Key result
Esophageal cooling cuts Zargar 2a lesions ~50% vs iced water during AF ablation.
Why the study?
Esophageal thermal injury remains a risk during ablation of the posterior left atrium despite existing devices, prompting evaluation of a commercially available esophageal cooling device for protection.
Does a commercially-available esophageal cooling device reduce esophageal mucosal damage in patients undergoing catheter ablation for atrial fibrillation?
RCT (n=6)
randomized
No
Does a commercially-available esophageal cooling device reduce esophageal mucosal damage in patients undergoing catheter ablation for atrial fibrillation?
An esophageal cooling device showed potential to reduce the severity of esophageal thermal injury during AF ablation in a small pilot study.
Supports esophageal cooling to reduce thermal injury during AF ablation; extends prior data with this RCT.
Background Esophageal thermal injury is a risk of ablation of the posterior left atrium despite various devices utilized to date. Objective Evaluate the potential of a commercially-available esophageal cooling device to provide esophageal protection during left atrial catheter ablation. Methods In this pilot study, we randomized 6 patients undergoing catheter ablation for atrial fibrillation. Three patients received standard of care for our site (use of a single-sensor temperature probe, with adjunct iced-water instillation for any temperature increases >1°C). Three patients received standard ablation after placement of the esophageal cooling device using a circulating water temperature of 4°C. All patients underwent transesophageal echocardiogram (TEE) and esophagogastroduodenoscopy (EGD) on the day prior to ablation followed by EGD on the day after. Results In the 3 control patients, one had no evidence of esophageal mucosal damage, one had diffuse sloughing of the esophageal mucosa and multiple ulcerations, and one had a superficial ulcer with large clot. Both patients with lesions were classified as Zargar 2a. In the 3 patients treated with the cooling device, one had no evidence of esophageal mucosal damage, one had esophageal erythema (Zargar 1), and one had a solitary Zargar 2a lesion. At 3-month follow-up, 1 patient in each group had recurrence of atrial fibrillation. Conclusions The extent of esophageal injury was less severe with a commercially available esophageal cooling device than with reactive instillation of ice-cold water. This pilot study supports further evaluation with a larger clinical trial.
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Clark et al. (2020) conducted an RCT in Atrial Fibrillation (n=6). Esophageal cooling device vs. Standard of care (single-sensor temperature probe with adjunct iced-water instillation) was evaluated on Esophageal mucosal damage (Zargar 2a lesions). An esophageal cooling device reduced the incidence of Zargar 2a esophageal lesions (33.3% vs 66.7%) compared to reactive iced-water instillation during catheter ablation for atrial fibrillation.
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