Acute and Long‐Term Clinical Outcome After Endoscopic Pulmonary Vein Isolation: Results from the First Prospective, Multicenter Study

INTRODUCTION: The acute and long-term outcome of pulmonary vein isolation (PVI) using an endoscopic ablation system (EAS) has only been reported in single-center studies. The current prospective, multicenter study assessed the acute and 1-year outcome following PVI using the EAS. METHODS AND RESULTS: Seventy-two patients (34 female, mean age 58 ± 10 years) with a history (5 ± 6 years) of drug-refractory paroxysmal atrial fibrillation (AF) were included. Endoscopic PVI was performed in all patients. Follow-up was based on regular telephone interviews, Holter ECG, and transtelephonic ECG recordings. Recurrence was defined as a symptomatic and/or documented AF episode >30 seconds following a blanking period of 3 months. In 72 patients, a total of 281 pulmonary veins (PVs) were targeted and 277/281 (98.6%) PVs were isolated successfully using only the EAS. PV stenosis, thrombembolic events, pericardial effusion, pericardial tamponade, and phrenic nerve palsy occurred in 0 of 72, 0 of 72, 3 of 72 (4.2%), 4 of 72 (5.6%), and in 1 of 72 (1.4%) patients, respectively. Sixty-seven of 72 (93.1%) patients completed a follow-up of 365 days and 42 of 67 (62.7%) patients remained in stable sinus rhythm after a single procedure. A total of 13 of 25 (52%) patients suffering from AF recurrence consented to repeat PVI using conventional radiofrequency energy 221 ± 121 days after the index procedure. LA to PV reconduction was found in 30 of 45 (67%) previously isolated PVs. CONCLUSIONS: A very high rate of acute electrical PVI is achieved using exclusively the EAS. The 1-year single-procedure success rate in patients with paroxysmal AF is comparable to conventional PVI. PV reconduction is the major determinant for AF recurrence.