Worldwide pacemaker and defibrillator reuse: Systematic review and metaâ analysis of contemporary trials
dc.contributor.author | Sinha, Sunil K. | |
dc.contributor.author | Sivasambu, Bhradeev | |
dc.contributor.author | Yenokyan, Gayane | |
dc.contributor.author | Crawford, Thomas C. | |
dc.contributor.author | Chrispin, Jonathan | |
dc.contributor.author | Eagle, Kim A. | |
dc.contributor.author | Barth, Andreas S. | |
dc.contributor.author | Rickard, John “jack” | |
dc.contributor.author | Spragg, David D. | |
dc.contributor.author | Vlay, Stephen C. | |
dc.contributor.author | Berger, Ronald | |
dc.contributor.author | Love, Charles | |
dc.contributor.author | Calkins, Hugh | |
dc.contributor.author | Tomaselli, Gordon F. | |
dc.contributor.author | Marine, Joseph E. | |
dc.date.accessioned | 2018-12-06T17:36:36Z | |
dc.date.available | 2020-01-06T16:41:00Z | en |
dc.date.issued | 2018-11 | |
dc.identifier.citation | 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. (2018). "Worldwide pacemaker and defibrillator reuse: Systematic review and metaâ analysis of contemporary trials." Pacing and Clinical Electrophysiology 41(11): 1500-1507. | |
dc.identifier.issn | 0147-8389 | |
dc.identifier.issn | 1540-8159 | |
dc.identifier.uri | https://hdl.handle.net/2027.42/146585 | |
dc.description.abstract | BackgroundPatients go without pacemaker, defibrillator, and cardiac resynchronization therapies (devices) each year due to the prohibitive costs of devices.ObjectiveWe sought to examine data available from studies regarding contemporary risks of reused devices in comparison with new devices.MethodsWe searched online indexing sites to identify recent studies. Peerâ reviewed manuscripts reporting infection, malfunction, premature battery depletion, and deviceâ 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.ResultsNine observational studies (published 2009â 2017) were identified totaling 2,302 devices (2,017 pacemakers, 285 defibrillators). Five controlled trials were included in metaâ 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 followâ up were similar. There were no deviceâ 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.ConclusionsDevice reuse utilizing modern protocols did not significantly increase risk of infection, malfunction, premature battery depletion, or deviceâ related death in observational studies. These data provide rationale for proceeding with a prospective multicenter noninferiority randomized control trial. | |
dc.publisher | Wiley Periodicals, Inc. | |
dc.subject.other | pacemaker reuse | |
dc.subject.other | pacemaker recycling | |
dc.subject.other | defibrillator reuse | |
dc.subject.other | defibrillator recycling | |
dc.subject.other | cardiac resynchronization therapy reuse | |
dc.subject.other | cardiac resynchronization therapy recycling | |
dc.title | Worldwide pacemaker and defibrillator reuse: Systematic review and metaâ analysis of contemporary trials | |
dc.type | Article | en_US |
dc.rights.robots | IndexNoFollow | |
dc.subject.hlbsecondlevel | Physiology | |
dc.subject.hlbtoplevel | Health Sciences | |
dc.description.peerreviewed | Peer Reviewed | |
dc.description.bitstreamurl | https://deepblue.lib.umich.edu/bitstream/2027.42/146585/1/pace13488_am.pdf | |
dc.description.bitstreamurl | https://deepblue.lib.umich.edu/bitstream/2027.42/146585/2/pace13488.pdf | |
dc.identifier.doi | 10.1111/pace.13488 | |
dc.identifier.source | Pacing and Clinical Electrophysiology | |
dc.identifier.citedreference | DerSimonian R, Laird N. Metaâ analysis in clinical trials. Controlled Clinical Trials. 1986; 7: 177 â 188. | |
dc.identifier.citedreference | Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in metaâ analysis of sparse data. Stat Med. 2004; 23: 1351 â 1375. | |
dc.identifier.citedreference | Higgins JP, Thompson SG. Quantifying heterogeneity in a metaâ analysis. Stat Med. 2002; 21: 1539 â 1558. | |
dc.identifier.citedreference | Egger M, Davey Smith G, Schneider M, Minder C. Bias in metaâ analysis detected by a simple, graphical test. BMJ. 1997; 315: 629 â 634. | |
dc.identifier.citedreference | Duval S, Tweedie R. A simple funnelâ plotâ based method of testing and adjusting for publication bias in metaâ analysis. Biometrics. 2000; 56: 455 â 463. | |
dc.identifier.citedreference | Jiangbo D, Xuebin L, Ping Z, et al. Reuse of infected cardiac rhythm management devices in the same individual. J Interv Card Electrophysiol. 2012; 35: 109 â 114. | |
dc.identifier.citedreference | Baman TS, Romero A, Kirkpatrick JN, et al. Safety and efficacy of pacemaker reuse in underdeveloped nations: A case series. J Am Coll Cardiol. 2009; 54: 1557 â 1559. | |
dc.identifier.citedreference | Tracy CM, Epstein AE, Darbar D, et al. ACCF/AHA/HRS focused update of the 2008 guidelines for deviceâ based therapy of cardiac rhythm abnormalities: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2012; 61: e6 â e75. | |
dc.identifier.citedreference | Brignole M, Auricchio A, Baronâ Esquivias G, et al. ESC guidelines on cardiac pacing and cardiac resynchronization therapy. The Task Force on Cardiac Pacing and Resynchronization Therapy of the European Society of Cardiology (ESC). Developed in collaboration with European Heart Rhythm Association (EHRA). Eur Heart J. 2013; 34: 2281 â 2329. | |
dc.identifier.citedreference | Mond HG, Proclemer A. The 11 th world survey of cardiac pacing and implantable cardioverterâ defibrillators: Calendar year 2009 â a World Society of Arrhythmiasâ project. Pacing Clin Electrophysiol. 2011; 34: 1013 â 1027. | |
dc.identifier.citedreference | Mond HG, Mick W, Maniscalco BS. Heartbeat International: Making â poorâ hearts better. Heart Rhythm. 2009; 6: 1538 â 1540. | |
dc.identifier.citedreference | Hughey AB, Desai N, Baman TS, et al. Heart Rhythm Society membersâ views on pacemaker and implantable cardioverterâ defibrillator reuse. Pacing Clin Electrophysiol. 2014; 37: 969 â 977. | |
dc.identifier.citedreference | Rosengarten M, Chiu R, Hoffman R. A prospective trial of new versus refurbished cardiac pacemakers: A Canadian experience. Can J Cardiol. 1989; 5: 155 â 160. | |
dc.identifier.citedreference | Panja M, Sarkar CN, Kumar S, et al. Reuse of pacemaker. Indian Heart J. 1996; 48: 677 â 680. | |
dc.identifier.citedreference | Grendahl H. Pacemaker reâ use. Tidsskr Nor Leegeforen. 1994; 114: 3420 â 3423. | |
dc.identifier.citedreference | Linde CL, Bocray A, Jonsson H, Rosenqvist M, Radegran K, Ryden L. Reâ used pacemakers: As safe as new? A retrospective caseâ control study. Eur Heart J. 1998; 19: 154 â 157. | |
dc.identifier.citedreference | Pescariu S, Stiubel M, Cozma D, et al. La réutilisation des pacemakers, une alternative pour les personnes âgées démunies: Etude rétrospective. Stim Coeur. 2003; 31: 186 â 189. | |
dc.identifier.citedreference | Baman TS, Pascal M, Romero J, et al. Safety of pacemaker reuse: A metaâ analysis with implications for underserved nations. Circ Arrhythm Electrophysiol. 2011; 4: 318 â 323. | |
dc.identifier.citedreference | Stroup DF, Berlin JA, Morton SC, et al. Metaâ analysis of observational studies in epidemiology: A proposal for reporting. Metaâ analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA. 2000; 283: 2008 â 2012. | |
dc.identifier.citedreference | Hasan R, Ghanbari H, Feldman D, et al. Safety, efficacy, and performance of implanted recycled cardiac rhythm management devices in underprivileged patients. Pacing Clin Electrophysiol. 2011; 34: 653 â 658. | |
dc.identifier.citedreference | Kantharia BK, Patel SS, Kulkarni G, et al. Reuse of explanted permanent pacemakers donated by funeral homes. Am J Cardiol. 2012; 190: 238 â 240. | |
dc.identifier.citedreference | Pavri BB, Lokhandwala Y, Kulkarni GV, Shah M, Kantharia BK, Mascarenhas DAN. Reuse of explanted, resterilized implantable cardioverterâ defibrillators: A cohort study. Ann Intern Med. 2012; 157: 542 â 548. | |
dc.identifier.citedreference | Nava S, Morales JL, Márquez MF, et al. Reuse of pacemakers: Comparison of short and longâ term performance. Circulation. 2013; 127: 1177 â 1183. | |
dc.identifier.citedreference | Feng Z, Xuebin L, Ping Z, et al. Reuse of infected cardiac rhythm management devices in the same patients: A single center experience. Pacing Clin Electrophysiol. 2014; 37: 940 â 946. | |
dc.identifier.citedreference | Jama ZV, Chin A, Badri M, Mayosi BM. Performance of reâ used pacemakers and implantable cardioverter defibrillators compared with new devices at Groote Schuur Hospital in Cape Town, South Africa. Cardiovasc J Afr. 2015; 26: 181 â 187. | |
dc.identifier.citedreference | Sosdean R, Mornos C, Enache B, et al. Safety and feasibility of biventricular devices reuse in general and elderly population â a singleâ center retrospective cohort study. Clinical Interventions in Aging. 2015; 10: 1311 â 1318. | |
dc.identifier.citedreference | Selvaraj RJ, Sakthivel R, Satheesh S, et al. Reuse of pacemakers, defibrillators, and cardiac resynchronization devices. Heart Asia. 2017; 9: 30 â 33. | |
dc.identifier.citedreference | Fuster V, Frazer J, Snair M, et al. The future role of the United States in global health: Emphasis on cardiovascular disease. J Am Coll Cardiol. 2017; 70: 3140 â 3156. | |
dc.identifier.citedreference | Crawford TC, Allmendinger C, Snell J, et al. Cleaning and sterilization of used cardiac implantable electronic devices with process validation. J Am Coll Cardiol EP. 2017; 3: 623 â 631. | |
dc.identifier.citedreference | Runge MW, Baman TS, Davis S, et al. Pacemaker recycling: A notion whose time has come. World J of Cardiol. 2017; 9: 296 â 303. | |
dc.identifier.citedreference | Vlay SC. Recycling pacemakers and defibrillators: A humanitarian cause â is it feasible. Heart Rhythm. 2016; 13: 1977 â 1978. | |
dc.identifier.citedreference | Kirkpatrick JN, Papini C, Baman TS, et al. Reuse of pacemakers and defibrillators in developing countries: Logistical, legal, and ethical barriers and solutions. Heart Rhythm. 2010; 7: 1623 â 1627. | |
dc.identifier.citedreference | Baman TS, Kirkpatrick JN, Romero J, et al. Pacemaker reuse: An initiative to alleviate the burden of symptomatic bradyarrhythmia in impoverished nations around the world. Circulation. 2010; 122: 1649 â 1656. | |
dc.identifier.citedreference | Gakenheimer L, Lange DC, Romero J, et al. Societal views of pacemaker reutilization for those with untreated symptomatic bradycardia in underserved nations. J Interv Card Electrophysiol. 2011; 30: 261 â 266. | |
dc.identifier.citedreference | Sinha SK, Crain B, Flickinger K, et al. Cardiovascular implantable electronic device function and longevity at autopsy: An underestimated resource. Heart Rhythm. 2016; 13: 1971 â 1976. | |
dc.identifier.citedreference | Kirkpatrick JN, Ghani SN, Burke MC, Knight BP. Postâ mortem interrogation and retrieval of implantable pacemakers and defibrillators: A survey of morticians and patients. J Cardiovasc Electrophysiol. 2007; 18: 478 â 482. | |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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