摘要目的:探讨国产新型经导管主动脉瓣系统治疗重度主动脉瓣狭窄病变的安全性和有效性。方法:本研究为前瞻性、多中心、单组目标值临床试验。纳入2021年7月至2022年4月全国13家中心收治的符合纳入和排除标准的接受国产新型经导管主动脉瓣系统治疗的重度主动脉瓣狭窄病变患者。主要观察指标为患者术后1年全因病死率。次要观察指标分为安全性指标和有效性指标，安全性指标包含术后30 d全因病死率、术后1年主要心血管不良事件发生率、器械使用成功率；有效性指标包括跨瓣压差、瓣周漏程度、纽约心脏病学会（NYHA）心功能分级等。采用Kaplan-Meier法进行生存分析。结果:研究共纳入患者134例。男性85例，女性49例，年龄（73.6±5.6）岁（范围：65.1~91.8岁）。二叶主动脉瓣畸形患者占59.7%（80/134）。手术成功率为99.3%（133/134），1例患者术中因冠脉梗阻中转为外科开胸手术。术后30 d及1年的全因病死率为0.8%（95% CI：0.1%~5.3%），低于目标值25%（ P<0.01）。术后30 d和1年时的永久起搏器植入率均为2.2%（3/134）。术后30 d、1年的脑卒中发生率分别为0.7%（1/134）、1.5%（2/134）。术后30 d和1年时新发心肌梗死发生率均为0.7%（1/134）。术后即刻主动脉瓣跨瓣压差为（6.6±3.1）mmHg（1 mmHg=0.133 kPa）（范围：4～8 mmHg）。32例（23.9%）患者存在轻度瓣周漏，4例（3.0%）患者存在中度瓣周漏，无重度瓣周漏。患者术后NYHA心功能分级Ⅰ~Ⅱ级患者比例自术前的18.7%（25/134）升至99.3%（133/134）。 结论:国产新型经导管主动脉瓣系统治疗重度主动脉瓣狭窄病变术后1年的随访结果满意，具有较好的安全性和有效性。

abstractsObjective: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.