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J Thorac Cardiovasc Surg 2005;130:803
© 2005 The American Association for Thoracic Surgery

Evolving Technology

Surgical ablation of atrial fibrillation with off-pump, epicardial, high-intensity focused ultrasound: Results of a multicenter trial

^a Hôpital Cardiologique Louis Pradel and Claude Bernard University, Lyon, France
^b Hôpital Haut Lévêque and Victor Segalen University, Bordeaux, France
^c AKH and Vienna University, Vienna, Austria
^d Hospital Clinico and University of Barcelona, Barcelona, Spain
^e Onze Lieve Vrouwziekenhuis, Aalst, Belgium
^f Epicor Medical, Inc, Sunnyvale, Calif
^g Division of Cardiothoracic Surgery, Washington University School of Medicine, St Louis, Mo

Received for publication February 6, 2005; revisions received May 7, 2005; accepted for publication May 18, 2005.

^_* Address for correspondence: Gerard Champsaur, MD, 1430 Channing Ave, Palo Alto, CA 94301 (Email: jean.ninet{at}chu-lyon.fr; gchampsaur{at}pacbell.net).

^_* Address for reprints: Jean Ninet, MD, Cardiac Surgery, Hôpital Cardiologique Louis Pradel, 59 Blvd Pinel, 69003, Lyon, France (Email: jean.ninet{at}chu-lyon.fr; gchampsaur{at}pacbell.net).

BACKGROUND: A simplified alternative to the Cox maze procedure to treat atrial fibrillation with epicardial high-intensity focused ultrasound was evaluated clinically, and the initial clinical results were assessed at the 6-month follow-up visit.

METHODS: From September 2002 through February 2004, 103 patients were prospectively enrolled in a multicenter study. Atrial fibrillation duration ranged from 6 to 240 months (mean, 44 months) and was permanent in 76 (74%) patients, paroxysmal in 22 (21%) patients, and persistent in 5 (5%) patients. All patients had concomitant operations, and ablation was performed epicardially on the beating heart before the concomitant procedure. The device automatically created a circumferential left atrial ablation around the pulmonary veins in an average of 10 minutes, and an additional mitral line was created epicardially in 35 (34%) patients with a handheld device by using the same technology.

RESULTS: No complications or deaths were device or procedure related. There were 4 (3.8%) early deaths and 2 late extracardiac deaths. The 6-month follow-up was complete in all survivors. At the 6-month visit, freedom from atrial fibrillation was 85% in the entire study group (80% in patients with permanent atrial fibrillation, 88% in the 35 patients who had the additional mitral line, and 100% in patients with paroxysmal atrial fibrillation). A pacemaker was implanted in 8 patients. Only the duration and type of atrial fibrillation significantly increased the risk of recurrence.

CONCLUSION: Epicardial, off-pump, beating-heart ablation with acoustic energy is safe and cures 80% of patients with permanent atrial fibrillation associated with long-standing structural heart disease.

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