Poor patients in developing countries may not receive permanent pacemakers (PPMs) even as lifesaving measures because of their high cost. In this report we examined whether PPMs that were explanted and donated by funeral homes in the United States could be safely and effectively reused in indigent patients in India. With permission from the deceased patients’ families, 121 PPMs were explanted and donated by funeral homes for reuse. These PPMs 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 (88%, 11 single-chamber PPMs, 21%, and 42 dual-chamber PPMs, 79%) were acceptable for reuse and implanted (37 new implants, 70%, and 16 for battery/generator replacement, 30%) in 53 patients (mean ± SD 64 ± 10 years old, 28 women, 53%). Indications for PPM implantation were complete heart block (n = 27, 51%) and sick sinus syndrome (n = 26, 49%). All patients were alive and well postoperatively. No significant complications including infections or device failures occurred over 19 to 1,827 days (mean 661) of follow-up. Of 40 patients (75%) who were followed locally, 4 (10%) died because of nonpacemaker-related causes; time to death was 121 to 750 days (mean 430) after PPM implantation. All except 2 patients (5%) reported marked improvement in their symptoms. There were only 4 patients (8%) who were previously employed, and all were able to resume their manual labor work. Also, of the women, 27 patients (96%) reported improvement in symptoms enabling them to resume regular household chores as housewives after PPM implantation. In conclusion, with proper device sterilization and handling protocols, reuse of explanted PPMs in poor patients in developing countries is safe and effective. Implantation of donated PPMs can not only save lives but also improve quality of life of needy poor patients.
Many poor and indigent patients in developing countries may not undergo implantation of permanent pacemakers (PPMs) because of financial constraints despite the presence of well-established indications. The International Cardiac Pacing and Electrophysiology Society’s worldwide quadrennial surveys on cardiac pacing and implantable cardioverter–defibrillators (ICDs) have repeatedly shown vast disparity in new device implantation rates between developed nations and many developing countries in the world. In India the cost of a basic pacemaker, excluding the cost of pacing leads and physician and hospital fees, varies from Rs 100,000 to 300,000 (approximately US$2,200 to $6,600). This amount often exceeds the annual income of many lower- to middle-income citizens in India. Because all currently available PPMs from different manufacturers have a long battery life, PPMs in deceased patients who received the PPMs only a few years before death would have a significant battery life. These PPMs, if refurbished, might be reused. In this study we examined the efficacy and safety of PPMs that were explanted postmortem and donated by funeral homes in the United States for reuse in indigent patients in India.
Methods
From January 2004 through January 2010, 121 PPMs were explanted and donated by funeral homes according to the patients’ living will and/or after obtaining consent from the deceased patients’ families. None of the PPMs were on the advisory or recall list from the United States Food and Drug Administration (FDA) or the manufacturers. From this pool of PPMs, 60 (50%) were found to have a battery life >3 years. These devices were selected for sterilization and reuse. The remaining 61 PPMs that were not selected were disposed of as medical waste. A rigorous protocol was followed for sterilization of explanted PPMs. First, all debris attached to the PPMs was removed with needle and brush-tipped instruments. Second, PPMs were soaked overnight in a commercial bleach solution (Clorox, The Clorox Company, Oakland, California) and then cleaned with Asepti-zyme (Ecolab, St. Paul, Minnesota). Third, PPMs were wiped with 70% ethanol, air dried, and packed in air-permeable envelopes. These PPMs were sent in small batches to Holy Family Hospital in Mumbai, India, where final sterilization with ethylene oxide gas took place. Holy Family Hospital is a nonprofit tertiary care center that provides health care services to all patients irrespective of race, religion, and socioeconomic status. Patients were selected after a detailed socioeconomic evaluation of their ability to afford the PPMs and to ensure appropriate follow-up. Although patients were not charged for the PPMs, they had to pay for the pacing leads. The inventory and records of the PPMs and confidentiality of the treatment process were maintained by a dedicated team of physicians, administrators, and social workers under strict directives from Holy Family Hospital.
Results
The study cohort consisted of 53 patients who underwent implantation of donated PPMs. Demographic characteristics of patients and device specifications of donated PPMs are presented in Table 1 . Of the donated 60 PPMs that were sent to India, 7 were deemed unusable because of further decay in the battery longevity when assessed at Holy Family Hospital. These 7 devices were disposed of as medical waste. The remaining 53 devices (88%) were implanted. None of the patients required temporary transvenous pacing while awaiting PPM implantation because the devices were already at the hospital site for use when required. All patients were alive and well during the acute 2-week postoperative period. One patient had lead migration 1 week after the procedure and underwent successful lead revision. No significant complications including pocket infections or device failures occurred over an average follow-up period of 661 days. Although 13 patients (25%) returned to their homes remote from Mumbai, 40 patients (75%) who lived locally continued long-term follow-up. Of this group 4 patients (10%) died 121 to 750 days (mean 430) after PPM implantation because of pneumonia, pulmonary embolism after hip surgery, cerebral hemorrhage, and acute myocardial infarction. All except 2 patients (5%, >80 years old, women) reported marked improvement in symptoms and quality of life after PPM implantation, which was assessed by simple personal interviews with the patients in their native language. Only 4 patients (8%, 3 men, 1 woman) were employed before PPM implantation. All 4 were able to resume their physically demanding manual labor work 2 weeks after PPM implantation. Of 28 women 27 patients (96%) were housewives who reported improvement in symptoms and were able to manage regular household chores after PPM implantation.
| Number of patients and devices | 53 |
| Age (years) | 64 ± 10 |
| Men/women | 25 (47%)/28 (53%) |
| Indication | |
| Complete heart block | 27 (51%) |
| Sick sinus syndrome | 26 (49%) |
| Implantation specification | |
| New implantation | 37 (70%) |
| Generator change | 16 (30%) |
| Single-/dual-chamber pacemakers | 11 (21%)/42 (79%) |
| Manufacturer | |
| Medtronic (Minneapolis, Minnesota) | 31 |
| St. Jude Medical (Sylmar, California) | 14 |
| Boston Scientific (Natick, Massachusetts) | 8 |
| Follow-up (days), mean (range) | 661 (19–1,827) |
Results
The study cohort consisted of 53 patients who underwent implantation of donated PPMs. Demographic characteristics of patients and device specifications of donated PPMs are presented in Table 1 . Of the donated 60 PPMs that were sent to India, 7 were deemed unusable because of further decay in the battery longevity when assessed at Holy Family Hospital. These 7 devices were disposed of as medical waste. The remaining 53 devices (88%) were implanted. None of the patients required temporary transvenous pacing while awaiting PPM implantation because the devices were already at the hospital site for use when required. All patients were alive and well during the acute 2-week postoperative period. One patient had lead migration 1 week after the procedure and underwent successful lead revision. No significant complications including pocket infections or device failures occurred over an average follow-up period of 661 days. Although 13 patients (25%) returned to their homes remote from Mumbai, 40 patients (75%) who lived locally continued long-term follow-up. Of this group 4 patients (10%) died 121 to 750 days (mean 430) after PPM implantation because of pneumonia, pulmonary embolism after hip surgery, cerebral hemorrhage, and acute myocardial infarction. All except 2 patients (5%, >80 years old, women) reported marked improvement in symptoms and quality of life after PPM implantation, which was assessed by simple personal interviews with the patients in their native language. Only 4 patients (8%, 3 men, 1 woman) were employed before PPM implantation. All 4 were able to resume their physically demanding manual labor work 2 weeks after PPM implantation. Of 28 women 27 patients (96%) were housewives who reported improvement in symptoms and were able to manage regular household chores after PPM implantation.
