Interventions for valvular disease and heart failure - Mini focus on TAVI

Twelve-month outcomes of the TaurusOne valve for transcatheter aortic valve implantation in patients with severe aortic stenosis

EuroIntervention 2022;17:1070-1076. DOI: 10.4244/EIJ-D-21-00040

Moyang Wang
Moyang Wang1, MD; Guangyuan Song1, MD; Mao Chen2, MD; Yuan Feng2, MD; Jian’an Wang3, MD; Xianbao Liu3, MD; Shenghua Zhou4, MD; Zhenfei Fang4, MD; Yaling Han5, MD; Kai Xu5, MD; Bo Yu6, MD; Bo Xu1, MBBS; Yuejin Yang1, MD; Nicolo Piazza7, MD; Yongjian Wu1, MD; Run-Lin Gao1, MD
1. National Centre for Cardiovascular Disease, Fuwai Hospital, Beijing, China; 2. West China Hospital, Sichuan University, Chengdu, China; 3. The 2nd Affiliated Hospital ZheJiang University School of Medicine, Hangzhou, China; 4. The 2nd XiangYa Hospital of Central South University, Changsha, China; 5. General Hospital of Northern Theater Command, Shenyang, China; 6. The 2nd Affiliated Hospital of Harbin Medical University, Harbin, China; 7. McGill University Health Center, Montréal, QC, Canada

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.

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