Enache Bogdan, Șoșdean Raluca, Macarie Răzvan, Dodinot Bernard, Pescariu Sorin
University of Medicine and Pharmacy "Victor Babes" Timisoara, Timisoara, Romania.
Institute of Cardiovascular Diseases Timisoara, Timisoara, Romania.
Pacing Clin Electrophysiol. 2019 Aug;42(8):1095-1098. doi: 10.1111/pace.13742. Epub 2019 Jun 30.
The safety of pacemaker reuse has been proven by numerous studies in the last two decades. With the exception of one research paper, the safety of reuse of implantable cardioverter-defibrillators has not been properly investigated. Our aim was to establish whether resterilized implantable cardioverter-defibrillators are as safe as new devices in relation to functionality and infection rates.
All the patients (n = 271) implanted with a new or a donated, used implantable cardioverter-defibrillator (ICD) at the Institute of Cardiovascular Disease Timisoara Romania between January 2001 and December 2012 were included in the study. The patients had class I indication for ICD implantation. One hundred fifty-seven patients received reused ICDs and 114 patients received new ICDs. Complications were defined as infections that required reintervention, device malfunction, and replacements due to untimely or unexpected battery depletion.
Complications occurred in 4.38% of the patients in the new ICD group and in 1.91% of the reused ICD group. The difference was not considered statistically significant (odds ratio 0.28, 95% confidence interval 0.04-1.82, P = .18).
According to our data, properly verified and resterilized ICDs are as safe as new devices, when risk of infection or malfunction rates are assessed. Due to the high costs of new ICDs, their safe reuse has profound humanitarian and financial implications.
过去二十年的众多研究已证实起搏器再利用的安全性。除了一篇研究论文外，植入式心脏复律除颤器再利用的安全性尚未得到妥善研究。我们的目的是确定经过重新灭菌的植入式心脏复律除颤器在功能和感染率方面是否与新设备一样安全。
纳入2001年1月至2012年12月期间在罗马尼亚蒂米什瓦拉心血管疾病研究所植入新的或捐赠的、使用过的植入式心脏复律除颤器（ICD）的所有患者（n = 271）。这些患者有植入ICD的I类适应症。157名患者接受了再利用的ICD，114名患者接受了新的ICD。并发症定义为需要再次干预的感染、设备故障以及由于电池过早耗尽或意外耗尽而进行的更换。
新ICD组4.38%的患者出现并发症，再利用ICD组1.91%的患者出现并发症。差异无统计学意义（优势比0.28，95%置信区间0.04 - 1.82，P = 0.18）。
根据我们的数据，在评估感染风险或故障率时，经过适当验证和重新灭菌的ICD与新设备一样安全。由于新ICD成本高昂，其安全再利用具有深远的人道主义和财务意义。
