Key result
AVEIR leadless pacemaker implantation is linked to a ~3% major complication rate.
Why the study?
The introduction of single-chamber atrial leadless pacemakers allows treatment of sinus node dysfunction without dual-chamber transvenous pacemakers, but outcomes and procedural data are limited.
What are the safety and procedural outcomes of a modular approach using the AVEIR leadless pacemaker?
Observational (n=89)
No
What are the safety and procedural outcomes of a modular approach using the AVEIR leadless pacemaker?
A modular approach to leadless pacing using the AVEIR device demonstrates a low rate of major (3.4%) and minor (1.1%) complications in real-world practice.
INTRODUCTION: The AVEIR leadless pacemaker (LP) is a novel device that can function as a single atrial/ventricular or dual-chamber pacemaker. The introduction of single-chamber atrial LP has allowed electrophysiologists to treat patients with sinus node dysfunction with this device instead of implanting a dual-chamber transvenous pacemaker. METHODS: We retrospectively identified all patients who underwent AVEIR LPs' implantation at Emory Healthcare between 2022 and 2025. Baseline characteristics, indications for pacing, and procedure outcomes were retrieved from electronic medical records. The device's electrical characteristics were reported from routine interrogations done at our device clinic. RESULTS: Between 2022 and 2025, 89 patients underwent implantation of 37 single-chamber atrial AVEIR, 34 single-chamber ventricular AVEIR, and 18 dual-chamber devices. Patients were followed for a median duration of 4.7 months [2;9]. The rate of major complications was 3.4% and minor complications 1.1%. Two patients with ventricular LP required upgrade to cardiac resynchronization therapy-defibrillator (CRT-D) due to pacing-induced cardiomyopathy (2.3%). One patient (2.7%) with a standalone atrial LP developed atrial fibrillation with slow ventricular response requiring the addition of a ventricular LP 10 months postimplantation. CONCLUSION: In our center, we adopted a modular pacing approach for leadless pacing. This strategy focuses on minimizing the amount of hardware in the heart. This reduces complications such as perforation and dislodgment while optimizing battery longevity, which is affected by i2i communication.
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Mekary et al. (2025) conducted an observational in Sinus node dysfunction and other pacing indications (n=89). AVEIR leadless pacemaker was evaluated on Major complications. Implantation of AVEIR leadless pacemakers in 89 patients resulted in a 3.4% rate of major complications and 1.1% rate of minor complications over a median follow-up of 4.7 months.
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