Short- and long-term efficacy of intragastric air-filled balloon (Heliosphere® BAG) among obese patients.

Background: Obesity is an increasing health problem worldwide. The intragastric balloon as a temporary endoscopic treatment of obesity can play an important role among the aforementioned group of obese individuals. It can also be used as a preoperative test before subjecting patients to restrictive bariatric surgery. Furthermore, the intragastric device may be applied to patients affected by severe obesity as a "bridge treatment" before they undergo major surgery in order to reduce chances of operation-related risks. To date, there are insufficient data in the literature on the long-term results of the intragastric balloon.

Methods: Our study includes an analysis of our experience with Heliosphere® BAG from 2006 through to 2010, concerning early weight loss and weight loss maintenance over at least 18 months since the device's removal. The 32 patients who completed the 6-month treatment had recorded a mean weight loss of 12.66 kg and a mean overweight loss of 24.37 % (SD, 12.74).

Results: A total of 16 patients are subjected to an 18-month follow-up. Their pretreatment and long-term body mass index (BMI) were calculated: 6 months later, when devices were removed, they showed a mean weight of 99.75 kg (SD, 17.90; p < 0.001) and a mean weight loss of 13.62 kg and 26.14 % (SD, 12.79). 18 months after removing Heliosphere® BAG, the 16 patients' mean BMI was 37.28 kg/m² (SD, 5.41; p = 0.004), with a mean weight of 103.56 kg (SD 17.25; p = 0.0125), and a mean weight loss of 9.8 kg or 18.2 % (SD, 12.07).

Conclusions: Heliosphere® BAG enables modest short-term weight loss with little side effects, although mid/long-term follow-up may entail partial weight gain. We believe it can be considered a useful bridge treatment in bariatric surgery in order to reduce chances of preoperative risks.