ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.
When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.
The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.
The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.
“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.
The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m2. The mean CHA2DS2-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.
After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.
Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.
The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.
In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.
According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.
“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.
Dr. Parikh has no industry relationships relevant to this study.