Reablation of atrial fibrillation targeting electrogram dispersion in patients with isolated veins: The RESTART trial

Pulmonary vein (PV) isolation is a well-established treatment for atrial fibrillation (AF), however, strategies for patients with recurrent AF and isolated PVs remain elusive.

This study aimed to evaluate the effectiveness of a personalized artificial intelligence (AI)-guided spatiotemporal dispersion mapping and ablation in patients undergoing a repeat ablation and whose PVs remain isolated from previous ablation procedures.

The Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion (RESTART) trial (NCT05477147) was an interventional, prospective, single-arm, multicenter clinical trial. Patients with previous catheter or surgical ablation for paroxysmal, persistent, or long-standing persistent AF and with documented symptomatic AF recurrences were enrolled. Patients with documented reconnected PVs during the procedure were prospectively withdrawn from the trial. Follow-up included 3-, 6-, and 12-month visits with 12-lead electrocardiogram and 24-hour Holter. The primary endpoint of the study was freedom from documented AF at 12 months after a single AI-guided repeat ablation procedure.

Of the 213 patients enrolled, the main causes for premature study exit were PV reconnection (n = 80) or noninducibility of AF (n = 14). The primary endpoint was achieved in 83% of patients (77 of 93), and freedom from any atrial arrhythmia after a single procedure was 70% (65 of 93). Notably, AF termination during ablation was achieved in 54% of patients, and right atrial dispersion was identified in 59%. The procedure was associated with improvements in quality-of-life metrics (AF Effect on Quality-of-Life questionnaire and 36-Item Short Form Survey scores).

In patients with documented isolated PVs, AI-guided dispersion ablation is safe and effective and represents an alternative to other ablative strategies.