Multicenter analysis of atrioesophageal fistula rates before and after adoption of active esophageal cooling during atrial fibrillation ablation

Abstract

Background: Active esophageal cooling reduces the incidence of endoscopically identified severe esophageal lesions during radiofrequency (RF) catheter ablation of the left atrium for the treatment of atrial fibrillation. No atrioesophageal fistula (AEF) has been reported to date with active esophageal cooling, and only one pericardio-esophageal fistula has been reported; however, a formal analysis of the AEF rate with active esophageal cooling has not previously been performed. Methods: Atrial fibrillation ablation procedure volumes before and after adoption of active cooling using a dedicated esophageal cooling device (ensoETM, Attune Medical) were determined across 25 hospital systems with the highest total use of esophageal cooling during RF ablation. The number of AEFs occurring in equivalent time frames before and after adoption of cooling were then determined, and AEF rates were compared using generalized estimating equations robust to cluster correlation. Results: Throughout the 25 hospital systems, which included a total of 30 separate hospitals, 14,224 patients received active esophageal cooling during RF ablation, with the earliest adoption beginning in March 2019 and the most recent beginning in March 2022. In the time frames prior to adoption of active cooling, a total of 10,962 patients received primarily luminal esophageal temperature (LET) monitoring during their RF ablations. In this pre-adoption cohort a total of 16 AEFs occurred, for an AEF rate of 0.146%, in line with other published estimates of <0.1% to 0.25%. No AEFs were found in the cohort treated after adoption of active esophageal cooling, yielding an AEF rate of 0% (P<0.0001). Conclusion: Adoption of active esophageal cooling during RF ablation of the left atrium for the treatment of atrial fibrillation was associated with a significant reduction in AEF rate.

Proactive esophageal cooling during laser cardiac ablation: A computer modeling study

“…This allowed a significant decrease in the percentage of damaged esophagus, where values of a maximum of 60% were seen in the control case without the use of protection to values of 0% in the protected cases using PEC. This reduction in esophageal injury aligns well with what has been seen with the use of PEC in RF ablation, both in preclinical and mathematical models 6,10,30,31 as well as in published clinical data 32,33 . Although the simplified geometric model has inherent limitations, recent clinical data have been presented with findings suggestive of a beneficial clinical effect from cooling during laser ablation, albeit without having a histopathological correlation on tissue effects.…”

Real-world results of oesophageal protection from a temperature control device during left atrial ablation

“…Although not yet appearing in the database search, there is one confirmed case of oesophago-pericardial fistula from 25 216 uses. 13 …”

Role of oesophageal cooling in the prevention of oesophageal injury in atrial fibrillation catheter ablation

“…Additionally, our analysis showed that oesophageal cooling was not associated with differences in procedural time, radiofrequency time, acute reconnection index or ablation index. Although retrospective studies of multicentre analysis and device registries have demonstrated a marked reduction of atrioesophageal fistula after the adoption of active oesophageal cooling using the EnsoETM device, 7 , 8 still there is no large randomized controlled study to demonstrate that benefit. Future directions should be guided towards a large randomized trial with long-term follow-up to better evaluate the role of oesophageal cooling in oesophageal injury prevention in patients undergoing AF catheter ablation.…”