Single-Centre Experience with the Balloon-Expandable Myval Transcatheter Aortic Valve System with the First 200...

Aims: The aim of this paper is to report 30-day and 1-year outcome data regarding the first 200 patients who underwent the TAVR procedure using the Myval THV system at our single centre. Methods: From November 2019 to October 2022, 200 consecutive patients underwent TAVR procedure. Outcomes were analysed according to the VARC-2 definitions, and device performance was assessed via transthoracic echocardiography. Data collection was approved by the local Ethical Committee. Results: The mean age of the cohort was 75.3 ± 6.9 years, and 122 (61%) participants were male. The mean EuroSCORE II and STS was 5.4 ± 5.4 and 5.8 ± 3.8, respectively. The proportion of patients with a bicuspid aortic valve was 18%. The transfemoral access approach was the most common (surgical vs. percutaneous: 1% vs. 98%), and in two patients, surgical subclavian access was used. VARC-2 outcomes were as follows: 99% device success, 2% STROKE, 5% and 4.5% major and minor vascular complications, respectively, and a 29.5% rate of new permanent pacemaker implantation. At discharge, the incidence of aortic regurgitation grade II or above was 5.5% without relevant PVL (grade II or above 0.5%). In-hospital mortality was only 1%. At 1 year, the all-cause mortality rate was 8.5% (cardiac origin in three cases), and two patients had valve-related dysfunction requiring surgical aortic replacement. Conclusions: Our results showed excellent 30-day and 1-year outcomes regarding patient survival, technical success, and valve-related adverse events using the Myval transcatheter heart valve system. The limitations of our study comprise a single-centre design with retrospective data collection.