Background: Esophageal injury is a feared complication of atrial fibrillation (AF) ablation. Esophageal temperature monitoring has been used as a surrogate marker for potential esophageal thermal injury. Often times, rise in esophageal temperature during radiofrequency ablation (RFA) for AF limits the ability to deliver RF energy.
Objective: The aim of this study was to evaluate the safety and efficacy of the EsoSure® (Northeast Scientific, Inc., Waterbury, CT), a mechanical esophageal deviation tool, during RFA for AF.
Methods: In this prospective observational series, we evaluated 135 consecutive patients from 4 centers in whom luminal esophageal temperature (LET) rise or likely rise was limiting RFA lesion delivery on the posterior wall of the LA. EsoSure® was used to deflect the esophagus away from the ablation site in the LA. Light Barium was used to visualize and confirm esophageal displacement in all patients. Baseline demographics, procedural variables and complication rates were collected and evaluated. Patients were followed up to 3 months for clinical signs and symptoms of esophageal injury.
Results: The mean age of our sample was 64 ± 10 years and 77 (57%) patients were males. Mean CHA2DS2-VASc score was 2.72 ± 1 and 97 (74 %) patients had paroxysmal AF. The mean deviation of the trailing edge of the esophagus with EsoSure® was 2.6 ± 1 cm (range: 0.8 - 4.5 cm). Successful intra-procedural end point, defined as successful pulmonary vein isolation, was achieved in 100% of patients. Among the 96 (71%) patients in whom EsoSure® was used after an increase in LET, the mean peak rise of LET was 1.3 ± 0.2° C prior to the EsoSure® use and 0.2 ± 0.1° C after the EsoSure® use (p<0.001). There were no complications related to the EsoSure® use through 3-month follow-up. No symptoms suggestive of esophageal injury were noted related to AF ablation.
Conclusions: Mechanical displacement of the esophagus with EsoSure® device appears to be safe and efficacious in enabling adequate RF energy delivery to the posterior wall of the LA during RFA for AF without significant luminal temperature rise and obvious clinical signs or symptoms of esophageal injury up to 3 months of follow up.