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

Abstract

Background: Solid organ transplant recipients (SOTRs) are at heightened risk for cardiovascular implantable electronic device-related complications, particularly infection, because of chronic immunosuppression and comorbidities. Although leadless pacemakers (LPs) reduce infection risk by eliminating transvenous leads and generator pockets, adoption in SOTRs has remained limited, largely because earlier systems were restricted to single-chamber ventricular pacing and lacked physiologic atrioventricular synchrony. The helix-fixation Aveir LP platform enables atrial, ventricular, and dual-chamber leadless pacing, but clinical experience in transplant recipients remains limited.

Methods: We conducted a retrospective, multisite analysis across an integrated health system, identifying all adult SOTRs who underwent Aveir LP implantation between January 2022 and October 2025. Clinical characteristics, transplant details, pacing indications, device configuration, procedural outcomes, and follow-up data were collected. Primary outcomes included procedural success, complications, and device-related infection. Secondary outcomes included pacing performance, need for system revision or upgrade, and early device durability.

Results: Thirteen SOTRs (mean age 64 ± 15 y; 15% female) underwent Aveir LP implantation, including atrial (n = 4), ventricular (n = 5), and dual-chamber (n = 4) systems. Transplanted organs included heart (46%), lung (31%), kidney (38%), and liver (15%), with 31% having multiple organ transplants. Over half of patients were critically ill at implantation, and 46% were dialysis-dependent, representing a high-risk cohort. All procedures were acutely successful with no intraprocedural complications. During a median follow-up of 258 d (interquartile range, 216-641 d), no device-related infections occurred. Electrical performance remained stable, with 1 atrial device replacement at 2.5 y for elevated capture thresholds.

Conclusions: In a high-risk population of SOTRs, atrial and atrioventricular synchronous leadless pacing using the Aveir platform was feasible, achieved high acute procedural success, and demonstrated favorable early safety signals, including absence of device-related infection over available follow-up. Larger studies with longer-term follow-up are needed to define durability and long-term outcomes.