Pacemakers do double duty
and can be used in treating
serious gastric conditions
in children and in adults
Pacemakers Help Kids With Stomach Problems
August 06, 2009
Physicians at Nationwide Children's Hospital in Columbus, OH, are now using pacemakers to help children with severe stomach conditions.
In June, surgeons implanted a pacemaker in a 16-year-old patient with gastroparesis, a debilitating stomach condition that affects the way the body processes food. This is the first time the procedure has been performed in a child at Nationwide Children's Hospital, which is now one of only a handful of institutions across the country offering this type of treatment in children.
Gastroparesis is a condition where the stomach contracts less often and less powerfully than it should, causing food and liquids to stay in the stomach for a long time.
In as many as 60 percent of children with gastroparesis, the cause is not known. The condition often leaves children feeling constantly bloated and nauseated and can result in malnourishment and significant weight loss. In severe cases, symptoms may prevent children from attending school or taking part in other daily activities.
The pacemaker is inserted into the abdomen, with electrical wires leading to the stomach. It sends electrical impulses to stimulate the stomach after eating.
"The pacemaker is surgically implanted under the skin and is connected to two electrodes placed on the stomach wall. It tells the stomach to empty at a certain frequency. The initial settings are fairly low and, as with a pacemaker in the heart, we can change the settings as needed," said pediatric surgeon Steven Teich, MD, surgical director of the Bariatric Surgery Program at Nationwide Children's Hospital and clinical assistant professor of surgery at The Ohio State University College of Medicine.
"It empties the stomach, alleviating bloating, vomiting and nausea," Dr. Teich says.
Pacemakers have been used for years in adults with delayed gastric emptying. Nationwide Children's received approval to implant the device in children as a humanitarian device exemption (HDE), and although this is a new procedure in children and adolescents, doctors at Nationwide Children's say the early results are promising.
"In patients who have received this type of treatment, nearly all symptoms were resolved within two weeks," said pediatric gastroenterologist Hayat Mousa, MD, medical director of the Motility Center at Nationwide Children's Hospital and Associate Professor of Clinical Pediatrics at The Ohio State University College of Medicine.
Other Treatments Largely Ineffective
Dr. DiLorenzo, M.D., Chief of Gastroenterology at Nationwide Children's Hospital, tells DOTmed News that the other treatment options, including medications, have been much less effective than the gastric pacemaker.
He says drugs currently used to treat gastroparesis in children and adults are: metoclopramide, which has a minimal effect on the stomach and a high risk of side effects; erythromycin, an antibiotic that has been found to stimulate gastric contractions but may cause diarrhea, nausea-- and there's a risk of developing antibiotic-resistant infections when erythromycin is used for prolonged periods of time; and domperidone, which is not FDA approved, but is widely available everywhere else in the world and can be used in the U.S. on a compassionate basis.
"None of these options are really that effective. Hence, the need for better treatment with the gastric pacemaker, "Dr. DiLorenzo says.
When asked if the gastric pacemaker will undergo clinical trials for children, Dr. DiLorenzo told DOTmed, "It is always difficult to do clinical trials in pediatrics, especially in this case, due to the severity of symptoms, the invasiveness of the pacemaker and the relative rarity of this condition in children. Given these factors, I doubt that traditional placebo controlled pediatric research studies will be developed."
However, he says, it will be possible for children to receive the pacemaker in hospitals "that are comfortable with its placement and use, since the device has been approved for use in adults.
"Most institutions would probably require that their local human protection committee be aware of its use, and would grant its approval for compassionate use in children," Dr. DiLorenzo says.
Source: Nationwide Children's Hospital