Background: In the last decade, Transcatheter Aortic Valve Implantation (TAVI) has rapidly developed in China. As TAVI progresses towards low surgical risk patients, the total number of TAVI procedures will grow exponentially. There is a need to develop a domestic TAVI device designed for Chinese patients.
Aims: To evaluate the safety and efficacy of a self-expanding valve (TaurusOne® transcatheter aortic valve system) in the treatment of patients with symptomatic severe aortic stenosis in China.
Methods: A prospective, multi-center, single arm study was designed to enroll 120 patients with symptomatic severe aortic stenosis receive TAVI using TaurusOne® valve. The primary endpoint was all-cause mortality at 1 year.
Results: From September 2017 to April 2019, 120 patients were enrolled (35% bicuspid aortic valve, mean Society of Thoracic Surgeon (STS) score 9.95%). 1-year mortality in 120 patients (follow-up rate, 100%), was 6.7% (upper 95% confidence interval: 12.9%) which was significantly lower than the performance goal of 30% (P<0.0001). All stroke, myocardial infarction, paravavular leak ≥ moderate, new pacemaker implantation occurred in 4.4%, 1.8%, 0.8%, and 22.1% at 1-year. The hemodynamic results and quality of life scores also improved significantly. Patients with bicuspid valve had similar outcomes as those with tricuspid aortic valve.
Conclusions: The 1-year clinical results confirm the safety and efficacy of the TaurusOne® transcatheter aortic valve system in the treatment of patients with symptomatic severe tricuspid and bicuspid aortic stenosis.