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

Year: 2025

Type: article

Abstract: BACKGROUND: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: ScienCrown demonstrated favorable safety and efficacy with sustained clinical and hemodynamic benefits at 1 year for patients with severe AS.

Source: International Journal of Surgery

DOI: 10.1097/js9.0000000000004017