Laager与Watchman左心耳封堵器临床疗效对比

Laager occluder versus Watchman occluder for left atrial appendage closure: comparison of the clinical efficacy

目的对比经皮左心耳封堵术中Laager封堵器与Watchman封堵器围手术期安全性和近期临床疗效。方法入选2018年1月至2019年1月在上海市周浦医院接受全身麻醉下经皮左心耳封堵术治疗的76例非瓣膜性心房颤动(房颤)患者,采集患者基线、围手术期、术后45 d、术后12个月经食管超声心动图(TEE)及术后12个月临床事件资料,通过倾向值匹配进行统计学分析。结果连续76例患者中16例植入Laager封堵器,60例植入Watchman封堵器。1∶1倾向值匹配后,Laager封堵器组、Watchman封堵器组均为16例,年龄分别为(68.5±7.7)岁、(71.1±6.7)岁,房颤血栓危险度评分(CHA2DS2-VASc)分别为4.5±1.3、4.7±1.6,抗凝治疗出血风险评估评分(HAS-BLED)均为3.1±0.7,差异均无统计学意义(P>0.05)。76患者封堵器植入均获成功。倾向值匹配后Laager封堵器组、Watchman封堵器组患者围手术期并发症发生率均为6.3%(1/16),临床复合终点发生率分别为25.0%(4/16)、18.8%(3/16),差异无统计学意义(P>0.05),术后12个月患者生存分析无差异。结论Laager左心耳封堵在器械植入成功率、围手术期安全性、临床有效性方面与Watchman封堵器对比无差异。

Objective To compare the perioperative safety and short-term efficacy of Laager occluder with those of Watchman occluder in treating non-valvular atrial fibrillation(AF)with percutaneous left atrial appendage closure(LAAC).Methods A total of 76 patients with non-valvular AF,who were admitted to Shanghai Zhoupu Hospital of China during the period from January 2018 to January 2019 to receive percutaneous LAAC under general anesthesia,were enrolled in this study.The patients’baseline data,the findings of transesophageal echocardiography(TEE)performed in perioperative period and at 45 days,12 months after treatment,and the clinical events occurring within postoperative 12 months were collected.The propensity score matching(PSM)method was used to make statistical analysis.Results A total of 76 consecutive patients with non-valvular AF were enrolled in this study.Of the 76 patients,16 received Laager occluder implantation and 60 received Watchman occluder implantation.After a 1∶1 PSM,Laager group had16 patients,and Watchman group also had 16 patients.In the Laager group and Watchman group,the average age was(68.5±7.7)years and(71.1±6.7)years respectively,the CHA2 DS2-VASc score was(4.5±1.3)points and(4.7±1.6)points respectively,and the HAS-BLED score was(3.1±0.7)points in both groups.No statistically significant differences in these indexes existed between the two groups(P>0.05).Successful implantation of occluder was accomplished in all 76 patients.After PSM,the incidence of perioperative complications was 6.3%(1/6)in both Laager group and Watchman group.The clinical incidence of composite endpoints in the Laager group and Watchman group were 25.0%(4/16)and 18.8%(3/16)respectively,and the difference was not statistically significant(P>0.05).There was no statistically significant difference in postoperative 12-month survival rate between the two groups.Conclusion Compared with Watchman occluder,Laager occluder has the same success rate of implantation,same perioperative safety and same clinical efficacy.(J Intervent Radiol,2021,30:230-234).