title: The ABLATE Trial: Safety and Efficacy of Cox Maze-IV Using a Bipolar Radiofrequency Ablation System.
abstract: BACKGROUND
  The Cox Maze-IV procedure (CMP-IV) has replaced the Cox Maze-III procedure as the most common approach for the surgical treatment of atrial fibrillation (AF). The Food and Drug Administration-regulated AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation (ABLATE) trial sought to demonstrate the safety and efficacy of the CMP-IV performed with the Synergy ablation system (AtriCure, Inc, Cincinnati, OH).
  
  
  METHODS
  Fifty-five patients (aged 70.5 ± 9.3 years), 92.7% of whom had nonparoxysmal AF, underwent CMP-IV to terminate AF during a concomitant cardiac surgical procedure. Lesions were created using the AtriCure Synergy bipolar radiofrequency ablation system. All patients were seen for follow-up visits after 30 days, 3 months, and 6 months, with 24-hour Holter monitoring at 6 months. Late evaluation was performed by 48-hour Holter monitoring at an average of 21 months.
  
  
  RESULTS
  The primary efficacy endpoint, absence of AF (30 seconds or less) at 6-month follow-up off antiarrhythmic medications (Heart Rhythm Society definition), indicated 76% (38 of 50) were AF free (95% confidence interval: 62.6% to 85.7%). The primary safety endpoint, the rate of major adverse events within 30 days, was 9.1% (5 of 55; 95% confidence interval: 3.9% to 19.6%), with 3.6% mortality (2 of 55). Secondary efficacy endpoints included being AF free with antiarrhythmic drugs (6 months, 84%; 21 months, 75%), successful pulmonary vein isolation (100%), and AF burden at 6 and 21 months. The results, together with those for the secondary safety endpoint (6-month major adverse events), demonstrated that the Synergy system performs comparably to the cut-and-sew Cox Maze-III procedure.
  
  
  CONCLUSIONS
  The CMP-IV using the AtriCure Synergy system was safe and effective for cardiac surgical patients who had persistent and longstanding persistent AF.
authors.affiliation: Department of Surgery, Eastern Virginia Medical School, Norfolk, Virginia; Mid-Atlantic Thoracic Surgeons, Sentara Heart Hospital, Norfolk, Virginia.
authors.forename: Jonathan M
authors.initials: JM
authors.lastname: Philpott
authors.affiliation: Department of Electrical and Computer Engineering, Old Dominion University, Norfolk, Virginia; Center for Bioelectrics, Old Dominion University, Norfolk, Virginia. Electronic address: czemlin@odu.edu.
authors.forename: Christian W
authors.initials: CW
authors.lastname: Zemlin
authors.affiliation: Washington University School of Medicine, Barnes-Jewish Hospital, St Louis, Missouri.
authors.forename: James L
authors.initials: JL
authors.lastname: Cox
authors.affiliation: Munson Medical Center, Traverse City, Michigan.
authors.forename: Mack
authors.initials: M
authors.lastname: Stirling
authors.affiliation: Baylor Heart Hospital, Plano, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Spectrum Health, Butterworth Hospital, Grand Rapids, Michigan.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Hooker
authors.affiliation: Mercy Heart Institute, Sacramento, California.
authors.forename: Allen
authors.initials: A
authors.lastname: Morris
authors.affiliation: Heart Center of Indiana, Indianapolis, Indiana.
authors.forename: David A
authors.initials: DA
authors.lastname: Heimansohn
authors.affiliation: Sutter Heart Institute, Sacramento, California.
authors.forename: James
authors.initials: J
authors.lastname: Longoria
authors.affiliation: McLaren Greater Lansing, Lansing, Michigan.
authors.forename: Divyakant B
authors.initials: DB
authors.lastname: Gandhi
authors.affiliation: Northwestern University, Chicago, Illinois.
authors.forename: Patrick M
authors.initials: PM
authors.lastname: McCarthy
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000503:physiopathology / Q000601:surgery*; D017115:Catheter Ablation / Q000295:instrumentation*; D015716:Electrocardiography, Ambulatory; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011667:Pulmonary Veins / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome