Innovative Reconditioned Pacemakers Offer New Hope in Low- and Middle-Income Countries

Reconditioned pacemakers are emerging as a promising solution for patients in low- and middle-income countries (LMICs) who otherwise have limited access to cardiac devices. A recent clinical trial demonstrated that these refurbished devices are as safe and effective as new pacemakers, with comparable infection rates and no device malfunctions. The study, conducted across several LMICs including Kenya, Mexico, Mozambique, Nigeria, Paraguay, Sierra Leone, and Venezuela, enrolled 306 adult patients averaging 71 years of age. Participants were randomized to receive either a reconditioned or a new pacemaker, with a primary focus on procedure-related infection rates at 12 months. Results showed an overall infection rate of only 1.6% in the reconditioned group versus 3.1% in the new device group, indicating non-inferiority.

The initiative is part of Project My Heart Your Heart, led by the European Society of Cardiology. The project aims to expand access to cardiac pacing by establishing protocols for cleaning, testing, sterilizing, and ethically exporting reconditioned pacemakers, which have received FDA approval for international use. Dr. Thomas Crawford from the University of Michigan explained that access to pacemakers is around 200 times lower in Africa compared to Europe. Reconditioning devices not only addresses this disparity but also offers a cost-effective alternative for patients with no financial means for new devices.

The trial revealed minimal complications, with only a few pocket infections requiring device removal and a small number of lead revisions. Notably, there were no device malfunctions, supporting the safety profile of reconditioned pacemakers. Dr. Crawford emphasized that this research provides a blueprint for broader implementation of device reuse, which could substantially improve cardiac care globally. Looking ahead, the team plans to explore reconditioning implantable cardioverter-defibrillators (ICDs), which are even more expensive and less accessible in LMICs.

Overall, the study affirms that reconditioned pacemakers are a safe and effective option, promising to bridge the gap in cardiac device access worldwide and save lives in underserved regions.