Bariatric Embolization of Arteries for the Treatment of Obesity

Inclusion criteria

• Willing, able and mentally competent to provide written informed consent.
• Body mass index (BMI) between 40-60.
• Residence within 25 miles of the enrolling institution
• Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography.
• Suitable for protocol therapy as determined by the interventional radiology Investigator.
• Adequate hematological, hepatic and renal function as follows:

Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L International Normalized Ratio (INR) <1.5

Hepatic Bilirubin ≤ 2.0 mg/dL Albumin ≥ 2.5 g/L

Renal Estimated Glomerular Filtration Rate (GFR) > 60ml/min.1.73m2

• Aged 18 years or older.

Exclusion criteria

• Prior history of gastric pancreatic, hepatic, and/or splenic surgery
• Prior radiation to the upper abdomen
• Prior embolization to the stomach, spleen or liver
• Portal venous hypertension
• Prior or current history of peptic ulcer disease
• Hiatal Hernia
• Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.
• Active H. Pylori infection
• Weight greater than 400 pound
• Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute
• Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.
• Complicated arterial anatomic variants including left gastric artery arising from the aorta, and/or hepatic arterial supply via a replaced or accessory left hepatic artery arising from the left gastric artery.
• Pregnancy
• Preexisting chronic abdominal pain
• Positive stool occult study
• Abnormal Endoscopy
• Abnormal Nuclear Gastric Motility examination
• American Society of Anaesthesiologists (ASA) Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects.
• History of Inflammatory Bowel Disease
• Autoimmune disease
• Cirrhosis
• Known history of allergy to iodinated contrast media