May 25, 2001 (Atlanta) -- Forget crash diets, prescription drugs, or radical stomach surgeries for treating obesity. Scientists now report that implanted pacemakers -- like those used to keep hearts beating properly -- can help severely overweight people feel satisfied with less food and shed excess pounds.
Findings from recent human studies of the gastric pacemakers were presented at the Digestive Disease Week conference held here recently.
Like the heart, the stomach has a natural, built-in pacemaker that sends out electrical impulses that regulate movement. In healthy people, the stomach pacemaker 'fires' about three times a minute, day and night. When you eat, additional spikes of current generate contractions that move food out of the stomach and into the small intestine. These waves of movement are called peristalsis.
A group of researchers, led by Valerio Cigaina, MD, of Transneuronix Inc., in Mt. Arlington, N.J., has been testing implanted pacing devices in obese human subjects since the mid '90s, and results look promising. In each of their most recent experiments, begun in 1998 and 2000, 10 morbidly obese individuals received an implanted gastric pacemaker.
Subjects were advised to avoid alcohol, sweets, and between meal snacks, but were not required to diet or follow a specific eating plan. In both groups, patients lost about 90% of their excess weight within years and have successfully maintained the loss.
There were some nonthreatening, technical complications in earlier studies, including broken electrical leads and dead batteries, says Cigaina, but these problems have been ironed out. There were no deaths or major complications, and no reports of device-related illness.
People who struggle with morbid obesity never feel full, says Cigaina, "but all of our patients said that they could reach satiety with the gastric pacemaker." They also reported becoming full more quickly, staying full longer, and being able to feel satisfied with less food. What's more, he tells WebMD, patients reported a significant drop in their level of anxiety.
"I remain skeptical at this point," says C. Daniel Smith, MD, chief of general and gastrointestinal surgery at Emory University School of Medicine in Atlanta. "Obesity is multifactorial, and controlling the quantity of food ingested is only one of the aspects of weight control in the morbidly obese patient." Smith commented on the procedure for WebMD.
"Previous attempts to induce and sustain weight loss solely by decreasing a person's capacity to consume large quantities have failed," says Smith. Right now, the gold standard in weight loss surgery is the gastric bypass, which works by three different mechanisms.
First, the small pouch created during the procedure limits the food a patient can eat at one sitting. Second, calories are not well absorbed because food never passes through portions of the small intestine. And third, patient who eat too much will experience dumping -- the rapid and unpleasant elimination of excess, indigestible foods. "So with gastric bypass, there's a restrictive, a malabsorptive, and a strong behavior component," he says.
And there is 14-year follow-up data showing that "90% of gastric bypass patients lost 50%-75% of their excess weight and kept it off," says Smith. "I think we still have a long ways to go with the gastric pacing data. It's far too early to recommend its application."
Cigaina cautions that gastric pacing is not a 'cure' for obesity. "You have to have the pacemaker all your life," he says, "because even though you are lean, you are still an obese person. Without the pacemaker, you will regain the weight."
Technology is continuing to improve, but for now, the cost of the unit is quite high, and batteries must be replaced every four years or so.
Still, Cigaina tells WebMD, receiving the gastric pacemaker is a much less invasive procedure for treating obesity than is the increasingly popular gastric bypass surgery. "In terms of quality of life, there's no comparison," he says.
In Europe, the device should be on the market by September of this year, says Cigaina. In the U.S., however, the rigorous FDA approval process will likely delay availability for at least a few more years.