My Heart Your Heart - MHYH

Nov 17, 2024
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Author/Summarized by Author:
Amit Saha, MD
Summary Reviewer:
Dharam J. Kumbhani, MD, SM, FACC
Trial Sponsor:
University of Michigan
Date Presented:
11/17/2024
Date Published:
11/17/2024
Original Posted Date:
11/17/2024
References

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 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, and Mexico.

  • Total number of enrollees: 298
  • Duration of follow-up: 1 year (90-day preliminary results presented here)
  • Mean patient age: 71 years
  • Percentage female: 50%

Inclusion criteria:

  • Age ≥18 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%

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. Interestingly, 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 has 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 American Heart Association Scientific Sessions, Chicago, IL, November 17, 2024.

Clinical Topics: Arrhythmias and Clinical EP

Keywords: AHA24, AHA Annual Scientific Sessions, Pacemaker, Artificial


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