Project My Heart Your Heart - MHYH

Sep 01, 2025
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Fred M. Kusumoto, MD, FACC; Dharam J. Kumbhani, MD, SM, FACC
Date Updated:
09/01/2025
Original Posted Date:
11/17/2024
References

Highlighted text has been updated as of Sept. 1, 2025.

Contribution To Literature:

The MHYH trial showed that in patients in low- and middle-income countries requiring permanent pacemaker implantation, reconditioned devices may provide a noninferior, more affordable alternative to new implants with respect to infection risk.

Description:

The goal of the trial was to assess the safety, risks of infection and device failure when implanting reconditioned permanent pacemakers (PPMs) in patients in low- and middle-income countries for whom a new device may be cost-prohibitive.

Study Design

  • International
  • Randomized
  • Single-blind

Patients with a class I indication for permanent pacing and with financial barriers to a new PPM were randomized in a 1:1 fashion to undergo implantation with a reconditioned (n = 149) or new (n = 149) device. Reclaimed devices with estimated remaining longevity >4 years undergo an extensive, 4-phase reconditioning process comprising decontamination, set screw and screw cap replacement, electrical testing, and sterilization and repackaging. Participants were enrolled in Venezuela, Nigeria, Paraguay, Kenya, Mozambique, Sierra Leone, and Mexico.

  • Total number of enrollees: 306
  • Duration of follow-up: 1 year (90-day preliminary results presented in 2024)
  • Mean patient age: 71 years
  • Percentage female: 50%

Inclusion criteria:

  • Age ≥18 years
  • Life expectancy ≥2 years
  • Class I indication for PPM
  • No financial means to acquire new PPM

Exclusion criteria:

  • Severe comorbidities (e.g., left ventricular ejection fraction <35%, dialysis requirement, active infection)
  • Pregnancy

Other salient features/characteristics:

  • Complete heart block: 79%
  • Sinus node dysfunction: 25%
  • Syncope: 25%
  • Syncope and bifascicular block: 3%

Principal Findings:

The primary outcome, procedure-related infection, for reconditioned vs. new PPM at 90 days, was: 1.5% vs. 2.9%; 90% upper bound of treatment difference (2.2%) below prespecified noninferiority margin (5%).

Secondary outcomes for reconditioned vs. new PPM at 90 days:

  • Median time to procedure-related infection: 42 vs. 20 days
  • Procedure-related infection requiring device extraction: 1.5% vs. 2.2%
  • Lead dislodgment: 7.3% vs. 5.0%
  • Death: 2.2% vs. 0%

12-month follow-up results (n = 259): The incidence of procedure-related infections was 1.6% for reconditioned vs. 3.1% for new PPMs. Two pocket infections requiring explantation occurred in reconditioned vs. three in new PPMs. One case of superficial cellulitis responsive to antibiotics occurred in a new PPM.

At 12 months, no device malfunctions occurred in either group. Lead revisions occurred in nine patients with reconditioned vs. five with new PPMs. Four deaths occurred in patients with reconditioned vs. two in patients with new PPMs; none were related to the implantation procedure.

Interpretation:

When procured and repurposed through an ethical and standardized framework, reconditioned PPMs may help fill a critical gap in bradyarrhythmia-related care for patients in low- and middle-income countries. The preliminary data from this cohort demonstrate a promisingly comparable rate of device-related infection between reconditioned and new PPM implants. At 12 months, procedure-related infection rates remained noninferior between reconditioned and new PPMs, with no malfunctions.

Interestingly, at 90 days, device infections in the reconditioned arm occurred a median of 3 weeks later than in new PPMs, although the significance of this is not clear. Lead dislodgment was slightly more frequent in the reconditioned arm, and a prior meta-analysis suggested higher rates of hardware-related malfunctions in reconditioned PPMs. Long-term follow-up of these patients will be critical to better understand the durability and consequent advantage of reconditioned PPMs in settings where new devices may be cost-prohibitive.

References:

Presented by Dr. Thomas Crawford at the European Society of Cardiology Congress, Madrid, Spain, Sept. 1, 2025.

Presented by Dr. Thomas Crawford at the American Heart Association Scientific Sessions, Chicago, IL, November 17, 2024.

Clinical Topics: Prevention, Arrhythmias and Clinical EP

Keywords: AHA24, AHA Annual Scientific Sessions, Pacemaker, Artificial, ESC25, ESC Congress, ACC International, Primary Prevention


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