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

Abstract

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 Holter recording and echocardiogram were obtained. Recurrent AF was defined as any atrial tachyarrhythmia (ATA) lasting over 30 seconds on the Holter 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.

Trial registration: ClinicalTrials.gov NCT00431834.

Keywords: AF; ATA; AV; Arrhythmia surgery; Atrial fibrillation; CS; CURE-AF; Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation; FDA; Food and Drug Administration; IDE; LA; LAA; LVEF; MAE; MI; MV; MVA; Maze procedure; NYHA; New York Heart Association; PV; PVI; RA; RF; Radiofrequency ablation; SVC; Surgical ablation; atrial fibrillation; atrial tachyarrhythmia; atrioventricular; coronary sinus; investigational device exemption; left atrial appendage; left atrium; left ventricular ejection fraction; major adverse event; mitral valve; mitral valve annulus; myocardial infarction; pulmonary vein; pulmonary vein isolation; radiofrequency; right atrium; superior vena cava.