De novo versus staged dual chamber leadless pacemaker implantation

Abstract Background Leadless pacemakers can reduce long-term complications in patients requiring pacemaker therapy for bradycardia. Recently, a novel modular, upgradeable dual-chamber leadless pacemaker with active fixation, featuring separate atrial and ventricular devices, has become available. Purpose To evaluate procedure time, safety, and outcomes of de novo versus staged (upgrade) implantation of a dual-chamber leadless pacemaker system with active fixation. Methods This retrospective single-center, single-operator analysis included consecutive patients undergoing implantation of a dual-chamber leadless pacemaker. We recorded procedure and x-ray time, procedure complications, as well as impedance, pacing threshold at 0.4 ms, and sensing from the atrial (AR) and ventricular (VR) device at implantation, one day post-implantation, and at the follow-up consultation. Results Fourteen patients (mean age 72 years, 50% male) were included, with a 100% success rate for implantation (7 de novo, 7 upgrades). No complications were observed. The mean procedure time was 30 minutes (±7) in the upgrade group and 38 minutes (±9) in the de novo group. The mean time between VR and AR implantation was 60 days (±39) in the upgrade group. Measurements at implantation, one day after atrial device implantation, and after a mean follow-up of 21 days (IQR 21–27) of the atrial and ventricular devices are presented in Figure 1. Conclusion Our first real-world European experience demonstrates that dual-chamber leadless atrial pacemaker implantation with active fixation is efficient and safe, with acceptable and stable measurements during follow-up, whether performed as a de novo implantation or as an upgrade from an existing single-chamber system.