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2020 AF Symposium

Protecting the Esophagus by Cooling It

Mark Gallagher. MD

“We know that most strategies (to prevent fistula) don’t work,” Says Dr. Mark Gallagher from St. George’s University Hospital in London, United Kingdom.

At the 2020 AF Symposium, he described an innovative strategy he and his colleagues developed to prevent fistula. He presented the completed IMPACT study which investigated whether Attune Medical’s ensoETM esophageal cooling system could effectively reduce the incidence and severity of thermal injuries to the esophagus during cardiac ablation.

What is Atrial Esophageal Fistula?
Atrial-Esophageal Fistula is the worst complication of a catheter ablation. Unlike most other ablation complications, this can kill you.

What is Atrial Esophageal Fistula? During an ablation, heat from the RF catheter applied to the back of the heart can damage the esophagus which often lies just behind the posterior wall of the left atrium. (This can also happen to some extent with Cryo ablation.)

How Atrial Esophageal Fistula can kill You: If RF heat damages the esophagus, ulcer-like lesions form in the esophagus. Then 2-3 weeks post-ablation, gastric acids (reflux) can eat away at these lesions creating a fistula (hole) from the esophagus into the heart. Without major intervention, blood can pump from the heart into the esophagus leading to death.

IMPACT Double Blind Randomised Controlled Trial

In their clinical trial, Dr. Mark Gallagher and colleagues divided 120 patients into two groups: a control group and a experimental group.

IMPACT stands for Improving Oesophageal Protection During Catheter Ablation for Atrial Fibrillation.

The Control Group: The control group received only standard care, in this case a temperature probe in the esophagus. If the temperature in the esophagus went too high, they would stop the ablation till the temperature went back down (current practice).

This would often lead to the EP not being able to effectively isolate all A-Fib signal areas in the heart which were too close to the esophagus. And often, by the time the temperature went up, damage had already been done to the esophagus.

The Experimental Group: Patients in the second (experimental) group instead received a 3-foot long silicone soft tube in their esophagus connected to what was basically a refrigerator. This closed loop system pumped cooled water (25  ͦ F) down one loop of the tube, then back through another loop to the console whenever the EP worked near the esophagus. The EP controls the temperature.

Double-Blind for Both Operators and Evaluators

This was a double-blind study. The EP doing the ablation didn’t know if they were working on a Control or Experimental patient. And the doctors evaluating the procedure for possible esophagus damage also were blinded.

After 7 days, an endoscopy was performed on each patient’s esophagus (an endoscopy examines the inside of an organ). They were looking for lesions and for gastroparesis (delayed emptying of the stomach).

IMPACT Study Results

The Control group who received the standard temperature probe had multiple epithelial lesions, while the Experimental group who experienced the closed loop cooling system had only one minor lesion.

The Experimental group also needed less fluoroscopy (X-ray) time. And, more importantly, the EP was able to ablate longer in areas near the esophagus (such as the posterior wall of the left atrium). That improved the success rate of the ablation and ablation efficacy.

Editor’s Comments

Most fistula patients die. And for those who live through the emergency treatment, they are often compromised for life. But with the esophageal cooling system, patients and doctors may never again have to worry about the dreaded complication Atrial-Esophageal Fistula!
Cooling the Esophagus, a Major Medical Breakthrough! Cooling the esophagus is simple and relatively easy to do. And, barring future research findings, it seems full proof.
The Attune Medical’s ensoETM esophageal cooling system is certainly cheaper than having to care for patients with a fistula.

The Attune Medical ensoETM esophageal cooling system can provide both cooling during RF ablation, and heating during Cryo ablation.

Probably among the major proponents of the esophagus cooling system will be hospital administrators. Treating patients with a fistula is a huge expense and a nightmare for hospital staff.
A fistula is an all-hands-on-deck emergency involving not just the EP department but surgeons and many hospital staffers. A surgeon may have to perform emergency surgery to insert stents in the esophagus in order to close off the fistula, or the surgeon may have to cut out part of the damaged esophagus, which is particularly risky
(I remember one EP describing how he and his staff were running down a hospital corridor with their fistula patient close to dying, in order to get the patient to an operating surgeon.).
Esophageal Cooling Means Better Ablations: And as a bonus, using the esophageal cooling system enables EPs to do a more thorough better job. They can ablate all areas of the heart rather than avoiding areas too close to the esophagus or using lower power with shorter duration or less contact force.
When Will Esophageal Cooling be Available? For catheter ablation application, probably not soon. In the U.S and probably worldwide, Attune Medical’s ensoETM esophageal cooling system is already in use and approved for specific purposes, for example, in cases of brain damage where a patient needs to have their whole body cooled down. But not for catheter ablation
In the United Kingdom, it will first have to be approved by NHS. In the U.S., it may not need to go through the FDA approval process again. (But this is a very speculative observation.)

Will Ablation Centers Implement? It will probably require a great deal of marketing to make EPs and ablation centers aware of and actually start using the esophageal cooling system. And because Atrial-Esophageal Fistula is such a rare complication, centers may not be willing to invest in an esophageal cooling system.

References
If you are looking for Dr. Mark Gallagher’s talk in the AF Symposium brochure, it was not listed. It was presented on Friday, January 24, 2020 in the session “Advances in Pulmonary Vein Isolation (Session II.)”

See also Zagrodzky, J. et al. Fluoroscopy Reduction During Left Atrial Ablation After Implementation of an Esophageal Cooling Protocol. AFS2020-03 AF Symposium brochure abstract, p. 28. St. David’s South Austin Medical Center, 2020.

Late-Breaking Clinical Study Evaluates Attune Medical’s ensoETM for Use During Cardiac Ablation Procedures. EPDigest. February 3, 2020. https://www.eplabdigest.com/late-breaking-clinical-study-evaluates-attune-medicals-ensoetm-use-during-cardiac-ablation-procedures

If you find any errors on this page, email us. Y Last updated: Wednesday, April 29, 2020

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