New minimally invasive
treatment for reflux stops heartburn
BY RUTHANN RICHTER
Heartburn will be a minor
annoyance for many who overindulge this holiday season.
For them a little "plop, plop, fizz, fizz" or
other over-the-counter remedy may bring relief.
But for the 14 million
Americans who suffer from gastroesophageal reflux disease
(GERD), a daily effort is required to keep this condition
at bay. Now, researchers at Stanford and the Veterans
Affairs Palo Alto Health Care System may be able to offer
a new treatment.
Some 85 percent of
patients with GERD have experienced relief and have been
able to discontinue their daily medications after
treatment with a new minimally invasive technique that
Stanford and Palo Alto VA researchers are evaluating.
The technique uses
radiofrequency energy to tighten the lower esophageal
sphincter, a valve designed to prevent stomach acid and
digestive enzymes from flowing backward from the stomach
into the esophagus. In people with reflux, this valve may
be defective, allowing these irritating substances to
drift into the throat and mouth, producing symptoms of
chronic heartburn, persistent sore throat, regurgitation,
difficulty swallowing, chronic cough, laryngitis,
difficulty sleeping and even asthma.
Researchers have tested
the approach on some 100 patients nationwide -- including
38 at Stanford -- with encouraging results, said David
Utley, MD, clinical instructor of surgery at Stanford and
the developer of the technique. Among patients who have
been followed for at least four months, 85 percent no
longer take any medication for heartburn and have shown
significant improvement in their quality of life, Utley
said. Preliminary data suggest increased relief of
symptoms in patients who have been followed for six
months, he said.
"The advantage of the
procedure is that it doesn't involve surgery," said
George Triadafilopoulos, MD, a Stanford professor of
medicine (gastroenterology) and the principal
investigator in the clinical trial. "If it doesn't
work, the procedure can be repeated or can be followed by
surgery. It's cheaper, it [doesn't require
hospitalization], it takes one hour and the patient can
play golf the next morning."
Some 14 million American
adults suffer daily from reflux, one of the most common
and most costly conditions in the United States today,
said Utley, an otolaryngologist and plastic and
reconstructive surgeon. Some $7 billion is spent on
antacids and other drugs to treat the symptoms of the
disease, which is a condition found principally in
Western nations.
Until recently, reflux
sufferers have had to rely on medications or surgery to
control the disease. They've also had to limit their
activities, sleep with the upper body elevated and avoid
consumption of fatty foods, chocolate, coffee, alcohol
and other substances.
While medication may
effectively squelch symptoms, it doesn't prevent the
continued regurgitation of bile and digestive enzymes
into the esophagus, which can cause further injury, Utley
said. Moreover, most patients must contend with the need
to take medications daily on a permanent basis, he said.
Some patients may opt for
a one-time surgical procedure -- known as Nissen
fundoplication -- in which doctors wrap a portion of the
stomach around the esophagus, like a doughnut, to tighten
the valve and prevent backflow into the esophagus.
Although this four-hour procedure now is done through a
laparascope, requiring six tiny incisions in the stomach,
it has the risks associated with general surgery and may
result in complications, such as difficulty swallowing,
Utley said.
Recognizing the
limitations of current therapy, Utley approached
Triadafilopoulos more than two years ago with the idea of
strengthening the valve using radiofrequency energy.
Utley had worked with Stanford colleagues who had
effectively used this form of energy to reshape the
tongue and soft palate to treat sleep apnea.
The two researchers
brought Mark Vierra, MD, assistant professor of surgery,
into the project and began by testing the approach in
pigs. In November 1998, they applied the technique to
their first patient under an approved Stanford Human
Subjects Protocol.
After the investigators
presented their preliminary results in May at the
Digestive Disease Week conference, they began to receive
calls from gastroenterologists around the country seeking
to test the therapy at their own medical centers,
Triadafilopoulos said.
The method is now being
offered at 17 other sites in a multicenter clinical trial
approved by the federal Food and Drug Administration,
Utley said. All of the Stanford patients have been
treated at the VA Palo Alto Health Care System, where
Utley and Triadafilopoulos are based.
The procedure is performed
much like a standard endoscopy, in which the patient
remains awake but receives a mild sedative. Doctors
insert a catheter, a small tube about the size of a pen,
into the mouth and down into the esophagus and stomach.
They position the catheter at the sphincter valve and
then inflate a balloon to anchor the tube in place. The
muscle then is heated by tiny electrodes on the tip of
the catheter. The electrodes may reach a temperature of
85 degrees Celsius, although the heat rapidly dissipates
as it gets further from the heated area, Utley said.
The heat effectively
tightens the valve to make it more resistant to reflux
events, Utley said. Patients have experienced no
significant complications, Triadafilopoulos said. A few
patients have had mild difficulty swallowing or have
experienced fevers, symptoms that went away after a day,
Utley said.
He said the technique is
believed to work through several different mechanisms.
It's thought that some patients experience reflux as a
result of misfiring nerves in and around the sphincter
that signal the brain to relax the muscle. Heat may
disrupt those nerves and prevent these misguided signals
from getting through, Utley said.
The technique also has
been found to effectively shrink the collagen in the
valve to make it tighter and less stretchy, he said.
Through the natural process of wound healing, thermal hot
spots also attract new collagen to the site so that by
six months the area is completely healed and the greatest
improvement is seen, he said.
The investigators expect
to follow patients for several years to see if the
results hold up over time, Triadafilopoulos said.
"If you can avoid the
use of drugs for five or 10 years with a procedure that
takes about an hour to do, that's good news," he
said.
The clinical trial is
supported by Conway Stuart Medical in Sunnyvale, a
company Utley founded to support the basic science
research and development of the technique. SR
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