title: Efficacy, tolerance and safety of new intragastric air-filled balloon (Heliosphere BAG) for obesity: the experience of 17 cases.
abstract: BACKGROUND
  Overweight and obesity lead to serious health consequences, so that many strategies were recommended for preventing or curing this emerging problem. Treatments are various: diet, physical activity, psychotherapy, drugs, and bariatric surgery. Moreover, during these years, the use of intragastric balloon (BIB) to treat obesity increased rapidly, aimed to (1) reduce bariatric surgical risks; (2) reduce general surgical risks; (3) lead to a significant reduction in the prevalence of cardiovascular diseases, diabetes, musculoskeletal disorders and some cancers. Recently, a new device inflated with air to reduce weight has been developed since 2004 (Heliosphere BAG).
  
  
  METHODS
  Between March 2006 and September 2006, in our unit, intragastric air-filled balloon insertion was performed under general anesthesia and endoscopic control. The balloons were removed after 6 months. We evaluated efficacy, tolerance, and safety of this technique. Seventeen patients (eight men, nine women), with a mean age of 43 +/- 10 years (range 18-65), mean basal BMI of 46 +/- 8 (range 35-58) were included, after providing informed consent. Weight and BMI loss were evaluated in all patients.
  
  
  RESULTS
  BMI decreased 4 +/- 3 (range +0.33/-11), weight loss was 11 +/- 9 kg (range +1/-29.5; 8.5%). 14/17 patients maintain a BMI > 35 at the time of balloon removal. The difference between initial weight and BMI was statistically significant (p = 0.02 for weight and p < 0.01 for BMI, T Student test). Tolerance was very good, limited only to some dyspeptic symptoms during the first 3 days after insertion. One asymptomatic gastric ulcer was seen at the removal of balloon. Only one severe adverse effect was registered at the time of insertion (acute coronary syndrome in patient with chronic coronary disease). No serious technical problems were noted at balloon insertion. Balloon removal was more difficult and successful in 15/17 cases (one distal migration and one patient led to surgery because of balloon fragmentation).
  
  
  CONCLUSIONS
  Intragastric air-filled balloon showed a good profile of efficacy and tolerance. Weight loss appeared to be equivalent to other type of balloons. On the other hand, technical problems (especially at the time of removal) probably linked to the device's material, set a low safety profile.
authors.affiliation: Internal Medicine and Gastroenterology Unit, New S'Agostino Hospital, Modena, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Trande
authors.forename: Alessandro
authors.initials: A
authors.lastname: Mussetto
authors.forename: Vincenzo G
authors.initials: VG
authors.lastname: Mirante
authors.forename: Elvira
authors.initials: E
authors.lastname: De Martinis
authors.forename: Giampiero
authors.initials: G
authors.lastname: Olivetti
authors.forename: Rita L
authors.initials: RL
authors.lastname: Conigliaro
authors.forename: Enrico A
authors.initials: EA
authors.lastname: De Micheli
mesh_terms: D000328:Adult; D000368:Aged; D015992:Body Mass Index; D020878:Device Removal; D005260:Female; D015905:Gastric Balloon / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000628:therapy*; D015431:Weight Loss; D055815:Young Adult