Photo Credit: Daniel de Andres Jimenez
Preliminary data from the My Heart Your Heart (MHYH) trial indicated that reconditioned pacemakers are non-inferior to new pacemakers in infection rate. Also, the investigators did not see any malfunctions or failures of the pulse generator in either new or reconditioned pacemakers. These promising findings represent an important step in addressing the global disparity in pacemaker access.
The MHYH trial enrolled 298 patients from Sierra Leone, Venezuela, Nigeria, Kenya, Paraguay, Mexico, and Mozambique, who had a class one indication for a de novo bradycardia pacing device and no financial means of acquiring a new pacemaker. The participants were randomly assigned 1:1 to the implantation of a new device or a reconditioned device. The primary endpoint was the procedure-related infection rate at 12 months. Dr. Thomas Crawford, MD, from the University of Michigan, in the US, shared the interim findings at 3 months of follow-up1.
The 90-day infection rate was 2.9% in the new-device arm and 1.5% in the reconditioned-device arm, meeting this endpoint for non-inferiority. Furthermore, no significant differences were seen between the two study arms concerning device malfunctions, such as lead dislodgment (new 5.0% vs reconditioned 7.3%) or pacemaker removal (2.2% vs 1.5%). “We observed three deaths in the reconditioned arm, but none of these cases were related to pacemaker system malfunctions,” added Dr. Crawford.
“Reconditioned pacemakers were non-inferior to new pacemakers about infection rates,” concluded Dr Crawford. “Longer follow-up and larger trials are needed to confirm the safety and efficacy of reconditioned pacemakers.”
Medical writing support was provided by Robert van den Heuvel.
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