Bariatric Arterial Embolization Using Novel Tightly-Calibrated 100-200µm Radiopaque Microspheres

The pilot phase of the Bariatric Embolization of ArTeries with imaging visibLe EmbolicS (BEATLES) clinical trial aims to evaluate the feasibility, safety, and efficacy of bariatric arterial embolization (BAE) in patients with obesity using a novel customized tightly calibrated 100-200µm radiopaque embolic microspheres “BTG-001933” (Boston Scientific Corporation).


Materials and Methods:

BEATLES is an IRB- and FDA-approved physician-initiated investigational device exemption prospective clinical trial. The pilot phase of this study started in October 2020, with 10 participants currently enrolled. Key inclusion criteria include age 21-70 years, BMI ≥35 kg/m², weight ≤400 lb, and vascular anatomy amenable to BAE (assessed by CTA). Absolute exclusion criteria include Prior abdominal surgery or embolization, taking hypoglycemic agents (except metformin), allergy to iodinated contrast, and renal insufficiency. After initial screening, participants have a six-week “run-in” to complete pre-BAE screening for psychiatric disorders and dietary coaching. Participants undergo upper endoscopy with gastric mucosal biopsy to rule out peptic ulcer disease or gastritis. Participants were admitted for routine supportive care (< 48 hours) 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)). Feasibility was assessed by the ability to visualize the microspheres under fluoroscopy and the extent of embolic fundal coverage on post-BAE MDCT.



Results:

Eight participants (mean age 39.8±9.8 years, 7 females) with class II-III obesity who underwent BAE were included in the preliminary analysis. The left gastric artery was embolized with or without the gastroepiploic artery with a 100% technical success rate in 8 and 5 participants, respectively. There were no major AEs. One minor AE was a healing mucosal ulcer at 3-month endoscopy. Pre-BAE mean weight was 124.7±19.8 kg and mean BMI 43.1±4.3 kg/m². Table 1 shows weight and BMI changes after BAE.

Conclusion:

BAE using customized tightly calibrated 100-200µm radiopaque microspheres “BTG-001933” is feasible and appears to be well tolerated by participants with severe obesity. Preliminary analysis of weight loss outcomes demonstrates promising efficacy.