151. Twelve-month outcomes of the TaurusOne valve for transcatheter aortic valve implantation in patients with severe aortic stenosis
- Author
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Guang-Yuan Song, Shenghua Zhou, Bo Xu, Mao Chen, Yuejin Yang, Kai Xu, Yaling Han, Jian-an Wang, Zhenfei Fang, Xianbao Liu, Yongjian Wu, Moyang Wang, Nicolo Piazza, Runlin Gao, Yuan Feng, and Bo Yu
- Subjects
Aortic valve ,medicine.medical_specialty ,Hemodynamics ,Transcatheter Aortic Valve Replacement ,Bicuspid aortic valve ,Bicuspid valve ,Risk Factors ,Clinical Research ,medicine ,Clinical endpoint ,Humans ,Myocardial infarction ,Prospective Studies ,Stroke ,business.industry ,Aortic Valve Stenosis ,medicine.disease ,Surgery ,Stenosis ,medicine.anatomical_structure ,Treatment Outcome ,Aortic Valve ,Heart Valve Prosthesis ,cardiovascular system ,Quality of Life ,Cardiology and Cardiovascular Medicine ,business - Abstract
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
- Published
- 2021