Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study

Background/Aims: Aspiration therapy (AT) involves endoscopic placement of a gastrostomy tube with an external device that allows patients to drain 30% of ingested calories after meals. Its efficacy for inducing weight loss has been shown. This study aimed to assess the effect of AT on obesity-related comorbidities. Methods: A meta-analysis of studies that assessed AT outcomes was conducted through December 2018. Primary outcomes were changes in comorbidities at 1 year following AT. Secondary outcomes were the amount of weight loss at up to 4 years and pooled serious adverse events (SAEs). Results: Five studies with 590 patients were included. At 1 year, there were improvements in metabolic conditions: mean difference (MD) in systolic blood pressure: -7.8 (-10.7 --4.9) mm Hg; MD in diastolic blood pressure: -5.1 (-7.0 -3.2) mm Hg; MD in triglycerides: -15.8 (-24.0 --7.6) mg/dL; MD in high-density lipoprotein: 3.6 (0.7-6.6) mg/dL; MD in hemoglobin A1c (HbA1c): -1.3 (-1.8 --0.8) %; MD in aspartate transaminase: -2.7 (-4.1 --1.3) U/L; MD in alanine transaminase: -7.5 (-9.8 --5.2) U/L. At 1 (n=218), 2 (n=125), 3 (n=46), and 4 (n=27) years, the patients experienced 17.8%, 18.3%, 19.1%, and 18.6% total weight loss (TWL), corresponding to 46.3%, 46.2%, 48.0%, and 48.7% excess weight loss (EWL) (p<0.0001 for all). Subgroup analysis of 2 randomized controlled trials (n=225) showed that AT patients lost more weight than did controls by 11.6 (6.5-16.7) 3) %EWL and experienced greater improvement in HbA1c and alanine transaminase by 1.3 (0.8-1.8) % and 9.0 (3.9-14.0) U/L. The pooled SAE rate was 4.1%. Conclusions: Obesity-related comorbidities significantly improved at 1 year following AT. Additionally, a subgroup of patients who continued to use AT appeared to experience significant weight loss that persisted up to at least 4 years. Clin Endosc 2020 Feb 28. [Epub ahead of print]

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“…1). [8][9][10][11][12] All studies were graded as high quality (JBI score of 7, NOS of 7, and JADAD scores of 3, 3, and 3).…”

Section: Search Resultsmentioning

confidence: 99%

“…Of the 5 articles, 3 were published studies and 2 were conference abstracts ( Table 1). [8][9][10][11][12] The 5 articles detailed the results Included of 4 studies. Specifically, 1 abstract 12 was a 2-4-year follow-up report of a previously published study 8 with a 1-year follow-up.…”

Section: Search Resultsmentioning

confidence: 99%

Effect of Aspiration Therapy on Obesity-Related Comorbidities: Systematic Review and Meta-Analysis

et al. 2020

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“…Results from the US multicentre Pivotal Aspiration Therapy with Adjusted Lifestyle ‘PATHWAY’ randomised clinical trial demonstrated a mean 14.2%±9.8% total body weight loss (%TBWL) among completers at 1 year with improvements in metabolic parameters and quality of life 1. A following multicentre postapproval study validated their findings, revealing even greater 1 year %TBWL at 18.2%+9.4%, with maintained weight loss at 4 years 2. However, in the PATHWAY study, the investigators found that early responders who lost greater than 5% TBWL by 14 weeks lost significantly more weight at 1 year than those who failed to reach 5% TBWL (17.2%±8.7% vs 4.9%±6.3%).…”

Section: Introductionmentioning

confidence: 91%

Accelerated gastric emptying is associated with improved aspiration efficiency in obesity

Vargas

Storm

Bazerbachi

et al. 2019

BMJ Open Gastroenterol

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BackgroundThe overall effectiveness of aspiration therapy (AT) for obesity relies on optimal aspiration timing after a meal, which can vary depending on a patient’s rate of gastric emptying (GE). Our aim was to identify if baseline GE rates were associated with differences in aspiration efficiency (AE).MethodsSubjects from an ongoing AT clinical trial were enrolled in this study. AE was calculated as the absolute gastric residual and calories aspirated at 20 and 40 min. Participants were then divided by baseline GE rate into two groups (slow vs fast). Wilcoxon rank-sum test was used to compare AE at 20 and 40 min between the groups. Exploratory linear regression was used to assess relationship between GE and AE.Results7 patients (85% female) were coenrolled in the study. Mean age and body mass index were 39.8±9.44 and 43±5, respectively. AE did not significantly differ between the 20 and 40 min time points for the group as a whole (34.3% vs 36.9%; p>0.5). However, those with fast GE aspirated more calories than those with slow GE (20 min: 200 kcal vs 72.5 kcal; 40 min: 154 kcal vs 63 kcal) (p=0.05). On linear regression, delayed GE was associated with poorer aspiration (20 min: β=−107 calories; p=0.019; R2=0.7). 4/7 patients had significant differences in residual/caloric aspiration across the two time points.ConclusionPatients undergoing AT may benefit from a GE test to optimise their AE. Paradoxically faster GE times saw better aspiration. Prospective studies are revealing a personalised approach to obesity.

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“…However, at least in the short to midterm, all of these interventions appear to produce clinically meaningful weight loss with similar improvement in obesity-related comorbidities such as type II diabetes and hypertension. [5][6][7] The combination of endobariatric techniques with weight loss medications currently is being studied, and in the future it may be possible to apply dual endobariatric techniques to maximize a patient's body weight loss and weight maintenance. More investigation is needed to determine the long-term benefits and the cost effectiveness of these minimally invasive procedures.…”

Section: Clinically Approved Endobariatric Proceduresmentioning

confidence: 99%

Endobariatrics: A Primer

Storm

Dayyeh

Topazian

2018

Clinical Gastroenterology and Hepatology

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F lexible gastrointestinal endoscopy offers an ever-expanding menu of minimally invasive alternatives to surgical interventions, most recently through procedures developed to address the obesity epidemic. Gastroenterologists are well positioned to manage obesity given their broad-based medical knowledge, understanding of gastrointestinal physiology, and training in endoscopic technique. The field of endobariatrics has emerged out of several recently Food and Drug Administration (FDA)-approved technologies. 1 This review focuses on techniques and FDA-approved devices used for endoscopic management of obesity, acknowledging that endobariatrics is in its infancy with many new devices and techniques in the pipeline, and much data still are needed. The Obesity Epidemic and the Role of Endobariatrics Most Americans are either overweight or obese, and obesity has become a public health crisis. 2 For most patients obesity is a chronic health condition that requires a multidisciplinary team approach to treatment. One-time interventions (whether endoscopic or surgical) are likely to fail unless accompanied by careful patient selection and ongoing care. Patients are best treated using a comprehensive bariatric medicine approach that addresses the nutritional, educational, psychological, and motivational aspects of weight management. Obesity therapies, including lifestyle and diet modification, accountability, exercise, counseling, medications, and surgery fall along a spectrum of invasiveness and efficacy (Figure 1). Endoscopic therapies appear to lie in the middle of this spectrum, offering efficacy with a risk profile similar to other therapeutic endoscopic procedures. Because endoscopic approaches are less invasive and have less risk than surgery, and are more efficacious than currently available medical interventions, they potentially are applicable to a large group of patients. Clinically available endobariatric procedures in the United States that use FDA-approved devices include several intragastric balloons (IGBs), gastric aspiration therapy, and endoscopic sleeve gastroplasty (ESG). 3 Duodenojejunal bypass liners, magnetic creation of small intestinal fistulas, and other techniques that do not use FDA-approved devices are not discussed at length in this review.

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Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study

Cited by 66 publications

References 23 publications

Effect of Aspiration Therapy on Obesity-Related Comorbidities: Systematic Review and Meta-Analysis

Effect of Aspiration Therapy on Obesity-Related Comorbidities: Systematic Review and Meta-Analysis

Accelerated gastric emptying is associated with improved aspiration efficiency in obesity

Endobariatrics: A Primer

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