Canine Model of Esophageal Injury and Atrial-Esophageal Fistula After Applications of Forward-Firing High-Intensity Focused Ultrasound and Side-Firing Unfocused Ultrasound in the Left Atrium and Inside the Pulmonary Vein

BACKGROUND: Left atrial-esophageal fistula is a serious and poorly understood complication of catheter ablation of atrial fibrillation. The purpose of this study was to (1) develop a canine model of esophageal injury and left atrial-esophageal fistula after applications of forward-firing high-intensity focused ultrasound (HIFU) and side-firing unfocused ultrasound (SFU); (2) examine the relationship to esophageal temperature (Eso-temp); and (3) study the evolution of injury/healing. METHODS AND RESULTS: Twenty dogs were studied. After transeptal puncture, HIFU catheter (ProRhythm Inc; 13 dogs) was positioned close to the esophagus, either outside (n=6) or inside (n=7) the inferior pulmonary vein (PV). In 7 other dogs, an SFU catheter was placed deep inside the PV, close to the esophagus. A balloon (20- to 25-mm diameter) with 7 thermocouples (2-mm separation) was positioned in the esophagus (Eso-balloon). Variable air filling of the Eso-balloon controlled the distance from the esophagus to the sonication source, pressing the esophagus against left atrium/PV. One to 9 (median, 5) HIFU (35 W) and 5 to 7 (median, 5) SFU (40 W) sonications were delivered for 40 seconds. Maximum luminal Eso-temp was closely related to HIFU Eso-balloon distance. For HIFU outside PV, Eso-temp >or=50 degrees C occurred only for HIFU Eso-balloon distance or=50 degrees C, with HIFU Eso-balloon distance up to 6.8 mm. Endoscopy identified esophageal ulcer immediately after ablation in 11 of 13 HIFU dogs and 7 of 7 SFU dogs, all with Eso-temp >or=50 degrees C. Endoscopy at 2 weeks showed ulcer healing in 5 of 11 chronic dogs and ulcer size progression with relaxation of the lower esophageal sphincter and esophagitis in 6 dogs. Two dogs developed left atrial-esophageal fistula and died at 2 weeks. CONCLUSIONS: This model produces esophageal ulcer when Eso-temp is >or=50 degrees C. Eso-temp is higher with HIFU/SFU applications closer to the esophagus and with HIFU/SFU applications inside the PV. Ulcer progression and left atrial-esophageal fistula were associated with reflux esophagitis.