Web edition: February 20, 2013
Print edition: April 6, 2013; Vol.183 #7 (p. 14)
A small ring of magnets cinched around the bottom of the esophagus can prevent acid reflux in many people. Eighty-six of 100 patients with persistent reflux who had the device surgically implanted no longer needed heartburn medications one year later, researchers report in the Feb. 21 New England Journal of Medicine.
“This is very encouraging,” says Peter Kahrilas, a gastroenterologist at the Northwestern University School of Medicine in Chicago who wasn’t part of the research. He says that for reflux disease, the magnet-laden ring is “the most promising device that has been introduced in a long time, if not ever.”
While the U.S. Food and Drug Administration approved the device for reflux in March 2012, scientists are still monitoring its long-term safety and effectiveness in patients with gastroesophageal reflux disease, or GERD. Chronic GERD can lead to esophageal scarring and a condition marked by abnormal cell growth called Barrett’s esophagus, which increases the risk of an esophageal cancer called adenocarcinoma. In the United States, nearly 18,000 people each year develop some form of esophageal cancer.
Medicines to treat GERD aim to neutralize acid in the stomach or limit its production. But they don’t address the anatomical problem at the core of acid reflux: the defective sphincter valve between the esophagus and the stomach that allows some of the stomach’s acidic digestive juices to backflow into the esophagus.
The device is an expandable ring of titanium beads with magnetic cores that looks like a tiny bracelet. A surgeon clips it around the bottom of the esophagus to close it off where it enters the stomach. The ring of magnets pulls inward to cinch the tube closed but can expand to allow food to pass downward. It even allows a person to belch as needed.
The high success rate in patients continued over three years, says study coauthor Robert Ganz, a gastroenterologist at the University of Minnesota in Minneapolis. The patients in the study who did continue to need heartburn medications decreased their doses. Also, the pH level of the lower esophagus, where acid has no business being, normalized in most patients after the ring was installed.
But six patients experienced pain, vomiting and difficulty swallowing and ultimately had the device removed. Two-thirds of the entire group reported some difficulty swallowing just after the ring was put in place, but this rate fell to 11 percent one year after surgery and 4 percent at three years.
Torax Medical of Shoreview, Minn., makes the device and markets it as LINX. Doctors at various hospitals have implanted a few hundred of the devices so far, the study authors note.
But questions remain, Kahrilas says. The study had no control group getting other treatment for comparison. Also, the participants were not a random sampling of GERD patients. While all were faring poorly on standard medications, the group excluded anyone who was obese, had advanced inflammation of the esophagus or had a large hiatal hernia, a bulge in the stomach that is commonly associated with GERD.
Kahrilas says further tests will be necessary to determine who the optimal patients would be, particularly when the device is stacked up against medications that curb acid production. That includes proton pump inhibitors sold under brand names such as Prilosec, Nexium and Aciphex. These drugs are effective, but scientists have questioned their long-term safety (SN: 12/04/10, p. 30).
The Torax website doesn’t say how much the device and its installation cost, but Medicare reimburses another esophageal sphincter valve surgery called fundoplication — an operation with a higher rate of side effects.
R. Ganz et al. Esophageal sphincter device for gastroesophageal reflux disease. New England Journal of Medicine. Vol. 368, February 21, 2013, p. 710. doi: 10.1056/NEJMoa1205544 [Go to]
N. Seppa. It’s enough to give you heartburn. Science News. Vol. 178, December 4, 2010, p. 30. [Go to]
L. Bonavina et al. Laparoscopic sphincter augmentation device eliminates reflux symptoms and normalizes esophageal acid exposure: one- and 2-year results of a feasibility trial. Annals of Surgery. Vol. 252, November 2010, p. 857. doi: 10.1097/SLA.0b013e3181fd879b [Go to]