A new guideline from the American Gastroenterological Association (AGA) provides recommendations on the therapeutic role of intragastric balloons (IGBs)—devices placed endoscopically in the outpatient setting that provide a restrictive form of weight-loss therapy.
Obesity affects 40% of the US population, yet only about 1% of eligible patients receives primary bariatric surgery. Endoscopic bariatric therapies can also produce weight loss, as well as metabolic and histologic improvements in patients with nonalcoholic steatohepatitis, but less than 5% of patients with obesity seeking a weight-loss therapy are aware of endoscopic options.
IGBs have been associated with significant reductions in weight compared with non-invasive standard of care approaches to obesity. In the April issue of Gastroenteorlogy, Thiruvengadam Muniraj et al provide a guideline to assist patients and providers in determining whether this procedure should be considered and/or pursued. This guideline on IGBs was developed by the AGA Institute’s Clinical Guidelines Committee and approved by the AGA Governing Board.
IGBs have been on the US market since 1982, yet few guidelines or consensus documents have specifically addressed the efficacy, safety, and role that IGBs play in weight-loss therapy. Multiple new devices have been introduced into the US market. Although IGBs are a plausible option for patients seeking weight loss, it is essential for providers, patients, and health care teams to understand how IGBs can increase the effects of lifestyle modifications on outcome measures such as weight loss, metabolic parameters, and comorbid conditions. It is also important for providers and patients to be aware of the adverse events and tolerability associated with IGBs, because these devices have evolved and newer models are available.
IGBs led to greater weight loss at 6, 9, and 12 months after initial placement compared with patients receiving standard of care. The amount of weight loss incrementally decreased, however, for each successive time period.
The authors write that adverse events were rare (bowel obstructions, perforation, death) and there has been a voluntary removal rate of 4.2%–7.0%. IGBs have been reported to be effective producing total body weight loss and improving histologic features in livers of patients with nonalcoholic steatohepatitis.
The guidelines states that IGB therapy (with lifestyle modification) is superior to lifestyle modifications alone at initial and maintenance of weight loss for patients in the short term (within at least 12 months of initial IGB placement).
- Obesity patients seeking a weight loss intervention should consider using IGB therapy to augment the effect of moderate- to high-intensity lifestyle modifications
- To minimize the risk of gastrointestinal bleeding, patients undergoing IGB therapy should receive prophylactic proton pump inhibitors
- During IGB placement, patients should receive intraoperative anesthetics associated with a low incidence of nausea and afterward continue anti-emetic medication for 2 weeks
- Although perioperative screening for nutritional deficiencies is not required, IGB recipients should take one or two multivitamins after placement
- To keep weight off after IGB removal, dietary interventions, pharmacotherapy, repeat IGB, or bariatric surgery are advised, with the maintenance strategy determined using a shared decision-making approach
In the context of limited evidence, the AGA suggests using the intraoperative anesthetic regimens associated with the lowest incidence of nausea and a scheduled antiemetic regimen for 2 weeks after IGB placement. In addition, the AGA recommends against perioperative laboratory screening for nutritional deficiencies, but does suggest daily supplementation with 1–2 adult dose multivitamins after IGB placement. After IGB removal, the AGA recommends subsequent weight-loss or maintenance interventions that include dietary interventions, pharmacotherapy, repeat IGB, or bariatric surgery, and that a strategy be determined based on a shared decision-making approach. The AGA acknowledges the limitations of the available evidence on this topic as well as the potential confounding based on IGB characteristics, RCT design, and geographic variations of included studies; however, a rigorous review of current data supports the efficacy and safety of IGBs for patients with obesity. The AGA recognizes that new evidence may emerge in the future that might strengthen or modify some of the recommendations for the use of IGB in management of obesity.