Secretaria de Estado da Saúde - BVS

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.

METHODS:

Single-center, single arm, open label prospective registry encompassing all consecutive patients referred to TAVR in our Institution between December 2020 and June 2023 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 136 pts were enrolled so far. 72 pts with year follow-up. Mean age was 78.1 ± 6.7 years, 44% were female and mean STS score was 3.3 ± 1.6 %. Pre-procedures mean gradient and aortic valve area were 57.7 ± 17.4 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 performed using transcarotid access and another using transubclavian access). 18,4% of pts were treated for bicuspid aortic stenosis and 10 pts (7.3%) underwent a valve-in- -valve procedure. Procedure success was achieved in all cases, and a post-procedure echo revealed a mean residual gradient of 5.2 ± 4.5 mmHg, with PVL greater than mild in nine cases (7%). A permanent pacemaker was required in 6 pts (4.4%), 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, 72 patients completed 12 months follow-up. One cardiovascular death was reported at follow-up and all the remaining patients were in NYHA class < II. We observed two cases of early valve deterioration with thrombosis, which were successfully managed with anticoagulation therapy. No further valve intervention was necessary for any of the patients.

CONCLUSION:

The mid-term follow-up of Meril's TAVR system was found to be satisfactory and comparable to other commercially available THV's. 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.