Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, USA.
Circ Arrhythm Electrophysiol. 2011 Jun;4(3):318-23. doi: 10.1161/CIRCEP.110.960112. Epub 2011 Apr 14.
A large disparity in medical health care is clearly evident between developed and underserved nations in the field of cardiac electrophysiology, specifically pacemaker implantation. This study aimed to assess the safety of pacemaker reuse.
A computerized search from January 1, 1970, to September 1, 2010, identified 18 studies with outcomes of pacemaker reuse. The primary outcome was pacemaker infection or device erosion as defined by each individual study protocol. Secondary end points were device malfunction defined as a defect in the structural or electric integrity of the pulse generator. Pooled individual patient data (n=2270) from 18 trials were included in the analysis. The proportion of patients in whom an infection developed after pacemaker reuse was 1.97% (1.15% to 3.00%). There was no significant difference in infection rate between pacemaker reuse and new device implantation (odds ratio, 1.31 [0.50 to 3.40], P=0.580). The proportion of patients in whom device malfunction developed after pacemaker reuse was 0.68% (0.27% to 1.28%). Compared with new device implantation, there was an increased risk for malfunction in the reuse group (odds ratio, 5.80 [1.93 to 17.47], P=0.002). This difference was mainly driven by abnormalities in set screws, which possibly occurred during device extraction, as well as nonspecific device "technical errors."
This study suggests that pacemaker reuse has an overall low rate of infection and device malfunction and may be a safe and efficacious means of treating patients in underserved nations with symptomatic bradyarrhythmias and no other method of obtaining a device. However, the results also denote a higher rate of device malfunction as compared with new device implantation. Patients with highly symptomatic conduction disease may benefit from pacemaker reuse; however, they should be closely monitored for device malfunction, especially during implantation.
在心脏电生理学领域,特别是起搏器植入方面,发达国家和服务不足的国家之间的医疗保健水平存在着明显的差距。本研究旨在评估起搏器再利用的安全性。
计算机检索 1970 年 1 月 1 日至 2010 年 9 月 1 日期间的文献,共确定了 18 项研究,评估了起搏器再利用的结果。主要结局是根据每个研究方案定义的起搏器感染或器械侵蚀。次要终点是器械故障,定义为脉冲发生器的结构或电气完整性的缺陷。纳入 18 项试验的 2270 例患者的个体患者数据进行汇总分析。起搏器再利用后感染的患者比例为 1.97%(1.15%3.00%)。起搏器再利用与新器械植入的感染率无显著差异(比值比 1.31[0.503.40],P=0.580)。起搏器再利用后器械故障的患者比例为 0.68%(0.27%1.28%)。与新器械植入相比,再利用组器械故障的风险增加(比值比 5.80[1.9317.47],P=0.002)。这种差异主要是由于在器械取出过程中,固定螺丝出现异常以及器械出现非特异性“技术故障”所导致。
本研究表明,起搏器再利用总的感染率和器械故障率较低,可能是治疗服务不足国家症状性心动过缓患者的一种安全有效的方法,这些国家没有其他获得器械的方法。然而,结果也表明与新器械植入相比,再利用组的器械故障发生率较高。对于有高度症状性传导疾病的患者,起搏器再利用可能受益;然而,应密切监测器械故障,特别是在植入过程中。