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Implantable Gastric Stimulator Effective Against Morbid Obesity

Posted: Thursday, October 30, 2003

A laparoscopically inserted weight loss device called the implantable gastric stimulator (IGS) caused weight loss in 80% of patients, according to new research.

The method may provide an alternative to more invasive surgical procedures for treating morbid obesity, the researchers suggest. Scott Shikora, MD, and Michael Tarnoff, MD, presented their findings on Sunday at the North American Association for the Study of Obesity (NAASO) annual meeting in Ft. Lauderdale, Florida.

The IGS consists of a stimulation lead implanted in the gastric wall connected to an electric programming unit implanted under the skin of the abdomen.

According to Dr. Shikora, the exact mechanism of action and how it translates to weight loss is unknown. We know it causes early satiety, but we don't know whether this is caused by stimulation of nerves, inhibition of hormones, or stimulation of the muscle of the stomach itself, he told Medscape in a phone interview.

However, the IGS offers a novel approach that does not alter gastrointestinal anatomy and has been shown to be safe in 450 study patients worldwide, the researchers state in their abstract.

In their current report, they discuss preliminary results of the current trial being conducted in the U.S. of 30 morbidly obese patients from two centers.

All patients were implanted with two bipolar leads along the lesser curvature of the stomach. The leads were connected to an electrical generator positioned subcutaneously in the abdomen. Two weeks after surgery, the generators were activated. Electrical parameters were adjusted for each patient based on their individual response.

All 30 patients were successfully implanted with the device with no complications. Of the patients, seven were men and 23 were women. Mean age was 39 years and mean body mass index was 42 kg/m2.

Data were available for 15 patients being treated at one of the two centers. Of those, 80% lost weight during a mean follow-up of 9.5 months, (range 8-14 months). Average amount of weight loss was 18.8% of excess weight, with 60% losing more than 10% of their excess weight.

In addition, there was a 15% change in appetite before meals, a 60% change in satiety between meals, and a 90% change in satiety at the end of a meal, the researchers report.

The IGS system may evolve into a low-risk and effective alternative to the currently popular surgical procedures to treat morbid obesity, Dr. Shikora and colleagues conclude.

For some patients, IGS is as good as other surgical methods, but overall it is probably going to be less effective, Dr. Shikora said. You are trading a bit of weight loss for safety since IGS doesn’t alter the gastrointestinal tract the way other procedures do."
According to Dr. Shikora, a screening algorithm that might accurately predict who this procedure will work for is currently under development.

The screening algorithm was found to separate responders from nonresponders, and responders had weight loss very much comparable to the other procedures, although this is still investigational.

We are doing what we hope will be the pivotal study this winter involving approximately 120 patients at five or six research centers," Dr. Shikora said. "If that demonstrates good results, we will probably get [Food and Drug Administration] approval within the next couple of years."

The study was funded by Transneuronix Inc., the manufacturer of the IGS. NAASO 2003 Annual Meeting: Abstract 40-OR. Presented Oct. 12, 2003.