Reconditioned and new pacemakers in low-resource countries: A pilot study

Abstract

Abstract Introduction: Cardiac pacemakers have brought a paradigm shift to the management of symptomatic bradyarrhythmia. It has led to a dramatic reduction in morbidity and mortality from cardiovascular disease over the many decades. Despite these merits, pacemakers remain unaffordable and beyond reach for many patients in low-and middle-income countries (LMICs) including Nigeria. These challenges and regulatory obstacles may be overcome with postmortem pacemaker reuse if they are proven to be feasible and safe as cost-effective strategy to provide life-saving therapy to patients in LMICs. The aim of this pilot study was to review the usefulness of reconditioned pacemakers among patients that could not afford new devices. Materials and Methods: A total of 16 patients were recruited for the pilot study. These included patients with a pacing indication who could not afford a new pacemaker or a battery change. The 16 patients were grouped into A and B. Group B had 8 patients that received new pacemaker batteries. Group A comprised 8 patients who received refurbished pacemaker batteries. All the pacemaker leads used in the study for both the groups were new. Implant charges were free. Ethical approval was got from the University of Port Harcourt Teaching Hospital, and the Cardiocare Multispecialty Hospital, Abuja, before commencement of the study. The refurbished pacemaker batteries were donated by the relatives of deceased patients, with a minimum 70% of remaining battery life. The donated pacemaker batteries were received from Pace4 life and My Heart Your Heart, University of Michigan, Michigan, United States. These reconditioned batteries were resterilized. Pacemaker functions were rechecked before and after sterilization. The devices were programmed on nonpacing (ODO) mode with adaptive pacing mode swift off. These devices were shipped to us for use. All sterile techniques were followed during implantation. Data were collected on wound healing and device malfunction during implant and follow-up for 3 months. Results: The average age for the patients was 62 ± 13 years. There was no pocket hematoma among both the groups. There were no complications during the 1–3-month follow-up period. There was no evidence of lead or battery malfunction among the two groups. The means of battery longevity for the new and refurbished pacemakers were 10.38 and 10.57 years, respectively. There was no statistical difference between the pulse generator longevity among new and refurbished pacemakers with P = 0.681. There was no infection and device malfunction in the 3 months. Conclusion: The reused pacemaker batteries are safe and do no increased risk of infection and malfunction. This provides an effective option for patients who cannot afford a new device or a replacement battery.