BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients

Background: The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increasing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities. Methods: Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling (∼1000 Kcal) and medical therapy. The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidities were evaluated. Results: From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9±14.7, range 12-71; mean BMI 44.4±7.8 kg/m² ; range 28.0-79.1; and mean excess weight 59.5±29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of peptic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4±11.8 kg/m² (range 24-73) and %EWL was 33.9±18.7 (range 0-87). BMI loss was 4.9±12.7 kg/m² (range 0-25). Conclusions: BIB is an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6 months. Previous gastric surgery is a contraindication to BIB placement.     

Intragastric Balloon in Ethnic Obese Chinese: Initial Experience

Background: We evaluated the effectiveness and safety of intragastric balloon (IGB) for the treatment of obesity in ethnic Chinese in Hong Kong. Methods: 15 Chinese patients (10 females; median age 40 years (range 21-58)) completed IGB treatment over a 10-month period since November 2004. Median baseline body weight (BW) and BMI were 100.1 (range 78.5-170.3) kg and 39.4 (range 29.6-56.9) kg/m² respectively. Coexistent obesity-related morbidities were present in 80% of patients. The Bioenterics Intragastric Balloon (BIB^?) was employed, and all placement and removal were performed endoscopically under intravenous conscious sedation. A restricted balanced diet (∼1200 kcal/day) and 150 minutes/week of moderate-intensity exercise were prescribed after balloon placement in a multidisciplinary approach. Outcome measures were collected and assessed in a prospective manner. Results: Median procedure time was 25 (range 19-45) minutes and median hospital stay was 2 (range 1-6) days. Median BW and BMI loss were 15.3 (range 5.3-30.9) kg and 5.6 (range 1.9-12.5) kg/m² after IGB. The median waist circumference (WC) loss was 9 (range 4-23) cm, and 66.7% of patients were highly satisfied with the treatment. No serious complication related to IGB was observed. Conclusion: IGB is a safe and effective device that achieves moderate weight loss in obese ethnic Chinese patients.     

Initial Japanese Experience with Intragastric Balloon Placement

Background

We introduced intragastric balloon placement in Japan and evaluated the initial data.

Methods

Between December 2004 and March 2008, intragastric balloons [BioEnterics® Intragastric Balloon (BIB®) system] were placed in 21 Japanese patients with obesity [six women, 15 men; mean age 40?±?9 years; mean body mass index (BMI) 40?±?9 kg/m²]. The inclusion criteria were morbid obesity (BMI?≥?35 kg/m²), the presence of obesity-related disorders, and failure with conventional treatments for at least 6 months. The balloon was routinely removed under endoscopy after 5 months.

Results

No serious complications occurred, but in two of the 21 patients (9.5%), early removal (within 1 week) of the balloon was required due to continuous abdominal discomfort. Two other patients (9.5%) could not control their eating behavior and were considered unresponsive to the treatment, and their balloons were also removed before 5 months. Seventeen of the 21 patients (81%) finished the treatment, and the average weight loss and percent excess weight loss (%EWL) at the time the balloons were removed were 12?±?5 kg and 27?±?9%, respectively. Eight patients were followed for 1 year without intervention of consecutive bariatric surgery, and at that time, four of these patients had kept more than 20% of %EWL. The other patients regained their weight in the first year.

Conclusions

Intragastric balloon placement is a safe and effective procedure in obese Japanese patients, and about half of the patients will maintain their weight loss after the balloon is removed.     

Multi-Centre European Experience with Intragastric Balloon in Overweight Populations: 13 Years of Experience

Background

The request to lose weight is expanding not only in obese and morbidly obese patients but also in overweight patients affected by co-morbidities as diabetes and hypertension and who do not tolerate diet regimen or lifestyle changes. The aim of this study is a multicenter evaluation of outcomes of intragastric balloon in overweight patients.

Methods

Patients (BMI 27–30 kg/m²) treated with a BioEnterics Intragastric Balloon (BIB) between 1996 and 2010 were extracted from the database of the participating centres in Rome (Italy), Liège (Belgium) and Madrid (Spain). Primary endpoints were the efficacy and safety at 6 and 42 months from balloon positioning. Secondary endpoints included resolution of co-morbidities.

Results

A total of 261 patients were included in this study. The most common indication for balloon placement was a psychological disorder (54 %). Mean body mass index (BMI) fell from 28.6?±?0.4 at baseline to 25.4?±?2.6 kg/m² at 6 months and to 27.0?±?3.1 kg/m² at 3 years from BIB removal. The mean %EWL was 55.6 % at 6 months and 29.1 % at 3 years. Forty-seven patients (18 %) had complications associated with placement of the intragastric balloon (leak?=?28, intolerance?=?14, duodenal ulcer?=?2, gastritis?=?1, oesophagitis?=?1, duodenal polyps?=?1). The rate of patients with hypertension decreased from 29 % at baseline to 16 % at 3 years. Diabetes decreased from 15 to 10 %, dyslipidaemia decreased from 20 to 18 %, hypercholesterolaemia decreased from 32 to 21 % and osteoarthropathy decreased from 25 to 13 %.

Conclusions

The intragastric balloon is safe and effective in overweight patients, helping to reduce progression to obesity and decreasing the prevalence of a number of important co-morbidities.     

Effectiveness of Intragastric Balloon Treatment for Obese Patients: One-Year Follow-up After Balloon Removal

Background

The Bioenterics Intragastric Balloon (BIB) is effective for weight loss. However, comparisons of its effectiveness between groups with different body mass index (BMI) are rare. This study compared the effectiveness of BIB treatment in patients with BMI <32 kg/m² and those with BMI ≧32 kg/m² at the time of BIB removal and at 1 year later.

Methods

Between April 2009 and June 2011, 28 obese patients who completed a full course of BIB treatment were enrolled. There are 16 patients with BMI <32 and 12 with BMI ≧32. Patients who lost more than 20 % of excess weight (% EWL) were categorized as responders.

Results

The BMI significantly fell from 32.4?±?3.7 to 28.5?±?3.7 kg/m² (P?<?0.01) at the time of BIB removal. All biochemical measurements except for cholesterol level were significantly improved. The median value of %EWL of all patients at BIB removal was 40.1, and 20 patients (71.4 %) were responders. Adherence to dietitian counseling was significantly better in responders than in non-responders (85 vs. 25 %, respectively; P?<?0.01). The percentage of responders at 1 year after BIB removal was significantly higher among patients with BMI <32 than those with ≧32 (62.5 vs. 16.7 %, respectively; P?=?0.02).

Conclusions

BIB placement can achieve significant weight loss and improvement of co-morbidities in obese patients. Better adherence to dietitian counseling is associated with better response. Patients with BMI <32 maintain better weight loss at 1 year after BIB removal.     

Intragastric Balloon in Obese Patients

Background: Since March 1998, 143 BioEnterics? Intragastric Balloons (BIB) were placed in 132 obese and morbidly obese patients, to study the clinical possibilities of a new system, both from the point of view of the materials used and the application method. Methods: 36 patients were male and 96 female; mean age was 43 years (21-70); mean weight was 115.4 kg (67-229), and mean BMI was 41.0 (29-81). 8 patients were affected by severe respiratory insufficiency. We placed and removed the balloon endoscopically under conscious sedation or general anesthesia. BIB was removed in the majority of patients 4 months after insertion. The patients were given a balanced diet of 800-1000 kcal/day; follow-up involved a monthly check-up (routine blood tests, weight control) and a visit every 15 days with the dietitian. Results: Mean weight loss was 14.4 kg; mean reduction in BMI was 5.2.Weight loss was much better in males. The weight loss produced an improvement of the complications associated with the obesity. Complications observed were: balloon intolerance (9 early removals), 1 balloon deflated and passed, 2 cases of gastric ulcer at balloon removal. Conclusions:The most correct indications for BIB should be: extremely obese patients (BMI>40) in preparation for a bariatric operation; obese patients with BMI 30-35 with a chronic disease otherwise unresolved; patients with BMI< 30 in a multidisciplinary approach.     

Use of Anti-Emetics after Intragastric Balloon Placement: Experience with Three Different Drug Treatments

Background: Tropisetron treatment was compared with alizapride treatment. The secondary aim was to assess whether droperidol supplement would still improve the therapeutic outcome of tropisetron. Materials and Methods: A series of 51 obese patients was treated with an intragastric balloon to obtain weight reduction. Patients were divided at random into 3 groups. Each group received a different antiemetic and spasmolytic regimen to control postoperative nausea and vomiting for 24 hours. Statistical analysis of both parameters showed that all 3 populations are comparable and the studied incidence of vomiting was only influenced by the choice of the antiemetics used. A specially developed form was completed during the recovery period every 6 hours until 24 hours postoperatively and recorded all episodes of vomiting. The incidence of vomiting was then calculated as number of episodes/24 hours Results: The incidence of vomiting was significantly lower in the tropisetron group compared to the alizapride group. There was no significant difference between the tropisetron group and the tropisetron plus droperidol group. Conclusion: To decrease the incidence of vomiting in patients undergoing intragastric balloon placement, tropisetron proved to be the most effective antiemetic. A supplement of droperidol gave no better results but impaired postoperative mood and wellbeing. Alizapride was least effective.     

Green Urine after Intragastric Balloon Placement for the Treatment of Morbid Obesity

Background: The intragastric balloon is filled with saline and methylene blue dye, to detect balloon deflation early and prevent bowel obstruction, by monitoring the patient's urine for changes in color. Methods: An intragastric balloon filled with 590 ml of saline plus 10 ml of methylene blue was endoscopically placed under sedation in a 22-year-old man with morbid obesity (BMI 42 kg/m²). 3 days later, the patient's urine changed to dark green, and, suspecting a leaking balloon, endoscopy was repeated under sedation. Results: No signs of balloon deflation were seen, and the urine returned to normal color. The next day, the urine turned green again. 7 days later, the urine discoloration finally disappeared. Conclusion: Propofol, a sedative commonly used by anesthesiologists during endoscopic procedures, is known to have several side-effects, and urine discoloration is one of them, albeit rare. This benign side-effect must be known to obesity surgeons to avoid pointless medical expenditure, unnecessary balloon removal and distress for patients and clinicians.     

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

Background  

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.     

Brazilian Multicenter Study of the Intragastric Balloon

Background: Intragastric balloons have been used in obese patients to provide early satiety and thereby induce weight loss. Several studies have reported promising results with a new balloon (BIB^?) designed to overcome some of the technical pitfalls of earlier devices. We assessed both safety and effectiveness of the BIB^?. Method: From November 2000 to February 2004, 483 overweight and obese patients were treated with the BIB^?. 323 patients completed a 6-month follow-up, and 85 of them completed a 1-year follow-up. All patients took part in a multidisciplinary program involving clinical, psychiatric, physical training, and dietary approaches. Results: Compared to baseline values, after a 6-month follow-up subjects showed significant reductions in weight (15.2 ± 10.5 kg), percent excess weight loss (48.3 ± 28.1), and BMI (-5.3 ± 3.4 kg/m²) (P < 0.000). At 1-year follow-up, 85 patients have maintained more than 90% of their BMI reduction. The main side-effects were nausea/vomiting (40%), and epigastric pain (20%), requiring removal of the BIB ? in 11 patients (3.4%). Minor complications were reflux esophagitis (12%) and symptomatic gastric stasis (9%). Balloon impaction occurred in 2 cases (0.6%), and in 1 patient (0.3%) there was spontaneous deflation of the balloon leading to a small-bowel obstruction solved by a surgical approach. Conclusion: The BIB^? has been effective to temporarily control obesity, inducing an excess weight loss of approximately 48%. It was not associated with mortality and showed minimal risk of major complications.     

Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience

Purpose

The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse? Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy.

Materials and Methods

The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m²). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy.

Results

There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m². Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed.

Conclusions

The results of this study on 38 consecutive patients demonstrate that the Elipse? Balloon is safe, effective, and very well accepted by patients.

     

Intragastric Balloon Treatment for Obesity: Results of a Large Single Center Prospective Study

Background  

The intragastric balloon is a widely used method in the treatment of obesity indicated for those patients who have failed to achieve and maintain the weight loss with conventional measures or for preparation of patients who are candidates for bariatric surgery.     

Single vs Repeated Treatment with the Intragastric Balloon: A 5-Year Weight Loss Study

Background  

Saline-filled intragastric balloons (IB) may be inserted for 6 months to promote weight loss. We aimed to assess potential benefits of repeating IB therapy.     

Management of Obesity with the New Intragastric Balloon

Background: The introduction of an endoscopically-placed Bariatric Intragastrric Balloon (BIB) provided the opportunity to reexamine weight reduction methods and also study potential weight loss without resorting to surgical intervention. Methods: 10 severely obese patients with mean age 33 years and mean body mass index 39, underwent BIB placement, 7 as a sole weight reduction procedure and 3 requiring weight reduction before repair of large incisional hernias. All patients were followed at 2-week intervals by a nurse practitioner and dietitian for 6 months. Results: Mean weight loss was 18.6 kg (range 6.6-40.0), equivalent to 40% excess weight loss (EWL), range 10-81%. EWL was 54% (29-81%) in those patients who had two balloons placed, who lost an average of 30.3 kg (24.0-40.0 kg). In the patients who had only one balloon placed, mean weight loss was 10.4 kg (8.8-12.5), equal to an EWL of 19% (10-37%). Conclusion:These results lead us to consider BIB placement as a successful short-term measure for weight loss or for patients requiring at least weight loss before other surgery.     

The Impact of Weight Loss on Depression Status in Obese Individuals Subjected to Intragastric Balloon Treatment

Background

Although depression is considered to be significantly related to morbid obesity disorder, no information exists on the evolution of depression status after weight loss, in particular when an intragastric balloon is used. This prospective 6-month study examines both the effect on depression status and the relation of weight loss to depression in morbidly obese patients treated by intragastric balloon.

Methods

One hundred consecutive females fulfilling criteria for balloon treatment were assessed for depression and divided into two groups (65 depressed, 35 non-depressed). Obesity-related parameters were comparable.

Results

During the treatment period, the depression status of the mildly, moderately, and severely depressed patients improved from 40, 32.3, and 27.7 % to 20, 7.7, and 1.5 %, respectively, with 70.8 % finally exhibiting no depression at all. During the same period, body weight, BMI, body fat, and excess weight loss (EWL) were comparable between all groups, the range of BMI affecting neither the depression score nor the reduction of obesity parameters. However, there was a significant [percentage of EWL >30] weight loss difference in favor of those who were less severely depressed initially.

Conclusion

The degree of weight loss observed in obese depressed females—being comparable to that achieved by non-depressed females—after intragastric balloon insertion was found to positively affect their depression status.     

Intragastric Balloon Device: Weight Loss and Satisfaction Degree

Background

An intragastric balloon is a non-surgical device enhancing a sensation of early satiety and reducing food intake. The aim of this study is to analyze the results in terms of weight loss and patient satisfaction undergoing intragastric balloon implantation.

Methods

Air-filled and water-filled devices were used. All patients were participated in strict follow-up programs. Weight, body mass index (BMI), total body weight loss (TWL), percentage of excess weight loss (EWL), and satisfaction degree were taken into account.

Results

Eighty-one patients completed a 6-month period with a device in place; 72 of them were then contacted for a follow-up at 12.3?±?2.4 months post-removal. During treatment period, in 76 cases (93.8 %), a statistically significant reduction in weight was observed. A statistically meaningful linear correlation between a 3-month EWL (or TWL) and a 6-month EWL (or TWL) was found. At the end of endoscopic treatment, a significant link between baseline BMI and EWL >20 % was found. Sixty-three percent of the patients were not satisfied with the procedure, did not deem useful to change their diet, and refused to perform it again.

Conclusions

In our study, at device removal and 1 year thereafter, a statistically significant reduction in weight was observed. Most of the patients were found to have a weight loss more than the cut-off of 20 %. The weight reached at the third month appears to be predictive of the effectiveness of endoscopic treatment. Data showed an overall dissatisfaction with procedure.

     

The BioEnterics Intragastric Balloon (BIB): how to use it

Background: The authors have been using the new saline-filled BioEnterics intragastric balloon (BIB) since 1995. Methods: By now, more than 650 BIBs have been implanted on our Unit. Results: Because of close collaboration between the engineers and the users, and after several modifications, an easy-to-use balloon is available. In addition, we have developed 3 instruments which provide easy and quick removal of the BIB. Conclusion: The device, supported by a competent motivated team, is another modality available for weight loss.