In Morbidly Obese, New Non-surgical Approach May Be an Option

In Morbidly Obese, New Non-surgical Approach May Be an Option

A minimally invasive radiology procedure may help patients with morbid obesity to lose weight, according to the preliminary data of a study recently presented at the annual meeting of the Radiological Society of North America (RSNA).

Obesity is a public health epidemic in the United States with significant costs to the individual, in terms of morbidity and life quality, and to the healthcare system. Despite advancements in therapeutic options for patients, including bariatric procedures, new ways of treating the disease are of interest.

Bariatric arterial embolization (BAE) has been performed for decades as an emergency procedure to halt bleeding. Using it to treat obesity is a new approach, however, and one that, if successful, represents a potentially non-surgical advancement.

“We are showing early results that this procedure is safe and potentially efficacious for the treatment of morbid obesity,” said Mubin Syed, MD, an interventional radiologist at Dayton Interventional Radiology in Dayton, Ohio, in a recent news release.

This technique stems from the 1999 discovery of the hormone ghrelin, which stimulates appetite. In obese patients, eating full meals often fails to lower ghrelin levels, causing them to overeat.

To suppress the hormone’s production, interventional radiologists embolize the gastric artery that delivers blood to the stomach. The technique involves injecting tiny beads into the blood flow that then “travel” to the artery and block the smaller vessels. The radiologists perform the embolization through a non-surgical procedure, using a small catheter inserted in the patients’ wrist or in the groin.

Dr. Syed read of promising results using the technique in animal studies and in preliminary studies in humans. He decided to bring the method to Ohio, which is known to have one of the country’s highest obesity rates.

The pilot clinical trial — “Gastric Artery Embolization Trial for Lessening Appetite Non surgically (GET LEAN)” — is being  conducted by Dr. Syed with Investigational Device Exemption (IDE) approval from The U.S. Food and Drug Administration (FDA). The approach was approved for five patients with morbid obesity (defined as a body mass index of 40 or higher), who had failed at previous efforts to lose weight through exercise, diet, and behavior modification.

All enrolled patients received treatment on an outpatient basis, with the investigators closely monitoring their health. Four patients have been treated to date.

Three initial patients were reported to lose weight following the surgery, including one who shed 50 pounds in nine months. The other two had mild weight loss. A fourth patient enrolled, who lost 26 pounds at the three-month mark, was the first diabetic to undergo the technique.

“This is important, because diabetes is strongly associated with obesity,” Dr Syed said. “We’ve shown that the procedure was feasible in a diabetic patient.”

The trial represents the first use of left gastric artery embolization in the Western Hemisphere to treat morbid obesity, and Dr. Syed is the first surgeon to introduce the embolic agents through the radial artery in the wrist, a procedure he thinks safer and more appropriate. “In obese patients, the groin can be difficult to access,” he said. “Our method is also potentially easier for patients, because they won’t have to lie flat for long.”

Patients who had a previous bypass or embolization are not considered eligible for the procedure, and the technique may not be of benefit to patients who suffer from recurrent depression.

The approach is still in its early stages and further studies are necessary before it could be used in clinical practice. Gastric bypass is still the gold-standard treatment approach for patients with morbid obesity who have been unsuccessful with other clinical interventions. Nevertheless, the preliminary outcomes are promising.

“We’re seeing good results so far,” Dr. Syed said. “We’ve had no major adverse events, and we hope to study more patients in the future with the same or different embolic agents.”

The team is currently in the process of choosing a fifth patient for its research.

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