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Active esophageal cooling for the prevention of thermal injury during atrial fibrillation ablation: a randomized controlled pilot study

Abstract

Background

Severe endoscopically detected esophageal thermal lesions (EDELs) have been associated with higher risk of progression to atrio-esophageal fistula (AEF) following radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF). We sought to evaluate safety and feasibility of active esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) to limit frequency or severity of EDELs.

Objective

We sought To evaluate safety and feasibility of active esophageal cooling using the Attune Medical Esophageal Heat Transfer Device (EnsoETM) to limit frequency or severity of EDELs

Methods

Consecutive patients undergoing first-time RFCA were randomized in a 1:1 fashion to esophageal cooling (device group) or standard temperature monitoring (control group). Ablation on the posterior wall was performed with a maximum power of 30W for up to 20s. All patients underwent EGD within 48 h. Endoscopy findings were classified as 1, erythema–mild injury; 2, superficial ulceration–moderate injury; 3, deep ulceration–significant injury; and 4, fistula/perforation. Severe EDELs were defined as grade 3 or 4 lesions.

Results

Forty-four patients completed the study (22 device group, 22 control group). Adjunctive posterior wall isolation was performed more frequently in the device group (11/22, 50% vs. 4/22, 18%). EDELs were detected in 5/22 (23%) control group patients, with mild or moderate injury in 2/5 patients (40%) and severe thermal injury in 3/5 patients (60%). In the device group, EDELs were detected in 8/22 (36%) patients, with mild or moderate injury in 7/8 (87%) patients and severe thermal injury in 1/8 (12%) patients. There was no acute perforation or AEF during follow-up.

Conclusions

Active esophageal cooling may reduce the occurrence of severe EDELs. A larger randomized study is warranted to further evaluate the benefit of this strategy.

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Acknowledgements

We would like to thank Erik Kulstad, MD, for his assistance during this study.

Funding

This research was supported by an investigator-initiated research grant from Attune Medical, the Winkelman Family Fund in Cardiovascular Innovation, and the Richard T. and Angela Clark Innovation Fund in Cardiovascular Medicine.

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Correspondence to Cory M. Tschabrunn.

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Competing interests

Drs. Santangeli and Tschabrunn received research grant support from Attune Medical. No other relevant financial disclosures.

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Tschabrunn, C.M., Attalla, S., Salas, J. et al. Active esophageal cooling for the prevention of thermal injury during atrial fibrillation ablation: a randomized controlled pilot study. J Interv Card Electrophysiol 63, 197–205 (2022). https://doi.org/10.1007/s10840-021-00960-w

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  • DOI: https://doi.org/10.1007/s10840-021-00960-w

Keywords

  • Atrial fibrillation
  • Ablation
  • Esophageal protection