Laser balloon ablation for atrial fibrillation: a prospective evaluation of short and long term effectiveness and safety

Background: The third generation of laser balloon (Cardiofocus Heartlight X3) with its compliant balloon and endoscope allows visualization of the ostium of the pulmonary veins and delivery of laser energy in a rapid semi-automatic mode, achieving a linear, continuous, and durable isolation of the pulmonary veins.Purpose: To evaluate the efficacy and safety of AF ablation with the Laser Balloon X3 system through a prospective observational study in a contemporary patient population, and secondly the impact of RAPID mode on procedural and clinical endpoints.Methods: We prospectively enrolled consecutive patients with symptomatic paroxysmal or persistent atrial fibrillation, indicated for pulmonary vein isolation according to current guidelines between September 2020 and December 2022. Efficacy was defined as freedom from clinical or significant subclinical atrial fibrillation recurrence at 3, 6, 12, and 24 months. All procedure-related complications were recorded.Results: We enrolled 126 patients with a mean age of 61 years (+/-10), including 25% women. 76.2% of patients suffered from paroxysmal atrial fibrillation, 23,8% persistent AF. At 3-6-12 and 24 months respectively 93%, 88%, 80%, and 74% of patients were free from atrial fibrillation. Among patients with paroxysmal AF at baseline, 83% and 78% were free from AF at 12 and 24 months, while for persistent AF patients, the figures were 73% and 63%, respectively. The Rapid mode utilization > 70% correlated with significantly shorter procedural times and a lower rate of late AF recurrence. Four serious adverse events (3.1%) were recorded with no life-threatening complications, two phrenic nerve palsies and one pericardial effusion without cardiac tamponade, one venous access complication.Conclusions: In our single-centre experience, the Laser Balloon X3 System demonstrates an excellent efficacy and safety profile in terms of AF recurrence and procedure-related complications. The novel Rapid Mode was associated with shorter procedural time and lower AF recurrence rate.