Safety and feasibility of biventricular devices reuse in general and elderly population – a single-center retrospective cohort study

Abstract

IntroductionCardiac 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.AimTo 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.MethodsA 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.ResultsA 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.ConclusionReuse 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.

Reuse of pacemakers, defibrillators and cardiac resynchronisation devices

“…Risk of infection is higher with implantation of complex devices10 21 and therefore our data showing no increase in risk with reused devices are reassuring. There is limited previous literature on reuse of complex devices 7 8 22. Our data are a significant addition to this literature.…”

“…While factors such as differences in population demographics and access to healthcare may contribute to this disparity, socioeconomic differences are likely to be most important, suggesting that a lot of patients who could potentially benefit from device implantation do not get the same. Outcome with reuse of pacemakers has been described in a few studies previously,2–6 while there are fewer reports where reuse of complex devices has been described 7 8. The uniform finding from these studies is that reuse of explanted devices is not associated with an increase in the rate of infection or mortality.…”

Worldwide pacemaker and defibrillator reuse: Systematic review and meta‐analysis of contemporary trials

“…An online search using the key search terms identified 172 articles (see Figure ). Detailed review ascertained 10 relevant clinical studies published between 2009 and 2017 involving device reuse . We excluded one case series due to duplication of data in a larger subsequent trial publication, leaving nine studies totaling 2,302 devices as summated in the pooled analysis (see Figure and Table ).…”

“…We included data derived from the five controlled trials totaling 2,114 devices in further analysis comparing the primary and secondary outcomes of patients with new devices (1,258) to reused devices (856). The median follow‐up and IQR was 2.2 years (1.0–2.8 years) for the new device group and 2.6 years (1.4–3.5 years) for the reused device group.…”

“…Detailed review ascertained 10 relevant clinical studies published between 2009 and 2017 involving device reuse. [18][19][20][21][22][23][24][25][26][27] We excluded one case series 18 due to duplication of data in a larger subsequent trial publication, 24 leaving nine studies totaling 2,302 devices as summated in the pooled analysis (see Figure 2 and Table 1). The demographic characteristics regarding age, gender, and indication for pacing therapy (when applicable) were similar between the new device and reused device populations (see Table 2).…”