AGA issues new guidelines on intragastric balloon use
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The American Gastroenterological Association published new clinical practice guidelines on the use of intragastric balloons in obesity management.
“Endoscopic bariatric therapies have evolved as an attractive tool for weight loss, however, less than 5% of patients with obesity seeking a weight loss therapy are aware of endoscopic weight loss options,” Thiruvengadam Muniraj, MD, MRCP, Yale University School of Medicine, said in a press release. “Our hope is that this new guideline can lead to shared decision making between patients and providers to determine if intragastric balloons (IGB) are the best weight loss option for that individual patient.”
Key guidelines include:
IGB therapy with lifestyle modification is recommended over lifestyle modification alone
Across clinical outcomes focused on weight loss, improving metabolic parameter/medical comorbidities and safety, guideline authors found IGBs performed better than standard of care alone for weight loss.
Pooled data from randomized controlled trials (RCT) showed IGBs led to an average weight loss of 15.46 lbs (95% CI, 10.42-20.51 lbs) at 6-months, an average weight loss of 13.12 lbs (95% CI, 10.53-15.7 lbs) at 9-months and an average weight loss of 9.76 lbs (95% CI, 6.38-13.14 lbs) at 12-months. Similarly, compared with standard of care alone, researchers saw a mean difference of 6.89% (95% CI, 4.09%-9.7%) total body weight loss between the groups at 6-months and 8-months.
“Patients who use an IGB for weight loss therapy attain greater weight loss across several parameters than standard of care/lifestyle modication therapy over a 6- to 12-month time frame,” the authors wrote.
Proton pump inhibitors may minimize GI bleeding risk
While there is an absence of RCTs assessing the direct outcomes of PPIs in patients with IGB, guideline authors found indirect evidence suggests PPI use reduces the risk for re-bleeding in patients with high-risk bleeding stigmata in the upper GI tract. Additionally, analyzed RCTs yielded lower device/non-procedure-related adverse events in patients receiving both IGB therapy and PPI therapy.
Authors recommend using the lowest dose, frequency and duration of PPIs to decrease overall risk in the short-term and long-term.
Further research on use of anesthetics associated with low incidence of nausea and anti-nausea medication required
Authors suggest the use of intraoperative anesthetics associated with a low incidence of nausea in conjunction with perioperative antiemetics during IGB placement. For 2-weeks following placement, they further suggest a scheduled anti-nausea medication regimen.
The choice of regimen is to be determined based on institutional policy, clinical context and availability; further research is required to determine a specific antiemetic regimen.
Daily multivitamin supplementation after IGB placement also recommended
Though there is little evidence available supporting prophylactic dosing of multivitamin supplements post-IGB, authors suggest a regimen of one to two adult dose multivitamins daily to avoid thiamine, folate, magnesium and potassium deficiencies.
Among studies reporting preoperative thiamine deficiency, prophylactic dosing of one to three multivitamins per day resulted in a decreased prevalence of deficiency from 0%-29% to 0%-9%.
Maintenance strategies determined by joint-decision following IGB removal
Weight-loss maintenance strategies may include dietary interventions, pharmacotherapy, subsequent IGB or bariatric surgery. Authors say open discussion with patients regarding the risks, benefits and alternatives of weight-loss management is required.
“Shared decision making is a critical component of obesity therapy — for everything from selecting the right IGB device to what concomitant lifestyle modifications, pharmacotherapy or sequential procedures a patient should pursue,” Muniraj added in the release. “This shared decision making should consider the patient’s values and preferences, balance benefits and harms within the patient’s clinical and behavioral context and consider cost and availability.”
Perspective
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Roberto Simons-Linares, MD, MSc
The new AGA guidelines on intragastric balloons (IGBs) in the management of obesity are a step forward toward improving care for obesity. Forty-two percent of U.S. adults had obesity as per multiple reports in 2018 and only around 1% of those who qualify for bariatric surgery actually underwent surgical intervention for obesity.
Clearly, endoscopic bariatric and metabolic therapies (EBMTs) add and complement the multiple available therapies that we can offer patients with obesity. In the AGA guidelines and technical review, patients who were treated with IGBs were almost two times more likely to achieve 5% total body weight loss (TBWL) response compared with lifestyle modification (diet/exercise) alone. In addition, randomized controlled trials that have tested the safety of IGBs have reported a very safe profile, and it is well summarized in the AGA guidelines and technical review.
When using IGB for weight loss, it also must be accompanied by a comprehensive multidisciplinary approach with lifestyle modifications, and ideally these should be continued after IGB removal. Although IGBs are not permanent nor as effective as other EBMTs, they are safe, more efficacious than lifestyle modification alone and complement the toolbox of the bariatric endoscopist. Finally, it’s great progress for the field of bariatric endoscopy to have AGA support and guidelines for this type of EBMTs for the management of obesity.
References:
Hales CM, et al. Prevalence of obesity and severe obesity among adults: United States, 2017–2018. NCHS Data Brief. 2020. Available at: https://www.cdc.gov/nchs/data/databriefs/db360-h.pdf Accessed: May 6, 2021.
ASMBS total bariatric procedure numbers are based on the best estimation from available data (BOLD,ACS/MBSAQIP, National Inpatient Sample Data and outpatient estimations). (2017). Available at: https://asmbs.org/resources/estimate-of-bariatric-surgery-numbers Accessed: May 6, 2021.
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