Pediatrics

Sept. 07, 2016

More than one-third of American adults are obese, with a body mass index (BMI) of 30 kg/m² or greater. Obesity is associated with functional impairments and comorbidities, including hypertension, cardiovascular disease, metabolic disorders, arthrosis and obstructive sleep apnea. In the U.S., obesity accounts for 18 percent of deaths among people ages 40 to 85.

Manpreet S. Mundi, M.D., a consultant in Endocrinology, Diabetes, Metabolism and Nutrition at Mayo Clinic's campus in Rochester, Minnesota, says: "Despite advances, obesity management remains challenging. Diet and exercise often don't produce significant and sustained weight loss. And although bariatric surgery produces durable weight loss and shows the most promise for diabetes resolution, only about 2 percent of people who qualify for surgery undergo it."

"There is a big gap in the management of obesity, where diet and exercise aren't enough, but patients either don't qualify for a surgical option or don't want it because of the cost and risks. People who fall into this gap represent the majority of those with mild to moderate obesity," says Barham K. Abu Dayyeh, M.D., a gastroenterologist who specializes in bariatric and metabolic endoscopy at Mayo Clinic in Rochester, Minnesota. "For these patients — with a BMI of 30 to 40 kg/m² — the newly approved intragastric balloon procedure represents an intermediate option between lifestyle change and bariatric surgery."

Intragastric balloon

Dr. Mundi explains: "The use of an endoscopically placed intragastric balloon for weight loss is not a new concept. This procedure was first introduced in the U.S. in the 1980s. The Garren-Edwards Gastric Bubble was an air-filled polyurethane device approved by the Food and Drug Administration (FDA) in 1985, but it was withdrawn from the market soon afterward due to lack of efficacy and serious complications such as bowel obstructions arising from balloon deflation.

"In August 2015, two next-generation intragastric balloons were approved by the FDA. These balloons — the Apollo Endosurgery Orbera Intragastric Balloon system and the ReShape Integrated Dual Balloon System — are made of silicone and are more resistant to deflation. They are endoscopically placed and filled with saline solution up to 650 mL. The outpatient placement procedure takes 20 minutes, and the balloon remains in place for six months.

"Although the Orbera system was available outside of the U.S., approval by the FDA was largely based on efficacy and safety data from a multicenter clinical trial that Dr. Abu Dayyeh presented at Digestive Disease Week 2015." Study results were published in Gastrointestinal Endoscopy in 2015.

Orbera Intragastric Balloon

Dr. Abu Dayyeh highlights: "In this trial, 125 patients were randomly assigned to balloon treatment and a 12-month behavioral therapy program compared with 113 patients who received only behavioral therapy and served as controls. The majority of participants were female with a mean BMI of 35 kg/m² and mean excess weight of 36 kg.

"After 52 weeks of follow-up, the patients in the balloon group lost 29.29 percent of the excess weight compared with 14.2 percent in the control group. The patients in the balloon group also experienced an improvement in quality of life as measured by Beck Depression Inventory scores in addition to a reduction in comorbid conditions such as diabetes mellitus, hypertension and dyslipidemia. Serious adverse events were rare."

ReShape Integrated Dual Balloon System

As opposed to the Orbera system, the ReShape Duo is an endoscopically placed system that features dual intragastric balloons that are attached to each other with a flexible tube. Dr. Abu Dayyeh explains: "Each balloon can be filled with 450 mL of saline, allowing one balloon to maintain the system in the stomach in case the other balloon ruptures.

"One of the main trials with this system randomized 326 participants with BMIs of 30 to 40 kg/m² to either the dual balloon system along with diet and exercise (n = 187) or sham endoscopy plus diet and exercise (n = 139). The trial showed that patients with the dual balloon lost 27.9 percent of excess weight compared with excess weight loss of 12.3 percent in the diet group. Most patients experienced nausea, vomiting, abdominal pain or a combination of all three, which resolved in three to seven days and was severe in 1 to 2 percent of patients."

Comprehensive obesity program

Dr. Abu Dayyeh says: "The balloon procedure is safe and fully reversible. Severe side effects such as small bowel obstruction, perforation or tears in the stomach, and bleeding are rare. Many patients experience nausea and epigastric pain in the first week after implantation, but these are usually easily managed with medication and typically resolve in a few days after the stomach adjusts to the balloon."

Dr. Mundi concludes: "The intragastric balloon aids weight loss by slowing the rate at which food enters the stomach and by stimulating gastric stretch receptors. But lifestyle changes, including behavior modification, exercise and a healthy diet are crucial for maintaining weight loss once the device is removed. We have designed a comprehensive 12-month program that uses a multidisciplinary team consisting of dietitians, psychologists, endocrinologists and gastroenterologists to support patients in their weight-loss journey. This program, unique to Mayo Clinic, uses innovative, proven tools to help people who aren't ready or don't qualify for surgery.

For more information

ASGE Bariatric Endoscopy Task Force and ASGE Technology Committee. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies. Gastrointestinal Endoscopy. 2015;82:425.