Background: Thermal injury to the esophagus is a known complication of ablation for atrial fibrillation (AF) and accounts for most procedure-related mortality. Thermal protection of the esophageal lumen by infusing cold liquid can reduce thermal injury to a limited extent.
Objective: To investigate the ability of a powerful temperature control device to protect the esophagus from ablation-related thermal injury.
Methods: A single-center, prospective, double-blinded randomized controlled trial was used to investigate the ability of the ensoETM device to protect the esophagus from thermal injury. This method was compared in a 1:1 randomization to a control group of standard practice utilizing a single-point temperature probe. In the study group, the device was used to keep the luminal temperature at 4 degrees during radiofrequency (RF) ablation for AF. Endoscopic examination was performed at 7 days post-ablation and esophageal injury was scored. The patient and the endoscopist were blinded to the randomization.
Results: We recruited 188 patients, of whom 120 underwent endoscopy. Thermal injury to the mucosa was significantly more common in the control group than in those receiving esophageal protection (12/60 versus 2/60; P=0.008), with a trend toward reduction in gastroparesis (6/60 Vs 2/60, p=0.27). There was no difference between groups in RF duration, force, power and combined ablation index (P value range= 0.2-0.9). Procedure duration and fluoroscopy duration were similar (P=0.97, P=0.91 respectively).
Conclusion: Thermal protection of the esophageal lumen significantly reduces ablation-related thermal injury compared to standard care. This method of esophageal protection is safe and does not compromise the efficacy of the ablation procedure.