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 - 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.
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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 -