First European experience with a leadless atrial pacemaker.

BACKGROUND

Leadless pacemakers (LPs) can reduce long-term complications compared with conventional devices. However, previous studies have primarily focused on single chamber right ventricular LPs.

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 LP 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 LP either as a standalone therapy or as part of a dual chamber LP system.

RESULTS

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 LP implantation. All implantations were successful and without the need for device repositioning. The median procedure time was 35 minutes (interquartile range 30-40), and complications occurred in 2 patients (4.4%) 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 implant-to-implant throughput was 88% for atrial-to-ventricular and 87% for ventricular-to-atrial. The estimated median battery life of the atrial device was significantly higher in single chamber vs dual chamber settings (11.9 years vs 5.8 years, .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.