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Background and Purpose: Intragastric balloons are used as a treatment for obesity. Much of the data collected on balloons had been in the context of clinical trials in academic medical centers or as a bridge to bariatric surgery in obesity centers. The aim of this study was to investigate the efficacy and safety of balloon treatment in private practice. Study Design: This is an interventional study. Subjects: The study included 1600 patients. Place: The study was conducted at the ElKatib Hospital. Method: This was a retrospective analysis of 6-month weight loss data and balloon-related complications of patients referred to a private center for obesity treatment. Assessment: The assessment was carried out by obtaining full patients' history (personal history, present illness, and previous drug history and operations). Laboratory work was done in the form of CBC, blood sugar, and viral markers. Bioenterics Intragastric Balloon (BIB) silicone balloon was used, filled with saline plus methylene blue dye with a volume ranging from 400 to 700 ml. The gained measures were analyzed by using SPSS program, and paired t test and chi-square test were used to compare between groups. Results: A total of 1600 patients were included (368 male (23%) and 1232 female (77%)) with mean age 34.1 ± 10.354, mean body weight 112.45 ± 26.24, and mean body mass index (BMI) 40.32 ± 8.17. There were 46 patients younger than 18 years and 12 patients older than 60 years. There were 109 patients with a BMI ranging from 25 to < 35 and 737 patients with a BMI ≥ 40 kg/m2. A total of 1567 patients who attended weight consultation had a mean weight loss 17.35 ± 11.07 from intragastric balloon implantation. Thirty-three patients from the total sample were not weighted after the removal of the balloon (dropped out). Percentage excess weight loss (% EWL) = 100% × (baseline absolute weight (AW)−last weight)/(baseline AW−initial body weight (IBW)) was found, and weight loss of more than 10% was considered significant. About 49.3% of patients showed significant weight loss > 10%, 24.7% of patients showed weight loss > 20%, while 26% of patients showed no significant weight loss < 10%. Conclusion: Intragastric balloons on their own, with an intensive lifestyle program and supportive consultations, resulted in safe and short-term substantial weight loss, and may fill the therapeutic gap between pharmacotherapy and surgery. [ABSTRACT FROM AUTHOR]

Background: The BioEnterics Intragastric Balloon [BIB] is a reliable, non-invasive technique to manage obesity for subjects who refuse or are unsuitable for bariatric surgery. In a prior study, BIB placed in the antrum [A] was found to have significantly better results on weight loss in relation to that in fundus [F], but many balloons initially placed in the F were eventually found in the A. The aim of the present analysis was to evaluate whether the balloon position [firmly in F, firmly in A, or transient from F to A [FA]] influences the 3- and 6-month weight loss.Material: Six hundred sixty-eight patients that underwent successful BIB treatment were assigned into three groups: group F [n = 354], group A [n = 159], and group AF [n = 155]. Weight loss parameters were recorded and analyzed at 3 and 6 months.Results: In all three groups, there was a significant, progressive reduction of BMI at 3 and 6 months. At 6 months, BMI reduction between groups F and A, and F and FA [p = 0.001] and groups A and FA [p = 0.018] was prominent.Conclusion: The position of the BIB affects its effectiveness: better results when antrum is involved. This observation seems to give a great perspective to newly established gastric space-occupying devices, which aim to have a compartment constantly present in the antrum. However, further studies have to be performed in order to validate the results and more importantly to clarify the mechanisms implied. [ABSTRACT FROM AUTHOR]

Background: Obesity is a major risk factor for several chronic diseases. The BioEnterics Intragastric Balloon (BIB) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB left in situ for more than 6 months. Materials and methods: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. Results: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI ( p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. Conclusion: Extending the duration of BIB use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications. [ABSTRACT FROM AUTHOR]

Abstract: Background: Morbid obesity is an increasing health problem. Dietary intervention often fails in the medium to long term, and surgery is the gold standard. Intragastric balloon is a valuable treatment in the short–term, and multiple balloon treatment has been shown to be effective in the medium term. The aim of this study was to investigate the efficacy of multiple balloon treatment in the long-term (6 years) in terms of weight loss, influence on co-morbidities, and quality of life in patients refusing surgery. Methods: Eighty-three patients with body mass index (BMI)>40, good candidates for surgery but refusing it, were enrolled in a clinical treatment protocol involving multiple intragastric balloon placement. After removing the first balloon, a second balloon was placed when the patients had regained≥50% of the weight loss achieved with previous balloon. Weight, co-morbidities parameters, and quality of life test were recorded during a follow-up of 72 months. Results: All patients experienced a second balloon placement; 22.2% had a third device placed and 1 patient had a fourth device placed. At 76 months follow-up, mean BMI was 37.6 kg/m2 (P<.001); weight cycling periods were observed. Significant difference was recorded in the presence of co-morbidities at baseline (80% of the patients) and follow-up (30%) (P = .02). Quality of life test in the follow-up indicated better scores than those at baseline (P<. .001). Conclusion: Despite the weight cycling, in patients refusing surgery, multiple intragastric balloon is the recommended treatment, allowing the patients to achieve a good weight loss, better control of co-morbidities, and better quality of life than at baseline. [Copyright &y& Elsevier]

Background: Intragastric balloon (BioEnterics Intragastric Balloon, BIB®) or pharmacotherapy are possible options for the treatment of obese patients when traditional approaches have failed. The aim of our study was to compare in obese patients the effect on weight loss and metabolic changes of lifestyle modifications associated with either BIB or pharmacotherapy or the two treatments in sequence as a maintenance strategy for weight loss. Methods: Fifty obese patients were recruited and randomly assigned to lifestyle modifications combined with either BIB for 6 months ( n = 30) or sibutramine (pharmacotherapy group) for 1 year ( n = 20). After BIB removal, patients were randomly assigned to either correct lifestyle (BIB/lifestyle) or lifestyle plus pharmacotherapy (BIB/pharmacotherapy). Results: At 6 months, patients treated with BIB lost significantly ( P < 0.05) more weight (percent of initial weight lost, %IWL = 14.5 ± 1.2; percent of excess BMI lost, %EBL = 37.7 ± 3.2) than patients who received pharmacological treatment (%IWL = 9.1 ± 1.5, %EBL = 25.3 ± 4.1). At 1 year, the weight lost was significantly ( P < 0.05) greater in patients treated with either BIB/pharmacotherapy (%IWL = 15.8 ± 2.3%, %EBL = 41.3 ± 6.7%) or BIB/lifestyle (%IWL = 14.3 ± 2.7, %EBL = 34.9 ± 6.5%) in respect to pharmacotherapy group (%IWL = 8.0 ± 1.4%, %EBL = 22.1 ± 3.9%). Moreover, patients treated sequentially with BIB/lifestyle or BIB/pharmacotherapy showed a significant ( P < 0.05) improvement in insulin sensitivity and triglycerides levels. Conclusions: BIB represents an efficacious long-term obesity treatment when supplemental strategies, as lifestyle modifications or pharmacotherapy, are established for weight maintenance after its removal. [ABSTRACT FROM AUTHOR]

Background: Different anesthesiological techniques are currently used for intragastric balloon positioning and removal. The aim of this study is to compare different anesthesiological approaches for balloon positioning and removal in a large multicentric patient population. Methods: Retrospective multicenter study was conducted. From May 2000 to April 2008, 3,824 patients underwent BIB placement [1,022 male/2,802 female; mean age 39.5 ± 14.7 years, range 12-71 years; mean body mass index (BMI) 44.8 ± 9.7 kg/m, range 28.0-79.1 kg/m; excess weight (EW) 59.1 ± 29.8 kg, range 16-210 kg; %EW 89.3 ± 31.7, range 21.4-262]. Patients were allocated to three groups according to anesthesiological technique used: conscious sedation (group A), deep sedation (group B), and general anesthesia (group C). Intragastric balloon was placed after diagnostic endoscopy and removed after 6 months. Both positioning and removal were done under different protocols. Conscious sedation was obtained with topical lidocaine spray, adding diazepam (0.05-0.1 mg/kg iv) or midazolam (0.03-0.05 mg/kg iv). Deep sedation was obtained with propofol alone or adding other drugs such as midazolam, meperidine/fentanyl or meperidine/fentanyl + midazolam. General anesthesia was obtained with midazolam premedication (0.01-0.02 mg/kg iv) followed by induction with propofol (1-1.5 mg/kg iv) + Norcuron (80 mcg/kg iv) + fentanyl (0.5-1 mcg/kg iv), and maintenance with propofol (50-150 μg/kg/min) or sevorane. Oxygen saturation, hemodynamic stability, major anesthesiological complications and related mortality, patient satisfaction, time to return to autonomous walking, duration of procedure, and hospital stay were considered. Results: Sedation-related mortality was absent. A significant number of patients with bronchoinhalation during balloon removal was observed with general anesthesia ( P < 0.001). Conclusions: BIB positioning and removal should be performed under conscious sedation for patient safety and comfort, and technical success. [ABSTRACT FROM AUTHOR]

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