Bariatric Arterial Embolization Research Articles

Bariatric Arterial Embolization for Obesity: A Review of Early Clinical Evidence.

Obesity is a worldwide public health epidemic that leads to increased morbidity, mortality, and cost burden to health care. Although bariatric surgery has been recognized as a standard invasive treatment for obesity, it is accompanied by relatively high morbidity and cost burden, as well as limited treatment outcome. Therefore, alternative treatments with lower morbidity and cost for surgery that target patients who are obese, but not morbidly obese, are needed. A minimally invasive trans-catheter procedure, named bariatric arterial embolization or bariatric embolization (BAE), has been identified as a potential solution, based on its safety and preliminary efficacy profiles. The purpose of this review is to introduce up-to-date clinical data and discuss future directions for BAE for the treatment of obesity.

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.

Bariatric Arterial Embolization with Non-spherical Polyvinyl Alcohol Particles for Ghrelin Suppression in a Swine Model.

To evaluate the effect of bariatric arterial embolization (BAE) with non-spherical polyvinyl alcohol (PVA) particles on systemic ghrelin levels, weight change, and gastric ulceration risk in a swine model. From March 2014 to February 2015, ten healthy swine were used in the study (mean weight 31.5kg; range 24.0-41.5kg). The animals were randomly assigned to two groups: the embolized group (n=5) in which BAE was performed and the control group (n=5). In the embolized group, BAE was performed by selectively infusing 150-250 or 50-150μm PVA into the gastric arteries that supplied the fundus of the stomach. In the control group, a sham procedure was performed with saline infusion. Plasma ghrelin levels were prospectively obtained at baseline and every 2weeks thereafter. Endoscopy was performed 3weeks after BAE to see whether any gastric ulcer occurred. To determine the durability of the occluded arteries, repeated celiac trunk angiography was performed 8weeks after BAE. Then, all the swine were killed and necropsies were performed. The mean post-procedure ghrelin value decreased by 370.0pg/mL in the embolized group at week3 (mean 536.0±334.3pg/mL) and week5 (mean 515.0±150.0pg/mL, p<0.05) relative to baseline (880.0±559.5pg/mL), respectively, but ghrelin levels were not significantly decreased between the embolized and control groups. There was a significant body weight change as follows: 35.1±9.5 to 46.6±15.7kg and 31.8±5.8 to 41.2±6.6kg at baseline and endpoint in the control and embolized groups, respectively (p<0.05). However, the difference between groups was not significant at endpoint. In the embolized group, ulcerations were identified in three animals (60%) and the recanalization of the embolized arteries was noted on follow-up angiography in three animals (60%), respectively. BAE with PVA particles can transiently suppress ghrelin levels in embolized animals, but levels are not significantly different compared to controls. Stomach ulcerations were identified in 60% of the embolized animals.

3:00 PMAbstract No. 148DISTINGUISHED ABSTRACT - Bariatric embolization of arteries for the treatment of obesity (BEAT Obesity): 6- to 12-month safety and efficacy data

of the stomach were coil or gelfoam embolized. Particular attention were made for diaphragmatic and left hepatic branches. The left gastric artery was then embolized with PVA particles. Embolization was performed until stasis. Patients were discharged on the day of the procedure. Patient were followed up at one week post procedure and monthly afterward. Monthly weight was obtained. Ghrelin levels were not measured prior or after LGAE. Results: Procedure was successful in all patients.Typical complaint was a subjective burning sensation at first few meals which resolved on its own. There were no report of long-term complication by the time this abstract was being prepared. Patient were able to feed normally post procedure. All patient reported an immediate decrease in their appetite. Loss of appetite was described as loss of interest in eating, absence of urge to eat and early satiety. This pattern persisted even in the 9 months-follow up patient. Gradual loss of weight was noted in all patients. Initial average BMI of 30.5 dropped to 27. All patients has a loss of 1-1.5 kg per month reaching up to 18 Kg in the longest followed patient (initial weight of 130 kg) and 1 kg in the 1 month follow up patient. Conclusions: Our small series follows initial reported results in LGAE for treatment of obesity. LGAE, a long-time procedure used for treating active upper GI bleeding is well tolerated and is highly suggestive of positive results for control of appetite and overweight in a safe and minimally invasive manner.

3:00 PMAbstract No. 11 - Quantitative assessment of gastric perfusion following bariatric arterial embolization in porcine model

3:00 PMAbstract No. 11 - Quantitative assessment of gastric perfusion following bariatric arterial embolization in porcine model

3:26 PMAbstract No. 14 - FEATURED ABSTRACT Bariatric embolization of arteries for the treatment of obesity (BEAT Obesity): 3-month safety and efficacy data

3:26 PMAbstract No. 14 - FEATURED ABSTRACT Bariatric embolization of arteries for the treatment of obesity (BEAT Obesity): 3-month safety and efficacy data

Abstract No: LB02 - Bariatric embolization using large calibrated spheres (300-500 μm): safety and long-term efficacy in a swine model

Abstract No: LB02 - Bariatric embolization using large calibrated spheres (300-500 μm): safety and long-term efficacy in a swine model

Abstract No: LB01 - Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity): Study Design and Initial Safety / Efficacy Data

Abstract No: LB01 - Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity): Study Design and Initial Safety / Efficacy Data

BARIATRIC ARTERIAL EMBOLIZATION AS TREATMENT FOR OBESITY: MECHANISMS USING HIGHLY CALIBRATED 50 MICRON EMBOLIC BEADS

Bariatric arterial embolization (BAE) is a new treatment for obesity. However, the mechanism of action is not well understood, including the effect of particle embolic size. Using a highly calibrated 50 µ X-ray-visible alginate embolic bead (XEB), we investigated the effect of BAE in immature swine