Re-Use of Pacemakers: Comparison of Acute and Long Term Performances
Background—In developing economies, there are patients in which pacemaker (PM) implantation is delayed because they cannot afford one. Reused devices have been a solution. To address concerns regarding safety, a cohort of consecutive patients implanted with a reused PM was compared with a control group.
Methods and Results—A cohort of 603 consecutive patients from 2000 to 2010 was studied in an ambispective non-inferiority study. The study group (n = 307) received a re-sterilized PM and the control group (n = 296) a new PM. A combined endpoint of three major outcomes was analyzed: Unexpected battery depletion, infection, and device dysfunction. A total of 85 PM had to be explanted 31 (10.5%) in the control group vs. 54 (17.6%) in the study group (RR 1.68, CI 95% 1.1 - 2.5; P= 0.02). Forty-three reach the primary endpoint, 16 (5.5%) in the control group vs 27(7.2%) in the study group (RR: 1.3; CI 95% 0.70 - 2.45; P = 0.794). Individual outcomes: (1) Unexpected battery depletion: 5 (1.7%) new PM vs 11 (3.6%) re-sterilized PM (RR 2.12, CI 95% 0.75 - 6; P = 0.116); (2) procedure-related infection: 3.7% in new PM vs 3.2% (RR 0.87, IC 95%: 0.38 - 2.03; P= 0.46); (3) malfunction: one case was encountered in the study group.
Conclusions—PM reuse is feasible and safe and a viable option for patient with bradyarrhythmias. Other than for the expected lower battery life, reuse of pacemaker generators is not-inferior to the use of new devices.
- Received January 25, 2013.
- Accepted February 1, 2013.
- Copyright © 2013, Circulation