机构:[1]Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[2]Laboratory of Cardiac Structure and Function, Institute of Cardiovascular Diseases, West China Hospital, Sichuan University, Chengdu, Sichuan, China四川大学华西医院[3]Cardiac Structure and Function Research Key Laboratory of Sichuan Province, West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[4]Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital, Capital Medical University, Beijing, China首都医科大学附属安贞医院[5]Department of Cardiology, Xijing Hospital, Air Force Medical University, Xi'an, China[6]Department of Cardiology, The Second Affiliated Hospital of Harbin Medical University, Harbin, China[7]Department of Cardiology, Xuanwu Hospital, National Clinical Research Centre for Geriatric Diseases, Capital Medical University, Beijing, China内科系统心脏科(内科专业)首都医科大学宣武医院[8]Department of Cardiology, Xiamen Cardiovascular Hospital of Xiamen University, Xiamen, Fujian, China[9]Department of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China[10]Division of Cardiology, McGill University Health Centre, Montreal, Quebec, Canada
Backgrounds Significant mitral regurgitation (MR) is common worldwide, yet surgical correction rates remain low due to high-risk patient profiles. Transseptal mitral valve replacement (TSMVR) has emerged as a minimally invasive alternative, but its feasibility in Asian populations remains underexplored. Aims This study assessed the short-term feasibility of the HighLife TSMVR system for treating symptomatic MR in China. Methods This prospective study included seven centers in China, integrating data from multicenter and localized cohorts with identical inclusion criteria. Patients with symptomatic MR (>= 3+) and high surgical risk were included, excluding those with unsuitable anatomy for the HighLife system. Preprocedural imaging was centrally adjudicated, and 30-day outcomes were analyzed using R software (version 4.4.0). Results Twenty-two patients (median age 70.5 years; 45.5% male) underwent the procedure. The predicted median mortality risk was 6.39%, with secondary MR in 81.8% of cases. Technical success was 95.5% (21/22). Median durations of valve delivery, ring closure, transseptal puncture, and looping were 4.00, 8.50, 22.25, and 42.75 min, respectively and 22.73% cases of tele-proctoring. One patient required conversion to transcatheter aortic valve replacement, and two deaths occurred within 30 days. Significant improvements were observed in New York Heart Association class (p = 0.033) and MR severity (p < 0.001). Conclusions The HighLife TSMVR system demonstrated safety and efficacy in treating symptomatic MR in high-risk Chinese patients, supporting its potential clinical applicability.
基金:
This work was supported by the National Natural Science Foundation of China (U23A20395, 82170375, and 82300570); Sichuan Science and Technology Program (2024NSFSC1714, 2023NSFSC1657); and 1<middle dot> 3<middle dot> 5 project for disciplines of excellence- [U23A20395, 82170375, 82300570]; National Natural Science Foundation of China [2024NSFSC1714, 2023NSFSC1657, 1<middle dot> 3<middle dot> 5]; Sichuan Science and Technology Program [ZYGD23021]; West China Hospital, Sichuan University
第一作者机构:[1]Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China[2]Laboratory of Cardiac Structure and Function, Institute of Cardiovascular Diseases, West China Hospital, Sichuan University, Chengdu, Sichuan, China[3]Cardiac Structure and Function Research Key Laboratory of Sichuan Province, West China Hospital, Sichuan University, Chengdu, China
共同第一作者:
通讯作者:
通讯机构:[1]Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China[2]Laboratory of Cardiac Structure and Function, Institute of Cardiovascular Diseases, West China Hospital, Sichuan University, Chengdu, Sichuan, China[3]Cardiac Structure and Function Research Key Laboratory of Sichuan Province, West China Hospital, Sichuan University, Chengdu, China
推荐引用方式(GB/T 7714):
Zhang Yi,Chen Fei,Yao Yijun,et al.Short-Term Feasibility of Transseptal Mitral Valve Replacement in China[J].CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS.2025,doi:10.1002/ccd.31685.
APA:
Zhang, Yi,Chen, Fei,Yao, Yijun,Zhu, Zhongkai,Li, Xi...&Chen, Mao.(2025).Short-Term Feasibility of Transseptal Mitral Valve Replacement in China.CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS,,
MLA:
Zhang, Yi,et al."Short-Term Feasibility of Transseptal Mitral Valve Replacement in China".CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS .(2025)