April 08, 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.
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's campus 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 balloons — Then and now
The use of an endoscopically placed intragastric balloon to treat obesity was first described in the early 1980s. An air-filled polyurethane device, approved by the Food and Drug Administration (FDA) in 1985, was later withdrawn due to a lack of supportive efficacy data and a high rate of serious complications.
The new generation of intragastric balloons are made of silicone, implanted in the stomach endoscopically and filled with a saline solution up to 650 cm3 through a self-sealing valve. The outpatient procedure takes less than 20 minutes, and the device is removed six months later.
In August 2015, the FDA approved two intragastric balloon systems, including Apollo Endosurgery's Orbera system, which has been used outside the U.S. since 1997. Approval was largely based on efficacy and safety data from a two-year multicenter clinical trial, which Dr. Abu Dayyeh presented at Digestive Disease Week 2015 in Washington, D.C.
The Orbera trial
In the trial, 125 patients were randomly assigned to balloon treatment and a 12-month behavioral therapy program; 113 patients receiving only behavioral management served as controls. The majority of participants were female, with a mean BMI of 35 kg/m2 and mean excess weight of 36 kg. Both groups were followed for 52 weeks.
Findings from the study include:
- The balloon group lost significantly more weight than did the control group over the course of the study and was able to maintain it at one year — six months after balloon removal.
- At one year, the balloon group lost 29.29 percent of their excess weight compared with 14.2 percent in the control group, surpassing efficacy thresholds set by the American Society for Gastrointestinal Endoscopy (ASGE) and the American Society for Metabolic and Bariatric Surgery. The ASGE recommendations were published in Gastrointestinal Endoscopy in 2011 and 2015.
- Both groups experienced a reduction in comorbid conditions, such as diabetes, hypertension and dyslipidemia, but the reduction was greater among balloon patients, who also experienced improved quality of life as measured by Beck Depression Inventory scores.
- Serious adverse events were rare in the intragastric balloon group.
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," he explains.
Comprehensive obesity program
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.
"The balloon is just one part of a comprehensive, 12-month obesity program we use to support patients in their weight-loss journey," Dr. Abu Dayyeh explains. "This is a strong, highly multidisciplinary program unique to Mayo that uses innovative, proven tools to help people with a BMI of 30 to 40 who aren't ready or don't qualify for surgery."
For more information
Ginsberg GG, et al. A pathway to endoscopic bariatric therapies. Gastrointestinal Endoscopy. 2011;74:943.
Abu Dayyeh BK, et al. 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.