S1197 An Appraisal of the Morbidity Risk After Intragastric Balloon Placement for Weight Loss: A Systematic Review

Abstract

INTRODUCTION: Surgical management is considered the most effective treatment for obesity; major series have estimated overall postoperative morbidity between 0.1 and 0.15%. Intragastric balloon (IGB) placement represents an endoscopic intervention that has shown efficacy at inducing weight loss. This study aimed to review the incidence of morbidity after IGB placement. METHODS: A systematic literature search was conducted on MEDLINE using the PICO framework and is reported under the PRISMA framework (Figure 1). Clinical trials (randomized and non-randomized) comparing intragastric balloon with medical management, placebo, or dietary restriction were included. Studies with non-FDA approved devices, on non-human subjects, or not in English were excluded. Adverse events were then classified by severity into Clavien-Dindo grades to standardize outcomes. RESULTS: Of the 49 studies screened after a systematic literature search, 23 clinical trials (n = 1996) met the inclusion criteria; 1327 of these patients underwent endoscopic intragastric balloon placement (Table 1). Six trials compared IGB with medical management, 8 with placebo, 7 trials did not have a comparison group, and 2 compared saline with air-filled balloons. Dietary restriction was included in the study protocol for 92.89% of the patients. The majority of the trials (n = 15) used saline-filled balloons, whereas the rest used air or nitrogen-filled balloons. The mean follow-up after the procedure was 13.60 ± 11.3 months. The pooled range of Clavien-Dindo grade III morbidity was 3.33%–19.37%, grade IV was 0.5%–4.76%, and grade V was 0%. Mild post-procedural morbidity had a wide spectrum ranging from 11.6% to 100%. CONCLUSION: The incidence of moderate to severe morbidity from an intragastric balloon appears to be comparable to published morbidity and mortality data for bariatric surgery. However, complications of mild severity are more common. Clinical trials comparing IGB with surgical weight loss are needed.Figure 1Table 1