What is the clinical evidence from this study?

Study design: Cohort. Population: Symptomatic permanent atrial fibrillation (n=168). Intervention: Leadless pacemaker vs. Standard single-chamber transvenous pacemaker. Primary outcome: 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).

What question did this study set out to answer?

The study aims to compare clinical outcomes of leadless pacemakers with conventional transvenous pacemakers in patients undergoing AVN ablation for permanent atrial fibrillation.

February 19, 2026Open Access

Precision patient selection for ablate-and-pace: a multi-center study comparing leadless pacemaker vs. standard pacemaker in patients with indication to ablate-and-pace for atrial fibrillation (LEAD-AP)

Q: What does this research mean for the field?

Leadless pacemakers provide comparable 24-month event-free survival to standard transvenous pacemakers in patients undergoing ablate-and-pace for atrial fibrillation, while enabling shorter hospitalizations through a single-step approach. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Key Result

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.

Key Points

The study aims to compare clinical outcomes of leadless pacemakers with conventional transvenous pacemakers in patients undergoing AVN ablation for permanent atrial fibrillation.
Conducted a retrospective, multicenter study over 168 patients from 2017 to 2024.
Patients received either leadless pacemaker or transvenous VVI pacemaker.
Primary efficacy endpoint measured composite outcomes including mortality and hospitalizations.
Secondary efficacy endpoint focused on device-related hospitalizations or reinterventions.
Primary safety endpoint assessed acute complications within 30 days.
Leadless group had a significantly higher rate of ablate-and-pace in a single step (96.4% vs. 10.9%, p < 0.001).
Shorter hospitalization for leadless pacemaker (1.1 days ± 3.1) compared to transvenous (5.7 days ± 2.2, p = 0.008).
No significant difference in event-free survival at 24 months (82.1% leadless vs. 80.4% transvenous, p = 0.29).

Study Design

Type

Cohort (n=168)

Multicenter

Yes

Structured PICO

Does a leadless pacemaker improve clinical outcomes compared to a standard transvenous pacemaker in patients undergoing ablate-and-pace for permanent atrial fibrillation?

Population

168 consecutive patients with symptomatic permanent atrial fibrillation (AF) and indication to ablate-and-pace, mean age 79.5, 45.2% male, multinational (4 European centers across Belgium, France, Italy). Key inclusion: symptomatic permanent AF with indication to ablate-and-pace. Key exclusion: age <18 years, left bundle branch pacemaker or biventricular CRT pacemaker, transient/reversible AF, planned rhythm control, QRS duration ≥130 ms, LVEF <50%.

Intervention

Leadless pacemaker (Micra VR) combined with atrioventricular node (AVN) ablation, programmed to VVI mode at a lower rate of 70 bpm.

Comparator

Conventional transvenous single-chamber VVI pacemaker (Azure XT SR MRI with CapSure Fix Novus MRI lead) combined with AVN ablation, programmed to VVI mode at a lower rate of 70 bpm.

Outcome

Composite incidence of all-cause mortality, cardiovascular mortality, AF-related hospitalizations, unplanned outpatient visits for AF, and device-related hospitalizations or reinterventions at 24 months.composite

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.

Main Result

Effect estimate: HR 0.60 (95% CI 0.34-1.38)

Absolute Event Rate: 82.1% vs 80.4%

p-value: p=0.29

Limitations

Retrospective design
Lack of randomization
Composite outcome used for consistency across centers
Did not incorporate genomic, multi-omics, or artificial intelligence-driven risk stratification

Abstract

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.

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