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Leadless Helix-fixation Pacemakers in Solid Organ Transplant Recipients: A Multisite Experience.

Amal Youssef1, Julie L Rosenthal1, Bashar A Aqel2

  • 1Department of Cardiovascular Medicine, Mayo Clinic, Phoenix, AZ.

Transplantation Direct
|May 20, 2026
PubMed
Summary
This summary is machine-generated.

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Leadless pacemakers (LPs) offer a safer alternative for solid organ transplant recipients (SOTRs), with the Aveir LP platform showing feasibility and no infections in a high-risk cohort. Further studies are needed for long-term outcomes.

Area of Science:

  • Cardiology
  • Medical Devices
  • Transplantation

Background:

  • Solid organ transplant recipients (SOTRs) face increased risks of cardiovascular implantable electronic device (CIED) complications, especially infection, due to immunosuppression and comorbidities.
  • Leadless pacemakers (LPs) mitigate infection risks by eliminating transvenous leads and generator pockets.
  • Previous LP systems were limited to single-chamber pacing and lacked atrioventricular synchrony, hindering their adoption in SOTRs.

Purpose of the Study:

  • To evaluate the feasibility, safety, and early outcomes of the helix-fixation Aveir LP platform in SOTRs.
  • To assess procedural success, complications, and device-related infections in this high-risk population.
  • To determine the pacing performance and early durability of the Aveir LP system in SOTRs.

Main Methods:

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  • A retrospective, multisite analysis of adult SOTRs who received Aveir LP implantation between January 2022 and October 2025.
  • Collection of data on clinical characteristics, transplant details, pacing indications, device configuration, procedural outcomes, and follow-up.
  • Primary outcomes included procedural success, complications, and device-related infection; secondary outcomes included pacing performance and device durability.

Main Results:

  • Thirteen SOTRs (mean age 64 ± 15 years) underwent implantation of atrial (n=4), ventricular (n=5), or dual-chamber (n=4) Aveir LPs.
  • The cohort included patients with heart, lung, kidney, and liver transplants, with over half critically ill and 46% dialysis-dependent.
  • All procedures were acutely successful with no intraprocedural complications. No device-related infections occurred during a median follow-up of 258 days, with stable electrical performance and one atrial device replacement for elevated capture thresholds.

Conclusions:

  • Atrial and atrioventricular synchronous leadless pacing with the Aveir platform is feasible in a high-risk SOTR population.
  • The Aveir LP platform demonstrated high acute procedural success and favorable early safety signals, including no device-related infections.
  • Larger studies with longer follow-up are necessary to establish the long-term durability and outcomes of Aveir LPs in SOTRs.