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Fixing a leaky valve in the esophagus

THE BALTIMORE SUN

For Liz Abate, choosing a new medical treatment without much of a track record was not as scary as the way she was living.

Abate suffered from gastroesophageal reflux disease, better known as GERD.

The Towson resident had to sleep sitting up because of severe heartburn. And not keeping food down was a common problem at all times of the day.

She took medicine and followed a strict diet of eating little or no fried, spicy or acidic foods. And she made sure she ate early in the evening, well before she went to bed. But instead of medication and lifestyle changes helping, her problem worsened.

"I knew I had to do something. I felt like I was a desperate person," said the optician who is in her early 50s. "I just felt like I couldn't live being sick all the time."

The new procedure she chose, which received FDA approval just last year, is known as Enteryx, and involves injecting a co-polymer into the esophagus to help close a leaky esophageal valve.

Last summer, Dr. Neil Goldberg, chief of gastroenterology at St. Joseph Medical Center, became the first doctor in Maryland to perform the procedure and one of the first 250 doctors nationwide to receive Enteryx training.

During the procedure, Enteryx, a liquid co-polymer, is injected into the lower esophageal sphincter through an endoscope -- a tube used to look at the esophagus and stomach. The compound solidifies and helps prevent an esophageal valve from opening when it should stay closed. During GERD episodes, that faulty valve allows gastric acid to move up into the esophagus, producing heartburn and other problems.

"My interest was being able to do tough patients that were not doing well on meds," said Goldberg, who treated Abate a year ago. "GERD is a very, very common problem. It's one of the two most common problems we see in GI practice."

Heartburn and acid reflux are GERD's main symptoms. About 20 million people in the United States experience heartburn every day and about twice that many experience symptoms at least once a week, according to the American Gastroenterological Association.

According to the American College of Gastroenterology, more than 10 million people are hospitalized each year for care of gastrointestinal problems, and the total health care costs exceed $40 billion annually.

Many control the condition with prescription and over-the-counter drugs. Globally, about $24 billion was spent on prescription acid reflux medication in 2003, according to IMS Health, a pharmaceutical and health care consulting company. Prevacid and Nexium, both used for acid reflux, were two of the top 10 leading prescription medications overall with a combined sales of $7.8 billion. But drugs do not work for everyone, and they can be expensive.

Before Enteryx was approved, treatment options included medication or complicated surgery. Because daily medication can be expensive, and there is always risk associated with any surgery, Goldberg said, "People started looking for alternatives."

The Enteryx injection, designed for those who rely on prescription medications to manage their symptoms, is a one-time treatment done under local anesthetic and usually only takes about 30 minutes. After the procedure, chest pain for one to two weeks is common.

In clinical trials, 70 percent of patients were off their medications one year after the procedure and another 10 percent were able to reduce their daily medication by at least half.

To be eligible for the procedure, a confirmed GERD diagnosis is needed, and patients can not have had previous surgeries for the condition.

As the procedure continues to become better known, other doctors in Maryland plan to offer the service.

Dr. David Cromwell, with Johns Hopkins Hospital, expects to start offering the procedure this summer. Patients already have begun to contact him about the treatment.

"It's a terrific concept," said Cromwell: "To provide patients with an option that is non-surgical and might, in essence, re-create the lower esophageal sphincter."

The two biggest concerns for doctors treating GERD, said Cromwell, are managing the symptoms so patients have a better quality of life and protecting the esophagus from damage that can develop after long-term reflux.

Patients who are good candidates for the procedure, Cromwell said, include those with daily -- or near daily -- GERD symptoms, and those who take daily medication.

But Dr. Stuart Spechler, a council member of the American Gastroenterological Association and Chief of Gastroenterology at Dallas Veterans Affairs Medical Center, cautions potential patients.

"Personally, if I were a patient I would wait until more data were available on both the safety and efficacy," Spechler said. "Enteryx appears to be very safe. But we won't know until we've had experience with a lot more patients that have been treated."

Although Boston Scientific Corp., the maker of Enteryx, would not provide figures on the number of patients nationwide who have undergone the procedure, Goldberg said he has performed 12 of the Enteryx injections. He also said that his patients' health insurance has covered the procedure.

The American Gastroenterological Association does not have an official position on Enteryx, Spechler said, but he believes it may become a good option for those with regurgitation problems.

"In some people that is a huge annoyance," he said. "And we do not have good medical therapy for that." But he cautions that trials have not been done on patients with this problem.

Abate said the procedure didn't cure her but it did make her symptoms manageable. She sleeps through the night now, lying down. Although she still takes medication daily and maintains a strict diet, she says she feels much better.

"I don't feel like a desperate person anymore," she said. "For people like me it was a no-brainer. Anything that would help me I was willing to do."

Check for symptoms

The American Gastroenterological Association suggests that serious gastroesophageal reflux disease -- GERD -- may be present if symptoms include:

Difficulty swallowing or a feeling that food is trapped in the chest.

Loss of appetite.

Unexplained weight loss.

Anemia (low red blood count).

Contact your doctor if you experience any of the above symptoms.

For more information about GERD, visit the American Gastroenterological Association Web site, www.gastro.org. For more information about the Enteryx procedure, visit Boston Scientific's Web site at www. bostonscientific.com.

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