真实世界二叶式主动脉瓣重度狭窄患者应用Venus-A瓣膜行经导管主动脉瓣置换术的多中心经验  

Transcatheter Aortic Valve Replacement With Self-expanding Venus-A Valve in Severe Aortic Stenosis Patients With Bicuspid Aortic Valves:Experience From Multi-center Real-world Data

作　　者：王墨扬[1] 周政 陶凌 罗建方 董念国[4] 张海波[5] 方臻飞[6] 姜楠[7] 王焱 吴延庆[9] 姜正明[10] 安健 陈韵岱[12] 苏晞 杨毅宁[14] 刘继红 郭延松[16] 彭小平[17] 郭然[18] 陈良龙[19] 于波[20] 何奔 陆方林 吴永健[1] WANG Moyang;ZHOU Zheng;TAO Ling;LUO Jianfang;DONG Nianguo;Z HANG Haibo;FANG Zhenfei;JIANG Nan;WANG Yan;WU Yanqing;JIANG Zhengming;AN Jian;CHEN Yundai;SU Xi;YANGY ining;LIU Jihong;GUO Yansong;PENG Xiaoping;GUO Ran;CHEN Lianglong;YU Bo;HE Ben;LU Fanglin;WU Yongjian(Coronary Heart Disease Center,National Center for Cardiovascualr Diseases and Fuwai Hospital,CAMS and PUMC,Beijing(100037,)China)

机构地区：[1]中国医学科学院北京协和医学院国家心血管病中心阜外医院冠心病中心,北京市100037 [2]空军军医大学第一附属医院心脏内科 [3]广东省人民医院心脏内科 [4]华中科技大学同济医学院附属协和医院心脏外科 [5]首都医科大学附属北京安贞医院心脏外科 [6]中南大学湘雅二医院心脏内科 [7]天津市胸科医院心脏外科 [8]厦门大学附属心血管病医院心脏内科 [9]南昌大学第二附属医院心脏内科 [10]郑州大学第一附属医院心脏内科 [11]山西省心血管病医院心脏内科 [12]中国人民解放军总医院心脏内科 [13]武汉亚心总医院心脏内科 [14]新疆医科大学第一附属医院心脏内科 [15]大连大学附属中山医院心脏内科 [16]福建省立医院心脏内科 [17]南昌大学第一附属医院心脏内科 [18]大连医科大学附属第一医院心脏内科 [19]福建医科大学附属协和医院心脏内科 [20]哈尔滨医科大学附属第二医院心脏内科 [21]上海交通大学附属胸科医院心脏内科 [22]海军军医大学第一附属医院心脏外科

出　　处：《中国循环杂志》2022年第4期329-334,共6页Chinese Circulation Journal

基　　金：国家重点研发计划(2020YFC2008100)。

摘　　要：目的:探索我国真实世界中采用第一代自膨胀式Venus-A瓣膜行经导管主动脉瓣置换术(TAVR)治疗二叶式主动脉瓣(二叶瓣)重度狭窄患者的临床疗效。方法:连续入选2017年4月至2020年3月共22个中心行TAVR的二叶瓣重度狭窄患者,根据CT核心实验室判断将患者按Sievers分型分为0型二叶瓣组和1型二叶瓣组。通过基线、术中及短期随访指标评价其安全性及有效性。主要终点为30 d全因死亡及致残性脑卒中。次要终点包括术中即刻不良事件指标;30 d随访指标:延迟冠状动脉阻塞及瓣环破裂、主要出血、新发永久起搏器植入、NYHA心功能分级以及经胸超声心动图结果。结果:共入选199例二叶瓣重度狭窄患者,平均年龄(71.77±8.13)岁,男性113例(56.8%),0型二叶瓣组121例(60.8%),1型二叶瓣组78例(39.2%)。所有患者均采用Venus-A瓣膜行TAVR治疗,术中无死亡、无冠状动脉闭塞、无瓣环破裂,1例(0.5%)患者急诊外科开胸,7例(3.5%)患者出现瓣膜移位,24例(12.1%)患者进行了第二枚瓣膜置换。释放后即刻4例(2.0%)患者出现中度及以上瓣周反流,6例(3.0%)患者仍有残余狭窄。术后30 d随访,全因死亡率0.5%,致残性脑卒中发生率0.5%,无延迟冠状动脉闭塞及瓣环破裂。新发永久起搏器植入19例(9.5%),1型二叶瓣组发生率高于0型二叶瓣组(19.2%vs.3.3%,P=0.023)。30 d随访超声心动图提示:主动脉瓣平均跨瓣压差、主动脉瓣峰值流速及左心室射血分数较基线有明显改善。5例(2.5%)患者仍存在中量及以上瓣周反流,0型二叶瓣组发生率高于1型二叶瓣组(4.1%vs.0%,P=0.034),1例(0.5%)患者仍有残余狭窄。结论:真实世界中采用Venus-A瓣膜行二叶瓣TAVR短期整体效果满意,体现出了良好的安全性及有效性。Objectives:To investigate the efficacy and safety of transcatheter aortic valve replacement(TAVR)by using the first generation self expanding prothesis(Venus-A valve)in severe bicuspid aortic valve stenosis in the real world of China Methods:Clinical data of 199 patients with severe native bicuspid aortic valve stenosis who underwent TAVR with Venus-Avalve from April 2017 to March 2020 in 22 centers were retrospectively analyzed.The primary endpoints included all-cause death and disabling stroke at 30 days post TAVR.The secondary endpoints included intraoperative death,conversion to surgery,the second valve implantation,valve malposition,coronary artery obstruction,annulus rupture,residual aortic valve stenosis and perivalvular leak(PVL)≥moderate immediately after implantation,and delayed coronary artery obstruction,annulus rupture,major bleeding,new permanent pacemaker implantation,NYHA claasification and echocardiography results at 30 days post TAVR.Results:A total of 199 patients were enrolled.The mean age was(71.77±8.13)years(56.8%male).One hundred and twenty one patients(60.8%)had a Sievers type 0 bicuspid valve,and others had type 1 bicuspid valve.One hundred and ninety two(96.4%)patients received balloon pre-dilation.The average prothesis perimeter oversizing rate was(4.1±1.2)%.There was no intraoperative death,coronary artery obstruction or annulus rupture,1 patient(0.5%)underwent emergency surgery,7 patients(3.5%)experienced valve malposition,and 24 patients(12.1%)needed second valve implantation.6 patient(3.0%)had residual aortic valve stenosis and 5 patients(2.0%)had PVL≥moderate immediately after implantation.At 30 days post TAVR,there were 1(0.5%)all-cause mortality and 1(0.5%)disabling stroke.There was no delayed coronary artery obstruction and annulus rupture.New permanent pacemaker implantation was performed in 19 cases(9.5%),new pacemaker implantation rate was significantly higher in type 1 patients than in type 0 patients(19.2%vs.3.3%,P=0.023).There were 1(0.5%)residual aortic valve stenos

关 键 词：二叶式主动脉瓣 经导管主动脉瓣置换术 自膨胀式瓣膜 真实世界 

分 类 号：R54[医药卫生—心血管疾病]