May 28, 2012
The Wall Street Journal
New Surgery Tries a Device to Treat Stubborn Heartburn
A fishing-rod-type device, made by EndoGastric Solutions, lets surgeons operate for heartburn without incisions.
When medications aren't enough to control the unpleasant symptoms of heartburn and acid reflux, surgery is sometimes necessary. A new procedure done with no incisions is being promoted as an alternative to conventional surgery.
Traditional heartburn surgery involves tiny incisions in the abdomen, through which surgical tools are inserted and a new valve is created that prevents stomach contents from rising up. In the new procedure, the valve is created by inserting a surgical device that looks like a toy fishing pole into the mouth and snaking it down the throat to where the esophagus meets the stomach. The device is sold by EndoGastric Solutions Inc., of Redwood City, Calif.
"It's not as aggressive a procedure" as traditional surgery but it isn't as effective based on patient satisfaction and elimination of acid in the esophagus, says Hiran C. Fernando, chief of thoracic surgery at Boston Medical Center. The upside is that the new technique has fewer longterm side effects, including bloating, says Dr. Fernando, who performs both types of procedures.
So far, most studies on the new procedure have followed patients for six months or a year afterward. "We honestly don't know what the efficacy is going to be long term," says Reginald C.W. Bell, a surgeon in Englewood, Colo., who occasionally serves as a paid consultant to Endogastric Solutions. The procedure typically costs $6,000 to $14,000; some insurers cover it, but many still consider it experimental.
Frequent heartburn or acid reflux are symptoms of a condition called GERD, or gastroesophageal reflux disease, which occurs when a sphincter muscle in the lower esophagus stops working properly. Some 20% of Americans experience symptoms of reflux of stomach contents at least weekly, including a burning sensation in the chest or throat or regurgitation, according to the National Institutes of Health.
Losing weight and avoiding problem foods can help. Medications, including proton-pump inhibitors, suppress stomach-acid production. But when symptoms persist, surgery is often recommended.
Heartburn surgery is called fundoplication because it involves folding the fundus, or top portion of the stomach, onto the esophagus and fastening it there using stitches in traditional surgery or plastic fasteners in the case of the new surgery. The new "valve" works because pressure in the stomach after eating constricts the esophagus, surgeons say.
Traditional surgery can be more effective because it allows more extensive repair of surrounding tissue, surgeons say. Also, the traditional procedure folds the stomach around the esophagus in a 360-degree arc, compared with 270 degrees in the new procedure.
"You are going to get better results with the [traditional] laparoscopic procedure every time—at least right now," says Blair A. Jobe, professor of surgery at the University of Pittsburgh.
An analysis of 10 studies involving a total of 393 patients, published earlier this year in the Journal of Thoracic and Cardiovascular Surgery, found between 26% and 83% of patients getting the new surgery were able to stop taking proton-pump inhibitors. Overall, says Boston Medical Center's Dr. Fernando, a co-author of the study, 70% to 80% of patients are satisfied with the outcome a year or two after the procedure. The traditional surgery typically has a satisfaction rate of 90% a decade after surgery, he says. So far there are no published studies directly comparing the new procedure to the traditional one.
A downside to the traditional surgery is a common side effect called gas-bloat syndrome, or abdominal pain caused by trapped gas. In a January study, Finnish researchers found nearly half of 48 patients who had a Nissen laparoscopic procedure, as the traditional surgery is called, were experiencing bloating and flatulence 15 years later.
Patients with certain conditions, including hiatal hernias, don't qualify for heartburn surgery through the mouth. "Is this for everyone? The answer is no," says Yvonne Romero, an assistant professor of medicine at the Mayo Clinic in Rochester, Minn.
Heartburn surgery, whether traditional or the newer variety, typically involves general anesthesia and a night in the hospital, surgeons say. In the case of incisionless surgery, patients must follow a modified diet for three months. Risks include the possibility of a small perforation in the esophagus, which often heals on its own, and internal bleeding, which in rare cases requires a transfusion.