First european experience with a leadless atrial pacemaker

Abstract Background Leadless pacemakers can reduce long-term complications in patients requiring pacemaker therapy for bradycardia. However, previous studies have primarily focused on right ventricular leadless pacemakers. Purpose To present our experience with the first real-world European use of an active-fixation atrial leadless pacemaker for either dual-chamber or single-chamber pacing. Methods For this retrospective, single-center, single-operator analysis, we included consecutive patients undergoing implantation of an active-fixation atrial leadless pacemaker either as standalone therapy or as part of a dual-chamber leadless pacemaker system. Results We included 23 patients (mean age 73 years, 52% male). Indications were sinus node disease in eight patients (35%), AV block in thirteen (57%), and binodal disease in two (9%). All implantations (7 de novo dual-chamber, 9 atrial single-chamber, 7 upgrades from ventricular single-chamber to dual-chamber) were successful without the need for device repositioning. The mean procedure time for atrial single-chamber implantation was 29 minutes (±11) and for dual-chamber 34 minutes (±9). The mean fluoroscopy time was 3 minutes (±1.5) for the atrial pacemaker (AR) and 3.2 minutes (±1.5) for the dual-chamber system (DR). Complications occurred in one patient (4%) who developed a small pericardial effusion. Median sensing, pacing threshold, and impedance were 1.5 mV (IQR 1–2.4), 1.8 V/0.4 ms (IQR 1.5–3), and 340 Ω (IQR 310–375) at implantation, and 4 mV (IQR 3–4.9), 0.5 V (IQR 0.5–0.5), and 320 Ω (IQR 310–360) after a mean follow-up of 22 days (IQR 21–27). Conclusion Our first real-world European experience demonstrates that leadless atrial pacemaker implantation with active fixation can be performed efficiently and safely, with acceptable and stable parameters during follow-up.