Intragastric Balloon Insertion Research Articles

Efficacy, Tolerance and Safety of New Intragastric Air-Filled Balloon (Heliosphere BAG) for Obesity: the Experience of 17 Cases

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). 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. 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). 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.

Bio-enteric Intragastric Balloon in Obese Patients: A Retrospective Analysis of King Faisal Specialist Hospital Experience

Bio-enteric intragastric balloon (BIB) insertion is gaining popularity for weight reduction in obese patients. We evaluated the efficacy, tolerability, and safety of BIB in the treatment of obesity. A total of 173 Saudi obese patients [mean+/-SD age 34.5 +/- 11.6 years, 58 (33.5%) were men] who underwent BIB (InaMed Corporation, California, USA) insertion were followed up clinically, biochemically, and endoscopically for 6-12 months. The mean+/-SD baseline body weight, excess weight, and body mass index (BMI) were 123.5 +/- 39.6 and 68.9 +/- 40.0 kg and 46.7 +/- 14.1 kg/m(2), respectively. Associated dietary control, exercise, and medical treatment were used in 67 (38.7%), 60 (34.7%), and 3 (1.7%), respectively. BIBs were safely and successfully inserted in 15.1 +/- 6.2 min, filled with 626.2 +/- 41.7 ml methylene blue solution, removed after a period of 189.7 +/- 68.3 days, within 14.1 +/- 6.3 min. BIB was not tolerated for 6 months in 33 (19.8%) patients. Body weight and BMI at 6 and 12 months postinsertion were significantly reduced to 112.5 +/- 35.7 kg and 43.1 +/- 13.1 kg/m(2), and 110.7 +/- 34.5 kg and 42.3 +/- 12.6 kg/m(2), respectively (p < 0.01 versus baseline by one-way ANOVA). Furthermore, the mean absolute weight loss and mean percentage excess weight reduction (EWR) at 6 and 12 months post-BIB insertion were 13.5 +/- 13.5 kg and 19.5 +/- 21.8, and 14 +/- 18.5 kg and 18.0 +/- 25.8, respectively. No mortality or major complications has occurred. EWR of >or=25% occurred in 24.1% and 30.1% of patients at 6 and 12 months postinsertion, respectively. BIB is a safe, simple, and potentially efficient procedure that is well-tolerated by the majority of patients.

The effect of intragastric balloon placement on weight loss and type 2 diabetes control

Sirs, We read with interest a review article by De Ridder et al.1 They concluded that bariatric surgery is a promising treatment in obese patients with non-alcoholic fatty liver disease. Weight reduction appears to decrease the grade of steatosis. A recent randomized study compared the use of adjustable gastric banding to conventional treatment in obese patients with type 2 diabetes.2 Surgery was more likely to achieve remission of diabetes through greater weight loss. In the study, nearly all patients who lost greater than 10% in weight remitted. A surgical approach represents a new horizon in the treatment of obese diabetic patients and disease associated complications. Placement of an intragastric balloon may be an attractive alternative in such patients. In one study, its placement for 6 months resulted in an excess weight loss of 33.9 ± 18.7%.3 In a proof-of-concept study, we postulated that, by reducing weight and diet intake via placement of intragastric balloon, diabetic control could be improved in the obese patients with poorly controlled type 2 diabetes. Between January and June 2007, patients who fulfilled the following criteria were invited to participate in the study: body mass index (BMI) ≥ 27, poorly controlled diabetes [glycosylated haemoglobin (HbA1c) ≥ 8] for the past 3 months and age between 18–70 years. They underwent an upper endoscopy and were excluded from the study if they were found to have large hiatal hernia, severe oesophagitis, peptic ulceration and/or previous gastric surgery. Then a Bioenteric Intragastric Balloon (BIB, Inamed Health, Santa Barbara, CA, USA) was inserted according to the manufacturer’s instruction, and the balloon was inflated with 500 mL saline with methylene blue in each subject. Control subjects were those who fulfilled same inclusion criteria, but without the insertion of an intragastric balloon. They were recruited at the same period at a 2:1 ratio to the case subjects. Both groups were followed up by an endocrinologist blind to the procedure undertaken. Both groups were given same dietary and exercise advice. Both body weight and HbA1c were measured and compared at the end of 6 months in the two groups. Six patients with the median age 42 years (range 34–57 years) received placement of an intragastric balloon and 12 patients with median age 53 years (range 33–75 years) were recruited as controls. There were no significant differences in age (P = 0.075), gender (50% vs. 75% male, P = 0.34), pre-BMI (35.7 vs. 28, P = 0.16) and pre-HbA1c (8.6% vs. 9.0%, P = 0.13) in the two groups. However, after the insertion of intragastric balloon in the treatment group, the HbA1c was much lower than the control group (7.3% vs. 9.0%, P = 0.002). When assessment was made within the group with intragastric balloon inserted, both the BMI and HbA1c were improved (BMI: 35.7 vs. 33.6, P = 0.006; HbA1c: 8.6% vs. 7.3%, P = 0.007; Figure 1). But no such improvement was seen in the control group during the follow-up period (BMI: 28 vs. 28.1, P = 0.91; HbA1c: 9.0% vs. 9%, P = 0.76; Figure 1). Body mass index (BMI) and glycosylated haemoglobin (HbA1c) at baseline and at 6-month in BIB and control subjects. Pharmacological treatment of obesity has evolved as a therapy. The resultant weight loss is often less than that after bariatric surgery, which should remain the most effective way of treating type 2 diabetes in severely obese patients. It is recommended for consideration in patients with BMI ≥ 35 kg/m2.4 Pories et al.5 demonstrated that 83% of patients with diagnosed type 2 diabetes exhibited normal blood glucose and normal glycosylated haemoglobin levels 7.6 years after bariatric surgery. The Swedish Obese Subjects study reported that, after 10 years, the average weight loss from baseline was 25% after gastric bypass, 16% after vertical banded gastroplasty and 14% after gastric banding.6 The group that had undergone surgical intervention had significantly lower incidence rates of diabetes.6 However, bariatric surgery is invasive and carries a mortality rate of 0.1–4.6% and can be associated with complications such as anastomotic leakage.7, 8 On the other hand, intragastric balloon is relatively less invasive and with few complications. It is also less expensive. With this safety profile, it can also be recommended to patients with a lower BMI associated with comorbidities. Indeed, it has now been recommended for weight reduction in patients with BMI ≥ 27 kg/m2 with one obesity-related comorbidity.9 From our current pilot study, we observed a significant improvement in diabetic control in the intragastric balloon placement group, despite small sample size. We thus recommend the use of intragastric balloon as an adjunct for managing overweight patients with poorly controlled type 2 diabetes. Further large-scale randomized studies are warranted. Declaration of personal interests: None declared.

Intragastric balloon in the treatment of patients with morbid obesity.

Morbid obesity is a major health problem. This study evaluated the effectiveness and safety of an intragastric balloon (IGB) for the treatment of morbid obesity. Sixty-nine IGBs were inserted endoscopically over a 3-year period in 63 consecutive patients (59 women; median age 41 (range 24-67) years). Median weight and body mass index were 124.5 (range 89.0-177.8) kg and 46.3 (range 36.2-72.4) kg/m(2) respectively. Significant coexistent disease was present in 34 patients. Median American Society of Anesthesiologists score was 3 (range 1-4). Data were recorded following retrospective review of patient case notes. Mean operating time was 22 (range 15-30) min and median inpatient stay was 1 (range 1-6) day. Vomiting was the commonest early complication following 31 procedures and necessitated early removal of four IGBs. Of 58 patients with long-term follow-up, 18 suffered displacement of the IGB after at least 6 months in situ and three required a laparotomy for intestinal obstruction. Fifty patients (86 per cent) lost weight; median weight loss was 15.0 kg (P < 0.001). Median excess weight loss was 16.4 (range - 49.0 to + 4.8) and 18.7 (range - 51.5 to 12.6) per cent by 4 and 7 months after IGB insertion respectively. The IGB represents a useful device for the treatment of morbid obesity, particularly in preparation for definitive antiobesity procedures. Early IGB replacement is essential to minimize complications.