Early experience with a novel transapical transcatheter aortic valve system in patients with severe aortic stenosis: a prospective, multicenter study.

Abstract

Objectives: Registered, prospective, multicenter study of the short-term clinical outcomes of a novel transcatheter aortic valve system (Xcor system, Saint Medical Technology, Inc., Nanjing) to evaluate its safety and efficacy.

Methods: 130 high risk patients with symptomatic severe AS from 11 institutions were treated with the novel Xcor system. All patients were pre-TAVR assessed by transthoracic echocardiography and computed tomography of the aortic valve (AV) and relevant left cardiac and vascular anatomy. Procedural, in-hospital, and follow-up clinical outcomes were evaluated after procedures.

Results: The average age of the 130 patients was 71.2 ± 4.4 years old, 55.4% were male, and the STS score was 8.0 ± 3.9%. Device and procedural success were achieved in 98.5% and 97.7% of the patients, respectively. At 30-day follow-up, all-cause mortality, the incidence of major adverse cardiovascular events, major vascular complications, and new permanent pacemaker implantation were 3.8%, 4.6%, 0.8%, and 0.8%, respectively. 7.7% of patients showed ≥ mild paravalvular leakage, and all 125 (100%) patients were in New York Heart Association Class ≤ II. The procedural and clinical outcomes of bicuspid AV patients were similar to those of tricuspid AV patients.

Conclusions: Overall, the 30-day follow-up shows that the procedural outcomes with the novel Xcor system with self-centering support arms are comparable or superior to other contemporary TAVI devices, with a low all-cause mortality, low major adverse cardiovascular events, low PVL and similar clinical outcomes for BAV and TAV patients.