Leadless pacemakers provided comparable 24-month event-free survival to standard transvenous pacemakers (82.1% vs. 80.4%, p=0.29) in patients undergoing ablate-and-pace for atrial fibrillation.
Cohort (n=168)
Yes
Does a leadless pacemaker improve clinical outcomes compared to a standard transvenous pacemaker in patients undergoing ablate-and-pace for permanent atrial fibrillation?
Leadless pacemakers provide comparable safety and efficacy to transvenous systems in patients undergoing ablate-and-pace for atrial fibrillation, while enabling shorter hospitalizations through a streamlined single-step approach.
Effect estimate: HR 0.60 (95% CI 0.34-1.38)
Absolute Event Rate: 82.1% vs 80.4%
p-value: p=0.29
Background In patients with symptomatic permanent atrial fibrillation (AF) who are not candidates for rhythm control, atrioventricular node (AVN) ablation followed by ventricular pacing “ablate-and-pace” offers reliable rate control and symptom relief. Conventional transvenous systems are effective but associated with lead- and pocket-related complications. Leadless pacemakers represent a promising alternative, yet comparative data in this setting remain scarce. The aim is to compare clinical outcomes of leadless vs. transvenous single-chamber pacemakers in patients undergoing AVN ablation for permanent AF. Methods We conducted a retrospective, multicenter study (LEAD-AP) of 168 consecutive patients undergoing ablate-and-pace between 2,017 and 2024 across four European centers. Patients received either a leadless pacemaker ( n = 56) or a conventional transvenous VVI pacemaker ( n = 112). The primary efficacy endpoint was the composite of all-cause mortality, cardiovascular mortality, AF-related hospitalizations, unplanned visits and device-related hospitalizations or reinterventions. The secondary efficacy endpoint was device-related hospitalizations or reinterventions. The primary safety endpoint was acute complications within 30 days. Results Patients in the leadless group more frequently underwent a single-step ablate-and-pace strategy (96.4% vs. 10.9%, p 0.001), resulting in shorter hospitalization (1.1 days ± 3.1 vs. 5.7 days ± 2.2, p = 0.008). At 24 months of follow-up, there was no statistically significant difference between patients with leadless pacemaker vs. standard single-chamber VVI pacemaker in the event-free survival for the clinical efficacy endpoint (82.1% vs. 80.4% Log-Rank p = 0.29). Conclusions Leadless pacemakers provide comparable safety and efficacy to transvenous systems in ablate-and-pace patients, while enabling shorter hospitalization through a streamlined single-step approach.
Overeinder et al. (2026) conducted a cohort in Symptomatic permanent atrial fibrillation (n=168). Leadless pacemaker vs. Standard single-chamber transvenous pacemaker was evaluated on Composite of all-cause mortality, cardiovascular mortality, AF-related hospitalizations, unplanned outpatient visits for AF, and device-related hospitalizations or reinterventions (HR 0.60, 95% CI 0.34-1.38, p=0.29). Leadless pacemakers provided comparable 24-month event-free survival to standard transvenous pacemakers (82.1% vs. 80.4%, p=0.29) in patients undergoing ablate-and-pace for atrial fibrillation.