新型盘式左心耳封堵器多中心临床研究的围术期和中期随访情况  

A multi-center clinical study of a novel disc-like left atrial appendage closure system:the periprocedural and mid-term outcomes

作　　者：李双[1] 朱梦云[1] 葛均波 周达新 张晓春 王建安[3] 樊友启[3] 王琰 常栋 陈义汉[5] 陈发东 付华[6] 胡宏德[6] 蔡衡[7] 张玉顺[8] 周箐 马为[9] 霍勇[9] 任重远 赵冬冬[1] 唐恺[1] 赵逸凡 常晓鑫 刘伟静[1] 陈维[1] 徐亚伟[1] Li Shuang;Zhu Mengyun;Ge Junbo;Zhou Daxin;Zhang Xiaochun;Wang Jianan;Fan Youqi;Wang Yan;Chang Dong;Chen Yihan;Chen Fadong;Fu Hua;Hu Hongde;Cai Heng;Zhang Yushun;Zhou Jing;Ma Wei;Huo Yong;Ren Zhongyuan;Zhao Dongdong;Tang Kai;Zhao Yifan;Chang Xiaoxin;Liu Weijing;Chen Wei;Xu Yawei(Department of Cardiology,Shanghai Tenth People’s Hospital,Tongji University School of Medicine,Shanghai 200072,China;Department of Cardiology,ZhongShan Hospital,Fudan University,Shanghai 226000,China;Department of Cardiology,The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzou 310009,China;Department of Cardiology,Xiamen Cardiovascular Hospital of Xiamen University,Xiamen 361006,China;Department of Cardiology,Shanghai East Hospital,Tongji University School of Medicine,Shanghai 200120,China;Department of Cardiology,West China Hospital,Sichuan University,Chengdu 610047,China;Department of Cardiology,General Hospital of Tianjin Medical University,Tianjin 300020,China;Department of Cardiology,The First Affiliated Hospital of Xi′an Jiaotong University,Shanxi 710061,China;Department of Cardiology,The First Hospital of Peking University,Beijing 100034,China)

机构地区：[1]上海市第十人民医院心内科,200072 [2]复旦大学附属中山医院心内科,上海226000 [3]浙江大学医学院附属第二医院心内科,杭州310009 [4]厦门大学附属心血管病医院心内科,361006 [5]上海市东方医院心内科,200120 [6]四川大学华西医院心内科,成都610047 [7]天津医科大学总医院心内科,300020 [8]西安交通大学第一附属医院心内科,710061 [9]北京大学第一医院心内科,100034

出　　处：《中华心律失常学杂志》2020年第3期270-275,共6页Chinese Journal of Cardiac Arrhythmias

基　　金：科技部国家重点研发计划数字诊疗装备研发重点专项(2017YFC0111800);国家自然科学基金(81800441);上海市科学技术委员会科研计划项目(16411965700)。

摘　　要：目的:研究旨在评价左心耳封堵器(LEFTEAR)用于长期口服抗凝治疗禁忌或抗凝治疗后仍有脑卒中风险的非瓣膜性心房颤动(房颤)患者进行左心耳封堵术(LAAC)的有效性和安全性。方法:本研究前瞻性纳入全国9家医院共计200例拟行LAAC的房颤患者。2018年8月至2019年10月顺利完成200例入组。患者年龄(68±8.7)岁,年龄范围38~89岁,男112例(56%),CHA 2DS 2-VASc评分(3.5±1.44)分,HAS-BLED评分(2.5±1.18)分。入组患者均植入新型盘式封堵器LEFTEAR。左心耳成功封堵标准是经食管超声心动图(TEE)评价封堵周边无或少量残余分流(PDL≤3 mm)。以术后12个月内的复合终点事件(出血性/缺血性脑卒中、系统性栓塞、心脏性/不明原因死亡)为主要有效性指标,以术后12个月内的严重不良事件(SAE)为安全性指标。结果:196例患者植入封堵器,余4例未予植入(1例发现左心耳开口>35 mm,1例尝试封堵失败后放弃,2例完成房颤消融后尝试行LAAC出现心脏压塞)。其中房颤一站式手术(消融联合LAAC)133例。截至2019年12月31日,平均随访6(4,11)个月。围术期和随访期均无主要复合终点事件发生。SAE均发生在一站式手术患者中,心脏压塞7例,封堵器脱落或明显移位3例。其中9例发生在围术期,心脏压塞6例,仅2例需要行急诊外科手术;封堵器脱落或明显移位3例。即刻成功率达到100%,其中178例未见残余分流。累计完成153例随访(79.7%,153/192)已经完成至少1次TEE检查患者中,左心耳成功封堵率为98.7%(151/153),未见封堵器表面血栓形成。结论:应用新型盘式封堵器(LEFTEAR)行左心耳封堵术,总体较有效和安全。房颤消融联合左心耳封堵的一站式术式一定程度上增加了不良事件的发生。Objective This study was designed to evaluate the efficacy and safety of the LEFTEAR closure system for left atrial appendage closure(LAAC)in patients with non-valvular atrial fibrillation(AF)who had contraindications of long-term oral anticoagulation or still high risks of stroke with anticoagulation treatment.Methods A total of 200 patients with AF underwent LAAC were prospectively recruited in 9 centers nationwide,between April 2014 and March 2019.The enrolled cases had 38-89(mean 68.3±8.71)years old.There were 112 males(56%).CHA2DS2-VASc scores were(3.5±1.44)points,and HAS-BLED scores(2.5±1.18)points.LAAC was conducted with a novel disc-like closure device,LEFTEAR.Successful closure of LAA was defined as there was no or a small amount of residual shunt(PDL≤3 mm),evaluated by transesophageal echocardiography(TEE).The composite end-point events(hemorrhagic/ischemic stroke,systemic embolism,cardiogenic/unexplained death)within 12 months after the procedure were the main efficacy indicators.Severe adverse events(SAE)within 12 months were safety indicators.Results Total 196 were implanted with an occluder,and the remaining 4 were not(1 case found with an large LAA which the ostium was great than 35 mm above the upper limit of the clinical program,1 case gave up after failed attempt of LAAC procedure,2 cases showed"pericardial tamponade"after AF ablation and no attempt was made to continue LAAC).Among them,the"hybrid procedures"(LAAC+AF ablation)reached up to 133 cases(66.5%).Up to December 31,2019,the mean follow-up was 6(4,11)months.There were none major composite endpoint events occurred during the perioperative and follow-up periods.SAE were recorded in 10 cases,of which 7 cases were"pericardial tamponade",and 3 cases of"occluder detachment or displacement".All SAE occurred in"hybrid procedures"cases,of which 9 cases occurred in the perioperative period(90%).Six cases of"pericardial tamponade"were recorded in the perioperative period,and only 2 cases required emergency surgery.The successful rate of immedi

关 键 词：心房颤动 左心耳封堵 并发症 

分 类 号：R654.2[医药卫生—外科学]