BACKGROUND:

TAVR has emerged as a revolutionary treatment for patients with symptomatic and severe AS, irrespective of surgical-risk scores. Novel transcatheter heart valves (THV) with a lower profile, easy of use and expected longer durability are being developed to target younger patients. Myval is a 14Fr-balloon expandable THV with a skirt to minimize the occurrence of paravalvular leak (PVL), and has been approved for commercial use in Brazil in 2020. We sought to report mid-term follow-up with this device.

METHODS:

Single-center, single arm, open label prospective registry encompassing patients referred to TAVR with myval in our Institution between December 2020 and april 2024 with clinical and echocardiography follow up at 30 days and up to 1 year. Clinical and echocardiographic outcomes were defined accordingly to VARC-III criteria.

RESULTS:

A total of 186 patients (pts) were enrolled so far 101 pts and 53 with 1 and 2 years follow up, respectively. Mean age was 77.4 ± 6.41 years, 41% were female and mean STS score was 3.24±1.59 %. Pre-procedures mean gradient and aortic valve area were 68.2 ± 27.9 mmHg and 0.65 ± 0.15 cm2, respectively. 55 % of pts were in class III/IV NYHA. In the majority of pts, TAVR procedures were performed under a minimalist, percutaneous transfemoral approach, except two cases (one using transcarotid access and another transubclavian access). 15.5% of pts were treated for bicuspid aortic stenosis and 12 pts (6.42%) underwent a valve-in-valve procedure. Procedure success was achieved in 95.2% of the cases, and a post-procedure echocardiogram revealed a mean residual gradient of 5.2 ± 4.5 mmHg, with PVL greater than mild in nine cases (4.8%). A permanent pacemaker was required in 7 pts (3.7%), and the average hospital length of stay was 3.3 ± 2.4 days. At 30-days, there were 4 deaths, one due to COVID-19, other one non cardiovascular and two classified as cardiovascular deaths. Currently, 87 patients completed 12 months follow-up and the valve area, and a mean gradient are 2.03±0.27 cm2 and 14±5.66 mmHg, respectively. One cardiovascular death was reported at follow-up and all the remaining patients were in NYHA class < II.

CONCLUSION:

The mid-term follow-up of Meril's TAVR system was found to be satisfactory and comparable to other commercially available THV systems. However, it is important to note that long-term follow-up studies are currently underway to further evaluate the performance and durability of the TAVR system.