The CURE-AF trial: A prospective, multicenter trial of irrigated radiofrequency ablation for the treatment of persistent atrial fibrillation during concomitant cardiac surgery

BACKGROUND Ablation technology has been introduced to replace the surgical incisions of the Cox-Maze procedure in order to simplify the operation. However, the efficacy of these ablation devices has not been prospectively evaluated. OBJECTIVE The purpose of this study was to examine the efficacy and safety of irrigated unipolar and bipolar radiofrequency ablation for the treatment of persistent and Long-standing persistent atrial fibrillation (AF) during concomitant cardiac surgical procedures. METHODS Between May 2007 and July 2011, 150 consecutive patients were enrolled at 15 U.S. centers. Patients were followed for 6 to 9 months, at which time a 24-hour Hotter recording and echocardiogram were obtained. Recurrent AF was defined as any atrial tachyarrhythmia (ATA) Lasting over 30 seconds on the Hotter monitor. The safety end-point was the percent of patients who suffered a major adverse event within 30 days of surgery. All patients underwent a biatrial Cox-Maze Lesion set. RESULTS Operative mortality was 4%, and there were 4 (3%) 30-day major adverse events. Overall freedom from ATAs was 66%, with 53% of patients free from ATAs and also off antiarrhythmic drugs at 6 to 9 months. Increased Left atrial diameter, shorter total ablation time, and an increasing number of concomitant procedures were associated with recurrent AF (P < .05). CONCLUSION Irrigated radiofrequency ablation for treatment of AF during cardiac surgery was associated with a low complication rate. No device-related complications occurred. The Cox-Maze Lesion set was effective at restoring sinus rhythm and had higher success rates in patients with smaller Left atrial diameters and longer ablation times.