Şoşdean Raluca, Mornoş Cristian, Enache Bogdan, Macarie Răzvan I, Ianoş Raluca, Ştefea Ana-Maria, Pescariu Sorin
Department of Cardiology, "Victor Babeş" University of Medicine and Pharmacy, Timişoara, Romania ; Cardiology Clinic, Institute of Cardiovascular Medicine, Timişoara, Romania.
Cardiology Clinic, Institute of Cardiovascular Medicine, Timişoara, Romania.
Clin Interv Aging. 2015 Aug 12;10:1311-8. doi: 10.2147/CIA.S88805. eCollection 2015.
Cardiac resynchronization therapy (CRT) is known to have very important beneficial effects on heart failure patients. Unfortunately, biventricular implantable cardiac devices (CRT devices), through which this therapy is implemented, are very expensive and sometimes hard to achieve, especially in underdeveloped/developing economies, making this an important problem of public health. As a possible solution, CRT reuse is of great interest nowadays, but unlike simple devices, data in the literature are scarce about biventricular device reuse.
To address safety concerns, we aimed to analyze infection burden in the general and elderly population and also early battery depletion and generator malfunction of resterilized biventricular devices compared to new devices.
A cohort of 261 CRT patients (286 devices), who underwent implantation between 2000 and 2014, was retrospectively analyzed. The study group included 115 patients and 127 resterilized devices, that was divided into a subgroup of 69 elderly patients (≥60 years) and 74 devices and a subgroup of 47 younger patients (<60 years) and 53 devices, and the control group included 146 patients and 159 new devices. The groups were compared using a multivariate logistic regression model.
A number of 12 (4.2%) infectious complications were encountered, five (3.9%) in the study group and seven (4.4%) in the control group (odds ratio, 2.83 [0.59-13.44], P=0.189), one (1.3%) in the elderly and four (7.5%) in the younger subgroup (odds ratio, 3.80 [0.36-40.30], P=0.266), with no statistically significant difference between them. There was only one case of early battery depletion, after 17 months, in one study group patient. No generator malfunction was detected.
Reuse of biventricular cardiac implantable electronics seems feasible and safe in both the general population and the elderly population, and it could be a promising alternative when new devices cannot be obtained in a safe period of time.
心脏再同步治疗(CRT)对心力衰竭患者具有非常重要的有益作用。不幸的是,实施这种治疗的双心室植入式心脏设备(CRT设备)非常昂贵,有时难以获得,尤其是在不发达/发展中经济体,这成为一个重要的公共卫生问题。作为一种可能的解决方案,CRT再利用如今备受关注,但与简单设备不同,关于双心室设备再利用的文献数据很少。
为解决安全问题,我们旨在分析普通人群和老年人群中的感染负担,以及与新设备相比,再消毒后的双心室设备的早期电池耗尽和发生器故障情况。
对2000年至2014年间接受植入的261例CRT患者(286台设备)进行回顾性分析。研究组包括115例患者和127台再消毒设备,分为69例老年患者(≥60岁)和74台设备的亚组以及47例年轻患者(<60岁)和53台设备的亚组,对照组包括146例患者和159台新设备。使用多变量逻辑回归模型对各组进行比较。
共遇到12例(4.2%)感染并发症,研究组5例(3.9%),对照组7例(4.4%)(比值比,2.83[0.59 - 13.44],P = 0.189),老年亚组1例(1.3%),年轻亚组4例(7.5%)(比值比,3.80[0.36 - 40.30],P = 0.266),两组之间无统计学显著差异。研究组仅1例患者在17个月后出现1例早期电池耗尽情况。未检测到发生器故障。
双心室植入式心脏电子设备的再利用在普通人群和老年人群中似乎都是可行且安全的,并且在无法在安全时间内获得新设备时,它可能是一个有前景的替代方案。