ABSTRACT
Background: Esophageal thermal injury is a complication of atrial fibrillation (AF) ablation, and it can be avoided by esophageal deviation during left atrial posterior wall radiofrequency catheter ablation. Objective: This study aimed to evaluate the safety of a nitinol-based mechanical esophageal displacement device (MEDD) and its performance. Methods: This preclinical safety study was conducted on 20 pigs, with 10 undergoing radiofrequency AF ablation using the MEDD and 10 serving as a control group under anticoagulation but without radiofrequency application. Esophageal traumatic injuries were classified from 0 to 4 and were grouped as absent (grade 0), minor (grade 1 or 2), moderate (grade 3), or major risk lesions (grade 4) by anatomopathological study. Grades 1 and 2 were considered acceptable. Fluoroscopy was used to measure displacement. Results: Five (25%) pigs developed traumatic lesions, 4 with grade 1 and 1 with grade 2 (2-mm superficial ulcer). There was no difference in lesion occurrence between the radiofrequency and control groups (30% and 20%, respectively; P = .43). Under rightward displacement, the right edge moved 23.9 (interquartile range [IQR] 21.3-26.3) mm and the left edge moved 16.3 (IQR 13.8-18.4) mm (P < .001) from baseline. Under leftward displacement, the right edge moved 13.5 (IQR 10.9-15.3) mm and the left edge moved 16.5 (IQR 12.3-18.5) mm (P = .07). A perforation to the pharyngeal diverticulum occurred in 1 pig, related to an accidental extubation. Conclusion: In pigs, the MEDD demonstrated safety in relation to esophageal tissue, and successful deviation. Esophageal traumatic injuries were acceptable, but improper manipulation led to pharyngeal lesion.
