Worldwide pacemaker and defibrillator reuse

Systematic review and meta-analysis of contemporary trials

Sunil K. Sinha, Bhradeev Sivasambu, Gayane Yenokyan, Thomas C. Crawford, Jonathan Chrispin, Kim A. Eagle, Andreas S. Barth, John Jack Rickard, David D. Spragg, Stephen C. Vlay, Ronald Berger, Charles Love, Hugh Calkins, Gordon F. Tomaselli, Joseph E. Marine

Research output: Contribution to journalReview article

1 Citation (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1500-1507
Number of pages8
JournalPACE - Pacing and Clinical Electrophysiology
Volume41
Issue number11
DOIs
StatePublished - Nov 1 2018

Fingerprint

Defibrillators
Meta-Analysis
Equipment and Supplies
Infection
Observational Studies
Cardiac Resynchronization Therapy Devices
Ethylene Oxide
Manuscripts
Disinfectants
Product Packaging
Gases
Odds Ratio
Demography
Outcome Assessment (Health Care)

Keywords

  • cardiac resynchronization therapy recycling
  • cardiac resynchronization therapy reuse
  • defibrillator recycling
  • defibrillator reuse
  • pacemaker recycling
  • pacemaker reuse

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Sinha, S. K., Sivasambu, B., Yenokyan, G., Crawford, T. C., Chrispin, J., Eagle, K. A., ... Marine, J. E. (2018). Worldwide pacemaker and defibrillator reuse: Systematic review and meta-analysis of contemporary trials. PACE - Pacing and Clinical Electrophysiology, 41(11), 1500-1507. https://doi.org/10.1111/pace.13488

Worldwide pacemaker and defibrillator reuse : Systematic review and meta-analysis of contemporary trials. / 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.

In: PACE - Pacing and Clinical Electrophysiology, Vol. 41, No. 11, 01.11.2018, p. 1500-1507.

Research output: Contribution to journalReview article

Sinha, SK, Sivasambu, B, Yenokyan, G, Crawford, TC, Chrispin, J, Eagle, KA, Barth, AS, Rickard, JJ, Spragg, DD, Vlay, SC, Berger, R, Love, C, Calkins, H, Tomaselli, GF & Marine, JE 2018, 'Worldwide pacemaker and defibrillator reuse: Systematic review and meta-analysis of contemporary trials', PACE - Pacing and Clinical Electrophysiology, vol. 41, no. 11, pp. 1500-1507. https://doi.org/10.1111/pace.13488
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. / Worldwide pacemaker and defibrillator reuse : Systematic review and meta-analysis of contemporary trials. In: PACE - Pacing and Clinical Electrophysiology. 2018 ; Vol. 41, No. 11. pp. 1500-1507.
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abstract = "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.",
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