Safety and effectiveness of the SAPIEN 3 transcatheter heart valve in the treatment of severe aortic stenosis: Early clinical outcomes of a multicenter study in China

Wenzhi Pan; Yuan Zhang; Yongjian WU; Jian'; an Wang; Mao Chen; Yuan Feng; Shasha Chen; Daxin Zhou; Junbo GE

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Safety and effectiveness of the SAPIEN 3 transcatheter heart valve in the treatment of severe aortic stenosis: Early clinical outcomes of a multicenter study in China

VernacularTitle:SAPIEN 3经导管主动脉瓣膜系统中国上市前研究的早期临床结果
Author: Wenzhi PAN ¹ ; Yuan ZHANG ¹ ; Yongjian WU ² ; Jian'an WANG ³ ; Mao CHEN ⁴ ; Yuan FENG ⁴ ; Shasha CHEN ¹ ; Daxin ZHOU ¹ ; Junbo GE ¹
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1. Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, 200032, P. R. China
2. Department of Cardiology, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, P. R. China
3. Department of Cardiology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, 310003, P. R. China
4. Department of Cardiology, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
Publication Type:Journal Article
Keywords: Transcatheter aortic valve replacement; aortic stenosis; balloon expandable valve
From: Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(05):553-559
CountryChina
Language:Chinese
Abstract: Objective To evaluate the safety and efficacy of transcatheter aortic valve replacement (TAVR) using the SAPIEN 3 system. Methods This was a prospective, multicenter, single arm study in 4 centers in China. The clinical data of 50 patients with high-risk symptomatic severe aortic stenosis who underwent TAVR using the SAPIEN 3 system from June 2017 to June 2019 were analyzed, including 27 males and 23 females aged 76.8±6.1 years. Results The Society of Thoracic Surgeon score was 6.0%±2.8%. Totally, 20.0% of patients had severe bicuspid aortic stenosis. The operation time was 41.8±16.5 min and the hospital stay time was 8.5±5.0 d. At the postoperative 30-day follow-up, no all-cause mortality occurred and the device success rate was 89.5%. Major vascular complications occurred in one (2.0%) patient, stroke in one (2.0%) patient, new pacemaker implantation in one (2.0%) patient, as well as coronary artery obstruction in one (2.0%) patient. There was no moderate or moderate/severe paravalvular leak. The aortic pressure gradient was decreased from 49.2±16.2 mm Hg before the operation to 12.4±4.6 mm Hg at the postoperative 30-day follow-up, and the valvular area was increased from 0.6±0.3 cm2 to 1.3±0.3 cm2 (P<0.01). Moreover, the New York Heart Association classification in 83.7% of the patients was improved during the follow-up. Conclusion This pre-marketing multicenter study has demonstrated the safety and effectiveness of transfemoral TAVR with the SAPIEN 3 transcatheter valve system in Chinese aortic stenosis patients at high risk for surgery.