Key result
Single-chamber leadless pacemakers show no significant benefit over lead-based pacemakers for 90-day complications.
Why the study?
Lead-based dual-chamber pacemakers for sick sinus syndrome carry significant complication and reintervention rates, prompting evaluation of newly available leadless atrial pacemakers.
Does a single-chamber leadless atrial pacemaker reduce periprocedural complications and reinterventions compared to a lead-based dual-chamber pacemaker in patients with sick sinus syndrome?
Cohort (n=52)
No
Does a single-chamber leadless atrial pacemaker reduce periprocedural complications and reinterventions compared to a lead-based dual-chamber pacemaker in patients with sick sinus syndrome?
In patients with sick sinus syndrome, single-chamber leadless atrial pacemakers are associated with significantly shorter procedure times and numerically lower, though not statistically significant, 90-day complication and reintervention rates compared to conventional lead-based dual-chamber pacemakers.
Answers are grounded in this paper and cite their sources.
May reduce complications and shorten procedures in sick sinus syndrome; leaves open need for randomized confirmation before practice change.
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.
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Felten et al. (2026) conducted a cohort in Sick sinus syndrome (n=52). Single-chamber leadless pacemaker vs. Lead-based dual-chamber pacemaker was evaluated on Complications within 90 days post-implantation (p=0.374). Single-chamber leadless pacemakers were associated with a non-statistically significant lower rate of complications at 90 days compared to lead-based pacemakers (5.9% vs 14.3%; p=0.374).
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