3:27 PM Abstract No. 104 ■ FEATURED ABSTRACT Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity): 12-Month Safety and Efficacy Data

Bariatric Embolization is a new endovascular procedure, developed for obesity treatment. BEAT Obesity is an investigator-initiated IDE, designed to assess the safety and efficacy of BAE to treat morbidly obese patients using 300-500μm Embospheres. We present our 12-month safety and efficacy data. Morbidly obese (BMI of 40-60) adult patients without comorbid conditions (n = 20, 4 male) were enrolled. Primary endpoints were weight loss and 30-day adverse events (AEs). Secondary endpoints (12-month follow-up) are: blood pressure, lipid profile, serum obesity hormones (Ghrelin, Leptin, GLP-1, PYY), hunger/satiety assessments, quality of life (QOL) (SF-36 and IWQOL) surveys, endoscopy and gastric emptying results. Complete 12-month data are presented. Mean age and BMI were 44.5 ± 10.7 years and 45.1 ± 4.1 kg/m2, respectively. The left gastric artery alone (LGA) was embolized in 5 patients and the LGA and gastroepiploic arteries were embolized in 15 patients. No major AEs occurred. Small superficial ulcers were seen in 8 of the 20 patients at 2-week endoscopy, all of which had resolved at 3-month endoscopy. There was 1 case of transient sub-clinical pancreatitis. Six patients were discharged the evening of their procedure, and the remainder stayed for the indicated <48 hr hospital stay for control of nausea, vomiting and pain. There was 8.3 ± 3.9% (n = 20), 11.5 ± 5.5% (n = 18), 12.8 ± 7.7% (n = 14), and 11.7 ± 10.8% (n = 12) Excess Weight Loss at 1, 3, 6, and 12 months, respectively. There was a trend towards improvement in QOL parameters and decreased appetite scores. Full updated hormonal profiles for all patients will be presented. Complete twelve-month data from the BEAT Obesity trial demonstrates that bariatric artery embolization is well-tolerated in severely obese patients. BAE appears to have sustained weight loss up to 12 months post procedure. Future clinical trials will focus on improving efficacy while maintaining the tolerated safety profile.