Congress Review | Editors Choice | AHA 2024
Recycled Pacemakers: A Cost-Effective and Environmentally Friendly Alternative for Low-Income Countries
Time to read: 02:52
Time to listen: 05:59
Published on MedED: 25 November 2024
Originally Published: 16 November 2024
Sourced: AHA Scientific Sessions 2024, NEJM
Type of article: Conference Review | In Brief
MedED Catalogue Reference: MCABC006
Category: Cardiovascular Disease
Cross Reference: Medical Devices, Infection Control
Keywords: pacemaker, LMIC, reconditioned devices, public health, cardiac surgery
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Presented at AHA Scientific Sessions 2024 as a Research Abstract.This summary does not represent the original research, nor is it intended to replace the original research. Content Disclaimer
Access to pacemakers is severely limited in low- and middle-income countries (LMICs) due to high costs.
While high-income countries report up to 1,000 pacemaker implants per million people annually, LMICs may see as few as 3 implants per million. Refurbishing pacemakers offers a potential solution, as the process costs $50–$100 compared to $6,000 for new devices in the U.S. or $2,000 in LMICs.1 However, questions remain regarding the safety and effectiveness of reconditioned devices.
The "My Heart Your Heart" (MHYH) study aimed to address this gap. The findings were presented as an abstract at AHA Scientific Sessions 2024, and the results should be considered preliminary until published in a peer-reviewed journal.
Study Intention
The trial sought to evaluate the safety and effectiveness of reconditioned permanent pacemakers (PPMs) compared to new devices. Specifically, it assessed the risks of infection, device failure, and procedural complications among patients in MICs for whom new pacemakers were financially inaccessible.
Participants
298 adults without the financial means to access a new pacemaker were included in the study.
The mean age of these participants was 71 years of age, and 51% were female.
79% of the participants had complete heart block, 25% had sinus node dysfunction, and 3% had syncope with bifascicular block.
Study Design
The MHYH trial was a randomized, single-blind study conducted in Venezuela, Nigeria, Paraguay, Kenya, Mozambique, and Mexico from May 2022 to June 2024.
Devices with an estimated lifespan of more than 4 years underwent a 4-phase reconditioning process, which included decontamination, component replacement, electrical testing, and sterilization.
Results
Participants were monitored in-hospital two weeks post-implantation and during subsequent visits up to 90 days. A total of 280 patients completed at least one follow-up visit.
The following broad findings were reported:
No device malfunctions were reported.
Five infections at implant sites required device removal: three were in the new PPM group and two from the reconditioned group.
The median time to recorded infection was 42 days for reconditioned pacemakers vs. 20 days for new pacemakers.
Lead dislodgment occurred in five new PPM patients and six reconditioned PPM patients, consistent with known risks of implantation procedures.
Three deaths in the reconditioned group were unrelated to device implantation.
There were no deaths recorded in the new device cohort.
Study Implications
The MHYH trial showed the potential of reconditioned pacemakers as a safe, cost-effective, and environmentally sustainable alternative to new devices in low- and middle-income countries (LMICs).
Comparable infection rates and only a slightly higher, clinically acceptable rate of lead dislodgement offer promise for the adoption of these programs in LIMC countries. However, further long-term follow-up is essential to validate their safety, efficacy, and battery performance.
Conclusion
In conclusion, the MHYH study demonstrates that reconditioned pacemakers are a promising and affordable option for addressing the unmet need for permanent pacing in LMICs.
In addition to the need for longer-term studies and studies to improve lead dislodgement complications, the development of ethical and logistical frameworks is crucial to ensure equitable distribution and access to reconditioned pacemakers. By standardising reconditioning processes, this approach could significantly close the global gap in bradyarrhythmia care.
Limitations
In addition to the small number of patients included in the study, a major limitation is the short follow-up period of up to 90 days. Longer follow-up may reveal problems with reconditioned devices occurring later, in particular premature battery depletion or late device malfunction.
AHA Scientific Sessions 2024 News Release
Additional Reference Article
Funding
Donations to MHYH provided funding, which allowed interested sites with government approval to purchase new and reconditioned pacemakers locally. Both hospital and physician resources were provided for free.
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