Feasibility, safety, and efficacy of a novel preshaped nitinol esophageal deviator to successfully deflect the esophagus and ablate left atrium without esophageal temperature rise during atrial fibrillation ablation: The DEFLECT GUT study

BACKGROUND Esophageal thermal injury is a feared complication of radiofrequency ablation for atrial fibrillation (AF). Rise in luminal esophageal temperature (LET) limits the ability to deliver radiofrequency energy on the posterior wall of the left atrium. OBJECTIVE The purpose of this study was to evaluate the feasibility, safety, and efficacy of a mechanical esophageal deviation (ED) tool during AF ablation. METHODS We evaluated 687 patients who underwent radiofrequency ablation for AF. In 209 patients, the EsoSure (Northeast Scientific) was used to deflect the esophagus away from the ablation site. Propensity score matching was performed to obtain 180 patients each in the ED and non-ED arms. ED was used for LET rise seen in 61.7% of patients (111/180) and was used if the esophagus was in the line of ablation on fluoroscopy in 38.3% of patients (69/180). RESULTS Mean deviation of trailing edge of esophagus with EsoSure was 2.45 +/- 0.9 cm (range 1-4.5). LET rise >1 degrees C was significantly lower in the ED than non-ED group (3% vs 79.4%; P <.001). Mean LET rise was also lower in the ED arm (ED 0.34 +/- 0.59 vs non-ED 1.66 +/- 0.54; P <.001). Intraprocedural success of pulmonary vein antral isolation, was slightly improved in the ED arm than in the non-ED arm without statistical significance. AF recurrence was lower in the ED arm at 3-month, 6-month, and 1-year follow-up than in the non-ED arm. No ED-related complications were noted. CONCLUSION Mechanical displacement of the esophagus with Eso-Sure seems to be feasible, safe, and efficacious in enabling adequate radiofrequency energy delivery to the posterior wall of the left atrium without significant LET rise and obvious clinical signs of esophageal injury.