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First European experience with a leadless atrial pacemaker.

Elia von Felten1, Alexander Breitenstein2, Andreas Müller1

  • 1Department of Cardiology, Triemli Hospital Zürich, Zürich, Switzerland.

Heart Rhythm O2
|September 8, 2025
PubMed
Summary

This study shows that leadless pacemakers (LPs) are safe and effective for atrial pacing in Europe. The active fixation atrial LP demonstrated efficient implantation and stable performance in real-world use.

Keywords:
AVEIRAtrialDual chamber pacemakerHelix fixationImplant procedureLeadless pacemakerPacemaker complications

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Area of Science:

  • Cardiology
  • Medical Devices
  • Electrophysiology

Background:

  • Leadless pacemakers (LPs) offer potential advantages over conventional devices by reducing long-term complications.
  • Previous research on LPs has predominantly focused on single-chamber right ventricular models.

Purpose of the Study:

  • To assess the implantation success, safety profile, and device performance of an active fixation atrial leadless pacemaker (LP) in a European real-world setting.
  • To evaluate the atrial LP in both dual-chamber and single-chamber pacing configurations.

Main Methods:

  • Prospective, single-center, single-operator study.
  • Inclusion of consecutive patients undergoing implantation of an active fixation atrial LP, either as a standalone device or within a dual-chamber system.
  • Analysis of implantation procedure, early safety events, and device parameters (sensing, impedance, stimulation thresholds) during follow-up.

Main Results:

  • Successful implantation in all 45 patients, with no need for device repositioning.
  • Low complication rate (4.4%) with two cases of pericardial effusion.
  • Stable or improved device measurements (sensing, impedance, stimulation thresholds) observed during a median 21-day follow-up.
  • High implant-to-implant throughput rates for atrial-to-ventricular (88%) and ventricular-to-atrial (87%) pacing.
  • Significantly longer estimated battery life for atrial LPs in single-chamber (11.9 years) versus dual-chamber (5.8 years) settings (P < .001).

Conclusions:

  • The first real-world European experience confirms that leadless atrial pacemaker implantation is efficient and safe.
  • The active fixation atrial LP demonstrates satisfactory device measurements in the early post-implantation period.
  • Device performance and battery longevity are key considerations, with single-chamber use showing extended battery life.