One-year outcomes of a novel domestic transcatheter aortic valve system in severe aortic stenosis: a multicenter cohort study
10.3760/cma.j.cn112139-20241107-00496
- VernacularTitle:国产经导管主动脉瓣系统治疗重度主动脉瓣狭窄术后1年随访结果
- Author:
Yuehuan LI
1
;
Jiawei ZHOU
;
Lai WEI
;
Yingqiang GUO
;
Liang MA
;
Huiming GUO
;
Xiangbin PAN
;
Dongjin WANG
;
Fanyan LUO
;
Jue WANG
;
Minxin WEI
;
Deguang FENG
;
Yingbin XIAO
;
Liming LIU
;
Jian′an WANG
;
Jiangang WANG
;
Haibo ZHANG
Author Information
1. 首都医科大学附属北京安贞医院瓣膜与房颤外科中心，北京 100029
- Publication Type:Journal Article
- Keywords:
Heart valve diseases;
Aortic valve stenosis;
Transcatheter aortic valve replacement;
Balloon-expandable valves;
Clinical trials
- From:
Chinese Journal of Surgery
2025;63(11):1052-1058
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To examine the safety and effectiveness of a novel domestic transcatheter aortic valve system in addressing severe aortic valve stenosis.Methods:This prospective, multicenter, single-arm target-value clinical trial enrolled patients with severe aortic stenosis meeting inclusion criteria from 13 Chinese centers between July 2021 and April 2022. The primary endpoint was all-cause mortality at 1-year post-procedure. Secondary endpoints included safety outcomes (30-day all-cause mortality, 1-year major adverse cardiovascular events, device success) and efficacy parameters (transvalvular pressure gradient, paravalvular leak severity, New York Heart Association(NYHA)class improvement, and quality of life). Survival analysis was performed using the Kaplan-Meier analysis.Results:The study included 134 patients, 85 males and 49 females, with an age of (73.6±5.6)years (range: 65.1 to 91.8 years). Bicuspid aortic valve morphology was present in 59.7% (80/134). Device success rate was 99.3%, with one case converted to open surgery due to coronary obstruction. All-cause mortality was 0.8% (95% CI: 0.1% to 5.3%) at both 30-day and 1-year follow-up, significantly lower than the 25% target value ( P<0.01). Permanent pacemaker implantation rates remained 2.2% (3/134) at both timepoints. Stroke incidence was 0.7% (1/134) at 30 days and 1.5% (2/134) at 1 year. Myocardial infarction rates were 0.7% (1/134) at both intervals. The postoperative transvalvular pressure gradient of the aortic valve was (6.6±3.1) mmHg(1 mmHg=0.133 kPa) (range: 4 to 8 mmHg). Among the patients, 32 cases (23.9%) had mild paravalvular leakage, 4 cases (3.0%) had moderate paravalvular leakage, and no severe paravalvular leakage was observed. NYHA class Ⅰ and Ⅱ patients increased from 18.7% preoperatively to 99.3% postoperatively. Conclusion:The novel domestic transcatheter aortic valve system demonstrates satisfactory 1-year safety and efficacy outcomes in treating severe aortic stenosis.
