Complication rates in leadless versus lead-based pacemaker therapy for sick sinus syndrome
E Von Felten, F Lugano, A Breitenstein, A Mueller, T Brix, C Wiederkehr, D HoferAbstract
Background
Current guidelines recommend conventional lead-based dual-chamber pacemakers for patients with sick sinus syndrome. However, lead-based pacemaker therapy is associated with significant rates of complications and reinterventions. An atrial leadless pacemaker has been made commercially available in 2024 within Europe, offering standalone leadless AAI pacing with an option for upgrade to a dual-chamber leadless pacemaker in case of progressive conduction system disease.
Purpose
To compare periprocedural complication and reintervention rates between leadless atrial single-chamber pacemakers and lead-based dual-chamber pacemakers in patients with sick sinus syndrome.
Methods
We included consecutive patients undergoing pacemaker implantation for sinus node disease between July 2024 and May 2025 in this retrospective single-center analysis. Complication and reintervention rates within 90 days post-implantation, as well as procedure duration, were assessed and compared between the leadless and lead-based pacemaker groups.
Results
A total of 52 patients were included (mean age 75±11 years, 56% male). Of these, 35 patients (67.3%) underwent lead-based dual-chamber pacemaker implantation, and 17 patients (32.7%) received a single-chamber leadless pacemaker. The mean procedure duration was significantly shorter in the leadless pacemaker group compared with the lead-based group (27±12 min vs. 72±19 min; p<0.001). Complications occurred in one patient (5.9%) in the leadless group and in five patients (14.3%) in the lead-based group. During the 90-day follow-up, no device revisions were required in the leadless group, whereas three patients (8.6%) in the lead-based group underwent revision. However, these differences did not reach statistical significance (p=0.374 and p=0.214, respectively). The distribution of complications between groups is illustrated in the accompanying figure.
Conclusion
We observed a lower rate of complications and reinterventions in patients with sick sinus syndrome treated with leadless pacemaker (n=17, complications=1 (5.9%), reintervention=0) compared to lead-based pacemaker implantations (n=35, complications=5 (14.3%), reinterventions=3 (8.6%)), albeit without statistical significance. Larger studies are warranted to confirm these findings and to further assess long-term outcomes.