Bariatric Embolization Research Articles

Adding Short to Left Gastric Artery Embolization for the Treatment of Obesity: Safety and Effectiveness.

This study assessed the safety and effectiveness of a technical modification that involves adding short gastric artery (SGA) embolization to left gastric artery (LGA) embolization. This retrospective single-center study analyzed twenty obese patients (median age of 53.5 (30-73)) who were not eligible for bariatric surgery and underwent bariatric embolization with 300-500-µm microspheres in addition to a lifestyle counseling program between March 2021 and July 2022. Eight patients had LGA + SGA embolization, and twelve had LGA embolization alone. The primary outcome measure was total body weight loss (TBWL) at 6months in the SGA + LGA and the LGA-only cohorts. Safety was assessed, defined as the 30-day adverse events rate according to the SIR classification. The mean 6-month post-embolization TBWL in the SGA + LGA cohort was 7.3kg (95%CI 2.1-12.4; p = .01) and 4.1kg (95%CI 0.4-8.6; p = 0.034) in the LGA-only cohort (mean difference - 3.1kg ± 2.8; 95%CI (- 9.1-2.8); p = .28). The mean 6-month post-embolization TBWL in the entire cohort was 5.3kg (p < .01). The rate of complications was similar between the two groups. Combined SGA and LGA embolization is safe and effective to treat obesity. Larger studies are needed to determine whether SGA + LGA embolization results in more significant weight loss than LGA embolization alone.

Morphological changes in the abdominal organs after left gastric artery embolization in an experiment

Objective – to experimentally evaluate the morphological changes of internal organs (liver, spleen, duodenum, pancreas) after embolization of gastric arteries.Material and methods. To conduct the experiment, 10 Vietnamese pigs aged 4-5 months, female, were selected and fed a high-fat diet for 2 months to simulate obesity. Aorta contrast and celiacography with "Vazipak" solution (5-10 ml per injection) were performed on animals under general anesthesia. Superselective bariatric embolization of the left gastric artery was performed with a 3F microcatheter. After 3 weeks, a morphological (hematoxylin-eosin staining) examination of such organs as liver, duodenum, spleen, pancreas was performed. Photofixation of the histopreparations of the relevant organs was carried out using a trinocular microscope of laboratory class Nikon Eclipse Ci-E with 10x, 20x and 40x plan achromat objectives.Results. In general, no macroscopic signs of ischemia of adjacent organs were noted against the background of the performed selective embolization of the left gastric artery. Blood filling of the liver was uneven, the perisinusoidal spaces were expanded, which indicated its edema. In the duodenum, reactive disturbances of microcirculation were manifested by expansion and congestion of venous vessels and blood stasis. Microscopic changes in the spleen were characterized by congestion of the sinusoids, while the vessels of the pancreas were unevenly filled with blood, and at the same time, venous congestion prevailed.Conclusion. Microcirculation disorders, dystrophic changes, and signs of a shock reaction, which can be considered transient, occur in the examined organs after embolization of the gastric arteries. These data indicate the safety of performing selective embolization of gastric arteries and the absence of signs of critical redistribution of blood flow or ischemia "robbing".

Angiographic Revascularization after Bariatric Embolization in a Swine Model

This study evaluated fundal arteriole angiographic revascularization after embolization with embolic microspheres of 3 different diameters in a swine model (16 swine, 31 arterioles). In the 50-μm group, 7 of 11 (64%) arterioles recanalized completely, 3 of 11 (27%) arterioles recanalized partially, and 1 of 11 (9%) arterioles had collateralization (no recanalization). In the 100- to 300-μm group, 7 of 10 (70%) arterioles recanalized completely and 3 of 10 (30%) arterioles) recanalized partially. In the 300- to 500-μm group, 7 of 10 (70%) arterioles recanalized completely, 1 of 10 (10%) arterioles recanalized partially, and 2 of 10 (20%) arterioles had collateralization. No difference was found between the groups in the degree of recanalization (P = .64). All embolized arterioles exhibited some degree of angiographic revascularization, irrespective of the microsphere size.

Identifying the Ideal Target Vessel Size for Bariatric Embolization: Histologic Analysis of Swine and Human Gastric Fundi

This study aimed to identify the ideal arteriole size to target in bariatric embolization, with the goal of maximizing weight loss efficacy while maintaining patient safety. Although all published clinical trials of bariatric embolization have used embolic microspheres that were at least 300 μm in diameter, optimal weight loss outcomes have been achieved safely in swine using 50-μm embolics. Human fundal remnants from bariatric surgery were compared with swine fundal sections after bariatric embolization with 50-μm embolic microspheres to assess the ideal fundal vessel size for bariatric embolization. In swine, the 50-μm embolic microspheres deposited in the luminal half of the submucosa with a mean arteriole size of 49 μm ± 30. The mean arteriole diameter in the corresponding submucosal layer of the human gastric fundi was 40 μm ± 30. These measurements may inform future clinical trials and direct the development of embolic agents for bariatric embolization.

Abstract 14047: Extended Follow-Up Results From a Prospective RCT for Transcatheter Bariatric Embolotherapy for Weight Loss in Obese Subjects

Introduction: Obesity is an important risk factor associated with poor cardiovascular outcomes. Lifestyle modification, pharmaceutical, and intragastric balloons weight loss therapy are often unsuccessful, unsustainable, or accompanied by risks. Transcatheter bariatric embolotherapy (TBE) is a promising therapy in which the left gastric artery is embolized to reduce the expression of “hunger” hormones from the gastric fundus. Despite several early clinical trials, long-term safety or efficacy has yet to be studied. We originally studied TBE in a double-blind, sham procedure, first in human RCT of 40 obese patients (pts) (NCT03185949). Complete details regarding the initial RCT were previously published, briefly the study demonstrated up to 9.3% TBWL at 1-year post-TBE. Following completion of the initial study at 1 year follow-up, we asked subjects to return for long-term evaluation. Methods: Subjects who previously completed the RCT with no major protocol deviations were asked to return for SOC follow-up visits at 2-, 2.5-, and 3-years post-embolization for further evaluation on weight loss, blood pressure, pre-diabetic clinical status, satiety, and Quality of Life (QoL). Given the evolving situation of the COVID-19 pandemic, the study site was unable to complete all planned study visits. Results: Between 2-3 years post-TBE subjects (n=11) demonstrated a mean 9% TBWL and 25% EBWL. This cohort of patients demonstrated a long-term weight loss maintenance, with previously reported weight loss of 8% TBWL at 1-year post-embolization. Overall QoL at 2 years post-TBE increased by approximately 22%. The volume to achieve satiety was reduced by 33% in long-term follow-up. Oral Disposition Index increased from 1.89 mM -1 at 6 months post-TBE to 4.41 mM -1 2 years post-TBE. 1-hr Oral Glucose Tolerance Test (OGTT) C-Peptide levels decreased from 3.22 nmol/L at 6 months to 2.53 nmol/L at 2 years post-TBE. 2-hr OGTT C-Peptide levels also showed a decrease from 2.95 nmol/L at 6 months to 1.78 nmol/L at 2 years post-TBE, possibly indicating an improvement in pre-diabetic status. Conclusions: Bariatric embolization is safe and when used along with lifestyle therapy, results in clinically significant and sustained weight loss up to 2-3 years post-TBE.

Bariatric Embolization in the Treatment of Patients with a Body Mass Index Between 30 and 39.9kg/m2 (Obesity Class I and II) and Metabolic Syndrome, a Pilot Study.

To evaluate the efficacyandclinical safetyof bariatric arterial embolization(BAE) inadults with body mass index (BMI) between 30 and 39.9kg/m2 and metabolic syndrome (MS). Between March and August 2018, ten female participants between 21 and 48-years-old,median BMIof36.37±2.58kg/m2 andMSwere enrolled in this prospective trial. We embolized the fundal branches from the left gastric and other artery sources, which resulted in embolization of at least two arteries in 9 out 10 participants. Six months after bariatric embolization, efficacywas assessedby changes in total body weight (TBW), ghrelin and HomeostaticModelAssessment-InsulinResistance (HOMA-IR) levelsand by changes inquality of life (QOL) andinbinge eatingscale (BES) scores. Safety was assessed by the identification of any related complications, including gastric ulcers, screened by gastrointestinal endoscopy, performed before and one week and one month after BAE. Six months after embolization, TBW decreased by 6.8% (6.22kg±3.6;p = .01), serum ghrelin dropped from 25.39pg/ml±10.63 to 17.1±8.07 (p = 0.01), and HOMA-IR decreased from7.29±5.66 to 3.73±1.99 (p = 0.01). The QOL scores improvedfrom 59.64±5.59 to 69.02±11.97 (p < 0.05) and in the BES from 21.50±8.89 to 9.60±4.40(p = 0.01). Endoscopy revealed symptomaticgastric ulcers in two participants, which had healed without sequelae. In one participant, ultrasound revealed an asymptomatic focal arterial thrombus at the left distal radial artery puncture site. BAE is effective in reducing weight, insulin resistance and ghrelin levels and improving BES and QOL scores in patients with class I and II obesity and MS,with no major complications.

Bariatric Embolization: A Procedure Dead or Alive?

Bariatric Embolization: A Procedure Dead or Alive?

Percutaneous transcatheter bariatric embolotherapy for weight loss in obesity: two year data from a prospective RCT

Abstract Background/Introduction Obesity is an important risk factor associated with poor cardiovascular and metabolic outcomes. Dietary, medical, and surgical weight loss strategies are often unsuccessful, unsustainable or accompanied by risks. Pre-clinical and early case series reported that transcatheter bariatric embolotherapy (TBE) of the left gastric artery reduces weight, by reducing “hunger” hormones from the gastric fundus. We studied TBE in a double-blind, sham procedure, first in human RCT of patients (pts) with obesity, and following completion of the initial study we asked subjects to return after 2 years post-embolization for further evaluation. Purpose The purpose of this extension study was to assess the long-term weight loss and other outcomes in subjects who underwent TBE for weight loss. Methods In the initial RCT subjects were randomized 1:1 to either a Sham (skin nick &amp; 1 hr wait) or TBE following IV Propofol sedation. All pts received Lifestyle Therapy (behavioral and diet education); these staff following the pts were also blinded to treatment. Subjects completed the initial study when reaching the 1 year-follow-up visit. Subjects were then invited to return to the weight loss clinic at 2 years post-embolization for further evaluation on weight loss, blood pressure, pre-diabetic clinical status, satiety, and quality of life. Results A total of 44 pts (age 45.5±9.8; 36/8 M/F; BMI 39.6±3.8) were enrolled, of which 40 pts were randomized equally to groups, with no major complications. Mild, transient epigastric pain was seen, but EGDs showed no major abnormalities. Weight loss was improved with TBE by 6 mo, and maintained over the full 12 mo by both intention-to-treat and per-protocol analyses. At 2 years post-embolization, subjects treated with TBE demonstrated a mean 9% TBWL and 25% EBWL. Conclusion(s) Bariatric embolization is safe and when used along with lifestyle therapy, results in clinically significant weight loss. Long-term data demonstrates evidence that subjects treated with TBE continue to maintain their weight loss up to 2 years post-treatment. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Endobar Solutions LLC

THE WAY TO PREDICT THE EFFECTIVENESS OF BARIATRIC SURGERY IN PATIENTS WITH COMORBID OBESITY IN POST-PANDEMIC PERIOD

Summary. It is estimated that from 650 million to 2 billion adults worldwide, are overweight or obese, the numbers indicating epidemic levels of disease. In individuals, body mass index (BMI) exceeding 27 kg/m2 is associated with a high risk of mortality and the presence of comorbid pathologies, in particular, atherogenic dyslipidemia, arterial hypertension (AH), type 2 diabetes mellitus (T2D), thromboembolism, hepatic steatosis, etc. Preliminary data indicate that obesity is among key risk factors in severe and fatal cases of COVID-19, when comorbid with AH and T2D.&#x0D; The aim of this study – to analyze the possibility of developing an optimized model utilizing anamnestic, clinical, biochemical and genetic parameters for predicting the outcomes of bariatric surgery in the patients with obesity, type 2 diabetes mellitus (T2D) and/or arterial hypertension (AH).&#x0D; Results. Lifestyle changes and conservative treatment of obesity usually only result in a short-term effect, since the measures aiming to induce weight loss consign the person to a constant struggle with natural homeostatic processes. Recurrence of obesity in such patients is observed in 95 % of the cases. Therefore, the International Association of Endocrinologists recommends that patients with a BMI greater than 40 kg/m2, as well as with a BMI of 35.0 to 39.9 kg/m2 and metabolic syndrome undergo a surgical treatment of obesity using minimally invasive techniques. At the same time, a number of issues associated with bariatric laparoscopic interventions remain unresolved, since these procedures are invasive and carry all the risks accompanying surgery, general anesthesia, and the postoperative recovery period. An innovative surgical approach, the X-ray endovascular bariatric embolization of the gastric arteries (BAE) is proposed as an alternative to laparoscopic intervention. However, the indications for the use of BAE are undefined, especially in the cases of comorbid obesity; there are no clear algorithms and guidelines for its use.&#x0D; Conclusions. There have been no comprehensive studies of short-term, intermediate and long-term outcomes of BEA in Ukraine. This warrants the need to develop an optimal model for predicting the outcomes of both classical bariatric laparoscopic surgery with regulated gastric band and innovative BEA procedure in patients with comorbid obesity in post-pandemic period using anamnestic, clinical, biochemical and genetic predictors.

Gastric artery embolization: studying the\xa0effects of catheter type and injection method on microsphere\xa0distributions within a benchtop arterial model

AimsThe objective of the study is to investigate the effect of catheter type and injection method on microsphere distributions, specifically vessel targeting accuracy.Materials and methodsThe study utilized three catheter types (a standard end-hole micro-catheter, a Surefire anti-reflux catheter, and an Endobar occlusion balloon catheter) and both manual and computer-controlled injection schemes. A closed-loop, dynamically pressurized surrogate arterial system was assembled to replicate arterial flow for bariatric embolization procedures. Four vessel branches immediately distal to the injection site were targeted for embolization. Embolic microspheres were injected into the model using these three catheter types and both manual and computer-controlled injections.ResultsAcross all injection methods, the catheter effect on the proportion of microspheres to target vessels (vs. non-target vessels) was significant (p = 0.005). The catheter effect on the number of non-target vessels embolized was nearly significant (p = 0.059). Across all catheter types, the injection method effect was not statistically significant for either of two outcome measures (percent microspheres to target vessels: p = 0.265, number of non-target vessels embolized: p = 0.148).ConclusionCatheter type had a significant effect on targeting accuracy across all injection methods. The Endobar catheter exhibited a higher targeting accuracy in pairwise comparisons with the other two injection catheters across all injection schemes and when considering the Endobar catheter with the manifold injection method vs. each of the catheters with the manual injection method; the differences were significant in three of four analyses. The injection method effect was not statistically significant across all catheter types and when considering the Endobar catheter/Endobar manifold combination vs. Endobar catheter injections with manual and pressure-replicated methods.

A Review of Past and Present Weight Loss Strategies and the Potential Role of Bariatric Arterial Embolization

AbstractThe obesity epidemic is a growing public health concern that has a severe effect on the health care system with significant morbidity, mortality, and cost. Treatment options for obesity include lifestyle modifications, pharmacotherapy, and bariatric surgery. Newer, less-invasive therapies including endoscopic bariatric procedures have been developed in recent years to fill the treatment gap that exists between noninvasive approaches and surgery. Bariatric artery embolization (BAE) is a novel minimally invasive endovascular procedure that has been developed to treat obesity. Recent evidence has suggested that bariatric embolization is well tolerated and can induce clinically significant weight loss through a hormonally mediated mechanism. This article will review existing preclinical and clinical data, and explore future directions of the endovascular treatment of obesity.

Future of Bariatric Embolization: A Review of Up-to-date Clinical Trials.

Obesity is a significant health issue with an overall rise in mortality; it has multiple risk factors, including hormonal effects, which play a significant role in the balance of food intake and weight gain. Ghrelin is an anabolic hormone secreted from stomach fundus and plays a significant role in this regulation. Management of obesity involves multiple interventions, including lifestyle adjustment, pharmacotherapy, and bariatric surgery. Bariatric embolization is a relatively new procedure; several animal studies show that embolization of the left gastric artery reduces serum ghrelin and induces weight loss. Also, several clinical studies were conducted in the past ten years which have shown bariatric embolization's effectiveness in inducing weight loss: a meta-analysis of 47 patients included in six different clinical studies of left gastric artery embolization resulted in 8% total weight loss from baseline body weight. Many studies also show this procedure's effect on lowering the HgA1C level and lipid profile. Clinical studies mostly reported minor adverse effects such as transient abdominal discomfort, nausea and vomiting, gastric ulcers, and major adverse effects were uncommon, suggesting the procedure is well tolerated. It may be an alternative line of management in patients who are not suitable candidates for bariatric surgery.Although future clinical studies will provide an answer to several questions like the exact effects of the procedure on diabetes and metabolic syndrome, future studies are also needed to establish particular guidelines to match different patient characteristics with their optimal procedural techniques and pre- and post-procedure evaluation tests.

Метаболические исходы у пациентов с ожирением после проведения бариатрической эмболизации левой желудочной артерии

Метаболические исходы у пациентов с ожирением после проведения бариатрической эмболизации левой желудочной артерии

Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

Is There a Role for Bariatric Embolization in the Treatment of the Diabetic Patient?

Is There a Role for Bariatric Embolization in the Treatment of the Diabetic Patient?

Radial Approach for Left Gastric Artery Angiography and Embolization for the Treatment of Obesity: Technical Considerations.

Bariatric embolization of the left gastric artery (LGA) is being investigated as a technique to induce substantial weight loss in obese patients. Radial access is associated with less vascular complications than femoral access, especially in patients with severe obesity. We sought to assess the feasibility, safety and technical challenges of LGA angiography through radial access. Patients with suspected coronary artery disease (CAD) and obesity (BMI > 30 kg/m2) referred for diagnostic catheterization and/or percutaneous coronary intervention (PCI) were eligible. After completion of diagnostic and/or PCI, selective cannulation of celiac artery was performed and images of the LGA were taken from multiple views. Detailed procedural parameters such as procedure time, contrast volume and radiation data as well as anatomical variations were assessed. Between February and December 2018, we successfully achieved 50 selective angiographies of celiac artery from 54 enrolled patients (92.6%) and LGA was optimally visualized in 47/50 (97%) of cases. Right radial access was used in 50 cases. Mean age was 63.9 ± 8.0 years and 74% were men. Median BMI was 34.4 kg/m2 [32.2-39.4]. The median procedural time was 7 [5-10] minutes, contrast volume was 41 ml [33-63], fluoroscopy time was 160 [103-248] seconds and radiation exposure was 3125 [1906-4735] Gy.cm2. No complications were noted. The mean difficulty of the procedure on a visual analogue scale was 4/10. LGA angiography via transradial approach was feasible in the large majority of CAD patients with obesity. No safety issues were encountered.

Research progress of bariatric embolization for treatment of obesity.

Research progress of bariatric embolization for treatment of obesity.

Bariatric Embolization of Arteries for the Treatment of Obesity (BEAT Obesity) Trial: Results at 1 Year.

Background Bariatric embolization is a new endovascular procedure to treat patients with obesity. However, the safety and efficacy of bariatric embolization are unknown. Purpose To evaluate the safety and efficacy of bariatric embolization in severely obese adults at up to 12 months after the procedure. Materials and Methods For this prospective study (NCT0216512 on ClinicalTrials.gov ), 20 participants (16 women) aged 27-68 years (mean ± standard deviation, 44 years ± 11) with mean body mass index of 45 ± 4.1 were enrolled at two institutions from June 2014 to February 2018. Transarterial embolization of the gastric fundus was performed using 300- to 500-µm embolic microspheres. Primary end points were 30-day adverse events and weight loss at up to 12 months. Secondary end points at up to 12 months included technical feasibility, health-related quality of life (Short Form-36 Health Survey ([SF-36]), impact of weight on quality of life (IWQOL-Lite), and hunger or appetite using a visual assessment scale. Analysis of outcomes was performed by using one-sample t tests and other exploratory statistics. Results Bariatric embolization was performed successfully for all participants with no major adverse events. Eight participants had a total of 11 minor adverse events. Mean excess weight loss was 8.2% (95% confidence interval [CI]: 6.3%, 10%; P < .001) at 1 month, 11.5% (95% CI: 8.7%, 14%; P < .001) at 3 months, 12.8% (95% CI: 8.3%, 17%; P < .001) at 6 months, and 11.5% (95% CI: 6.8%, 16%; P < .001) at 12 months. From baseline to 12 months, mean SF-36 scores increased (mental component summary, from 46 ± 11 to 50 ± 10, P = .44; physical component summary, from 46 ± 8.0 to 50 ± 9.3, P = .15) and mean IWQOL-Lite scores increased from 57 ± 18 to 77 ± 18 (P < .001). Hunger or appetite decreased for 4 weeks after embolization and increased thereafter, without reaching pre-embolization levels. Conclusion Bariatric embolization is well tolerated in severely obese adults, inducing appetite suppression and weight loss for up to 12 months. Published under a CC BY-NC-ND 4.0 license. Online supplemental material is available for this article.

03:45 PM Abstract No. 28 Histological sequelae of selective bariatric arterial embolization with radiopaque microspheres in swine

03:45 PM Abstract No. 28 Histological sequelae of selective bariatric arterial embolization with radiopaque microspheres in swine

Bariatric embolization for obesity

Bariatric embolization for obesity