BioEnterics Intragastric Balloon Removal Research Articles

Propofol Sedation for Intragastric Balloon Removal: Looking for the Optimal Body Weight Descriptor.

Sedation is considered as a prerequisite for the safe and effective conclusion of Bioenterics Intragastric Balloon (BIB) removal (our aim was to ascertain the most appropriate body size scalars for propofol dosing and assess the efficacy and safety of a sedative approach involving the infusion of propofol for BIB removal. Retrospective analysis of prospectively collected data of 414 adults scheduled to undergo BIB removal. Our primary end-point was to delineate the relationship between propofol dosing and body size descriptors namely body mass index, total body weight, ideal body weight, lean body weight (LBW) and normalized LBW. Sedative efficacy of this practice, anesthesia or procedural-related adverse events and patients' satisfaction level served as secondary outcome parameters. Propofol dose (mg/kg/min) was positively related to all body weight descriptors in an important manner (p < 0.001). Among them, LBW was singled out as the body size descriptor to best capture the appropriate needs of propofol (R2= 0.432; p= 0.000). Hypoxemia, hemodynamic compromise, gastroesophageal reflux or moderate movement occurred rarely; all of them were readily reversed. The majority of participants had no recollection of the noxious phase of the procedure or declared at least adequately satisfied from the experience (84% and 95%, respectively). LBW could serve as relatively more accurate dosing scalar compared to actual or ideal body weight descriptors, in obese individuals undergoing BIB removal under propofol sedation. The conscious/deep sedation based on propofol infusion emerges as a feasible and efficacious sedative approach for this procedure.

Effect of intragastric balloon-induced weight loss on body composition, fatty liver, and comorbidities in Egyptian middle-aged obese women: a 6-month follow-up study

Background Paralleling the increasing prevalence of obesity in the Egyptian population, metabolic syndrome and liver steatosis are also on the rise. Body composition measurement is used to describe the percentages of fat, bone, water, and muscle in human bodies. The available classic weight loss treatments such as low-calorie diet, exercise, behavioral modification, and pharmacotherapy usually achieve only limited weight loss. The BioEnterics Intragastric Balloon (BIB) is an endoscopic liquid-filled device for the treatment of obesity. Aim The aim of this study was to examine the safety of BIB insertion in a group of obese middle-aged Egyptian women treated with intragastric balloon to induce weight loss for 6 months and report its effect on their anthropometric measurements, body composition, fatty liver, and comorbidities. Patients and methods During the period from February 2012 until August 2013, 47 consecutive middle-aged female patients were enrolled for BIB insertion. Inclusion criteria were mainly based on the BMI (≥30.0 kg/m 2 ) and on associated comorbidities. Apart from physical and anthropometric evaluation, body composition analysis was performed using a bioelectrical impedance analyzer to estimate fat mass, body fat percentage, and fat-free mass. The Adult Treatment Panel III criteria were used to diagnose metabolic syndrome, and ultrasound evaluation of the liver for the presence and grade of steatosis was performed. BIB placement was carried out after diagnostic endoscopy, under intravenous conscious or unconscious sedation. Results The total percentage of complications from BIB insertion was 12.8%, which were mostly mild and reversible. Three (6.4%) patients had their gastric balloon removed early (two voluntarily and one due to de-novo peptic ulcer) and were excluded from the study, whereas the remaining 44 patients continued their 6-month therapy duration. Overall, BIB insertion significantly reduced weight from a mean value of 96.82 ± 14.18 kg at baseline to 83.45 ± 12.03 kg after 6 months (P Conclusion This study provides anthropometric, biochemical, and body composition evidence on significant improvement in metabolic syndrome, obesity-associated comorbidities, and fatty liver after weight loss induced by the minimally invasive and relatively safe technique. However, it is recommended to continue a weight-reducing diet after BIB removal for achieving long-term effectiveness and to add exercise programs to dietary restriction for promoting more favorable change in body composition.

Does the intragastric balloon have a predictive role in subsequent LAP-BAND® surgery? Italian multicenter study results at 5-year follow-up

BackgroundThe intragastric balloon has been reported to be a safe and effective tool for temporary weight loss. The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding. MethodsA longitudinal multicenter study was conducted in patients with body mass index (BMI)>35 kg/m2 who underwent gastric banding with the BioEnterics Intragastric Balloon (BIB). After balloon removal (6 mo), patients were allocated into 2 group according to their percentage of excess weight loss (%EWL): group>25 (%EWL>25%) and group<25 (%EWL<25%). Patients from both group underwent laparoscopic adjustable gastric banding (LAGB) 1–3 months after BIB removal. The LAP-BAND AP band was placed in all patients via pars flaccida. Weight loss parameters were considered in both groups. ResultsFrom January 2005 to December 2009, 1357 patients were enrolled in this study. Mean BMI at time of BIB positioning was 44.9±8.4 (range 29–82.5). After 6 months, at time of removal, mean BMI was 39.4±7.3. According to the cutoff, patients were allocated into group A (n = 699) and group B (n = 658). At this time the mean BMI was 36.4±6.4 and 42.7±6.9 (P = .001) in groups A and B, respectively. At 1-year follow-up from LAGB, mean BMI was 35.8±6.5 and 40.0±7.4 (P<.001) in groups A and B, respectively. This significant difference was confirmed at 3- and 5-year follow-ups. A similar pattern was observed with the %EWL. ConclusionSatisfactory results with BIB are predictive of a positive outcome of LASB at 1, 3, and 5 years after the procedure, and poor results do not inevitably indicate a negative outcome for gastric banding.

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

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/m(2) and those with BMI ≥ 32 kg/m(2) at the time of BIB removal and at 1 year later. 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. The BMI significantly fell from 32.4 ± 3.7 to 28.5 ± 3.7 kg/m(2) (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). 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.

Adjustable Intragastric Balloon vs Non-Adjustable Intragastric Balloon: Case–Control Study on Complications, Tolerance, and Efficacy

The objective of this study is the comparison of a new intragastric balloon recently introduced, the Adjustable Balloon System (ABS), with the BioEnterics intragastric balloon (BIB) in terms of tolerance, safety, and weight loss parameters. A case-control study was done: 40 patients were matched with 80 controls. To achieve the same duration therapy (12 months), a single ABS positioning was compared with a BIB followed by another BIB (6 + 6 months). Length of procedure, hospital stay, complications, and weight loss parameters after 6 months (time of first BIB removal) and after 12 months from baseline (time of Spatz and second BIB removal) were considered. Statistical analysis was done by means of Student's t test, χ2 test, or Fisher's test. P < 0.05 was considered significant. Mortality, positioning, and extraction complications were absent. Both the devices were well tolerated with slight duration of post placement symptoms. During this study, the Spatz balloon was adjusted with inflation of 200 cm(3) of saline (total, 800 cm(3)) in 9/40 (22.5 %) patients, for poor weight loss after first 6-months treatment. In the Spatz group, there occurred 7/40 complications linked to the device and in 6/7 patients the balloon was removed. At the end of the study, the weight loss parameters were similar between groups: BMI 31.0 ± 11.8 (Spatz group) vs 31.3 ± 12.3 (BIB group) (p = Ns). The idea of dynamic balloon therapy needs to be confirmed with wider series. The rate of complication reported is very high, and several studies regarding safety and efficacy are needed.

Five Percent Weight Lost in the First Month of Intragastric Balloon Treatment May Be a Predictor for Long-Term Weight Maintenance

Most of the weight loss with the BioEnterics intragastric balloon (BIB) has occurred during the first 3-4 months. This study aimed to evaluate the effect of initial weight loss on long-term weight maintenance. From 2008 to 2011, 50 patients who had mean body mass index (BMI) of 44.7 ± 12.4 kg/m(2) underwent BIB therapy for 6 months. All patients were given a diet of 1,100 kcal/day. Weight loss parameters [absolute weight loss, BMI loss, percentage of body weight loss (BWL%), and percentage of excess BMI loss] were recorded at the baseline, 1 month, 6 months (time of BIB removal), 12 months, and 18 months from the baseline. Successful weight loss was defined as ≥ 10 % weight loss after 6, 12, and 18 months. Twenty-seven patients (54 %) achieved a percentage of BWL ≥ 10 at the time of removal. Eighteen (36 %) and 12 (24 %) patients were able to maintain weight loss of 10 % at 12 and 18 months. Percentage of BWL after 1 month was positively correlated with BWL% after 6, 12, and 18 months (r = 0.77, 0.65, and 0.62, p < 0.001, respectively). Twenty-four patients who lost 5 % of the BWL after 1 month of treatment succeeded in maintaining a lasting percentage of BWL ≥ 10 after the BIB removal: more precisely, this cutoff point was achieved in 96 % at the time of removal and in 71 %, 50 % at 12 months, and 18 months of follow-up. Five percent BWL after 1 month of treatment may be a predictor for long-term weight maintenance.

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

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. 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. 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%. 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.

500 Intragastric Balloons: What Happens 5 Years Thereafter?

The BioEnterics Intragastric Balloon (BIB) has been considered an effective, less invasive method for weight loss, as it provides a permanent sensation of satiety. However, various non-randomized studies suggest BIB is a temporary anti-obesity treatment, which induces only a short-term weight loss. The purpose of this study was to present data of 500 obese who, after BIB-induced weight reduction, were followed up for up to 5 years. The BioEnterics BIB was used, and remained for 6 months. At 6, 12, and 24 months post-removal (and yearly thereafter), all subjects were contacted for follow-up. From 500 patients enrolled, 26 were excluded (treatment protocol interruption); 474 thus remained, having initial body weight of 126.16 ± 28.32 kg, BMI of 43.73 ± 8.39 kg/m2, and excess weight (EW) of 61.35 ± 25.41. At time of removal, 79 (17%) were excluded as having percent excessive weight loss (EWL) of <20%; the remaining 395 had weight loss of 23.91 ± 9.08 kg (18.73%), BMI reduction of 8.34 ± 3.14 kg/m2 (18.82%), and percent EWL of 42.34 ± 19.07. At 6 and 12 months, 387 (98%) and 352 (89%) presented with weight loss of 24.14 ± 8.93 and 16.31 ± 7.41 kg, BMI reduction of 8.41 ± 3.10 and 5.67 ± 2.55 kg/m2, and percent EWL of 42.73 ± 18.87 and 27.71 ± 13.40, respectively. At 12 and 24 months, 187 (53%) and 96 (27%) of 352 continued to have percent EWL of >20. Finally, 195 of 474 who completed the 60-month follow-up presented weight loss of 7.26 ± 5.41 kg, BMI reduction of 2.53 ± 1.85 kg/m2, and percent EWL of 12.97 ± 8.54. At this time, 46 (23%) retained the percent EWL at >20. In general, those who lost 80% of the total weight lost during the first 3 months of treatment succeeded in maintaining a percent EWL of >20 long term after BIB removal: more precisely, this cutoff point was achieved in 83% at the time of removal and in 53%, 27%, and 23% at 12-, 24-, and 60-month follow-up. BIB seems to be effective for significant weight loss and maintenance for a long period thereafter, under the absolute prerequisite of patient compliance and behavior change from the very early stages of treatment.

Intragastric balloon treatment of obesity must be combined with bariatric surgery: A pilot study in Turkey

The treatment of morbid obesity by intragastric balloon (BioEnterics) placement is a safe and effective procedure. Cultural, social and economical factors are known to have an impact on the outcome of therapeutic interventions. This study aimed to evaluate the effect of this method on weight loss and long-term outcome following balloon removal in a cohort of Turkish patients. Twenty-five patients (11 male, 14 female) who selected BioEnterics intragastric balloon method for weight loss over surgery were included in the study. Their mean age was 35.2±13.4 and mean body mass index was 43.5±8.7 kg/m2. Patients who had any contraindication for endoscopic BioEnterics intragastric balloon placement were excluded. BioEnterics intragastric balloon was performed under deep sedation with propofol, and all patients were placed on a 1000 kcal/day diet for six months. Patients were reevaluated six months following balloon removal. Excess weight loss of greater than 25% was considered as end of treatment success. Maintenance of excess weight loss greater than 25% at the end of a six-month follow-up period was considered as long-term success. Results were reported as mean body mass index and mean %excess weight loss±SD. Statistical analysis was done using SPSS computer program. One patient was excluded from the study because of psychological intolerance (1/25) prompting early balloon removal. Twenty-four patients completed both the initial phase and the follow-up period. At the end of the initial six months, the mean body mass index was 35.7±4.6 kg/m2 and mean excess weight loss was 46.9±11.3%. Although 22 out of 24 patients (91.6%) had achieved end of treatment success, the mean body mass index was back to 41.9±7.7 kg/m2 at the end of the follow-up period. Only two patients were able to maintain excess weight loss of 25% at the completion of the study, resulting in a long-term success rate of 8.3%. BioEnterics intragastric balloon is a safe and effective but temporary therapeutic modality for obesity treatment. After BioEnterics intragastric balloon removal, almost all patients had returned to their initial weights. Therefore, BioEnterics intragastric balloon must only be offered for patients who accept to undergo bariatric surgery after BioEnterics intragastric balloon removal. Losing weight by BioEnterics intragastric balloon before bariatric surgery will improve the morbidity and mortality rates of this modality.

Effect of the BioEnterics intragastric balloon on weight, insulin resistance, and liver steatosis in obese patients

In obese patients, positioning of the BioEnterics intragastric balloon (BIB) proved beneficial for weight loss, but the effect of the device on ameliorating some components of the metabolic syndrome associated with obesity remains uncertain. To evaluate the effectiveness of BIB insertion on weight control and amelioration of components of the metabolic syndrome. A prospective intervention study performed at baseline, 6 months after BIB insertion, and after a mean (standard deviation [SD]) of 21 (3) months (range 14-26) of follow-up. Division of Gastroenterology and Endoscopic Unit, "Casa Sollievo della Sofferenza" Hospital. One hundred thirty obese patients with a mean (SD) weight of 118 (24) kg and mean (SD) body mass index (BMI) of 43 (8) kg/m(2). Positioning of BIB. Anthropometric and laboratory parameters. Overall, the mean (SD) weight and BMI decreased by 13.2 (8.2) kg and 5.1 (3.2) kg/m(2), respectively, compared with baseline. The mean glycemia, insulinemia, Homeostasis Model Assessment index, triglyceridemia, and alanine aminotransferase levels were significantly reduced. In the 91 responders (BMI decrease of > or = 3.5 kg/m(2)), the mean (SD) weight and BMI decreased by 16.4 (6.3) kg and 6.4 (2.3) kg/m(2), respectively, and severe liver steatosis decreased from 52% to 4% (P < .0001). On multivariate analysis, severe steatosis and the Homeostasis Model Assessment index were predictive of the response to BIB: odds ratios of 6.71 (95% CI, 2.23-20.19) and 3.18 (95% CI, 1.20-8.42). After a median follow-up of 22 months after BIB removal, 50% of responders maintained or continued to lose weight. No sham-treated patients were included as comparative controls. Treatment was effective in inducing weight loss, improving liver steatosis, and restoring some components of the metabolic syndrome.

Laparoscopic sleeve gastrectomy versus intragastric balloon: a case-control study

To compare the efficacy of laparoscopic sleeve gastrectomy (LSG) and BioEnterics intragastric balloon (BIB) to lose weight and comorbidities after 12 months of follow-up before a more invasive bariatric procedure. From January 2004 to December 2006, 40 patients underwent laparoscopic sleeve gastrectomy (LSG) as a first step in biliopancreatic diversion with duodenal switch. Controls (n = 80) were selected based on charts of patients who, during the same period, underwent BioEnterics intragastric balloon therapy. In both groups we considered: length of procedure, hospital stay, intraoperative or endoscopic complications, postoperative or postendoscopic complications, comorbidities at baseline, after 6 months (time of BIB removal), and after 12 months from baseline, and weight loss parameters [weight in kg, percentage excess weight less (%EWL), body mass index (BMI), and percentage excess BMI loss (%EBL)]. Results are expressed as mean +/- standard deviation. Mortality, intra- and postoperative complications (in LSG group), and intra- and postendoscopic complications (in BIB group) were absent. Mean operative time in the LSG group was 120 +/- 40 (range 60-200) min. Mean positioning time for BIB was 15 +/- 5 (range 10-25) min. BMI at baseline was 54.1 +/- 2.9 (range 45.1-55.9) kg/m(2) and 54.8 +/- 2.5 (range 45.1-56.2) kg/m(2) in BIB and LSG groups, respectively. At 6-month follow-up, mean BMI was 46.2 +/- 3.5 and 45.3 +/- 5.5 kg/m(2) in the BIB and LSG patients, respectively [p = not significant (ns)]. After 12 months BIB patients regained BMI, even if strictly followed with a diet regimen, while LSG patients continued to lose weight. Significant differences between groups were absent for the comorbidities considered. Laparoscopic sleeve gastrectomy and BioEnterics intragastric balloon are two valid options for producing weight loss as a first-step procedure. LSG has all the related risks of general anesthesia, laparoscopic surgery, and digestive anastomosis, whereas BIB presents a very low rate of minor complications, such as psychological intolerance. For all these reasons, at this time, BIB is considered a better option than LSG as a first-step procedure in the short term (12 months).

Evidence-based Review of the Bioenterics Intragastric Balloon for Weight Loss

We reviewed clinical studies performed with the Bioenterics intragastric balloon (BIB) to promote weight loss. Thirty studies were included [18 prospective (5 randomized), 12 retrospective], totaling 4,877 patients. Only one of three sham-controlled trials found a significantly higher weight loss with the BIB vs the sham procedure plus exhaustive follow-up. In nonrandomized studies, weight loss with the BIB averaged 17.8 kg (range, 4.9-28.5), corresponding to BMI changes of 4.0-9.0 kg/m(2). Comorbidities resolved or improved in 52-100% of patients. Best short-term results were observed in patients devoid of binge eating disorder with a BMI in the 30.0-40.0 kg/m(2) range; the BIB also helped to prepare superobese patients for bariatric surgery. Severe complications were exceptional (gastric perforation and intestinal obstruction; 0.2% each); digestive intolerance prompted early BIB removal in 2.5% of patients. Long-term (>or=2 years) results are awaited, as well as well-designed studies to define the best indications for this therapy.

Intragastric Balloon or Diet Alone? A Retrospective Evaluation

Very few studies have reported results of the BioEnterics Intragastric Balloon (BIB) at > or =12 months follow-up. The aim of this study is the retrospective evaluation of the results of BIB placement compared to diet regimen alone. From January 2005 to June 2006, 130 outpatients underwent a structured diet plan with simple behavioral modification at our institutions. Controls (n = 130) were selected from the charts of patients who, during the same period, underwent BIB treatment. Patients in the outpatient group were given a structured balanced diet with a caloric intake between 1,000 and 1,200. The approximate macronutrient distribution, according the "Mediterranean diet," was 25% protein (at least 60 g/day), 20-25% lipids, and 50-55% carbohydrates. In the BIB group, patients received generic counseling for eating behavior. In both groups, we considered weight loss parameters (kilograms, percentage of excess weight loss [%EWL], body mass index [BMI], percentage of excess BMI loss [%EBL]) at 6 and 24 months from baseline and comorbidities at baseline and after 24 months. Results are expressed as mean+/-standard deviation. Statistical analysis was done by Student's t-test and chi (2)-test or Fisher's exact test. p < .05 was considered significant. At the time of BIB removal (6 months), significantly better results in terms of weight loss in kilograms (16.7 +/- 4.7 vs. 6.6 +/- 2.6; p < 0.01), BMI (35.4 +/- 11.2 vs. 38.9 +/- 12.1; p < 0.01), %EBL (38.5 +/- 16.1 Vs 18.6 +/- 14.3; p < 0.01), and %EWL (33.9 +/- 18 vs. 24.3 +/- 17.0; p < 0.01) were observed in patients treated by intragastric balloon as compared to diet-treated patients. At 24 months from baseline, patient dropout was 1/130 (0.7%) and 25/130 (19.2%) in the BIB and diet groups, respectively (p < 0.001). At this time, patients treated with intragastric balloon have tended to regain weight, whereas diet-treated patients have already regained most of lost weight. Although the strength of this study may be limited by its retrospective design, the results indicate that, in the short-to-medium term, BIB is significantly superior to diet in terms of weight loss.

Intragastric balloon for high-risk super-obese patients: a prospective analysis of efficacy

Background Super-obese patients with many co-morbidities present a challenge in bariatric surgery because of the high perioperative morbidity and mortality. The BioEnterics intragastric balloon (BIB) is an endoscopic device used preoperatively to induce weight loss to reduce the risk of surgery for morbid obesity. Methods From November 2003 to April 2006, the BIB was endoscopically placed in 26 high-risk super-obese patients with a mean body mass index of 65.3 ± 9.8 kg/m 2 and severe co-morbidities (mean 4.33 ± 1.12, range 3–7). The BIB was endoscopically removed 6 months later, at which time the patients were evaluated in terms of weight loss and improvement of co-morbid conditions. Results BIB placement was uneventful in all patients. The major side effect related to the procedure was occasional vomiting during the first 2 days (65%). One patient died (3.8%) of cardiac arrest after aspiration on the first postinsertion day as a direct result of BIB placement. The mean weight loss was 28.5 ± 19.6 kg, and clinical re-evaluation revealed significant improvement in patient co-morbidity status (mean 2.23 ± .7, range 1–3; P = .024). Twenty patients underwent a primary bariatric surgical procedure the day after BIB removal; 2 patients were rejected for surgery because of inadequate weight loss. Conclusions BIB placement can be considered an effective first-stage treatment of high-risk super-obese patients in need of surgical intervention. Although not without risk, it is generally a simple procedure leading to satisfactory weight loss, improvement in co-morbidities, and consequent reduction of the perioperative mortality and morbidity rates associated with surgery.

Is Bariatric Surgery Necessary after Intragastric Balloon Treatment?

The use of the Bio-Enterics intra-gastric balloon (BIB) has been shown to be a safe and effective procedure for the temporary treatment of morbid obesity. We conducted a retrospective comparative analysis of the weight loss in patients that after BIB removal underwent bariatric surgery and those who did not wish surgery. From January 2000 to March 2004, 182 BIBs were positioned in 175 patients (104 F / 71 M; mean age 37.1+/-11.6 years, range 16-67; mean BMI 54.4 +/- 8.1 kg/m(2), range 39.8-79.5; mean %EW 160.8+/-32.9% range 89-264). Patients were excluded from this study who had emergency BIB removal for balloon rupture (n=2, 1.1%) and for psychological intolerance (n=7, 7.8%). All patients were scheduled for a bariatric operation, before BIB positioning. After BIB removal, a number of patients now declined surgery. Consequently, patients were allocated into 2 groups: Group A in whom BIB removal was followed by bariatric surgery (Lap-Band, laparoscopic gastric bypass, duodenal switch) (n=86); Group B patients who after BIB removal refused any surgical procedure (n=82). Both groups were followed for a minimum of 12 months. Results were reported as mean BMI and %EWL +/- SD. Statistical analysis was done by Student t-test or Fisher's exact test, with P<0.05 considered significant. Mean BMI and mean %EWL in the 166 patients at time of removal were 47.3 +/- 8.1 kg/m(2) and 32.1+/-16.6%, respectively. At the same time, mean BMI was 47.6+/-6.9 and 48.1+/-6.5 kg/m(2) in group A and B (P=NS). At 12 months follow-up (100%), mean BMI was 35.1 kg/m(2) in Group A (BIB + surgery) and 51.7 kg/m(2) in Group B (BIB alone) (P<0.001). After BIB removal, half (49.4%) of the patients scheduled for surgery refused a bariatric operation. These patients returned to their mean initial weight at 12 months follow-up. Therefore, bariatric surgery after BIB removal is highly recommended.

The Intragastric Balloon – Smoothing the Path to Bariatric Surgery

Intragastric balloon placement in association with diet for weight reduction is steadily gaining popularity. However, long-term follow-up studies on the effect of this method in maintaining weight loss are lacking. This study evaluated the long-term outcome following balloon removal in morbidly obese patients who had selected this method for weight loss. 140 morbidly obese patients who refused bariatric surgery because of fear of complications and mortality, underwent intragastric balloon placement and were followed over a 6- to 30-month period (mean 18.3 months) after balloon extraction. The 34 males and 106 females, with median age 38 years (range 16-62), median weight 122 kg (range 85-203), median BMI 42.3 kg/m(2) (range 35-61.3) and median excess weight (EW) 59 kg (range 29-132), received a Bioenterics Intragastric Balloon (BIB). Excess weight loss (EWL) > or =25% when the BIB was removed was considered a success. Weight fluctuations and any further interventional therapy requested by the patients after balloon removal were recorded. 100 patients (71.4%) lost > or =25% of their EW on balloon extraction and were categorized as successes, while 40 patients (28.6%) did not achieve that weight loss and were categorized as failures of the method. During the follow-up period, 44 of the originally successful patients (31.4%) regained weight and were categorized as recurrences, while the remaining 56 patients (40%) maintained their EWL of > or =25% and were considered long-term successes. During follow-up, 45 patients (32.1%) requested and underwent bariatric surgery for their morbid obesity (21 Adjustable Gastric Band, 11 Laparoscopic Sleeve Gastrectomy, 13 Laparoscopic Gastric Bypass). Of these, 13 (32.5%) were from the group of 40 patients categorized as failures on BIB removal, 28 (63.6%) were from the group of 44 patients whose obesity recurred, and 4 (7.1%) were from the 56 patents who although they maintained successful weight loss requested further weight reduction. The BIB served as a first step and a smooth introduction to bariatric surgery for morbidly obese patients who initially refused surgical intervention. The incidence of surgical intervention was double in patients who initially experienced the benefits of weight loss and then had obesity recurrence, compared with patients in whom the method failed. Indeed, a significant number of patients were assisted in their efforts to lose and maintain an acceptable weight loss over a 6- to 30-month follow-up period.

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

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. 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 ( approximately 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. 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/m(2) ; 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/m(2) (range 24-73) and %EWL was 33.9+/-18.7 (range 0-87). BMI loss was 4.9+/-12.7 kg/m(2) (range 0-25). 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.

What Becomes of Patients One Year after the Intragastric Balloon has been Removed?

The BioEnterics Intragastric Balloon (BIB) is a saline-filled balloon recommended to remain in the gastric cavity for a maximum of 6 months. Is this short period sufficient to change patients' lifestyle and eating practices to maintain weight reduction after BIB removal? 100 patients who received a BIB were included in this prospective study and followed for 1 year after BIB removal. The post-implantation follow-up visits took place monthly, during which the patient was seen by the surgeon, dietitian, and if necessary, psychologist. At BIB removal, mean weight loss for the group was 12.0 kg. Mean percent excess weight loss (%EWL) was 39.8%. 12 months after removal of the BIB, mean weight loss was 8.6 kg and mean %EWL was 26.8% for the group as a whole. The results 1 year after removal of the BIB were encouraging. Because the BIB is a temporary non-surgical and non-pharmaceutical treatment for obesity that is reversible and repeatable, we recommend it to patients who have previously failed traditional methods of weight reduction. Careful patient follow-up is of primary importance in avoiding complications and supporting efficacy of the treatment. Although 1 year follow-up cannot be considered long term, these results are encouraging. Concurrent behavior modification is needed for durable weight loss.

Body composition modification in obese patients treated with intragastric balloon

At the Centre for the Therapy of Morbid Obesity, a multidisciplinary team attends severely obese patients in a day-care hospital setting. The patients' psychological and nutritional profiles are studied and their body composition investigated with bioelectrical impedance. After the diagnosis, several approaches are proposed; among them, the insertion of a Bioenterics Intragastric Balloon (BIB). For 6 months after insertion, patients were periodically examined and followed a strict personal regimen, behaviour schedule and physical activity programme compatible with the BIB. The results obtained from the first 20 subjects are encouraging. No severe complications have been reported, and after the BIB removal, subjects are maintaining the obtained results with some of them continuing to lose weight.

Three years experience with the new intragastric balloon, and a preoperative test for success with restrictive surgery.

The BioEnterics Intragastric Balloon (BIB) is a smooth, spherical, saline-filled, silicone elastomer with a black radiopaque filling valve, intended to induce weight loss by limiting food consumption. This can be considered a "restrictive" procedure, and by using this balloon, we can assess the patient's eligibility for a restrictive surgical procedure (the BIB-Test). From May 1997 to May 2000, 87 BIB were inserted in 77 moderately to severely obese patients (4 BIB in 1 patient, 2 BIB in 7 patients). 64 patients completed the treatment. Out of these, 18 (16 female, 2 male) underwent laparoscopic gastric banding after BIB removal. After the treatment (3-6 months), weight loss results were as follows: WL 14.3 kg, %EWL 23.5 and loss in BMI 5.3. 12 patients after the preliminary BIB, have been followed > or = 6 months after gastric banding, and have significant further weight loss. BIB appears to have good results. A supervised nutritional and behavioral regimen is mandatory. The balloon may be indicated to: 1) induce weight loss in patients whose obesity is not severe enough to warrant surgery; 2) reduce the surgical risk in those who are massively obese; 3) select patients for gastric restrictive surgery if they lose weight with the balloon. The data showed that patients who had good results with the BIB (positive BIB-Test) are still losing weight after subsequent gastric banding.