Bariatric Arterial Embolization for Obesity: A Review of Early Clinical Evidence.
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ABSTRACT:
SUBMITTER: Zhong BY
PROVIDER: S-EPMC6281784 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
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Bariatric Arterial Embolization for Obesity: A Review of Early Clinical Evidence.
Zhong Bin-Yan BY Abiola Godwin G Weiss Clifford R CR
Cardiovascular and interventional radiology 20180605 11
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-cathet ...[more]
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Project description:Purpose To conduct a pilot prospective clinical trial to evaluate the feasibility, safety, and short-term efficacy of bariatric embolization, a recently developed endovascular procedure for the treatment of obesity, in patients with severe obesity. Materials and Methods This is an institutional review board- and U.S. Food and Drug Administration-approved prospective physician-initiated investigational device exemption study. This phase of the study ran from June 2, 2014, to August 4, 2015. Five severely obese patients (four women, one man) who were 31-49 years of age and who had a mean body mass index of 43.8 kg/m2 ± 2.9 with no clinically important comorbidities were enrolled in this study. Transarterial embolization of the gastric fundus with fluoroscopic guidance was performed with 300-500-μm Embosphere microspheres. The primary end point was 30-day adverse events (AEs). The secondary end points included short-term weight loss, serum obesity-related hormone levels, hunger and satiety assessments, and quality of life (QOL) surveys, reported up to 3 months. Simple statistics of central tendencies and variability were calculated. No hypothesis testing was performed. Results The left gastric artery, with or without the gastroepiploic artery, was embolized in five patients, with a technical success rate of 100%. There were no major AEs. There were two minor AEs-subclinical pancreatitis and a mucosal ulcer that had healed by the time of 3-month endoscopy. A hospital stay of less than 48 hours for routine supportive care was provided for three patients. Mean excess weight loss of 5.9% ± 2.4 and 9.0% ± 4.1 was noted at 1 month and at 3 months, respectively. Mean change in serum ghrelin was 8.7% ± 34.7 and -17.5% ± 29 at 1 month and 3 months, respectively. Mean changes in serum glucagon-like peptide 1 and peptide YY were 106.6% ± 208.5 and 17.8% ± 54.8 at 1 month. There was a trend toward improvement in QOL parameters. Hunger/appetite scores decreased in the first 2 weeks after the procedure and then rose without reaching preprocedure levels. Conclusion Bariatric embolization is feasible and appears to be well tolerated in severely obese patients. In this small patient cohort, it appears to induce appetite suppression and may induce weight loss. Further expansion of this study will provide more insight into the long-term safety and efficacy of bariatric embolization. © RSNA, 2017 Online supplemental material is available for this article.
| S-EPMC5410948 | biostudies-literature
Project description:Obesity is a public health epidemic in the United States that results in significant morbidity, mortality, and cost to the health care system. Despite advancements in therapeutic options for patients receiving bariatric procedures, the number of overweight and obese individuals continues to increase. Therefore, complementary or alternative treatments to lifestyle changes and surgery are urgently needed. Embolization of the left gastric artery, or bariatric arterial embolization (BAE), has been shown to modulate body weight in animal models and early clinical studies. If successful, BAE represents a potential minimally invasive approach offered by interventional radiologists to treat obesity. The purpose of the present review is to introduce the interventional radiologist to BAE by presenting its physiologic and anatomic bases, reviewing the preclinical and clinical data, and discussing current and future investigations.
| S-EPMC4414740 | biostudies-other
Project description: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.
| S-EPMC6542625 | biostudies-literature
Project description:BackgroundDespite accumulating evidence of the important health benefits of bariatric surgery in morbidly obese patients in general, bariatric surgery outcomes are less clear in higher-risk, high-priority populations of patients with BMI ≥ 50 kg/m2. To help the Department of Veterans Affairs (VA) Health Services Research & Development Service (HSR&D) develop a research agenda, we conducted a rapid evidence review to better understand bariatric surgery outcomes in adults with BMI ≥ 50 kg/m2.MethodsWe searched MEDLINE®, the Cochrane Database of Systematic Reviews, the Cochrane Central Registry of Controlled Trials, and ClinicalTrials.gov through June 2016. We included trials and observational studies. We used pre-specified criteria to select studies, abstract data, and rate internal validity and strength of the evidence (PROSPERO registration number CRD42015025348). All decisions were completed by one reviewer and checked by another.ResultsAmong 1892 citations, we included 23 studies in this rapid review. Compared with usual care, one large retrospective VA study provided limited evidence that bariatric surgery can lead to increased mortality in the first year, but decreased mortality long-term among super obese veterans. Studies that compared different bariatric surgical approaches suggested some differences in weight loss and complications. Laparoscopic gastric bypass generally resulted in greater short-term proportion of excess weight loss than did other procedures. Duodenal switch led to greater long-term weight loss than did gastric bypass, but with more complications.ConclusionsThe published literature that separates the super obese is insufficient for determining the precise balance of benefits and harms of bariatric surgery in this high-risk subgroup. Future studies should evaluate a more complete set of key outcomes with longer follow-up in larger samples of more broadly representative adults.
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Project description: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.
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Project description:Ranked highly in its association with serious medical comorbidities, obesity, a rapidly growing epidemic worldwide, poses a significant socio-economic burden. While bariatric procedures offer the most efficacious treatment for weight loss, a subset of patients risk weight recidivism. Due to the heterogeneity of obesity, it is likely that there are phenotypes or sub-groups of patients that require evidence-based psychological support to produce more sustainable outcomes. So far, however, characteristics of patients have not led to a personalized treatment algorithm for bariatric surgery. Maintenance of weight loss following bariatric surgery requires long-term modification of eating behaviors and physical activity. A recent Clinical Obesity Maintenance Model (COMM) proposed a conceptual framework of salient constructs, including the role of habit, behavioral clusters, emotion dysregulation, mood, health literacy, and executive function as interconnected drivers of obesity maintaining behaviors relevant to the field of bariatric psychology. The primary aim of this concise review is to bring together emerging findings from experimental and epidemiological studies relating to the COMM constructs that may inform the assessment and follow up of bariatric surgery. We also aim to explain the phenotypes that need to be understood and screened prior to bariatric surgery to enable better pre-surgery intervention and optimum post-surgery response.
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Project description:The prevalence of childhood obesity in the UK and in many countries worldwide remains high. Behavioural interventions to modify lifestyle, such as diet and physical activity, usually form part of weight management strategies for obese children. Whether or not surgical interventions are effective and safe in treating childhood obesity is unclear.We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of surgical interventions for the treatment of childhood obesity? We searched Medline, Embase, The Cochrane Library, and other important databases up to August 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this overview).At this update, after deduplication and removal of conference abstracts, 67 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 19 studies and the further review of 48 full publications. Of the 48 full articles evaluated, two systematic reviews were included at this update.In this systematic overview, we categorised the efficacy for two comparisons based on information about the effectiveness and safety of bariatric surgery versus no intervention and different types of bariatric surgery versus each other.
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