摘要
目的 评估并总结上海地区无导线起搏器(Micra)的患者选择、植入策略、起搏参数以及不良事件发生情况.方法 本研究为描述性研究.回顾性选取2019年12月至2023年7月在复旦大学附属中山医院等50家上海地区心脏中心植入无导线起搏器的患者,观察和评估无导线起搏器的适应证、植入部位、程控检测起搏参数(阈值、感知、阻抗)、手术时间、X线曝光量、术后程控随访参数(阈值、感知、阻抗)、AV同步率(如为Micra AV)及不良事件.结果 入选1 620例患者,年龄(72.6±15.3)岁,男923例、女697例,其中心房颤动(房颤)伴慢心室率496例(30.6％,496/1 620),病态窦房结综合征476 例(29.4％,476/1 620),房室传导阻滞 648 例(40.0％,648/1 620),植入成功率 99.8％(1 617/1 620).手术时间(43.8±17.6)min,X 线曝光量(82.82±38.0)mGy,其中 1 283 例(79.2％,1 283/1 620)患者植入部位在中位室间隔,248例(15.3％,248/1 620)植入部位在低位室间隔,58例(3.6％,58/1 620)植入部位在高位室间隔,31例(1.9％,31/1620)植入部位在心尖部.术中测得的起搏阈值(0.56±0.26)V/0.24ms,心室感知(10.04±4.16)mV,阻抗(888.0±250.7)Ω.Micra AV 1个月随访时平均房室同步率为76.6％,1年随访时平均房室同步率为79.0％.共发生了 38例(2.35％,38/1 620)不良事件:股静脉血栓6例(0.37％,6/1 620)、动静脉瘘3例(0.19％,3/1 620)、假性动脉瘤4例(0.25％,4/1 620)、心脏穿孔9例(0.56％,9/1 620)、无导线起搏器移位3例(0.19％,3/1 620)、感染1例(0.06％,1/1 620)、起搏阈值升高5例(0.31％,5/1 620)、设备故障2例(0.12％,2/1 620)、非手术死亡5例(0.31％,5/1 620).结论 无导线起搏器植入总体上安全可行,术者多首选植入在中位室间隔.尽管并发症发生率低,但是一旦发生,较传统经静脉起搏系统严重且处理相对更困难并可能危及生命.
Abstract
Objective To evaluate and summarize the patient selection,implantation strategies and complications of leadless pacemakers(Micra)in Shanghai.Methods This is a descriptive study.Patients with leadless pacemaker implanted in 50 heart centers(including Zhongshan Hospital,Fudan University.etc)from December 2019 to July 2023 were retrospectively selected to observe and evaluate the indications,intraoperative implant site,program-controlled detection parameters(threshold,perception,impedance),operation duration,X-ray exposure,postoperative program-controlled follow-up parameters(threshold,perception,impedance),AV synchronization rate(e.g.Micra AV)and adverse events.Results A total of 1 620 patients[mean age(72.6±15.3)years old,923 males and 697 females]were enrolled,including 496 patients(30.6％,496/1620)with atrial fibrillation(AF)with slow ventricular rate,476 patients(29.4％,476/1 620)with sick sinus syndrome,and 648 patients(40.0％,648/1620)with atrioventricular block.The success rate of implantation was 99.8％(1 617/1 620).The mean operative time was(43.8±17.6)min,and the X-ray exposure was(82.82±38.0)mGy.Among them,1 283 patients(79.2％,1 283/1 620)were implanted in the middle interventricular septum,248 patients(15.3％,248/1 620)in the low interventricular septum,58 patients(3.6％,58/1 620)in the high interventricular septum,and 31 patients(1.9％,31/1 620)in the apex of the heart.The mean pacing threshold was(0.56±0.26)V/0.24 ms,the mean ventricular perception was(10.04±4.16)mV,and the mean impedance was(888.0±250.7)Ω.The mean atrioventricular synchronization pacing rate of Micra AV was 76.6％at 1-month and 79.0％at 1-year follow-up.There were 38 cases(2.35％,38/1 620)of adverse events including 6 cases of femoral vein thrombus(0.37％,6/1 620),3 cases of arteriovenous fistula(0.19％,3/1 620),4 cases of pseudoaneurysm(0.25％,4/1 620),9 case of cardiac perforation(0.56％,9/1 620),3 cases of translocation(0.19％,3/1 620),1 case of device infection(0.06％,1/1 620),5 cases of high pacing threshold(0.31％,5/1 620),2 cases of device malfunction(0.12％,2/1 620),and 5 cases of non-operational related death(0.31％,5/1 620).Conclusion Leadless pacemaker implantation is generally safe and feasible with low incidence of complications,and is preferred to be implanted in the middle interventricular septum.However,the complications are relatively severe with difficulties to solve and even life-threatening as compared with conventional pacemakers.
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