Spanish Intragastric Balloon Consensus Statement (SIBC): practical guidelines based on experience of over 20 000 cases.

BACKGROUND: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.

Evaluating the Safety of the Intragastric Balloon: Spanish Multicenter Experience in 20,680 Cases and with 12 Different Balloon Models.

INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.