Safety and Efficacy of Radiofrequency Ablation

San Diego—Outcomes in patients with Barrett’s esophagus who, after having fundoplication (a surgical antireflux procedure), underwent radio frequency ablation (RFA) were similar to those in patients who did not undergo the surgical procedure, according to a retrospective analysis of the US RFA registry.

Both groups needed a similar number of treatments to be free of their precancerous condition, and the side effect profile was similar. Among the people in the database, 2.9% had a side effect.

Nicholas Shaheen, MD, the lead author, presented the results during a news conference and abstract session at DDW. GI Solutions, a subsidiary of Covidien and the manufacturer of the radiofrequency ablation equipment used, sponsored the registry and funded the study. Dr. Shaheen said the registry contains the largest number of patients treated with RFA for Barrett’s esophagus and the largest number of patients who underwent RFA after fundoplication.

“If you are a huge proponent of surgery before ablation, this study does not really support that,” said Dr. Shaheen, professor of medicine and epidemiology and director of the Center for Esophageal Diseases & Swallowing at the University of North Carolina Chapel Hill. “On the other hand, if you really thought [surgery] was a bad thing to do before the ablation, we do not see that, either. The short answer is that ablation works well in either patient population.”

Dr. Shaheen said that for the vast majority of people with gastroesophageal reflux disease (GERD), it is a “nuisance condition” that is treated with prescription or over-the-counter medications. However, some have severe reflux and a precancerous condition known as Barrett’s esophagus. He added that there have been >100,000 fundoplication surgeries in the United States, although ablative therapies such as RFA are more common in treating the condition. RFA uses high-energy waves to eliminate precancerous cells in the esophagus.

The registry included patients who received RFA treatment for endoscopic and histologic Barrett’s esophagus and enrolled between July 2007 and July 2011 at 113 community-based and 35 academic-affiliated institutions. They were given proton pump inhibitors (PPIs) twice daily and used the HALO catheter for endoscopic treatment of Barrett’s esophagus. The authors collected demographic data, relevant medical history, histologic grade prior to treatment, endoscopic findings, date and number of RFA treatment sessions, ablation outcomes, and complications.

The mean age of patients was approximately 61 years, while 27% were female and 94% took PPIs twice daily. Of the 5539 patients in the registry, 318 (6%) had prior surgery.

Of the patients who had fundoplication, 0.9% developed stricture (defined as an abnormal narrowing of the esophagus) after RFA and 1.3% were hospitalized. The rates of complications such as perforation, stricture, bleeding (requiring hospitalization or transfusion), and hospitalization were not statistically significant when comparing patients who had surgery with those who did not undergo surgery.

There was also no difference in the groups (surgery vs nonsurgery) in the percentage of patients who had complete eradication of intestinal metaplasia or complete eradication of dysplasia.

Dr. Shaheen cited several study limitations. The authors used observational data, which may cause selection bias. There was also an unknown functional status of fundoplication, and most fundoplication patients received PPIs, which, Dr. Shaheen said, would bias in favor of fundoplication.