采用LAmbre与Watchman装置对非瓣膜性心房颤动患者进行左心耳封堵的安全性与有效性比较  

Safety and efficacy of left appendage closure with LAmbre versus Watchman devices in patients with non-valvular atrial fibrillation:a retrospective cohort study

作　　者：刘彬 郝子雍[2] 江立生 何奔 Liu Bin;Hao Ziyong;Jiang Lisheng;He Ben(Graduate School of Bengbu Medical College,Bengbu 233004,China;Department of Cardiology,Shanghai Chest Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200030,China)

机构地区：[1]蚌埠医学院研究生院,安徽蚌埠233000 [2]上海交通大学医学院附属胸科医院心内科,上海200030

出　　处：《中华心血管病杂志（网络版）》2023年第1期195-207,共13页Chinese Video Journal of Cardiology

基　　金：国家自然科学基金(82170247);上海市自然科学基金(19ZR1449600)。

摘　　要：目的比较非瓣膜性心房颤动(non-valvular atrial fibrillation,NVAF)患者采用LAmbre与Watchman装置进行左心耳封堵(left atrial appendage closure,LAAC)的安全性与有效性。研究对象本研究对象为2017年9月至2020年9月在上海交通大学医学院附属胸科医院使用LAmbre与Watchman装置进行LAAC的519例NVAF患者。干预措施根据LAAC手术所用封堵器类型将患者分为LAmbre组和Watchman组。观测指标及测量方法对患者的基线资料、手术过程特征及临床和影像随访数据进行记录和分析,对2组患者7 d围手术期或出院前发生的与操作相关主要并发症(包括需要干预的心包积液、血管入路并发症、封堵器脱位、需要输血的大出血、卒中和死亡),出院后发生的与器械相关的迟发性大量心包积液组成的主要安全终点事件和随访期内发生的全因卒中/短暂性脑缺血发作/系统性栓塞、非操作相关性出血和死亡组成的主要临床不良事件进行了比较。采用倾向性得分匹配方法(propensity score matching,PSM)对组间差异进行平衡。同时将所有患者作为一个整体队列,针对上述预设终点进行COX多元回归分析,评估封堵器类型和手术方式等因素是否是影响预后的独立危险因素。结果519例接受LAAC手术的患者中,LAmbre组152例,Watchman组367例,2组人口学基线特征相同,LAmbre组行导管消融+LAAC“一站式”(40.8%vs.51.0%,P=0.035)和术中使用经食管超声(transesophageal echocardiography,TEE)(37.5%vs.79.6%,P<0.001)的比例低于Watchman组,但封堵器置入成功率与Watchman相当(100.0%vs.99.2%,P=0.559)。术后TEE或CTA随访发现,LAmbre组发生装置周围残余漏(peri-device residual leak,PDL)的比率高于Watchman组(41.1%vs.27.3%,P=0.023),但装置相关血栓(device related thrombosis,DRT)发生率差异无统计学意义。在平均随访期内[LAmbre组(24.4±14.3)个月vs.Watchman组(32.7±13.2)个月],LAmbre组发生的与操作/器械相关的主要安�Objective To compare the safety and efficacy of left atrial appendage closure(LAAC)using the LAmbre and Watchman devices in patients with non-valvular atrial fibrillation(NVAF).Subjects This study enrolled 519 patients with NVAF who underwent LAAC with the Lambre or Watchman devices at Shanghai Chest Hospital,Shanghai Jiao Tong University School of Medicine,between September 2017 and September 2020.Interventions The patients were divided into the LAmbre and Watchman groups according to the type of occluder used in the LAAC procedure.Main Outcomes and Measurements Patient baseline and procedural characteristics and clinical and imaging follow-up data were recorded and analyzed.We also compared the differences between the groups,including the major composite safety endpoints consisting of severe procedure-related complications(including pericardial effusion requiring intervention,vascular access complications,device dislocation,major bleeding requiring blood transfusion,stroke,and death)occurring during a 7-day perioperative period or before discharge and the delayed massive pericardial effusion requiring intervention that occurred after discharge,and the major clinical adverse events consisting of all-cause stroke/transient ischemic attack/systemic embolism,non-procedure-related bleeding,and death during the follow-up period.Propensity score matching(PSM)was used to balance the differences between the groups.After all patients were treated as the whole cohort,COX multiple regression analysis was conducted for the aforementioned preset endpoints to assess whether factors,such as device type and operational approach,were independent risk factors for prognosis.Results Of the 519 patients who underwent LAAC,152 and 367 were in the LAmbre and Watchman groups,respectively.The demographic baseline characteristics were similar in both groups.The LAmbre group had lower rates of the"one-stop"combined procedure with catheter ablation and LAAC(40.8%vs.51.0%,P=0.035)and utilization of transesophageal echocardiography(TEE)durin

关 键 词：心耳 心房颤动 左心耳封堵术 生存分析 

分 类 号：R541.75[医药卫生—心血管疾病]