Single-center experience with merils myval transcatheter heart valve

RESUMO

BACKGROUND: TAVR has emerged as a revolutionary treatment for symptomatic and severe AS patients, irrespective of surgical-risk profile. Novel transcatheter heart valves (THV) with a lower profile, easy-of-use, and expected longer durability are being developed to target the younger and low-risk population. Myval is a 14Fr, balloon- -expandable THV with a skirt to minimize the occurrence of paravalvular leak (PVL) and has been recently approved for commercial use in Brazil. METHODS: Single-center, prospective observational study encompassing all consecutive patients (pts) who underwent TAVR with MyVal between December 2020 and May 2022. Indications for TAVR were in accordance with current international guidelines. Clinical and echocardiographic outcomes were defined accordingly to VARC-III criteria. RESULTS: A total of 60 pts were enrolled so far. The mean age was 74.4±3.2 years, 63% were male, and the mean STS score was 3.6±2.8%; 50% of pts were in class III/IV NYHA. Pre-procedure mean gradient and aortic valve area were 56.4±17.6mmHg and 0.7±0.2cm2, respectively. In the majority of pts, TAVR procedures were performed under a minimalist, percutaneous transfemoral approach, except two cases (one performed using transcarotid access and another using transubclavian access). 12% of pts were treated for bicuspid aortic stenosis and four pts (6.7%) underwent a valve-in-valve procedure. Procedure success was achieved in all cases, and a post-procedure echocardiogram revealed a mean residual gradient of 3,3±0,6mmHg, with PVL greater than mild in a single case (1.7%). A permanent pacemaker was required in 3 pts (5%), and the average hospital length of stay was 2,7±2,8 days. At 30- days, there were 3 deaths, one due to COVID-19 and two classified as cardiovascular deaths. Currently, 19 patients completed 6 months follow-up. One non-cardiovascular death was reported at follow-up and all the remaining patients were in NYHA class < II. Conclusion: In this initial experience with the Myval THV, short-term clinical and echocardiographic outcomes were encouraging, with good hemodynamic performance and symptomatic improvement.