Abstract
PURPOSE: We sought to quantify the capabilities of a commercially available cooling device to protect the esophagus from RF injury in an animal model and develop a mathematical model to describe the system and provide a framework from which to advance this technology. METHODS: A series of ablations (10 W, duration 30-45 seconds) were performed directly on exposed swine esophagus. Control ablations were performed with static 37°C water, and treatment ablations were performed with water (range 5°C-37°C) circulating within the device. Mucosal lesions were evaluated visually and with target tissue histology. A mathematical model was then developed and compared against the experimental data. RESULTS: All 23 ablations (100%) performed under control conditions produced visible external esophageal lesions; 12 of these (52%) were transmural. Under treatment conditions, only 5 of 23 ablations (22%) produced visible external lesions; none (0%) were transmural. Transmurality of lesions decreased as circulating water temperature decreased, with absolute reduction ranging from 5.1% with the use of 37°C water (p=0.7) to 44.5% with the use of 5°C water (p<0.001). Comparison to the mathematical model showed an R^2 of 0.75, representing good agreement. CONCLUSION: Under worst-case conditions, with RF energy applied directly to the adventitial side of the esophagus, internal esophageal cooling with an esophageal cooling device provides significant protective effect from thermal injury. A mathematical model of the process provides a means to further investigate this approach to preventing esophageal injury during RF ablation and can serve to guide ongoing clinical investigations currently in progress.