Endoscopic fundoplication bridges gap in GERD management

Gastroesophageal reflux disease (GERD) is the most common reason U.S. adults see a gastroenterologist and the leading indication for upper endoscopy. The current standard of care continues to be proton pump inhibitors (PPIs) although a large proportion of people may not need them. Of those who do, 10 to 40 percent have a partial or suboptimal response for a variety of reasons, including noncompliance and failure of the drugs to address the underlying incompetent sphincter.

It was once widely believed that PPIs had few adverse effects, but mounting evidence demonstrates that this is not the case. Long-term use is now associated with vascular disease, kidney injury and dementia due to effects on small blood vessels in the body and with increased risk of infection and certain types of fractures. In 2015, PPIs were added to the American Gerontological Society's Beers Criteria of potentially inappropriate treatments for older adults.

Until recently, Nissen fundoplication and, most commonly, laparoscopic fundoplication were the primary alternatives for patients who are intolerant to PPIs, concerned about long-term medication use or have complications of GERD such Barrett's esophagus. The surgery is not without drawbacks, however; even when performed laparoscopically, fundoplication is prone to complications and side effects such as bloating, diarrhea and dysphagia, and to a high rate of recidivism to medical therapy.

Endoscopic GERD management

In the last two decades, transesophageal endoscopic therapies have emerged to bridge the treatment gap between open or laparoscopic fundoplication and chronic medical management of GERD. Three procedures have been approved by the Food and Drug Administration for use in the United States:

  • Stretta delivers thermal energy to multiple sites in the lower esophageal sphincter and gastric cardia, producing a tissue-tightening effect related to heat-induced fibrosis.
  • Transoral incisionless fundoplication (TIF), in its current iteration, is anatomically and functionally similar to fundoplication. During the procedure, the gastric fundus is folded up and around the distal esophagus and anchored with polypropylene fasteners.
  • Medigus Ultrasonic Surgical Endostapler (MUSE), also a type of endoscopic fundoplication, uses five standard surgical staples — instead of fasteners — in three staggered rows to attach the fundus of the stomach to the esophagus, creating an anterior partial fundoplication.

Barham K. Abu Dayyeh, M.D., a gastroenterologist specializing in endoscopic procedures, including bariatric endoscopy, at Mayo Clinic's campus in Rochester, Minnesota, says although TIF has been used in the U.S. longer, both TIF and MUSE have reasonable data showing efficacy.

"Within six months and up to three years, both procedures seem to be associated with a significant improvement in GERD-related quality of life and perception of acid reflux. And two-thirds of patients are able to reduce or eliminate PPIs," he says.

MUSE

Mayo Clinic has been using the MUSE procedure for more than a year. It has the advantage of enhanced safety resulting from ultrasound guidance; when direct visualization isn't possible, an ultrasonic range finder automatically engages to measure tissue thickness. Staples are also believed to have greater durability than the fasteners used in TIF.

The procedure, which lasts about 60 to 70 minutes, is performed on an outpatient basis under general anesthesia. Patients consume a transition diet for five to seven days and then resume eating normally. They are titrated off PPIs over a period of weeks and if they continue to do well, discontinue medication completely. According to studies and Mayo Clinic experience, close to two-thirds of patients are able to discontinue PPIs.

A multicenter prospective study of 66 patients treated with the MUSE procedure found that 42 patients (64.6 percent) were no longer using daily PPI medication six months after the procedure. Of the 23 patients who continued to take medication, more than half reported a greater than 50 percent reduction in dose. Further, GERD health-related quality of life (GERD-HRQL) improved by greater than 50 percent in nearly three-quarters of patients six months after the procedure. Study details were published in Surgical Endoscopy in 2015.

Enrollment in a three-year post-marketing surveillance registry is ongoing. Mayo Clinic's campus in Minnesota is one of the sites recruiting patients, with Dr. Abu Dayyeh as principal investigator. "Many patients don't want to be on PPIs for years and years," he says. "In addition to the vascular complications, there is often suboptimal response. As we do more of these endoscopic fundoplication procedures, patients will realize that this is a very good option for them."

For more information

Zacheri J, et al. Endoscopic anterior fundoplication with the Medigus Ultrasonic Surgical Endostapler (MUSE™) for gastroesophageal reflux disease: Six-month results from a multi-center prospective trial. Surgical Endoscopy. 2015;29:220.

Medigus Ultrasonic Surgical Endostapler (MUSE) Registry. ClinicalTrials.gov.