Sustained Weight Loss Observed in 6-Month Results From BEAT Obesity Bariatric Embolization Study

April 3, 2016—Data from a study evaluating bariatric embolization have shown the procedure to be safe and effective in a group of severely obese patients through 6 months. Clifford R. Weiss, MD, and colleagues presented favorable outcomes from seven patients enrolled in the Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) study in an abstract at the Society of Interventional Radiology’s 2016 Annual Scientific Meeting in Vancouver, British Columbia. 

BEAT Obesity is one of several ongoing evaluations of the effects of suppressing hunger by decreasing blood flow to the fundus portion of the stomach via bariatric arterial embolization (BAE), which produces ghrelin, a hormone that regulates appetite. 

The study is being conducted by a multidisciplinary team of researchers at Johns Hopkins, and BEAT Obesity participants are enrolled in a program at the Johns Hopkins Weight Management Center, wherein lifestyle and diet changes are implemented before and after the procedure and monitoring for weight loss and ghrelin level are conducted, as well as hunger/satiety and quality of life assessments. 

Presenting results on seven patients who were described as being severely obese (body mass index ranging from 40 to 60) but otherwise healthy, Dr. Weiss said that all treated patients experienced weight loss and hunger reduction postprocedure. Specifically, patients experienced an average excess weight loss of 5.9% in the first month, a figure that grew to 9.5% at 3 months and 13.3% at 6 months. 

Ghrelin levels were also shown to be lowered, and quality of life reporting improved. There were no adverse events reported. 

Dr. Weiss, an Associate Professor of Radiology and Radiological Science at Johns Hopkins and the Medical Director of the Johns Hopkins Center for Bioengineering Innovation and Design, discussed BEAT Obesity with the media covering SIR’s annual meeting. One reason so many people fail in their diets is the strong hormonal drive to eat, he said; ghrelin is stimulated by an empty stomach. Hormonal changes have been observed in patients undergoing bariatric surgical bypass, and the goal of embolization in this setting is to produce similar favorable hormonal changes without open surgery and its associated complications. 

Although the initial results are encouraging and the Hopkins team and other groups have been researching this potential treatment option for about 10 years, Dr. Weiss cautioned that the therapy is still in its early stages. The study recently received FDA approval to include more patients, now enrolling up to 20, and a second site has opened at New York’s Mount Sinai Hospital, where patients will be treated via radial access. Larger, long-term studies will be needed to further better understand and determine the effects of bariatric embolization, but Dr. Weiss feels it is currently too early for a randomized sham-controlled trial. In terms of next research steps, he suggested the need to improve effectiveness without increasing risk and possibly looking at patients with lower body mass indexes, evaluating smaller beads (300-500 µm are used in BEAT Obesity) and different types of materials. Other key questions his group is exploring include the degree to which BAE affects future bariatric surgery possibilities, and the exact mechanism of action of BAE.  

The research team is encouraged by the findings to date in this study, and Dr. Weiss believes the current results indicate that additional FDA- and IRB-approved studies can safely be explored. He concluded by stressing the importance of a multidisciplinary team in this research, noting the multifaceted nature of factors related to obesity.