First short-term European experiences with dual-chamber leadless pacing: Early safety and electrical outcomes compared with transvenous systems

BACKGROUND: Leadless pacemakers (LPMs) eliminate the need for transvenous leads and subcutaneous pockets. However, comparative real-world data between dual-chamber LPMs and conventional transvenous pacemakers, are lacking to date. AIMS: Our aim was to present the first single-center experience with dual-chamber leadless pacemakers and to compare early electrical performance, safety, and 90-day clinical outcomes with contemporary dual-chamber transvenous systems. METHODS: This investigator-initiated registry included consecutive patients undergoing dual-chamber pacemaker implantation: 178 dual-chamber transvenous pacemakers (2023-2024) and 27 dual-chamber LPMs (2024-2025). Leadless implantations were performed as two stages due to reimbursement regulations. Baseline characteristics, procedural parameters, electrical performance at implantation and 90 days, and complication rates were analyzed. RESULTS: Patients receiving LPMs had a higher prevalence of prior device infection (22.2% vs. 1.1%; P <0.001), chronic dialysis (22.2% vs. 1.1%; P <0.001), and malignancy (18.5% vs. 3.4%; P = 0.007). Procedural success was achieved in all LPM cases. Despite staged implantation, the 90-day complication rate was low and comparable between patient groups (7.4% vs. 4.5%; P = 0.62). Electrical parameters improved over time in the LPM group, with stable low pacing thresholds at 90 days. However, an estimated battery longevity was shorter in the LPM cohort. CONCLUSIONS: In this real-world preliminary comparison, dual-chamber leadless pacing demonstrated promising short-term safety outcomes despite implantation in a clinically complex population, traditionally considered as at elevated risk for transvenous systems. These findings may suggest consideration of dual-chamber leadless pacing in selected high-risk patients.