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Abstract：
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.
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.
摘要：
在过去的二十年中，许多研究证明了起搏器重复使用的安全性。除了一篇研究论文外，植入式心律转复除颤器重复使用的安全性尚未得到适当研究.我们的目的是确定再灭菌的可植入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。
所有患者（n=271）植入了新的或捐赠的，本研究纳入了2001年1月至2012年12月在罗马尼亚心血管疾病研究所使用的植入式心律转复除颤器(ICD).患者具有ICD植入的I类指征。一百五十七名患者接受了重复使用的ICD，114名患者接受了新的ICD。并发症被定义为需要重新干预的感染，设备故障,和更换由于不及时或意外的电池耗尽。
在新的ICD组中，并发症发生率为4.38％，在重复使用的ICD组中，并发症发生率为1.91％。差异没有统计学意义（比值比0.28，95％置信区间0.04-1.82，P=.18）。
根据我们的数据,经过适当验证和重新灭菌的ICD与新设备一样安全，当感染或功能障碍的风险被评估。由于新ICD的高成本，它们的安全再利用具有深远的人道主义和财务影响。
所有患者（n=271）植入了新的或捐赠的，本研究纳入了2001年1月至2012年12月在罗马尼亚心血管疾病研究所使用的植入式心律转复除颤器(ICD).患者具有ICD植入的I类指征。一百五十七名患者接受了重复使用的ICD，114名患者接受了新的ICD。并发症被定义为需要重新干预的感染，设备故障,和更换由于不及时或意外的电池耗尽。
在新的ICD组中，并发症发生率为4.38％，在重复使用的ICD组中，并发症发生率为1.91％。差异没有统计学意义（比值比0.28，95％置信区间0.04-1.82，P=.18）。
根据我们的数据,经过适当验证和重新灭菌的ICD与新设备一样安全，当感染或功能障碍的风险被评估。由于新ICD的高成本，它们的安全再利用具有深远的人道主义和财务影响。
