons score was 5.6 ± 3.9. All patients were followed up for three years or until death. The rates of all-cause mortality, cardiac mortality and stroke were 28%, 7% and 5%, respectively. After three years, residual moderate aortic regurgitation was detected in eight patients without severe grade, and bioprosthetic valve dysfunction was observed in 17: structural valve deterioration in 10 (only stage 2), non-structural valve deterioration in three (paravalvular leak in one, patient–prosthesis mismatch in two), and endocarditis in four. Definite transcatheter heart valve thrombosis (hypoattenuated leaflet thickening) was not observed. Bioprosthetic valve failure was detected in four patients (stage 1: 1, stage 2: 0, stage 3: 3). After three years of follow-up, survival analysis revealed no significant differences in all-cause mortality, cardiac mortality, or the composite endpoint (including cardiac mortality, stroke and valve-related dysfunction) between patients with bicuspid (BAV) and tricuspid (TAV) aortic valve morphology and across annulus sizes (small, intermediate and large). Conclusions: TAVR resulted in significant and sustained improvements in valve haemodynamics with low rates of valve dysfunction and adverse clinical outcomes over a three-year follow-up period. Valve morphology (BAV vs. TAV) and annulus size did not significantly impact survival, haemodynamic performance, or valve durability. These results support the expanded use of TAVR in diverse patient populations, although extended follow-up is essential to fully establish long-term durability.