Premium
Worldwide pacemaker and defibrillator reuse: Systematic review and meta‐analysis of contemporary trials
Author(s) -
Sinha Sunil K.,
Sivasambu Bhradeev,
Yenokyan Gayane,
Crawford Thomas C.,
Chrispin Jonathan,
Eagle Kim A.,
Barth Andreas S.,
Rickard John “Jack”,
Spragg David D.,
Vlay Stephen C.,
Berger Ronald,
Love Charles,
Calkins Hugh,
Tomaselli Gordon F.,
Marine Joseph E.
Publication year - 2018
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/pace.13488
Subject(s) - medicine , observational study , randomized controlled trial , meta analysis , odds ratio , implantable cardioverter defibrillator , intensive care medicine , emergency medicine
Background Patients go without pacemaker, defibrillator, and cardiac resynchronization therapies (devices) each year due to the prohibitive costs of devices. Objective We sought to examine data available from studies regarding contemporary risks of reused devices in comparison with new devices. Methods We searched online indexing sites to identify recent studies. Peer‐reviewed manuscripts reporting infection, malfunction, premature battery depletion, and device‐related death with reused devices were included. The primary study outcome was the composite risk of infection, malfunction, premature battery depletion, and death. Secondary outcomes were the individual risks. Results Nine observational studies (published 2009–2017) were identified totaling 2,302 devices (2,017 pacemakers, 285 defibrillators). Five controlled trials were included in meta‐analysis (2,114 devices; 1,258 new vs 856 reused). All device reuse protocols employed interrogation to confirm longevity and functionality, disinfectant therapy, and, usually, additional biocidal agents, packaging, and ethylene oxide gas sterilization. Demographic characteristics, indications for pacing, and median follow‐up were similar. There were no device‐related deaths reported and no statistically significant difference in risk between new versus reused devices for the primary outcome (2.23% vs 3.86% respectively, P = 0.807, odds ratio = 0.76). There were no significant differences seen in the secondary outcomes for the individual risks of infection, malfunction, and premature battery depletion. Conclusions Device reuse utilizing modern protocols did not significantly increase risk of infection, malfunction, premature battery depletion, or device‐related death in observational studies. These data provide rationale for proceeding with a prospective multicenter noninferiority randomized control trial.