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Infections With Resterilized Pacemakers and Defibrillators
Quick Takes
- There is a great disparity between patients’ access to cardiac implantable electronic devices in resource-poor countries and wealthy nations.
- Based on matched cohort data, the risk of infection does not appear to significantly differ between new and reconditioned devices.
Study Questions:
How does the risk of infection differ between patients implanted with resterilized pacemakers or implantable cardioverter-defibrillators in underserved nations and patients receiving new devices in Canada?
Methods:
A multinational program was initiated in 1983 to provide tested and resterilized pacemakers and defibrillators to underserved nations; a prospective registry was established in 2003. Patients who received reused devices were matched in a 1:3 ratio with control patients who received new devices implanted in Canada. The primary outcome was infection or device-related death, with mortality from other causes modeled as a competing risk.
Results:
Resterilized devices were implanted in 1,051 patients (average age 63.2 years) in Mexico, the Dominican Republic, Guatemala, and Honduras. Overall, 85% received pacemakers and 15% received defibrillators, with one (55.5%), two (38.8%), or three (5.7%) leads. Baseline characteristics did not differ between these patients and the 3,153 matched control patients. At 2 years of follow-up, infections had occurred in 21 patients (2.0%) with reused devices and in 38 (1.2%) with new devices (hazard ratio, 1.66; 95% confidence interval, 0.97-2.83; p = 0.06). There were no device-related deaths.
Conclusions:
Among patients in underserved countries who received a resterilized and reused pacemaker or defibrillator, the incidence of infection or device-related death at 2 years was 2.0%, an incidence that did not differ significantly from that seen among matched control patients with new devices in Canada.
Perspective:
Many patients in resource-poor countries do not have access to potentially life-saving and quality-of-life enhancing implantable cardiovascular electronic devices (pacemakers and implantable cardioverter-defibrillators) due to cost. The authors report on the infection rate among patients with resterilized devices and find that it is not substantially different than that of Canadian patients receiving new devices. The authors should be congratulated on their monumental and highly impactful work since 1983. The next step in proving the safety of reconditioned devices would be a randomized prospective trial comparing the complications with new versus resterilized devices.
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Arrhythmias, Cardiac, Defibrillators, Implantable, Heart Failure, Infections, Pacemaker, Artificial, Quality of Life, Risk Assessment, Secondary Prevention
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