无导线起搏器与传统单腔起搏器临床应用的对比分析

Leadless pacemaker versus transvenous single-chamber pacemaker therapy

目的:通过比较无导线起搏器和传统单腔起搏器在真实世界的临床应用,分析无导线起搏器临床应用的有效性与安全性。方法:回顾性分析2018年8月至2018年12月,就诊北京安贞医院心内科并首次置入无导线起搏器和传统单腔起搏器的患者,收集临床基线资料,置入术中、出院前,术后1,3,6,12个月的起搏电学参数,记录与起搏器相关的再住院率、患者不适主诉、并发症及主要不良事件,不适主诉包括伤口疼痛、肩部疼痛,并发症包括气胸,囊袋血肿,电极脱位,股静脉穿刺部位血肿、出血,假性动脉瘤及动静脉瘘,主要不良事件包括置入器械移位,心脏穿孔,心包积液和感染。结果:共入选患者46例,其中置入无导线起搏器15例,置入传统单腔起搏器31例,手术成功率100%。无导线起搏器组置入时电学参数:阈值0.5(0.38,0.63)V/0.24 ms,感知(9.14±4.46)mV,阻抗(873.83±228.26)Ω,传统单腔起搏器组置入时电学参数:阈值(0.95±0.21)V/0.4 ms,感知(10.71±4.10)mV,阻抗(784.97±167.65)Ω,两组患者的电学参数在出院前,术后1,3,6,12个月均在理想范围且稳定。无导线起搏器组与传统单腔起搏器组相比,伤口疼痛(零vs. 25.8%,P=0.030),肩部疼痛(零vs. 22.6%,P=0.046)及总并发症发生率(零vs. 25.8%,P=0.030),显著降低,差异有统计学意义。电极脱位(零vs. 3.2%,P=0.482),气胸(零vs. 3.2%,P=0.482),囊袋血肿(零vs.19.4%,P=0.068)及与起搏器相关的再住院率(零vs. 9.7%,P=0.213),两组间差异无统计学意义,但是,无导线起搏器组低于传统单腔起搏器组,两组患者均未发生股静脉穿刺部位血肿、出血,假性动脉瘤及动静脉瘘等并发症及置入器械移位,心脏穿孔,心包积液和感染等主要不良事件。结论:无导线起搏器置入手术成功率高,避免了囊袋和电极导线相关的并发症,创伤小,感染风险低,电学参数理想且稳定,在临床应用中安全有效。

Objective:To investigate the efficacy and safety of leadless pacemaker(LPM)by compa-ring the difference of the therapy and complication between LPM and transvenous single-chamber pacemaker(TV-SPM).Methods:Between August 2018 and December 2018,patients underwent Micra transcatheter pacemaker and transvenous single-chamber pacemaker in Beijing Anzhen hospital were enrolled.The baseline characteristics,electrical parameters(threshold,R-wave amplitude,impedance)at implant,hospital dis-charge,1,3,6 and 12 months post-implant,rates of pacemaker related rehospitalization,complain,complication and adverse events of pacemaker were recorded.Complains included wound pain and shoulder pain.Complications included pneumothorax,pocket hematoma,electrode dislodgement and femoral access site related hematoma,hemorrhage,pseudoaneurysm,and arteriovenous fistula.Adverse events included dislodge-ment,cardiac effusion/perforation and infection.Results:Totally 46 patients were enrolled and implantation was successful in all patients.LPM group had 15 cases and TV-SPM group had 31 cases.The electrical parame-ters at implantation in LPM group were threshold 0.5(0.38,0.63)V/0.24 ms,R-wave amplitude(9.14±4.46)mV and impedance(873.83±228.26)Ω.The electrical parameters at implantation in TV-SPM group were threshold(0.95±0,21)V/0.4 ms,R-wave amplitude(10.71±4.10)mV and impedance(784.97±167.65)Ω.Electrical parameters at implant,hospital discharge,1,3,6 and 12 months post-implant in two groups were low and stabled.The complain and complications of LPM were low in comparison to TV-SPM in terms of wound pain(0 vs.25.8%,P=0.030),shoulder pain(0 vs.22.6%,P=0.046)and total complications(0 vs.25.8%,P=0.030).There was no significant difference in lead dislodgement(0 vs.3.2%,P=0.482),pneumothorax(0 vs.3.2%,P=0.482),pocket hematoma(0 vs.19.4%,P=0.068)and rate of pacemaker related rehospitalization(0 vs.9.7%,P=0.213).No incidence of femoral access site complications,dislodgement,cardiac effusion/perforation and infections occurred in two groups.Conclusions:The leadless pacemaker appears to be safe and efficient with high implant success rate,low pocket and lead related complications and low and stable electrical parameters.