First-line therapy for persistent atrial fibrillation with anatomically guided third-generation laser balloon ablation: multicentre study results with continuous rhythm monitoring

Abstract Background Transcatheter ablation for atrial fibrillation (AF) prevents recurrences, reduces AF burden, and improves quality of life. Robust evidence supports its use as a first-line therapy for rhythm control, demonstrating a comparable risk of adverse events to antiarrhythmic drug (AAD) therapy. Anatomically guided third-generation laser balloon ablation provides a safe and effective option, offering excellent long-term outcomes in both paroxysmal and persistent AF cases. Aims This study presents the first prospective multicentre assessment of third-generation laser balloon ablation as an initial therapy for paroxysmal and persistent AF, conducted without acute confirmation of pulmonary vein isolation Methods We conducted a multicentre study in Italy involving patients with either paroxysmal or persistent AF, who had not previously undergone rhythm control therapy. Participants were treated with third-generation laser balloon ablation targeting pulmonary vein isolation. The primary endpoint was freedom from any atrial tachyarrhythmia (ATa) recurrence following a 3-month blanking period (BP), monitored using implantable cardiac monitors (ICM). Results Among the 113 patients (71% male; mean age 60.2 ± 10.9 years) who underwent ablation, 76% had paroxysmal AF. The mean left atrial volume/body surface area was 33.9 ± 7.0 mL/m², with 7% of patients (n=8) presenting moderate left atrial dilation. No significant periprocedural or follow-up complications occurred. At an average follow-up of 35.7 ± 9.6 months, freedom from ATa recurrence was achieved in 77% of patients with paroxysmal AF and 59% with persistent AF. Recurrences during the BP [hazard ratio (HR) = 2.334, P = 0.030] and left atrial dilation (HR = 2.843, P = 0.035) were independent predictors of recurrence. Conclusions Anatomically guided third-generation laser balloon ablation is a safe and effective first-line therapy for paroxysmal and persistent AF, providing strong clinical outcomes with nearly three years of ICM-based follow-up.