An implanted magnetic device could offer a new treatment option for people
with chronic heartburn that is not controlled with medication, a small study
suggests.
The study tested a newer approach to taming stubborn cases of
gastroesophageal reflux disease (Gord) - one of the most common health
conditions diagnosed in the United States.
GERD arises when the ring of muscle between the oesophaguses and stomach
fails to close properly, allowing stomach acids to splash up into the
oesophaguses. The main symptom is chronic heartburn.
For people who have frequent heartburn - more than twice a week - the go-to
medications are the so-called proton pump inhibitors, such as Prilosec, Prevacid
and Nexium. But studies estimate that up to 40% of people on those drugs
do not get enough relief.
The new study included 100 such Gord patients. They all received an implant -
a bracelet-like device composed of magnetic beads - that wraps around the
portion of muscle where the oesophaguses joins the stomach. The point is to
"augment" the muscle and prevent stomach acid reflux.
After three years, researchers found, 64% of the patients had their acid
reflux cut by at least half. And 87% had been able to stop taking their proton
pump inhibitors altogether.
"That's huge," lead researcher Dr Robert Ganz said of the medication
reduction.
What the study found
It's estimated that Americans spend $14 billion a year on prescription proton
pump inhibitors. Because of the costs and potential side effects, many people
would like to drop the drugs, said Ganz, an associate professor at the
University of Minnesota in Minneapolis.
He cited bone-thinning as one potential long-term side effect. "A lot of
women do not want to be on proton pump inhibitors for that reason in
particular," Ganz said.
The device his team studied is already approved in the United States and
marketed as the LINX Reflux Management System by Torax Medical, Inc., which also
funded the study.
Ganz said he could envision the device as an option for "some fraction" of
the 20 million to 30 million Americans who take a daily medication for GERD
symptoms.
There are, of course, less extreme ways to manage your heartburn. Diet
changes and weight loss often help, and if your heartburn is milder,
over-the-counter antacids or drugs called H2 blockers - brands like Zantac and
Tagamet - may be enough.
Proton pump inhibitors, which block acid production, are often recommended
for people with more frequent heartburn. If that doesn't work, surgery is
typically seen as the last-ditch option.
Traditionally, that has meant a 50-year-old procedure called Nissen
fundoplication, where the upper part of the stomach is stitched around the lower
end of the oesophaguses.
Performed by an experienced surgeon, that procedure is very effective, said
Dr F Paul Buckley III, director of general surgery at the Heartburn and Acid
Reflux Center, Scott and White Clinic in Round Rock, Texas.
Option for no relief
The problem, though, is that the surgery creates a rigid ring around the
oesophaguses, explained Buckley, who was not involved in the new study. That
often leaves patients with difficulty swallowing or with other natural bodily
functions - including belching and vomiting.
The LINX device, Buckley said, is designed to be "dynamic," expanding when
food passes through, then quickly contracting again to prevent reflux.
"I think this will have a significant effect on how we treat GERD," Buckley
said.
However, the device is not without problems: Two-thirds of the study patients
had difficulty swallowing at first, although that dropped to 11% after one year,
and 4% after three years.
Six patients had more serious side effects, including four who had the device
removed - mostly for substantial problems with swallowing. Two other patients
had the device removed for "disease management," the study noted.
"The device seems to be a reasonable and fairly effective alternative," said
Dr Sigurbjorn Birgisson, a gastroenterologist and director of the Center for
Swallowing and Esophageal Disorders at the Cleveland Clinic.
It might be an option for people who do not find relief from medication - or
cannot stick with long-term drug treatment because of side effects or expense,
according to Birgisson, who was not involved in the study.
He added, though, that there should be further studies that compare the
device with existing therapies, and look at the long-term effects.
Ganz agreed. The long-term risks are one question. So far, Ganz said, none of
the patients in this study has seen the device erode or "migrate" from its
intended location. But they have only been followed for a few years.
For his part, Buckley noted that there is a long history of failed therapies
in the Gord world. One example is the Angelchik prosthesis, a doughnut-shaped
silicone implant developed in the 1970s that wrapped around the junction between
the oesophaguses and stomach. At first, it seemed to work well, but then doctors
found high rates of longer-term complications; many people had lasting problems
with swallowing, and in some cases the device eroded or slipped out of
place.
The LINX device is designed much differently, but no one yet knows how it
fares in the long run.
The estimated cost of the device was not available at publication time. The
procedure is not currently available at most hospitals. Right now, Buckley said,
only certain medical centers in the United States offer it.
More information
Learn more about GERD treatments from the US
Agency for Healthcare Research and Quality.
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