title: Effectiveness and safety of air-filled balloon Heliosphere BAG® in 82 consecutive obese patients.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Air-filled Heliosphere BAG® has been effective in achieving a relevant loss of body weight.
authors.affiliation: Endocrinology and Nutrition Department, Fundación Jiménez Díaz-Capio, Avda. Reyes Católicos n 2, Madrid, Spain. edurnelecumberri@hotmail.com
authors.forename: Edurne
authors.initials: E
authors.lastname: Lecumberri
authors.forename: Waeel
authors.initials: W
authors.lastname: Krekshi
authors.forename: Pilar
authors.initials: P
authors.lastname: Matía
authors.forename: Carlos
authors.initials: C
authors.lastname: Hermida
authors.forename: Nuria García
authors.initials: NG
authors.lastname: de la Torre
authors.forename: Lucio
authors.initials: L
authors.lastname: Cabrerizo
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Rubio
mesh_terms: D000328:Adult; D005260:Female; D015905:Gastric Balloon; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery*; D016896:Treatment Outcome; D015431:Weight Loss