Study title: Project MHYH: One-Year Results

Published in Congress: European Society of Cardiology (ESC) Congress, 2025

Link: https://www.escardio.org/The-ESC/Press-Office/Press-releases/Reconditioned-pacemakers-provide-new-hope-for-patients-in-low-and-middle-income-countries

Prepared by: Dr. Özkan Karaca

Introduction
More than three-quarters of cardiovascular deaths occur in low- and middle-income countries (LMICs), where access to pacemaker implantation is substantially limited compared with high-income settings. Barriers include inadequate insurance coverage, limited access to diagnostic tools and equipped facilities, a shortage of trained personnel, and high device costs. Safe and effective postmortem device reuse represents a potential solution.

Objective

To determine whether reconditioned (postmortem retrieved and reprocessed) pacemakers are non-inferior to new pacemakers with respect to procedure-related infection at 12 months.

Methods

Randomized, multicenter, single-blind, non-inferiority trial. Primary endpoint: freedom from procedure-related infection at 12 months. Key secondary endpoints: freedom from device software/hardware malfunction (premature battery depletion, device or lead malfunction) or unexplained death at 12 months. Inclusion: de novo bradycardia pacing indication, no financial means to obtain a new device, appropriate consent. Exclusion: inability to follow-up, severe comorbidities (LVEF<35%, dialysis, active infection), life expectancy <2 years, pregnancy, age <18. A total of 306 patients were randomized across 7 sites in 6 countries: Reconditioned (R-PM) n=154; New (N-PM) n=152. Overall, 282 patients (93%) completed 12-month follow-up.

Results

• Primary endpoint (infection at 12 months): New 2.8% vs Reconditioned 2.1%. Non-inferiority was met with a 90% upper bound of the difference at 2.1% against a 5% margin.
• Other 12-month outcomes: Lead dislodgement New 3.5% vs Reconditioned 2.1%; pacemaker removal New 1.4% vs Reconditioned 6.4%; death New 2.9% vs Reconditioned 2.9%. Reported causes of death included COVID with renal failure, pulmonary embolism, metastatic endometrial cancer, subdural hematoma, stroke, and ventricular tachycardia; no deaths were attributed to pacemaker system malfunction.

Conclusions

Reconditioned pacemakers were non-inferior to new devices for infection through 12 months of follow-up. No pulse generator malfunctions or failures were observed in either group. Longer-term follow-up is warranted to confirm safety and effectiveness and to inform regulatory frameworks for broader implementation.

Comment

This trial supports a standardized, ethically grounded reprocessing pipeline as a viable strategy to expand access to life-saving pacing therapy in LMICs. Imbalances in site enrollment and a modest sample size may limit detection of rare events; independent audits and extended follow-up will be important.