Safety, Efficacy, and Effectiveness of Pulsed Field Ablation with Farapulse™ to Treat Atrial Fibrillation: A Prospective Single-center Study

Abstract

Pulsed field ablation (PFA) using the Farapulse™ system (Boston Scientific, Marlborough, MA, USA) is a novel, non-thermal ablation technology developed to treat atrial fibrillation (AF) with improved safety and procedural efficiency. We present prospective single-center data on the safety, efficacy, and effectiveness of PFA in a real-world patient population. We enrolled 100 consecutive patients with symptomatic AF undergoing catheter ablation with the Farapulse™ system. Procedural characteristics, clinical outcomes, and acute safety events were evaluated. Freedom from AF recurrence was assessed at 6 months. The cohort had a mean age of 69.2 ± 10.9 years, and 47% were women. Pulmonary vein isolation was achieved in 96% of patients, with additional posterior wall ablation performed in 66%. The median procedure and fluoroscopy times were 42 and 12 min, respectively. No major adverse events occurred. At 6 months, 82% of patients were free from atrial arrhythmia recurrence off anti-arrhythmic drugs. PFA with the Farapulse™ system demonstrated high acute efficacy, excellent safety, and promising short-term effectiveness in a real-world population with AF. These findings support the broader adoption of PFA in routine clinical practice.