Intragastric Balloon: A Large Brazilian Multicentric Study Over 10,000 Cases and 20 Years of Experience

Abstract

Introduction: The intragastric balloon has been used for more than 20 years in Brazil as an endoscopic method for assisting weight loss, and some intercurrences were observed during more than 10,000 procedures performed. With the assistance of a multidisciplinary team the results have been satisfactory. Aims & Methods: To assess the efficacy and complications of the weight loss with IGB in patients seen at the 07 private centers. A total of 10,255 patients with IGB implanted from 1997 to 2017 were analyzed from a prospective fed databank. A liquid filled IGB with a volume in-between 620 to 700 ml was used. Initial BMI started at 27 kg/m2 (as approved by Brazilian health authorities) and were followed up by a multidisciplinary team during implant. IGB maximum period implant was 09 months. Statistical analysis was performed according to sex and degree of excess weight (overweight and grade I, II and III). Data were analyzed using Student t-test, and and Tukey post-test. The level of significance was set at p<0.05. Results: 492 patients (4,8%) were excluded from the final analysis associated with weight loss: 226 (2,2%) due to early removal-These were analyzed in relation to the previous consultation with psychologist and 94% of them did not make a psychological evaluation before the procedure, 158 (1.54%) due fail on weight loss or weight gain-These were analyzed in relation to follow-up with nutritionist and 88% did not undergo nutritional monitoring during the use of IGB, 108 (1.05%) due to incomplete data. There were also spontaneous hyperinflation on 0.99% (n=101) and balloon spontaneous deflation or leakage in 0.82% (n=84). Incidence of complications not leading to removal were 6.65% (n=682). Complications other happened as fungal contamination in in 7.9% (n=810); Wernick Korsakoff syndrome 0.01% (n=2), pregnancy during implant period was 1.2% (n=123) and Dieulafoy lesion 0.009% (n=1). The incidence of complications with IGB removal was 0.05% (n=6): gastric perforation. On the 9,763 remaining patients, 7.615 (78%) were women and 2.148 (22%) were men. Mean age was 31.13 years. The patients showed a significant weight loss, with a significantly lower final BMI (27.16±8.42 kg/m2; range: 15.71-34) than the initial BMI (33.42±6.62 kg/m2; range: 27-79.35). The mean Weight Loss was -16.98 kg (+/-16.8 kg). Percent EW L was higher in the overweight group (129.92%EWL), followed by obesities grades I (73.64%), II (57.85%) and III (41.33%) sequentially. A total of 5.2% (66/1,268) of the patients followed up for 18 months after withdrawal of the IGB were submitted to bariatric surgery. Conclusion: The intragastric balloon has been established as an valid endoscopic therapeutic option for weight loss, especially in patients with overweight and obesity grades I and II and multidisciplinary team follow-up is mandatory for successful treatment.