title: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri. Electronic address: damianor@wustl.edu.
authors.forename: Ralph J
authors.initials: RJ
authors.lastname: Damiano
authors.affiliation: Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Vinay
authors.initials: V
authors.lastname: Badhwar
authors.affiliation: Division of Cardiovascular Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Acker
authors.affiliation: Department of Cardiothoracic Surgery, John Muir Medical Center, Concord, California.
authors.forename: Ramesh S
authors.initials: RS
authors.lastname: Veeragandham
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, Aurora St. Luke's Medical Center, Milwaukee, Wisconsin.
authors.forename: David C
authors.initials: DC
authors.lastname: Kress
authors.affiliation: Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Jason O
authors.initials: JO
authors.lastname: Robertson
authors.affiliation: Division of Cardiac Surgery, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Thoralf M
authors.initials: TM
authors.lastname: Sundt
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000150:complications / Q000503:physiopathology / Q000601:surgery*; D006348:Cardiac Surgical Procedures; D017115:Catheter Ablation / Q000379:methods* / Q000401:mortality; D004452:Echocardiography; D015716:Electrocardiography, Ambulatory; D005260:Female; D005500:Follow-Up Studies; D006329:Heart Conduction System / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D015996:Survival Rate / Q000639:trends; D007507:Therapeutic Irrigation; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
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