Reused, resterilized implantable cardiac devices show similar 2-year outcomes as new
Pacemakers or implanted cardiac defibrillators that were retrieved postmortem, resterilized and reused in underserved countries conferred similar rates of infection and device-related deaths as new devices implanted in Canada.
According to a study published in The New England Journal of Medicine, access to pacemakers and implantable cardioverter defibrillators may be limited in countries such as Mexico, the Dominican Republic, Guatemala and Honduras. In 1983, a program was launched to provide tested and resterilized pacemakers and defibrillators to underserved nations, and a prospective registry of the related data was established in 2003. Investigators sought to compare the 2-year outcomes of infection and device-related death associated with the implantation of these devices with the outcomes of procedures performed in Canada with new devices.
Researchers observed that, at 2 years, infection had occurred in 2% of patients who received resterilized and reused devices compared with 1.2% among patients who received new devices (HR = 1.66; 95% CI, 0.97-2.83). These infections included:
- Staphylococcus aureus (reused, 61.9%; new, 60.5%);
- S. epidermidis (reused, 14.3%; new, 23.7%);
- Cutibacterium acnes (one infection involving a reused device vs. three in new);
- Pseudomonas aeruginosa (zero in reused devices vs. two in new); and
- other or unknown infections (four in reused devices vs. one in new).
According to the study, the only factor associated with infection was younger age (HR per year of age = 0.98; 95% CI, 0.97-0.99).
There were no device-related deaths reported in either cohort.
“Physicians in underserved areas cite unaffordable costs as the greatest impediment to offering device therapy to their patients. Indeed, the cost for a new pacemaker generator has been estimated to be (U.S.) $2,500 to $8,000 and for an ICD approximately $10,000 to $18,000,” Paul Khairy, MD, PhD, from the Montreal Heart Institute of Université de Montréal, and colleagues wrote. “To address the need for wider access to these devices, programs have emerged to donate previously used devices to underserved nations.
“As such, these results cannot definitively exclude the possibility of a higher risk associated with reused devices,” the researchers wrote. “Nevertheless, in this study, in which the incidence of infection was low, the estimated absolute difference in risk was less than 1 percentage point.”
For this study, investigators matched patients who received reused implantable devices (mean age, 63 years; 44% women) 1:3 with those who received new devices. Among the cohort, 85% of participants received permanent pacemakers and 15% received cardiac resynchronization devices.
“Although cardiac implantable electronic devices must be removed before cremation owing to the risk of battery explosion if incinerated, practices are inconsistent regarding burial,” the researchers wrote. “Depending on local jurisdictions, explanting a pacemaker or ICD may or may not be legally required.” – by Scott Buzby
Disclosures: Khairy reports he holds a chair endowed by the Chagnon Family. The other authors report no relevant financial disclosures.
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