Re-Use of Pacemakers: Comparison of Acute and Long Term Performances
How safe are re-used pacemakers (PMs)?
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.
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).
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.
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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