Safety Profile of Primary Intragastric Balloon Placement in Class III Obesity: An MBSAQIP Analysis of 4,555 Patients

Intragastric balloon (IGB) therapy is a minimally invasive endoscopic intervention primarily utilized for weight reduction in patients with Class I and II obesity. While less frequently utilized in individuals with Class III obesity (BMI ≥ 40 kg/m²), IGB placement may be considered as a bridge to bariatric surgery or when surgery is contraindicated or declined. However, data regarding short-term safety outcomes in this higher-risk population remain limited. This study aims to compare 30-day safety outcomes after IGB placement in patients with BMI ≥ 40 kg/m² versus BMI < 40 kg/m². This was a retrospective cohort study of 4,555 patients undergoing primary IGB placement from 2016 to 2023 using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. Primary outcomes included hospital length of stay and 30-day rates of outpatient intravenous (IV) treatments, emergency department (ED) visits, readmissions, reoperations, interventions, and mortality. Patients were stratified by BMI ≥ 40 kg/m² and BMI < 40 kg/m² for comparative analysis using propensity score-matching (PSM). 962 pairs were identified for PSM. Patients with BMI ≥ 40 kg/m² were younger on average and more likely to be male and non-Hispanic Black. This group exhibited a higher prevalence of associated medical problems, including diabetes, obstructive sleep apnea, hypertension, renal insufficiency, immunosuppressant use, thromboembolic events, and therapeutic anticoagulation use. After adjustment for baseline differences, patients with BMI ≥ 40 kg/m² were more likely to require a postoperative hospital length of stay longer than one day (p = 0.003). No significant differences in 30-day outpatient IV treatments, ED visits, readmissions, reoperations, interventions, or mortality, were observed. Patients with BMI ≥ 40 kg/m² exhibited a greater burden of associated medical problems and longer hospital length of stay, but otherwise demonstrated comparable short-term safety outcomes to those with BMI < 40 kg/m². These findings suggest comparable 30-day hospital-based safety outcomes after IGB placement in patients with BMI ≥ 40 kg/m² compared with BMI < 40 kg/m².