Effectiveness and Safety of Air-Filled Balloon Heliosphere BAG® in 82 Consecutive Obese Patients

Abstract

Intragastric balloon is a widely used technique to treat obesity that is considered to be more efficient than conservative treatment before bariatric surgery. To describe air-filled balloon (Heliosphere BAG®) effectiveness [absolute weight loss, body mass index (BMI) loss, percentage of body weight loss (BWL), percentage of excess weight loss (EWL)] and complications 6 months after its insertion. Eighty-four consecutive intragastric balloons were placed endoscopically. Individualized nutritional counseling was given. The follow-up was carried out in an endocrinology outpatient clinic. Due to the weight or height data missed in two cases, only 82 patients were included in this report, 63 women with a mean age 39 years (SD, 11.1); mean BMI, 39.1 kg/m(2) (SD, 5.8). The median follow-up was 182 days. The mean weight loss and BMI loss were 14.5 kg (SD, 8.2); and 5.3 kg/m(2) (SD, 2.8), respectively (for difference, p < 0.001). The mean percentage of BWL was 13.4% (SD, 7.0). Of the sample, 70.4% achieved a percentage of BWL >10%. The percentage of EWL reached 33.2% (SD, 19.2). After adjusting by sex and initial BMI, absolute weight loss (p = 0.033), BMI loss (p = 0.034), percentage of BWL (p = 0.034), and percentage of EWL (p = 0.034) were inversely related to age. Absolute weight loss and BMI loss were greater in higher initial BMI, but the percentage of EWL was lower. Two spontaneous deflations occurred (3%), but only one surgical early removal (1.2%) was required. Nausea and vomiting developed in 7.4% of the patients during the first week. Air-filled Heliosphere BAG® has been effective in achieving a relevant loss of body weight.