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Re-Use of Pacemakers: Comparison of Acute and Long Term Performances
Study Questions:
How safe are re-used pacemakers (PMs)?
Methods:
This was a single-center cohort noninferiority study in which consecutive patients were enrolled from 2000 to 2010. The analysis was conducted retrospectively from 2000-2005, and prospectively from 2005-2010. The “control” group (n = 296) consisted of those patients with a class I indication for pacing and who could afford the cost of a new pacing device. The “study” group (n = 307) consisted of those who could not afford a new PM and that, after serious efforts to secure donation of a new device and following a waiting period, were offered a re-sterilized device (96% from cadaveric donation). The primary outcome was defined as the need to remove or change the device because of unexpected battery depletion, infection, or device or electrode malfunction.
Results:
Eighty-five devices had to be explanted for any reason, with 31 (10.5%) in the control group versus 54 (17.6%) in the study group (relative risk [RR], 1.68; 95% confidence interval [CI], 1.1-2.5; p = 0.02). Of these 85 devices, 43 were explanted because they had reached the primary event, with 16 (5.5%) in the control group and 27 (7.2%) in the study group (RR, 1.3; 95% CI, 0.70-2.45; p = 0.794). Ten cases (3.2%) of procedure-associated infection were observed in the study group versus 11 (3.7%) in the control group (RR, 0.87; 95% CI, 0.38-2.03; p = 0.466). There was only one case of malfunction during follow-up in the study group, presenting as intermittent failure to sense and capture secondary to screw deterioration. The battery life of re-sterilized PMs was shorter than that of new devices (average duration, 6.3 ± 0.3 years vs. 8.8 ± 0.24 years; p = 0.001).
Conclusions:
The authors concluded that PM re-use is safe and feasible. While the battery life of re-sterilized PMs is expectedly shorter than that of new devices, the implantation of re-sterilized devices was noninferior in terms of the need to remove or change the device because of unexpected battery depletion, infection, or device or electrode malfunction.
Perspective:
Although PM reuse is common practice in some countries, this analysis establishes the safety and feasibility of this approach in resource-limited settings. The careful use of re-sterilized devices is a scientifically sound, safe option that should not be discounted when the best therapy—a new device—is not available.
Keywords: Risk, Follow-Up Studies, Pacemaker, Artificial, Bone Screws, Polydactyly
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