TAVI using the TaurusOne valve resulted in a one-year all-cause mortality of 6.7%, which was significantly lower than the performance goal of 30% (p<0.0001).
Does the TaurusOne transcatheter aortic valve system safely and effectively treat symptomatic severe aortic stenosis in Chinese patients?
The TaurusOne self-expanding transcatheter aortic valve system demonstrated safety and efficacy in Chinese patients with severe aortic stenosis, achieving a 1-year mortality rate of 6.7%.
Absolute Event Rate: 6.7% vs 30%
p-value: p=<0.0001
BACKGROUND: In the last decade, transcatheter aortic valve implantation (TAVI) has developed rapidly 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: The aim of this study was 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, multicentre, single-arm study was designed to enrol 120 patients with symptomatic severe aortic stenosis undergoing TAVI using the TaurusOne valve. The primary endpoint was all-cause mortality at one year. RESULTS: From September 2017 to April 2019, 120 patients were enrolled (35% bicuspid aortic valve, mean Society of Thoracic Surgeons STS score 9.95%). One-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, paravalvular leak ≥moderate, and new pacemaker implantation occurred in 4.4%, 1.8%, 0.8%, and 22.1% of patients, respectively, at one year. The haemodynamic results and quality of life scores also improved significantly. Patients with a bicuspid valve had similar outcomes to those with a tricuspid aortic valve. CONCLUSIONS: The one-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.
Wang et al. (Sat,) conducted a other in symptomatic severe aortic stenosis (n=120). TaurusOne transcatheter aortic valve system vs. Performance goal was evaluated on all-cause mortality at one year (95% CI upper 12.9, p=<0.0001). TAVI using the TaurusOne valve resulted in a one-year all-cause mortality of 6.7%, which was significantly lower than the performance goal of 30% (p<0.0001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: