Gastric
Stimulation Device May Curb Hunger
Potential weight loss tool
A new surgical approach to obesity that doesn't
alter the anatomy of the stomach appears to be
effective, low risk, and reversible. Electrical
gastric stimulation using an implanted device
has been shown to reduce symptoms of
gastroparesis, but the Food and Drug
Administration has not approved this procedure
for use in treating obesity.
The gastric pacing technique has been shown to
be safe in a total of 450 patients worldwide,
said Dr. Shikora, surgical director of the
Obesity Consult Center at the Tufts-New England
Medical Center, Boston.
He shared data on 30 morbidly obese patients
(mean BMI, 42 kg/m2) whom he treated
using the Transcend gastric stimulation system
at Tufts-NEMC. Among the 23 women and 7 men
(mean age, 39 years), 80% lost at least some
weight, and 60% lost more than 10% of their
excess weight over a period of 12 months.
Patients reported an average 15% decrease in
appetite, and said they had consistently
decreased appetite before and between meals,
with a 90% increase in satiety at the end of
meals. They also reported that they finished
meals much sooner and snacked less.
In the procedure, the surgeon inserts two
electrodes in the gastric wall near the lesser
curvature and then implants a pulse generator,
which is a bit larger than a silver dollar and
connected by leads to the electrodes, under the
skin of the abdomen. The degree of stimulation
can be adjusted to reduce feelings of hunger.
"There's tremendous variability from
patient to patient," Dr. Shikora said. He
sets the device's power just short of the point
at which the patient reports feelings of nausea,
cramping, or bloating. The exact mechanism of
action is unknown, but could involve vagal nerve
stimulation, hormonal reaction, or direct
stimulation of the muscle of the stomach. The
gastric stimulator may not replace other
procedures such as Roux-en-Y gastric bypass
surgery, but it could be a good option for
carefully selected patients, he said. It could
play a role in weight maintenance, helping
patients maintain weight loss without
medications.
The procedure appears extremely safe, with no
deaths and no major complications, Dr. Shikora
commented.
No long-term sequelae or vitamin issues have
been seen, even in the earliest patients treated
almost 6 years ago. One-fourth of the patients
dropped out of the trial, and their devices were
removed without difficulty. Many of those who
dropped out went on to have gastric bypass
surgery.
"When we looked at patients around the
world, what came out most glaringly was that
some patients performed exceedingly well and
others performed very poorly," he said at
the meeting, which was jointly sponsored by the
American Diabetes Association.
After analyzing data from 224 patients
worldwide, Dr. Shikora and his colleagues have
devised a screening tool that could be used to
identify patients likely to respond well. He
explained during the question-and-answer session
that the algorithm involves information that
could be gathered easily from patients
preoperatively.
But some physicians believe that it's still
early to jump on the gastric stimulator
bandwagon. "Gastric pacing is a fascinating
idea," Dr. Eric J. DeMaria said at the
annual meeting of the American College of
Gastroenterology.
European trials suggested that the technique
could produce significant weight loss, he said.
Dr. Shikora's results are intriguing, but the
technique is still experimental and needs
further study, added Dr. DeMaria, a professor of
general/trauma surgery at the Medical College of
Virginia, Richmond.
Reported at the annual meeting of the North
American Association for the Study of Obesity
================================
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Another "heart
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