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


CONCLUSIONS
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.
Ninet
Jean
J
Hôpital Cardiologique Louis Pradel and Claude Bernard University, Lyon, France. jean.ninet@chu-lyon.fr
Roques
Xavier
X
Seitelberger
Rainald
R
Deville
Claude
C
Pomar
Jose Luis
JL
Robin
Jacques
J
Jegaden
Olivier
O
Wellens
Francis
F
Wolner
Ernst
E
Vedrinne
Catherine
C
Gottardi
Roman
R
Orrit
Javier
J
Billes
Marc-Alain
MA
Hoffmann
Drew A
DA
Cox
James L
JL
Champsaur
Gerard L
GL
D000328:Adult; D000368:Aged; D001281:Atrial Fibrillation / Q000601:surgery*; D006348:Cardiac Surgical Procedures / Q000295:instrumentation / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods