浙江大学学报（医学版）2025，Vol.54Issue(2)：141-148,8.DOI:10.3724/zdxbyxb-2024-0487
XcorTM经导管主动脉瓣置换术系统治疗重度主动脉瓣狭窄患者近期临床疗效观察
Single-center experience in the treatment of severe aortic stenosis with XcorTM transcatheter aortic valve replacement system:1-year follow-up results
摘要
Abstract
Objective:To analyze the early clinical outcomes of the XcorTM transcatheter aortic valve replacement(TAVR)system in treating severe aortic stenosis.Methods:This single-arm,prospective clinical trial enrolled patients with severe aortic stenosis treated with the XcorTM TAVR system at the Section of Heart Valve&Coronary Artery Surgery,Guangdong Provincial People's Hospital.Perioperative and follow-up parameters were compared to evaluate differences in hemodynamic outcomes.All-cause mortality,aortic regurgitation,paravalvular leakage,cerebrovascular events,and reoperation were analyzed.Results:Thirty-two patients with severe aortic stenosis were included(20 males,12 females),with(70.9±4.3)years old and a Society of Thoracic Surgeons(STS)score of 6.45%(6.07%,7.28%).Notably,87.5%of patients had New York Heart Association(NYHA)class≥Ⅲ.All patients underwent successful XcorTM bioprosthesis implantation,achieving an immediate technical success rate of 100.0%and device success rate of 96.9%.Mean aortic valve gradient decreased from(55.21±23.17)mmHg(1 mmHg=0.133 kPa)to(8.45±5.30)mmHg,peak aortic jet velocity decreased from(4.66±0.85)m/s to(1.99±0.48)m/s,aortic valve area increased from(0.66±0.21)cm² to(2.09±0.67)cm²(all P＜0.01).Intraoperative ventricular fibrillation occurred in one patient,while one case exhibited moderate prosthetic valve regurgitation and paravalvular leakage post-procedure.At 12-month follow-up,sustained improvements were observed in cardiac function,left ventricular ejection fraction,hemodynamic parameters,and SF-12 quality-of-life scores(all P＜0.01).All-cause mortality was 12.5%(4/32),with 13.8%(4/29)developing moderate paravalvular leakage.Conclusion:The XcorTM TAVR system demonstrated favorable early outcomes in severe aortic stenosis patients,significantly improving symptoms and hemodynamics while exhibiting excellent performance in preventing malignant arrhythmias and coronary obstruction.关键词
主动脉瓣狭窄/经导管主动脉瓣置换术/XcorTM经导管主动脉瓣置换术系统/治疗效果/前瞻性研究Key words
Aortic stenosis/Transcatheter aortic valve replacement/XcorTM transcatheter aortic valve replacement system/Therapeutic efficacy/Prospective study分类
医药卫生引用本文复制引用
王圣文,刘健,刘浩忠,郭海江,谭桐,谢含祥,刘湘,邱海龙,陈寄梅,郭惠明..XcorTM经导管主动脉瓣置换术系统治疗重度主动脉瓣狭窄患者近期临床疗效观察[J].浙江大学学报（医学版）,2025,54(2):141-148,8.基金项目
国家科技重大专项(2024ZD0527205) （2024ZD0527205）
广东省基础与应用基础研究基金(2024A1515220143)This study was supported by the National Science and Technology Major Project(2024ZD0527205)and Guangdong Basic and Applied Basic Research Foundation(2024A1515220143) （2024A1515220143）
