Reconditioned Pacemakers Show Comparable Infection Rates To New Devices

Procedure-related infection rates were akin pinch reconditioned and caller pacemakers, according to late-breaking investigation presented successful a Hot Line convention coming astatine ESC Congress 2025.

Explaining nan rationale for Project My Heart Your Heart, Doctor Thomas Crawford from nan University of Michigan, Ann Arbor, USA, said: "Patients successful galore low- and middle-income countries (LMICs) still person very constricted entree to cardiac pacing contempt its regular usage successful higher-income countries. Indeed, entree to pacemaker implantation is astir 200-fold little successful Africa than successful Europe. To facilitate nan usage of reconditioned devices, Project My Heart Your Heart has developed a broad protocol for cleaning, functional testing and sterilisation, and has gained FDA support for their export to countries whose governments person provided definitive support for pacemaker importation. We initiated a objective proceedings to analyse nan information of implanting pacemakers reconditioned utilizing our protocol compared pinch caller devices successful respective LMICs."

A randomized controlled proceedings was conducted successful Kenya, Mexico, Mozambique, Nigeria, Paraguay, Sierra Leone and Venezuela from May 2022 to June 2024. Adult patients pinch life expectancy of astatine slightest 2 years, a people I denotation for pacemaker therapy and nary financial intends to get a caller instrumentality were randomized 1:1 to person a reconditioned pacemaker aliases a caller pacemaker. The superior endpoint was procedure-related infection astatine 12 months.

The proceedings included 306 patients who had a mean property of astir 71 years. Approximately half were female. Follow-up information astatine 12 months were disposable for 259 patients (84.9%).

Over 12 months, location were 2 pouch infections requiring explantation successful nan reconditioned pacemaker group and 3 successful nan caller pacemaker group. There was 1 lawsuit of superficial cellulitis responsive to antibiotics successful nan caller pacemaker group. Overall, nan incidence of procedure-related infections astatine 12 months was 1.6% successful patients successful nan reconditioned pacemaker group and 3.1% successful nan caller group. The precocious bound of nan 90% assurance interval for nan quality successful infection rates betwixt nan groups was 2.2%, which is wrong nan pre-specified noninferiority separator of 5%.

There were nary instrumentality malfunctions successful either group. Lead revisions occurred successful 9 patients successful nan reconditioned pacemaker group and 5 successful nan caller group. Unrelated to nan implantation procedure, location were 4 deaths successful nan reconditioned pacemaker group and 2 successful nan caller group.

Concluding, Doctor Crawford said: "Our proceedings demonstrates nan information of pacemakers reconditioned utilizing a circumstantial protocol, pinch noninferior infection rates to caller pacemakers and nary malfunctions. The activity of Project My Heart Your Heart serves arsenic a blueprint that tin beryllium replicated by different organisations to alteration wider pacemaker reuse. We would besides for illustration to grow into reconditioned implantable cardioverter-defibrillator devices, which are moreover much costly and retired of scope for galore patients crossed nan world."