Safety and feasibility of biventricular devices reuse in general and elderly population – a single-center retrospective cohort study
Authors ┼×o┼čdean R, Morno┼č C, Enache B, Macarie R, Iano┼č R, ┼×tefea A, Pescariu S
Received 18 May 2015
Accepted for publication 17 June 2015
Published 12 August 2015 Volume 2015:10 Pages 1311—1318
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Chung-Liang Lai
Peer reviewer comments 2
Editor who approved publication: Dr Richard Walker
Raluca ┼×o┼čdean,1,2 Cristian Morno┼č,1,2 Bogdan Enache,1,2 R─âzvan I Macarie,2 Raluca Iano┼č,2 Ana-Maria ┼×tefea,2 Sorin Pescariu1,2
1Department of Cardiology, “Victor Babe┼č” University of Medicine and Pharmacy, 2Cardiology Clinic, Institute of Cardiovascular Medicine, Timi┼čoara, Romania
Introduction: 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.
Aim: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
Keywords: biventricular implantable cardiac devices, reuse, infectious complications, malfunction
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