Reuse of pacemakers: comparison of short and long-term performance

Circulation. 2013 Mar 19;127(11):1177-83. doi: 10.1161/CIRCULATIONAHA.113.001584. Epub 2013 Feb 20.

Abstract

Background: In developing economies, there are patients in whom pacemaker implantation is delayed because they cannot afford one. Reused devices have been a solution. To address concerns about safety, a cohort of consecutive patients implanted with a reused pacemaker was compared with a control group.

Methods and results: A cohort of 603 consecutive patients from 2000 to 2010 was studied in an ambispective noninferiority study. The study group patients (n=307) received resterilized pacemakers, and the control group patients (n=296) received a new pacemaker. A combined end point of 3 major outcomes-unexpected battery depletion, infection, and device dysfunction-was analyzed. A total of 85 pacemakers had to be explanted, 31 in the control group (10.5%) and 54 in the study group (17.6%; relative risk, 1.68; 95% confidence interval, 1.1-2.5; P=0.02). Forty-three reached the primary end point, 16 in the control group (5.5%) and 27 in the study group (7.2%; relative risk, 1.3; 95% confidence interval, 0.70-2.45; P=0.794). In terms of individual outcomes, 5 new pacemakers (1.7%) and 11 resterilized pacemakers (3.6%) had unexpected battery depletion (relative risk, 2.12; 95% confidence interval, 0.75-6; P=0.116); 3.7% new pacemakers and 3.2% reused pacemakers had a procedure-related infection (relative risk, 0.87; 95% confidence interval, 0.38-2.03; P=0.46); and 1 pacemaker in the study group malfunctioned.

Conclusions: Pacemaker reuse is feasible and safe and is a viable option for patient with bradyarrhythmias. Other than the expected shorter battery life, reuse of pacemaker generators is not inferior to the use of new devices.

Publication types

  • Comparative Study
  • Controlled Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Bradycardia / therapy*
  • Cohort Studies
  • Electric Power Supplies / statistics & numerical data
  • Equipment Failure / statistics & numerical data*
  • Equipment Reuse
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Pacemaker, Artificial / adverse effects*
  • Pacemaker, Artificial / statistics & numerical data*
  • Retrospective Studies
  • Surgical Wound Infection / epidemiology
  • Time Factors