Key result
Active-fixation atrial leadless pacemakers show 100% implant success with doubled battery life in single-chamber settings.
Why the study?
Previous studies on leadless pacemakers have primarily focused on single-chamber right ventricular devices, with limited data on active-fixation atrial leadless pacemakers in real-world European use.
Observational (n=45)
No
In a real-world European setting, implantation of an active-fixation atrial leadless pacemaker was highly successful and safe, though dual-chamber use significantly reduces estimated battery longevity.
Background Leadless pacemakers can reduce long-term complications compared to conventional devices. However, previous studies have primarily focused on single-chamber right ventricular leadless pacemakers. Objective This study aimed to evaluate the implantation, safety, and device performance characteristics in a first real-world European use of an active-fixation atrial leadless pacemaker for either dual-chamber or single-chamber pacing. Methods For this prospective, single-center, single-operator analysis, we included consecutive patients undergoing implantation of an active-fixation atrial leadless pacemaker either as a standalone therapy or as part of a dual-chamber leadless pacemaker system. Results Out of the 45 included patients, 22 (48.9%) underwent de novo dual chamber, 9 (20%) an upgrade from ventricular single-chamber to dual-chamber, and 14 (31.1%) an atrial single chamber leadless pacemaker implantation. All implantations were successful and without the need for device repositioning. The median procedure time was 35 minutes (IQR 30-40) and complications occurred in 2 (4.4%) patients who developed pericardial effusions. Sensing, impedance, and stimulation thresholds of the atrial and ventricular device remained stable or improved over a median follow-up of 21 days. Median i2i TM throughput was 88% for A2V and 87% for V2A. Estimated median battery life of the atrial device was significantly higher in single chamber versus dual chamber settings (11.9 years vs 5.8 years, p <0.001). Conclusion Our first real-world European experience demonstrates that leadless atrial pacemaker implantation can be performed efficiently and safely, with satisfactory device measurements during the early follow-up period.
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Felten et al. (2025) conducted an observational in Indication for atrial pacing (n=45). Active-fixation atrial leadless pacemaker was evaluated on Estimated median battery life (single chamber vs dual chamber settings) (p=<0.001). Implantation of an active-fixation atrial leadless pacemaker was 100% successful; estimated battery life was 11.9 vs 5.8 years in single vs dual chamber settings (P<0.001).
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