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)
 
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) ■
 
Ingrid Overeinder, Ingrid Overeinder, Luigi Pannone, Luigi Pannone, Domenico Laviola, Domenico Laviola, Wael Zaher, Wael Zaher, Giacomo Mugnai, Giacomo Mugnai, Gianmarco Arabia, Gianmarco Arabia, Ivan Eltsov, Ivan Eltsov, Ioannis Doundoulakis, Ioannis Doundoulakis, Domenico Giovanni Della Rocca, Domenico Giovanni Della Rocca, Paul Adrian Calburean, Paul Adrian Calburean, Vedran Pašara, Vedran Pašara, Ludovica Carmagnola, Ludovica Carmagnola, Tommaso Sattin, Tommaso Sattin, Antonio Sorgente, Antonio Sorgente, Alvise Del Monte, Alvise Del Monte, Giacomo Talevi, Giacomo Talevi, Gezim Bala, Gezim Bala, Alexandre Almorad, Alexandre Almorad, Erwin Ströker, Erwin Ströker, Juan Sieira, Juan Sieira, Ali Gharaviri, Ali Gharaviri, Mark La Meir, Mark La Meir, Pedro Brugada, Pedro Brugada, Andrea Sarkozy, Andrea Sarkozy, Gian Battista Chierchia, Gian Battista Chierchia, Antonio Curnis, Antonio Curnis, Serge Boveda, Serge Boveda, Carlo de Asmundis, Carlo de Asmundis
 
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.