title: Clinical Safety of Bariatric Arterial Embolization: Preliminary Results of the BEAT Obesity Trial.
abstract: Purpose To conduct a pilot prospective clinical trial to evaluate the feasibility, safety, and short-term efficacy of bariatric embolization, a recently developed endovascular procedure for the treatment of obesity, in patients with severe obesity. Materials and Methods This is an institutional review board- and U.S. Food and Drug Administration-approved prospective physician-initiated investigational device exemption study. This phase of the study ran from June 2, 2014, to August 4, 2015. Five severely obese patients (four women, one man) who were 31-49 years of age and who had a mean body mass index of 43.8 kg/m2± 2.9 with no clinically important comorbidities were enrolled in this study. Transarterial embolization of the gastric fundus with fluoroscopic guidance was performed with 300-500-μm Embosphere microspheres. The primary end point was 30-day adverse events (AEs). The secondary end points included short-term weight loss, serum obesity-related hormone levels, hunger and satiety assessments, and quality of life (QOL) surveys, reported up to 3 months. Simple statistics of central tendencies and variability were calculated. No hypothesis testing was performed. Results The left gastric artery, with or without the gastroepiploic artery, was embolized in five patients, with a technical success rate of 100%. There were no major AEs. There were two minor AEs-subclinical pancreatitis and a mucosal ulcer that had healed by the time of 3-month endoscopy. A hospital stay of less than 48 hours for routine supportive care was provided for three patients. Mean excess weight loss of 5.9% ± 2.4 and 9.0% ± 4.1 was noted at 1 month and at 3 months, respectively. Mean change in serum ghrelin was 8.7% ± 34.7 and -17.5% ± 29 at 1 month and 3 months, respectively. Mean changes in serum glucagon-like peptide 1 and peptide YY were 106.6% ± 208.5 and 17.8% ± 54.8 at 1 month. There was a trend toward improvement in QOL parameters. Hunger/appetite scores decreased in the first 2 weeks after the procedure and then rose without reaching preprocedure levels. Conclusion Bariatric embolization is feasible and appears to be well tolerated in severely obese patients. In this small patient cohort, it appears to induce appetite suppression and may induce weight loss. Further expansion of this study will provide more insight into the long-term safety and efficacy of bariatric embolization.©RSNA, 2017 Online supplemental material is available for this article.
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Clifford R
authors.initials: CR
authors.lastname: Weiss
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Olaguoke
authors.initials: O
authors.lastname: Akinwande
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Kaylan
authors.initials: K
authors.lastname: Paudel
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Cheskin
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Brian
authors.initials: B
authors.lastname: Holly
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Kelvin
authors.initials: K
authors.lastname: Hong
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Aaron M
authors.initials: AM
authors.lastname: Fischman
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Rahul S
authors.initials: RS
authors.lastname: Patel
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Eun J
authors.initials: EJ
authors.lastname: Shin
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Kimberley E
authors.initials: KE
authors.lastname: Steele
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Timothy H
authors.initials: TH
authors.lastname: Moran
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Kristen
authors.initials: K
authors.lastname: Kaiser
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Amie
authors.initials: A
authors.lastname: Park
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: David M
authors.initials: DM
authors.lastname: Shade
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Dara L
authors.initials: DL
authors.lastname: Kraitchman
authors.affiliation: From the Departments of Radiology (C.R.W., O.A., K.P., B.H., K.H., D.L.K.), Gastroenterology and Hepatology (E.J.S.), Surgery (K.E.S.), and Psychiatry (T.H.M.), Johns Hopkins University School of Medicine, Sheikh Zayed Tower, Suite 7203, 1800 Orleans St, Baltimore, MD 21287; Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md (L.J.C.); Department of Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, NY (A.M.F., R.S.P.); Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md (K.K., A.P., D.M.S.); and Department of Radiology, Piedmont Healthcare, Atlanta, Ga (A.A.).
authors.forename: Aravind
authors.initials: A
authors.lastname: Arepally
mesh_terms: D000328:Adult; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000000981:diagnostic imaging* / Q000628:therapy*; D010865:Pilot Projects; D015641:Radiography, Interventional / Q000379:methods*; D013270:Stomach / Q000098:blood supply*; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics