Abstract No. 218 Bariatric Embolization of ArTeries with imaging visibLe EmbolicS (BEATLES): Pilot Study

To evaluate the safety and efficacy of bariatric arterial embolization (BAE) in patients with obesity using novel customized tightly calibrated 100-200μm radiopaque embolic microspheres "BTG-001933" (Boston Scientific). BEATLES is an institutional review board– and US Food and Drug Administration–approved physician-initiated investigational device exemption prospective clinical trial. The pilot phase started in Oct 2020 with one-year follow up due in Dec 2023. Key inclusion criteria include age 21-70 years, BMI ≥35 kg/m2, weight ≤400 lb and vascular anatomy amenable to BAE (assessed by CTA). Exclusion criteria include prior abdominal surgery/embolization, taking hypoglycemic agents (except metformin), contrast allergy and renal insufficiency. After initial screening, participants had a six-week "run-in" to complete pre-BAE screening for psychiatric disorders and dietary coaching. Upper endoscopy with gastric mucosal biopsy was performed to rule out peptic ulcer or gastritis. Participants were admitted for routine supportive care (< 48h) after BAE. Primary endpoints included efficacy measured by the change in body weight and BMI at 1, 3, 6 and 12 months and safety (30-day adverse events (AEs)). Changes in multi-compartment fat and muscle composition were assessed by whole body MRI. Ten participants (mean age, 38.3±9.4 years, 9 females) with class II-III obesity were included in this study. The left gastric artery (10) was embolized with or without the gastroepiploic artery (6) with a 100% technical success rate. No major AEs. Minor AEs included a healing mucosal ulcer at 3-month endoscopy and a vascular access site pseudoaneurysm (unrelated). Pre-BAE mean weight was 123.1±18.3 kg and mean BMI 43.6±4.3 kg/m2. Table 218.1 shows weight and BMI changes after BAE. MRI showed weight-to-muscle volume ratios were 10.3±1.9, 10.0±0.5 and 9.2±1.3 kg/L (Rrm=.89, P=.001, 95%CI 0.64-0.97) at 0, 3 and 6 months, respectively. BAE using tightly calibrated 100-200μm radiopaque microspheres "BTG-001933" is feasible and appears to be well tolerated by patients with severe obesity with weight loss outcomes demonstrating higher efficacy compared to other embolic agents used in previous studies. BAE is associated with significant muscle-sparing weight loss via subcutaneous and intra-muscular fat reduction.