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Radiology. 2019 Jun;291(3):792-800. doi: 10.1148/radiol.2019182354. Epub 2019 Apr 2.

Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) Trial: Results at 1 Year.

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1
From the Russell H. Morgan Department of Radiology and Radiological Science (C.R.W., J.V., B.P.H., O.A., F.N., K.P., K.H., T.D., H.Z., D.L.K.), Department of Medicine (E.J.S.), Department of Surgery (K.E.S.), and Department of Psychiatry and Behavioral Sciences (T.H.M.), The Johns Hopkins University School of Medicine, Baltimore, MD 21287; Department of Health, Behavior, and Society (L.J.C.) and Department of Biostatistics (R.E.T.), The Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; The Johns Hopkins University School of Medicine, Baltimore, MD (G.O.A., S.B.); Department of Radiology, Mount Sinai Hospital, New York, NY (A.M.F., R.S.P.); and Department of Radiology, Piedmont Healthcare, Atlanta, GA (A.A.).

Abstract

Background Bariatric embolization is a new endovascular procedure to treat patients with obesity. However, the safety and efficacy of bariatric embolization are unknown. Purpose To evaluate the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure. Materials and Methods For this prospective study (NCT0216512 on ClinicalTrials.gov ), 20 participants (16 women) aged 27-68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 were enrolled at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300- to 500-µm embolic microspheres. Primary end points were 30-day adverse events and weight loss at up to 12 months. Secondary end points at up to 12 months included technical feasibility, health-related quality of life (Short Form-36 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. Results Bariatric embolization was performed successfully for all participants with no major adverse events. Eight participants had a total of 11 minor adverse events. Mean excess weight loss was 8.2% (95% confidence interval [CI]: 6.3%, 10%; P < .001) at 1 month, 11.5% (95% CI: 8.7%, 14%; P < .001) at 3 months, 12.8% (95% CI: 8.3%, 17%; P < .001) at 6 months, and 11.5% (95% CI: 6.8%, 16%; P < .001) at 12 months. From baseline to 12 months, mean SF-36 scores increased (mental component summary, from 46 ± 11 to 50 ± 10, P = .44; physical component summary, from 46 ± 8.0 to 50 ± 9.3, P = .15) and 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. Conclusion Bariatric embolization is well tolerated in severely obese adults, inducing appetite suppression and weight loss for up to 12 months. Published under a CC BY-NC-ND 4.0 license. Online supplemental material is available for this article.

PMID:
30938624
DOI:
10.1148/radiol.2019182354

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