Reusing Pacemakers from Deceased Donors Is Safe

Researchers at Loyola University Medical Center (Maywood, IL, USA) and the University of Texas-Health Science Center (Houston, TX, USA) examined the function of 121 donated PPMs that were sterilized and sent for implantation in needy and indigent patients at a charity hospital in Mumbai (India). From the pool of donated 121 PPMs, 53 were acceptable for reuse and implanted in corresponding patients (mean age 64 years, 53% women). The indications for PPM implantation were complete heart block and sick sinus syndrome.

The researchers found that all the patients were alive and well postoperatively. No significant complications, including infections or device failures, occurred during an average two years of follow-up. All but two patients reported marked improvement in their symptoms. Of the 40 patients (75%), who were followed locally, 4 died due to nonpacemaker-related causes; time to death was a mean 430 days after PPM implantation. While there were only four patients (8%) who were previously employed, all were able to resume their manual labor work. Of the women, 27 patients (96%) reported improvement in symptoms enabling them to resume regular household chores after PPM implantation. The study was published online ahead of print on October 12, 2011, in the American Journal of Cardiology.

“Without pacemakers, these patients would pretty much be forced to remain on confined rest, due to cardiac fatigue,” concluded lead author Gaurav Kulkarni, MD, of Loyola University Medical Center, and colleagues. “Reusing pacemakers could alleviate the burden of symptomatic bradyarrhythmia in impoverished nations around the world.”

The US Food and Drug Administration (FDA) forbids the implantation of used pacemakers within the United States and severely questions its safety, calling it an objectionable practice due to potential sterilization issues, especially in the terminals. There are no federal prohibitions, however, on harvesting used pacemakers for implantation abroad. In India, a new pacemaker costs USD 2,200 to USD 6,600, well beyond the means of many patients.

Related Links:
Loyola University Medical Center
University of Texas-Health Science Center