Esophageal Protection

Proactive cooling during radiofrequency (RF) cardiac ablation^*
The ensoETM^® system has been shown to reduce the risk of thermal injury through proactive cooling during RF cardiac ablation,¹ as well as demonstrating a reduction in mean procedure time,^3,4 increased mean lab throughput,⁵ and a 14% absolute increase in freedom from atrial arrhythmia at one year.⁶ Additionally, a real world retrospective study of 25,186 patients showed a statistically significant reduction in atrioesophageal fistula (AEF) from 0.146% with LET monitoring to 0% after adoption of the ensoETM^® system.²

ensoETM®

FDA-granted indication to reduce the likelihood of ablation-related esophageal injury resulting from RF cardiac ablation procedures.¹

Akin to a standard orogastric tube circulating chilled water, the ensoETM^® system has been shown to reduce the risk of thermal injury through proactive cooling during RF cardiac ablation.¹

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* For ensoETM models ECD01-A and ECD02-A. Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions, adverse events and instructions for use.
† Results are from studies comparing the ensoETM system to luminal esophageal temperature (LET) monitoring.
1. Leung, L. W. M., Bajpai, A., Zuberi, Z., Li, A., Norman, M., Kaba, R. A., Akhtar, Z., Evranos, B., Gonna, H., Harding, I., Sohal, M., Al-Subaie, N., Louis-Auguste, J., Hayat, J., Gallagher, M. M. (2021). Randomized comparison of oesophageal protection with a temperature control device: results of the IMPACT study. EP Europace, 23(2), 205–215. https://doi.org/10.1093/europace/euaa276
2. Sanchez, J, Woods, C, Zagrodzky, J. et al. Atrioesophageal Fistula Rates Before and After Adoption of Active Esophageal Cooling During Atrial Fibrillation Ablation. J Am Coll Cardiol EP. 2023 Dec, 9 (12)2558–2570. DOI: https://doi.org/10.1016/j.jacep.2023.08.022
3. Joseph, C., Nazari, J., Zagrodzky, J. et al. Improved 1-year outcomes after active cooling during left atrial radiofrequency ablation. J Interv Card Electrophysiol 66, 1621–1629 (2023). https://doi.org/10.1007/s10840-023-01474-3
4. Cooper, J., Joseph, C., Zagrodzky, J., et al. (2022). Active esophageal cooling during radiofrequency ablation of the left atrium: data review and update. Expert Review of Medical Devices, 19(12),949–957. https://doi.org/10.1080/17434440.2022.2150930
5. Joseph C, et al. Impact of active esophageal cooling on catheter ablation procedure times across five healthcare systems. Euro Heart J 2023;44 (Suppl 2).
6. Joseph C, et al. Procedural time reduction associated with active esophageal cooling during pulmonary vein isolation. J Interv Card Electophysiol 2022; (65):617-622. https://doi.org/10.1007/s10840-022-01204-1.7.
7. Leung, L. W. M., Ahkhtar Z, Elbatran A.I., Bajpai A., Li A., Norman M., Kaba R., Sohal, M., Zuberi Z., Gallagher M.M. on behalf of the IMPACT study group. Effect of esophageal cooling on ablation lesion formation in the left atrium; Insights from ablation index data in the IMPACT trial and clinical outcomes. J Cardiovasc Electrophysiol 2022;22:2546-2557. https://DOI:10.1111/jce.15717
8. Zagrodzky W, Cooper J, Joseph C, et al. Association between proactive esophageal cooling and increased lab throughput. J Cardiovasc Electrophysiol. 2024; 1-6. doi: https://doi.org/10.1111/jce.16263

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