Single-Centre Experience with the Balloon-Expandable Myval Transcatheter Aortic Valve System with the First 200 Patients: 30-Day and 1-Year Follow-Up.

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.