April 2, 2019
Bariatric Embolization Evaluated in BEAT Obesity Study
April 3, 2019—An evaluation of the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure concluded that the treatment is well tolerated and induces appetite suppression and weight loss for this time period. The findings from the prospective BEAT Obesity study were published by Clifford R. Weiss, MD, et al online ahead of print in Radiology.
The study enrolled 20 patients (16 women) aged 27 to 68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 kg/m2 at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300–500-µm embolic microspheres.
As summarized in Radiology, the primary endpoints were 30-day adverse events and weight loss at up to 12 months. Secondary endpoints at up to 12 months included technical feasibility, health-related quality of life (36-Item Short Form Health Survey [SF-36]), impact of weight on quality of life (IWQOL-Lite), and hunger or appetite using a visual assessment scale. Analysis of outcomes was performed by using one-sample t tests and other exploratory statistics.
Bariatric embolization was performed successfully for all participants with no major adverse events. Eight patients had a total of 11 minor adverse events.
According to the investigators, mean excess weight loss at 1, 3, 6, and 12 months, respectively, was 8.2% (95% confidence interval [CI], 6.3%–10%; P < .001); 11.5% (95% CI, 8.7%–14%; P < .001); 12.8% (95% CI, 8.3%–17%; P < .001); and 11.5% (95% CI, 6.8%–16%; P < .001).
From baseline to 12 months, mean SF-36 scores increased as follows: mental component summary from 46 ± 11 to 50 ± 10 (P = .44) and physical component summary from 46 ± 8.0 to 50 ± 9.3 (P = .15). Additionally, mean IWQOL-Lite scores increased from 57 ± 18 to 77 ± 18 (P < .001). Hunger or appetite decreased for 4 weeks after embolization and increased thereafter, without reaching pre-embolization levels, reported the investigators in Radiology.
Dr. Weiss discussed the BEAT Obesity study in an interview with Endovascular Today. He commented, "In this prospective, single-arm, dual-center study, we demonstrated that bariatric embolization in conjunction with lifestyle-based weight management intervention is well tolerated and leads to clinically significant weight loss for up to 12 months. This procedure may represent a new tool in the growing multidisciplinary toolbox that is being developed to help treat patients with obesity. Ideally, this procedure would aid in the treatment of patients who have failed lifestyle management but do not qualify for or choose not to have bariatric surgery."
Dr. Weiss advised that the BEAT Obesity study findings require and encourage further investigation. He commented to Endovascular Today, "Although these results are exciting and promising, they are far from definitive. There are a number of critical questions that need to be answered prior to widespread adoption. Some of these include: What is the long-term efficacy of this procedure when compared to a control/placebo arm? What patient population would most benefit from this procedure? What are the implications for future bariatric surgery?"