Percutaneous versus thoracoscopic ablation of symptomatic paroxysmal atrial fibrillation: a randomised controlled trial - the FAST II study.

BACKGROUND:The most efficient first-time invasive treatment, for achieving sinus rhythm, in symptomatic paroxysmal atrial fibrillation has not been established. We aimed to compare percutaneous catheter and video-assisted thoracoscopic pulmonary vein radiofrequency ablation in patients referred for first-time invasive treatment due to symptomatic paroxysmal atrial fibrillation. The primary outcome of interest was the prevalence of atrial fibrillation with and without anti-arrhythmic drugs at 12 months. METHODS:Ninety patients were planned to be randomised to either video-assisted thoracoscopic radiofrequency pulmonary vein ablation with concomitant left atrial appendage excision or percutaneous catheter pulmonary vein ablation. Episodes of atrial fibrillation were defined as more than 30 s of atrial fibrillation observed on Holter monitoring/telemetry or clinical episodes documented by ECG. RESULTS:The study was terminated prematurely due to a lack of eligible patients. Only 21 patients were randomised and treated according to the study protocol. Thoracoscopic pulmonary vein ablation was performed in 10 patients, and 11 patients were treated with catheter ablation. The absence of atrial fibrillation without the use of anti-arrhythmic drugs throughout the follow-up was observed in 70% of patients following thoracoscopic pulmonary vein ablation and 18% after catheter ablation (p < 0.03). CONCLUSION:Thoracoscopic pulmonary vein ablation may be superior to catheter ablation for first-time invasive treatment of symptomatic paroxysmal atrial fibrillation with regard to obtaining sinus rhythm off anti-arrhythmic drugs 12 months postoperative. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01336075 . Registered April 15th, 2011.