ABSTRACT
Background: TAVR has emerged as a revolutionary treatment for patients with symptomatic and severe AS, irrespective of surgical-risk profile. Novel transcatheter heart valves (THV) with a lower profile, ease of use and expected longer durability are being developed to target 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. We sought to report our initial experience with this novel device. Methods: Single-center, single arm, open label prospective registry encompassing all consecutive patients referred to TAVR in our Institution between December 2020 and November 2021. Indication for TAVR was according to current international guidelines. Clinical and echocardiographic outcomes were defined accordingly to VARC-III criteria. Results: A total of 39 patients were enrolled so far. Mean age was 79.5 years, 42% were female and mean STS score was 4%. Pre-procedures mean gradient and aortic valve area were 53.3 mmHg and 0.7cm2, respectively. All procedures were performed under minimalist approach using percutaneous, femoral access. Two patients were treated for bicuspid aortic stenosis and four patients underwent a valve-in-valve procedure. Procedure success was achieved in 100% of the cases, and post-procedure echocardiogram revealed a mean residual gradient of 5 mmHg, with PVL greater than mild in a single case. Permanent pacemaker was required in only 2 patients, and mean hospital stay was 3.1 days. At 30-days, there were two deaths, one due to COVID in a patient who presented major access bleeding requiring prolonged hospital stay, and another one a cardiovascular death. Conclusion: In our initial experience with the Myval THV, valve performance and 30-day clinical results were encouraging. Low rates of complications were observed, comparable to the best last-generation THV. At the time of the meeting, three-month clinical and echocardiographic FU will be available.
ABSTRACT
Background: TAVR has emerged as a revolutionary treatment for patients with symptomatic and severe AS, irrespective of surgical-risk profile. Novel transcatheter heart valves (THV) with a lower profile, ease of use and expected longer durability are being developed to target 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. We sought to report our initial experience with this novel device. Methods: Single-center, single arm, open label prospective registry encompassing all consecutive patients referred to TAVR in our Institution between December 2020 and November 2021. Indication for TAVR was according to current international guidelines. Clinical and echocardiographic outcomes were defined accordingly to VARC-III criteria. Results: A total of 39 patients were enrolled so far. Mean age was 79.5 years, 42% were female and mean STS score was 4%. Pre-procedures mean gradient and aortic valve area were 53.3 mmHg and 0.7cm2, respectively. All procedures were performed under minimalist approach using percutaneous, femoral access. Two patients were treated for bicuspid aortic stenosis and four patients underwent a valve-in-valve procedure. Procedure success was achieved in 100% of the cases, and post-procedure echocardiogram revealed a mean residual gradient of 5 mmHg, with PVL greater than mild in a single case. Permanent pacemaker was required in only 2 patients, and mean hospital stay was 3.1 days. At 30-days, there were two deaths, one due to COVID in a patient who presented major access bleeding requiring prolonged hospital stay, and another one a cardiovascular death. Conclusion: In our initial experience with the Myval THV, valve performance and 30-day clinical results were encouraging. Low rates of complications were observed, comparable to the best last-generation THV. At the time of the meeting, three-month clinical and echocardiographic FU will be available.