Initial Japanese Experience with Intragastric Balloon Placement

BACKGROUNDOver one-third of Americans carry the diagnosis of obesity, many also with obesity-related comorbidities. This can place patients at increased risk of operative and postoperative complications. The intragastric balloon has been shown to aid in minor weight loss, however its weight recidivism in patients requiring short interval weight loss has not been well studied.AIMTo evaluate weight loss, ability to undergo successful elective surgery after intragastric balloon placement, and weight management after balloon removal.METHODSThis study is a retrospective review of patients in a single academic institution undergoing intragastric balloon placement from 2019-2023 to aid in weight loss prior to undergoing elective surgery. Clinical outcomes including weight loss, duration of balloon placement, successful elective surgery, weight regain post-balloon and post-procedure complications were assessed. Exclusion criteria included those with balloon in place at time of study.RESULTSThirty-three patients completed intragastric balloon therapy from 2019-2023 as a bridge to elective surgery. All patients were required to participate in a 12-month weight management program to be eligible for balloon therapy. Elective surgeries included incisional hernia repair, umbilical hernia repair, inguinal hernia repair, and knee and hip replacements. The average age at placement was 53 years ± 11 years, majority (91%) were male. The average duration of intragastric balloon therapy was 186 days ± 41 days. The average weight loss was 14.0 kg ± 7.4 kg and with an average percent excess body weight loss of 30.0% (7.9%-73.6%). Over half of the patients (52.0%) achieved the goal of 30-50 lbs (14-22 kg) weight loss. Twenty-one patients (64%) underwent their intended elective surgery, 2 patients (6%) deferred surgery due to symptom relief with weight loss alone. Twenty-one of the patients (64%) have documented weights in 3 months after balloon removal, in these patients the majority (76%) gained weight after balloon removed. In patients with weight regain at 3 months, they averaged 5.8 kg after balloon removal in the first 3 months, this averaged 58.4% weight regain of the initial weight lost.CONCLUSIONIntragastric balloon placement is an option for short-term weight management, as a bridge to elective surgery in patients with body mass index (BMI) > 35. Patients lost an average of 14 kg with the balloon, allowing two-thirds of patients to undergo elective surgery at a healthy BMI. However, most patients regained an average of 58% of the original weight lost after balloon removal. The intragastric balloon successfully serves as a tool for rapid weight loss, though patients must be educated on the risks including weight regain.

INTRODUCTION: Obesity is an expanding public health problem, resulting in more than half a billion adults worldwide who were considered obese in 2016. Similarly, in Puerto Rico, as stated by the Behavioral Risk Factor Surveillance System from the Centers for Disease Control and Prevention there was a prevalence of 32.9% in 2017. Intragastric balloon (IGB) placement is a weight loss alternative for obese patients with an inadequate weight loss response to diet and exercise. The aim of this study is to examine the efficacy and safety of the single-chamber fluid-filled IGB for weight loss and compare its results across different age groups. METHODS: We performed a database review of all consecutive patients from two outpatient GI clinics who underwent placement of an IGB. Our final analysis comprised of 239 IGB placements in 232 patients (mean age, 44.5 ± 10.3 years; 67% female; baseline BMI 42.1 ± 9.0). Efficacy outcomes included: the percentage of the total (%TWL) and excess weight loss (%EWL), and Body Mass Index (BMI) reduction at 3 and 6 months. Safety outcomes was measured as the number of patients who required early IGB removal (before 6 months). RESULTS: %TWL at 3 months was 10.4%, and 14.5% at 6 months. Overall, 92%, 74%, and 46% of patients lost 5%, 10%, and 15% of total weight at 6 months, respectively. %EWL was 22.1% and 30.3% at 3 and 6 months post-IGB placement, respectively. We observed a BMI reduction of 4.4 kg/m2 at three months and 6.3 kg/m2 at six months overall. Subgroup analysis revealed that females %EWL significantly higher than males (31.9% vs 25.9%, P-value < 0.05). Similarly, patients between ages 51-60 had the highest %EWL (37.3%, P-value < 0.05) among all studied age groups. Likewise, patients grouped by BMI ranges showed a significant weight loss compared to baseline (BMI 30-40 kg/m2 %TWL: 14.6%, BMI 40-50 kg/m2 %TWL: 15.0% and BMI ≥ 50 kg/m2 %TWL: 14.4%), yet there was no significant statistical difference between them. The balloon was safely removed at six months after placement in most patients, whereas in 13.0% of cases early removal was performed at an average of 11.7 weeks after placement (range, 2 days-23 weeks). CONCLUSION: Patients among ages 51- 60 showed a significant decrease in %EWL in comparison with other age groups. Women achieved a greater weight loss than men. Subgroup analysis revealed no statistical differences in weight loss percentage among different BMI ranges.

The aim of this study is the prospective evaluation of the results of Bioenterics intragastric balloon (BIB) with sibutramine and BIB placement alone in the treatment of obesity. The patients evaluated between March 2006 and January 2007 and enrolled in this study were assessed in two groups as group A (BIB + sibutramine) and group B (BIB). After the follow-up of the patients for 6 months, body mass index (BMI), weight loss, excess weight loss (EWL%), and excess body mass index loss (EBMIL%) values of the patients in both groups were compared. According to the comparison of the weights of the patients in groups A and B at 6 months with the beginning weights of the patients in both groups, there was statistically significant weight loss (p < 0.01). The total weight loss at 6 months in group A was statistically significantly higher than that in group B (p < 0.05). The patients in group A had a mean BMI 34.53 +/- 6.63 kg/m(2), EWL% 38.77 +/- 11.88%, EBMIL% 49.93 +/- 21.52% after 6 months; the patients in group B had a mean BMI 35.29 +/- 6.36 kg/m(2), EWL% 29.06 +/- 17.82%, EBMIL% 36.51 +/- 23.69% after 6 months. There was no statistically significant difference between group A and group B according to the BMI, EWL%, and EBMIL% values (p > 0.05). In the management of obesity, using BIB together with sibutramine before the treatment in the patient group who are planned to have surgery, compared with using only BIB, provides more effective weight loss.

&lt;b&gt;&lt;br&gt;Introduction:&lt;/b&gt; Intragastric balloon (IGB) insertion is used as a bridging therapy in patients with body mass index (BMI) ≥ 50 kg/m2 . We arranged a retrospective study to evaluate whether pre-operative IGB treatment influences perioperative and postoperative weight loss outcomes after laparoscopic sleeve gastrectomy (SG), and especially to evaluate the impact of post - IGB percentage of excessive weight loss (%EWL) on postoperative %EWL.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Materials and methods:&lt;/b&gt; Patients who underwent IGB placement followed by laparoscopic SG were divided into the following groups considering %EWL after IGB: Group 1 &lt;=10.38%; Group 2 &gt;10.38% and &lt;=17.27%; Group 3 &gt;17.27% and &lt;=24.86%; Group 4 &gt;24.86%. 1 year after SG data were collected. The following parameters were compared between groups: operative time, total blood loss, length of stay and weight, BMI, percentage of total weight loss (%TWL), %EWL.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Results:&lt;/b&gt; There were no statistically significant differences between groups in perioperative results. Post-SG %EWL was the highest in intermediate groups: 2 and 3. Post-treatment results were observed: body weight and BMI were the lowest in Group 4 and the highest in Group 1. Post-treatment %EWL was the highest in Group 4, the lowest in Group 1 and grew gradually in subsequent groups.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Discussion:&lt;/b&gt; The study confirmed the impact of weight loss on IGB on postoperative results. The study showed that %EWL after the IGB treatment influences %EWL after SG and most of all affects definitive %EWL after two-stage treatment and it could be a foreshadowing factor of these outcomes.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Importance:&lt;/b&gt; The importance of research for the development of the field %EWL after IGB influences the final BMI and final weight, which means that patients with the greatest %EWL after IGB are more likely to have the greatest postoperative weight loss and overall weight loss.&lt;/br&gt;

The BioEnterics® Intragastric Balloon (BIB®) is a well-established device for temporary treatment in morbidly obese patients. The aim of this study is the evaluation, in a population of 714 consecutive outpatient setting cases, BIB® results in terms of weight loss and comorbidity change. BIB® was positioned in all cases after diagnostic endoscopy. The device was inflated under direct endoscopic vision with saline solution (600-700 ml) and methylene blue (10 ml). Intubation was carried out in patients with body mass index (BMI) > 40 kg/m(2) affected by sleep apnea or chronic obstructive pulmonary disease. After 6 months, balloon removal was carried out, and patients were discharged with drug therapy and 1,000 kcal diet. More than 100 patients underwent a second consecutive balloon positioning. One month from the removal of the first BIB, patients were given a second BIB. Patients were followed up weekly. Mortality, complications and their treatment, postplacement symptoms, comorbidities, BMI, percentage of excess BMI loss (%EBL), and percentage of excess weight loss (%EWL) were considered. Data are expressed as mean ± standard deviation. From June 1, 2005, to May 31, 2007, 714 patients underwent BIB® placement (143 males/571 females; mean age, 38.4 ± 16.1; mean BMI, 37.6 ± 5.7 kg/m(2); mean EW, 56.3 ± 27.1 kg). After 6 months, mean BMI was 31.1 ± 7.2, mean %EWL was 41.6 ± 21.8, mean BMI loss was 6.5 ± 12.7, and mean %EBL was 44.5 ± 22.6. Of 714 patients, 112 underwent a second BIB placement. At the time of the second balloon placement, mean BMI was 32.9 ± 6.7 kg/m(2); range was 31-51. After the second balloon removal, mean BMI was 30.3 ± 7.2. BIB® treatment is a safe and effective procedure for weight reduction, without mortality and with very low morbidity rates even in nonhospitalized patients. A second balloon can also be positioned without difficulties, achieving good results after 12 months of treatment.

Introduction: Obesity is a major global health problem associated with comorbidities such as diabetes, cardiovascular disease, and cancer. Bariatric surgery is recognized to be the most effective weight loss intervention, but it is highly invasive and costly and can have serious side effects. Intragastric balloon (IGB) placement by endoscopy and hypocaloric diets are among a number of techniques that have been used in patients unsuitable for, or unwilling to undergo, obesity surgery. In this study, we compared the efficacy, safety, and cost-effectiveness of the hypocaloric OPTIFAST program (OPT) with endoscopic IGB placement for weight loss. Methods: In this retrospective observational cohort propensity score-weighted comparison (performed May 2014 to December 2020), participants with a BMI of 30–55 kg/m2, aged 18–70 years, were randomized to OPT or IGB for 26 weeks, followed by a weight maintenance phase. Patients were matched according to age, gender, and BMI. The study outcomes were percentage excess body weight lost, total body weight lost (TBWL), and percentage TBWL (%TBWL). Results: A total of 148 participants (75% of those randomized; 74 OPT, 74 IGB) made up the ITT population. Mean age was 44.1 ± 10.4 years, and the patients were predominantly female (77%). Baseline BMI was 44.1 ± 10.4 kg/m2. At 26 weeks, %TBWL in the OPT group was 19.6 ± 6.8% versus 11.9 ± 6.7% for IGB (p < 0.001). At 52 weeks, %TBWL for OPT was 18.2 ± 9.0% versus 12.0 ± 6.6% for IGB (p < 0.001). The OPT cohort also experienced significantly fewer adverse events compared with the IGB group. Conclusion: IGB placement and OPT induce clinically meaningful weight loss. However, OPT appears to induce clinically superior weight loss and has economic advantages through lower rates of complications and adverse events.

Sex difference in the safety and efficacy of bariatric procedures: a systematic review and meta-analysis.

In recent years, particular attention has been paid to the effect that eating disturbances and especially binge eating can have on the outcome of surgical treatments for obesity. Endoscopic positioning of the Bioenterics intragastric balloon (BIB) is mainly used in the work-up for surgical treatment of morbid obesity. Available data show that the BIB is a valid tool for reducing weight and co-morbidity, even if only a temporary treatment in morbidly obese patients. We evaluated the results of treatment with the BIB with the patient's tendency to indulge in binge eating. Between April 2003 and March 2006, 89 patients with morbid obesity (BMI 39-55) were enrolled in the study. Before introducing the BIB and within 3 months after removal, patients underwent a psychiatric evaluation and the following psychodiagnostic tests: SCID (Structured Clinical Interview for DSM IV), ED-SCID (Eating Disorder Module, Structured Clinical Interview) and BSQ (Binge Scale Questionnaire). All those positive for the BED criteria according to the DSM IV, and who had at least one binge eating episode per week, were considered Binge Eaters (BE). Of the 89 patients enrolled, 75 were eligible for evaluations (M:F = 12:63), and 27 were positive for binge eating (BE). There were no significant differences in age and preoperative BMI between the BE group and the 48 patients without BE (NBE group). The complication and failure rates with the BIB treatment were significantly higher in the BE group (P<0.01). After treatment with the BIB, both groups showed a significant reduction in BMI (P<0.01), but the NBE-group showed a significantly higher weight (BMI 5.7 +/- 2.5 kg/m2) than the BE-group (BMI 3.3 +/- 2.2 kg/m2) (P=0.03). The results of treatment with the intragastric balloon appear to be affected by binge eating pattern in morbidly obese patients, even if the presence of this behavior does not prevent a successful reduction in the BMI. Binge eating does not seem to be a contraindication for the adjuvant use of the BIB before a bariatric operation. A limitation of our study is the short period of observation, related to the period of the BIB in the gastric lumen (not more than 6 months). Further studies may show whether the association of psychiatric treatment with the BIB in patients affected by binge eating may enhance the results of the treatment.

British National guidelines (NICE) recommend bariatric surgery for patients with a body mass index (BMI) > 40kg/m2, or BMI > 35kg/m2 with any comorbidities of the metabolic syndrome. Intra-gastric balloons (IGB) can be used in super obese patients as a first step, before definitive surgery. Quantify weight loss 6months after IGB placement, measure progression to definitive surgery and identify complications. Data collected retrospectively on 50 patients. Forty-six proposed for definitive bariatric surgery, four patients excluded. Analysis performed using SPSS v23.0. Median weight decreased from 165.5 to 155kg (range 78 to 212, p < 0.01), BMI from 57.4 to 52.15 (range 32.9 to 70.5, p < 0.01), percentage excess weight loss (%EWL) was 12.9% (range - 3.3 to 64.66%, p < 0.01) and BMI reduction was 4.25kg/m2 (range - 1.3 to 13.9, p < 0.01). Twenty-nine out of 46 patients (63%) progressed to definitive bariatric surgery. Ten out of 46 patients (21.7%) had complications requiring readmission. Seven of these patients required early balloon removal and six failed to progress to definitive surgery. Six patients had a second balloon placement, their actual weight loss was less successful, with some regaining weight. IGB is useful to aid weight loss prior to definitive bariatric surgery. Results from first balloon placement are encouraging and comparable with other studies "as reported by Genco et al. (Int J of Obes 30:129-133, 2006)." Readmission due to nausea, vomiting, dehydration and poor compliance may be associated with poor weight loss and failure to progress to definitive surgery. Second balloon placements were less successful. IGB as bridging therapy is a safe and useful adjunct. Sequential IGBs do not seem to provide additional benefit.

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

Aim: To compare the effects of endoscopic intragastric balloon (IGB) placement and intragastric botulinum toxin-A (BTX-A) injection in terms of weight loss among patients with non-morbid obesity. Methods: This retrospective single center study was conducted between 01.08.2020 and 01.01.2022. A total of 39 patients with a body mass index (BMI) of &amp;lt;40 without comorbidities were included in the study. Nineteen underwent intragastric BTX-A injection and 20 underwent IGB placement. Patients were evaluated 1 month and 6 months after the procedures. Results: Mean age was 39.4 ± 8.6 in the BTX-A group and 37.3 ± 10.4 in the IGB group (p = 0.496). 78.9% of the BTX-A group and 75.0% of the IGB group were female (p = 1.000). In both groups, the median weight 1 month after the procedure was significantly lower than before the procedure, and the median weight 6 months after the procedure was significantly lower than 1 month after the procedure (p&amp;lt;0.001 for both groups). The median weight loss in the IGB group at both the 1st and 6th months was significantly greater than the corresponding values of the BTX-A group (p &amp;lt; 0.001 for both). Conclusion: IGB insertion appears to be a more successful endoscopic bariatric procedure than intragastric BTX-A injection, as measured by weight loss at post-intervention 1 month and 6 months. IGB may be preferred in patients with a BMI below 40 without obesity-related comorbidity.

Background and Objectives: Intragastric balloon (IGB) is a safe option for obesity management. However, studies determining the factors influencing the procedure’s outcomes are scarce. Therefore, our goal was to determine the factors affecting weight reduction after IGB insertion. Materials and Methods: This retrospective study included 126 obese patients who underwent IGB treatment using the ORBERA® Intragastric Balloon System. Patients’ records were retrieved; and demographic data, initial body mass index (BMI), complications, compliance with both diet and exercise programs, and percentage of excess weight reduction were recorded. Results: The study included 108 female (85.7%) and 18 male (14.3%) patients. The mean age was 31.7 ± 8.1 years. The percentage of excess weight loss (EWL) was 55.8 ± 35.7%. The mean weight loss was 13.01 ± 7.51 kg. A significant association was found between EWL and age, initial weight, initial body mass index, and the number of pregnancies. No major complications were observed. However, the balloon had to be removed early in two patients (1.59%) due to its rupture and in two other patients (1.59%) due to severe gastritis. Conclusions: IGB therapy is a safe and effective option for obesity management, associated with low rates of complications. The EWL after IGB insertion is significantly higher among older patients, those with a relatively low initial body mass index, those with a longer duration of IGB insertion, and female patients with less parity. Larger prospective studies are needed to support our results.

Sa1964 THE DUAL EFFICACY OF PHARMACOTHERAPY WITH INTRAGASTRIC BALLOONS FOR SUSTAINED WEIGHT LOSS - A RETROSPECTIVE ANALYSIS

Obesity causes increased morbidity, disability and mortality rates as well as affects the quality of life. Given the known risks to the patient’s health, the International Federation for the Surgery of Obesity and Metabolic Disorders pays special attention to the problem of morbid obesity (body mass index ≥ 40 kg/m2), with particular emphasis on super‑obesity (body mass index ≥ 50 kg/m2). Objective is to investigate the role of endoluminal interventions in the preparation of super obese patients with high risk of surgical and anaesthesia‑related complications for bariatric surgery. Materials and methods. From 2011 to 2018, 97 patients with morbid obesity and high risk of surgery and anaesthesia‑related complications (ASA PS III — IV) underwent a course of treatment at the clinical setting of the Department of General Surgery No2 of Bohomolets National Medical University. The treatment was carried out in 2 stages. In the main group (n = 60), the first stage of treatment included the intragastric balloon placement for a term of 6 months. The control group (n = 37) received a six‑month conservative therapy. In the second stage of treatment the patients of both groups underwent a surgical procedure for the morbid obesity management. Results. The outcomes of the first stage of treatment showed that the patients, who underwent the intragastric balloon placement, had statistically significantly (p &lt; 0.001) higher mean the percentage of excess weight loss (% EWL) than the patients who received conservative therapy. In the main group, the average ASA PS score, which is identified as an anaesthetic and surgical risk indicator, decreased from 3.28 (95 % confidence interval (CI) 3.17 — 3.40) to 2.15 (95 % CI 2.06 — 2.24, p &lt; 0.001), and in the control group — from 3.24 (95 % CI 3.10 — 3.39) to 3.14 (95 % CI 2.96 — 3.31, p &gt; 0.05). Conclusions. The results of the study provide strong evidence that the intragastric balloon placement for a term of 6 months reduces surgical and anaesthetic risks, contributes to the improved function of the cardiovascular and respiratory systems as well as gives a boost to carbohydrate metabolism, and, therefore, can be suggested for the preparation of super obese patients with high risk of surgical and anaesthesia‑related complications for bariatric surgery.

Intra-gastric balloon therapy and weight reduction