PMID- 28195823 OWN - NLM STAT- MEDLINE DCOM- 20170421 LR - 20240213 IS - 1527-1315 (Electronic) IS - 0033-8419 (Print) IS - 0033-8419 (Linking) VI - 283 IP - 2 DP - 2017 May TI - Clinical Safety of Bariatric Arterial Embolization: Preliminary Results of the BEAT Obesity Trial. PG - 598-608 LID - 10.1148/radiol.2016160914 [doi] AB - 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/m(2) +/- 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-mum 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. ((c)) RSNA, 2017 Online supplemental material is available for this article. FAU - Weiss, Clifford R AU - Weiss CR AD - 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.). FAU - Akinwande, Olaguoke AU - Akinwande O AD - 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.). FAU - Paudel, Kaylan AU - Paudel K AD - 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.). FAU - Cheskin, Lawrence J AU - Cheskin LJ AD - 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.). FAU - Holly, Brian AU - Holly B AD - 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.). FAU - Hong, Kelvin AU - Hong K AD - 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.). FAU - Fischman, Aaron M AU - Fischman AM AD - 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.). FAU - Patel, Rahul S AU - Patel RS AD - 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.). FAU - Shin, Eun J AU - Shin EJ AD - 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.). FAU - Steele, Kimberley E AU - Steele KE AD - 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.). FAU - Moran, Timothy H AU - Moran TH AD - 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.). FAU - Kaiser, Kristen AU - Kaiser K AD - 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.). FAU - Park, Amie AU - Park A AD - 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.). FAU - Shade, David M AU - Shade DM AD - 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.). FAU - Kraitchman, Dara L AU - Kraitchman DL AD - 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.). FAU - Arepally, Aravind AU - Arepally A AD - 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.). LA - eng GR - R01 EB017615/EB/NIBIB NIH HHS/United States GR - T32 EB006351/EB/NIBIB NIH HHS/United States PT - Case Reports PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20170214 PL - United States TA - Radiology JT - Radiology JID - 0401260 RN - 0 (Hemostatics) SB - IM MH - Adult MH - Embolization, Therapeutic/adverse effects/*methods MH - Female MH - Hemostatics/adverse effects/*therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Obesity, Morbid/*diagnostic imaging/*therapy MH - Pilot Projects MH - Radiography, Interventional/*methods MH - Stomach/*blood supply MH - Treatment Outcome PMC - PMC5410948 EDAT- 2017/02/15 06:00 MHDA- 2017/04/22 06:00 PMCR- 2018/05/01 CRDT- 2017/02/15 06:00 PHST- 2017/02/15 06:00 [pubmed] PHST- 2017/04/22 06:00 [medline] PHST- 2017/02/15 06:00 [entrez] PHST- 2018/05/01 00:00 [pmc-release] AID - 10.1148/radiol.2016160914 [pii] AID - 10.1148/radiol.2016160914 [doi] PST - ppublish SO - Radiology. 2017 May;283(2):598-608. doi: 10.1148/radiol.2016160914. Epub 2017 Feb 14.