Efficacy of a novel bipolar radiofrequency ablation device on the beating heart for atrial fibrillation ablation: a long-term porcine study.

OBJECTIVE: Over recent years, a variety of energy sources have been used to replace the traditional incisions of the Cox maze procedure for the surgical treatment of atrial fibrillation. This study evaluated the safety and efficacy of a new bipolar radiofrequency ablation device for atrial ablation in a long-term porcine model.

METHODS: Six pigs underwent a Cox maze IV procedure on a beating heart off cardiopulmonary bypass using the AtriCure Isolator II bipolar ablation device (AtriCure, Inc, Cincinnati, Ohio). In addition, 6 pigs underwent median sternotomy and pericardiotomy alone to serve as a control group. All animals were allowed to survive for 30 days. Each pig underwent induction of atrial fibrillation and was then humanely killed to remove the heart en bloc for histologic assessment. Magnetic resonance imaging scans were also obtained preoperatively and postoperatively to assess atrial and ventricular function, pulmonary vein anatomy, valve function, and coronary artery patency.

RESULTS: All animals survived the operation. Electrical isolation of the left atrial appendage and the pulmonary veins was documented by pacing acutely and at 30 days in all animals. No animal that underwent the Cox maze IV procedure was able to be induced into atrial fibrillation at 30 days postoperatively, compared with all the sham animals. All 257 ablations examined were discrete, linear, and transmural, with a mean lesion width of 2.2 +/- 1.1 mm and a mean lesion depth of 5.3 +/- 3.0 mm.

CONCLUSIONS: The AtriCure Isolator II device was able to create reliable long-term transmural lesions of the modified Cox maze procedure on a beating heart without cardiopulmonary bypass 100% of the time. There were no discernible effects on ventricular or valvular function.