Abstract Body (Do not enter title and authors here): Introduction: Patients in low- and middle-income countries have poor access to pacemaker (PM) therapy, in part due to their inability to pay for the devices. Reconditioned pacemakers (R-PMs) may improve patient access without increased risk of infection and/or malfunction.
Methods: R-PMs were refurbished using U.S. FDA approved protocol. We conducted a multicenter randomized controlled trial of new pacemakers (N-PMs) vs. reconditioned pacemakers (R-PMs) from May 2022 to June 2024. Study sites were in Sierra Leone, Venezuela, Nigeria, Kenya, Paraguay, Mexico, and Mozambique. Governmental approval and a completed legal contract were required. Sites received funding to locally source N-PMs and leads for all PMs. Funding was provided by donations to MHYH. Outcomes were assessed up to 90 days.
Sample Size: 298
Power Calculations: Assuming one-sided type I error of 5%, non-inferiority margin of -5%, 2% infection rate, 80% power, 97 patients per group were needed. Assuming drop-out rate of 30%, 278 total patients were needed.
Population Studied: Patients with class I indication for PM and no financial means to acquire a new device.
Primary End Point: Procedure-related infection at 12 months.
Secondary End Point: Device malfunction at 12 months.
Intervention: Patients randomized 1:1 to N-PM or R-PM.
Outcomes: 298 patients were randomly assigned to N-PM or R-PM (149 in each arm). 280 (94.3%) patients had at least one follow-up completed. There were 5 pocket infections requiring explantation (3 N-PMs, 2 R-PMs), and one superficial cellulitis responsive to antibiotics (1 N-PM). There were no device malfunctions; 11 patients required lead revisions (5 N-PM, 6 R-PM). Three deaths unrelated to the implantation procedure occurred in the R-PM group. The upper bound of the 90% confidence interval for the difference in infection rate was 2.2%, less than the noninferiority margin 5%.
Conclusion: R-PMs refurbished under a specific protocol are noninferior to N-PMs in terms of safety and efficacy up to 90 days of follow-up. Longer term follow-up will be necessary to confirm the safety and efficacy of R-PM.