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Ann Thorac Surg. 2015 Nov;100(5):1541-6; discussion 1547-8. doi: 10.1016/j.athoracsur.2015.07.006. Epub 2015 Sep 19.

The ABLATE Trial: Safety and Efficacy of Cox Maze-IV Using a Bipolar Radiofrequency Ablation System.

Author information

1
Department of Surgery, Eastern Virginia Medical School, Norfolk, Virginia; Mid-Atlantic Thoracic Surgeons, Sentara Heart Hospital, Norfolk, Virginia.
2
Department of Electrical and Computer Engineering, Old Dominion University, Norfolk, Virginia; Center for Bioelectrics, Old Dominion University, Norfolk, Virginia. Electronic address: czemlin@odu.edu.
3
Washington University School of Medicine, Barnes-Jewish Hospital, St Louis, Missouri.
4
Munson Medical Center, Traverse City, Michigan.
5
Baylor Heart Hospital, Plano, Texas.
6
Spectrum Health, Butterworth Hospital, Grand Rapids, Michigan.
7
Mercy Heart Institute, Sacramento, California.
8
Heart Center of Indiana, Indianapolis, Indiana.
9
Sutter Heart Institute, Sacramento, California.
10
McLaren Greater Lansing, Lansing, Michigan.
11
Northwestern University, Chicago, Illinois.

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.

[Indexed for MEDLINE]

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