Transcatheter aortic valve replacement with a fully-recyclable self-expanding short-frame sciencrown valve for severe...

Transcatheter aortic valve replacement (TAVR) is performed in patients with aortic stenosis (AS) with some technical challenges, necessitating a specialized TAVR device designed for these patients. This study aimed to evaluate the safety and efficacy of a novel fully recyclable self-expanding short-frame ScienCrown TAVR system for severe AS.

A prospective, multicenter, single-arm study (NCT05202977) was conducted. We enrolled consecutive patients with symptomatic severe AS undergoing TAVR with the ScienCrown valve. The primary endpoint was all-cause mortality at 1 year.

Overall, 128 patients were enrolled (mean Society of Thoracic Surgeons score, 5.40%), of whom 63.28% had a bicuspid aortic valve (BAV). The device success rate was 99.20% (124/125), and the procedure success rate was 96.88% (124/128). The 1-year mortality rate (follow-up rate, 100%) was 5.47%, significantly lower than the performance goal of 25% ( P < 0.0001). At the 1-year point, specific clinical outcomes included stroke, myocardial infarction, paravalvular leak ≥ moderate, and new pacemaker implantation in 3.91%, 4.69%, 2.34%, and 7.03% of patients, respectively. Hemodynamic performance (mean transaortic valve gradient, 10.51 ± 5.63 vs. 56.63 ± 20.00 mmHg; effective orifice area, 1.88 ± 0.52 vs. 0.61 ± 0.25 cm 2 ; and peak velocity, 2.16 ± 0.52 vs. 4.76 ± 0.79 m/s) and quality of life scores (82.93 ± 11.62 vs. 61.09 ± 19.02) had significantly improved. Patients with different types of BAV had outcomes similar to those of patients with tricuspid aortic valves.

ScienCrown demonstrated favorable safety and efficacy with sustained clinical and hemodynamic benefits at 1 year for patients with severe AS.