TY - JOUR
T1 - Bariatric embolization of arteries for the treatment of obesity (BEAT obesity) trial
T2 - Results at 1 year
AU - Weiss, Clifford R.
AU - Abiola, Godwin O.
AU - Fischman, Aaron M.
AU - Cheskin, Lawrence J.
AU - Vairavamurthy, Jay
AU - Holly, Brian P.
AU - Akinwande, Olaguoke
AU - Nwoke, Franklin
AU - Paudel, Kalyan
AU - Belmustakov, Stephen
AU - Hong, Kelvin
AU - Patel, Rahul S.
AU - Shin, Eun J.
AU - Steele, Kimberley E.
AU - Moran, Timothy H.
AU - Thompson, Richard E.
AU - Dunklin, Taylor
AU - Ziessman, Harvey
AU - Kraitchman, Dara L.
AU - Arepally, Aravind
N1 - Funding Information:
Disclosures of Conflicts of Interest: C.R.W. Activities related to the present article: disclosed institutional grant from Merit Medical and Siemens Healthcare, and materials support from SureFire Medical. Activities not related to the present article: disclosed institutional grant and payment received for consultancy from BTG and Medtronic. Other relationships: disclosed no relevant relationships. G.O.A. disclosed no relevant relationships. A.M.F. Activities related to the present article: disclosed institutional grant from Merit Medical. Activities not related to the present article: disclosed receipt of payment from Embolx for board membership, from Terumo Medical for consultancy, and
Funding Information:
Our study was performed under a physician-initiated investigational device exemption from the U.S. Food and Drug Administration and was approved by the institutional review boards at The Johns Hopkins Hospital (Baltimore, Md) and Mount Sinai Hospital (New York, NY). All participants provided written informed consent. Data were protected in a manner compliant with the Health Insurance Portability and Accountability Act of 1996. We received financial support from Merit Medical and Siemens Healthcare and material support from Merit Medical and SureFire Medical. The funding organizations were not involved with the study design or in the collection, analysis, or interpretation of data. The authors had full control of the data, its analysis, and all information submitted for publication.
Funding Information:
This was a physician-sponsored investigational device exemption study. The funding organizations were not involved with the study design or in the collection, analysis, and interpretation of data. Supported by National Institute of Biomedical Imaging and Bioengineering (R01EB017615 [C.R.W., D.L.K., A.A.] and T32EB006351 [J,V., O.A., F.N., K.P.]). C.R.W. and D.L.K. supported by Siemens Healthineers (Erlangen, Germany). C.R.W. and A.M.F. supported by Merit Medical (South Jordan, UT) (material and financial support). C.R.W. and A.M.F. supported by TriSalus Life Sciences (Westminster, CO) (material support).
Publisher Copyright:
© 2019 RSNA.
PY - 2019
Y1 - 2019
N2 - 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-mm 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 ± 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.
AB - 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-mm 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 ± 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.
UR - http://www.scopus.com/inward/record.url?scp=85065891567&partnerID=8YFLogxK
U2 - 10.1148/radiol.2019182354
DO - 10.1148/radiol.2019182354
M3 - Article
C2 - 30938624
AN - SCOPUS:85065891567
SN - 0033-8419
VL - 291
SP - 792
EP - 800
JO - Radiology
JF - Radiology
IS - 3
ER -