Intragastric Balloons: Practical Considerations.

Obesity is escalating, projected to affect 17.5% of adults globally and afflict 400 million children by 2035. Managing this intricate and chronic condition demands personalized, multidisciplinary approaches. While dietary changes, lifestyle modifications, and medications yield short-term results, long-term outcomes are often poor, with bariatric surgery standing out as the most effective option. However, only a small fraction undergoes surgery due to various barriers. Intragastric balloon (IGB) emerges as a minimally invasive alternative, approved by major regulatory bodies. This review adresses the pivotal role of IGB in obesity management, delving into its history and technological evolution.

The Future of Endobariatrics: Bridging the Gap.

With the growing global burden of obesity, the field of endobariatrics has emerged as a promising alternative, filling the void between lifestyle interventions with modest efficacy and more invasive surgical procedures. This article explores the latest advancements in endobariatric therapies, encompassing endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), endoscopic metabolic therapies, and promising pharmacologic and surgical combination approaches that integrate multiple therapeutic modalities. It also outlines the critical factors and strategic considerations necessary for the successful integration of endobariatric interventions into clinical practice.

Complications resulting from an intragastric balloon in a patient without follow-up and monitoring.

The intragastric balloon (IGB) is recognised as a minimally invasive intervention for the treatment of obesity. Here, we detail a rare and life-threatening complication stemming from this procedure. A female patient in her 40s, who had an IGB in situ for 14 months, presented at the emergency department with septic shock characterised by abdominal guarding and emesis. These symptoms were a direct result of IGB-induced bowel obstruction. We emphasise that the patient missed the recommended 6-month removal window, which in our opinion is the decisive cause leading to deflated balloon migration and subsequent complications. In the course of managing multiple critical events, the patient required multiple operations related to the bowel obstruction, numerous nutritional and psychological challenges. Currently, the patient is living with short bowel syndrome, secondary to the chronic intestinal failure, necessitating the administration of parenteral nutrition 6 days per week.

Complications of the intragastric balloon treatment. Small bowel obstruction caused by migrated intragastric balloon - clinical case report and literature review.

INTRODUCTION: An endoscopic intragastric balloon (IGB) placement is one of the minimally invasive methods of obesity treatment. One of the rare serious complications is mechanical bowel obstruction requiring operative management. We report a case of a male patient with small bowel obstruction due to IGB migration and the literature review of complications during IGB treatment. Detailed Case Description: A patient with a BMI of 28 kg/m2 was admitted to the hospital with spontaneous deflation of an IGB. Due to the suspected location of IGB in the ileum laparoscopy was performed. The enterotomy was performed and the IGB removed. The procedure and the postoperative period were uneventful. DISCUSSION: Spontaneous IGB ruptures are reported in the literature with a frequency ranging from 0.6 to 23%. The majority of deflated devices are spontaneously excreted with the stool with no abdominal symptoms. Only 0.38% of IGBs cause mechanical bowel obstruction of requiring surgical management. Based on our own experience and literature review, we propose the diagnostic and therapeutic algorithm. CONCLUSION: Complications after IGB placement can range from mild to severe, that is why it is so important to make an early diagnosis based on the emerging symptoms and to implement prompt management to reduce or avoid serious complications. Any patient reporting disturbing symptoms occurring over a pro- longed period of time requires hospitalization and careful observation for the occurrence of gastrointestinal obstruction. The ideal option is hospitalization in the center which implemented the IGB and start with the algorithm we proposed.

One-Year Outcomes in a Supervised Program of Swallowable Intragastric Balloon-Analysis of 486 Patients in a High-Volume Bariatric Centre in Malaysia.

INTRODUCTION: The swallowable intragastric balloon (IGB) has recently emerged as a popular alternative for weight loss in Malaysia. It can reduce total body weight loss (TBWL) by 6-15%. We aim to observe positive weight loss up to a year after the swallowable IGB is implanted. METHODS: A total of 486 consecutive patients with overweight or obesity who underwent swallowable IGB insertion were included in this prospective data collection. RESULTS: Out of 486 patients, 404 patients (83%) had complete data at the end of 4 and 12 months. Patients included in the study had a starting mean body mass index of 35.3 ± 7.2 kg/m2 which decreased to 31.5 ± 5.7 kg/m2 (p < 0.0001) at the end of 4 months and further reduced to 30.3 ± 5.4 kg/m2 (p < 0.0001) at the end of 12 months. At 4 months, the overall average weight loss was 9.8 kg, meanwhile, at 12 months, the average weight loss increased to 12.9 kg. At 4 months, the average TBWL was 10.5%, while at the end of 1 year, the combined %TBWL increased to 13.7%. CONCLUSION: Most weight loss is typically observed within the first 4 months following the procedure. However, it is important to note that patients can continue to experience ongoing weight loss for up to 1 year. The swallowable IGB is a safe and effective option for patients seeking weight loss solutions. It offers numerous advantages, especially its non-invasive procedureless nature, which makes it more appealing to individuals considering this treatment.

Intragastric Balloon as a First Step Before Metabolic Bariatric Surgery in Patients with BMI ≥ 50 kg/m2: are the Results After Balloon Related to Global Outcomes After Surgery?

INTRODUCTION: Patients with body mass index (BMI) ≥ 50 kg/m2, classified with obesity class IV/V, require complex treatments. Intragastric balloon (IGB) is a possible treatment before metabolic bariatric surgery (MBS) that may reduce peri-operative complications. This study evaluates IGB outcomes and complications before MBS in patients with Obesity IV/V, and subsequent MBS results, regarding weight loss and comorbidity resolution. METHODS: Retrospective cohort study of all patients with BMI above 50 kg/m2 submitted to IGB before MBS between 2009 and 2023 in a high-volume center. Variables analyzed included weight loss after IGB and MBS, IGB complications, and comorbidity resolution. Suboptimal clinical responses were defined as %TWL < 5% for IGB, %TWL < 20% for MBS, and %TWL < 25% or BMI ≥ 35 kg/m2 for IGB + MBS. RESULTS: Seventy-four patients (mean BMI 58.8 ± 8 kg/m2) were included. After IGB, the mean %TWL was 14.2 ± 8.5%, with a 21.6% complication rate, predominantly nausea and vomiting, and one death. Suboptimal clinical response of IGB affected 13.5% of patients, and 5.4% required early removal. Two years after MBS, the mean %TWL was 38.2 ± 11.6%, mainly due to MBS, yet approximately one-third of %TWL was attributed to IGB. No correlation was found between IGB and MBS outcomes. At 2-year follow-up, 45.1% patients had %TWL ≥ 25 and BMI < 35 kg/m2. CONCLUSION: The IGB is a treatment option before MBS in patients with Obesity Class IV/V, with acceptable weight loss outcomes but not infrequent complications. A multidisciplinary approach is mandatory, and all treatments must be considered in this difficult subset of patients.

Evaluating the Safety of the Intragastric Balloon: Spanish Multicenter Experience in 20,680 Cases and with 12 Different Balloon Models.

INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.

Spontaneous Intragastric Balloon Hyperinflation: Two Cases and Outcomes.

Endoscopic bariatric therapies can provide treatment options for obesity in non-surgical candidates, as a part of combination or serial treatment plans, and for the reduction of obesity-related comorbidities. Several complications of intragastric balloons have been documented, but spontaneous hyperinflation is a risk that has not been well reported previously. We describe two cases of spontaneous intragastric balloon hyperinflation and their outcomes.

Effect of preoperative intragastric balloon treatment on perioperative and postoperative outcomes after laparoscopic sleeve gastrectomy: A retrospective cohort study.

<b><br>Introduction:</b> 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.</br> <b><br>Materials and methods:</b> Patients who underwent IGB placement followed by laparoscopic SG were divided into the following groups considering %EWL after IGB: Group 1 <=10.38%; Group 2 >10.38% and <=17.27%; Group 3 >17.27% and <=24.86%; Group 4 >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.</br> <b><br>Results:</b> 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.</br> <b><br>Discussion:</b> 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.</br> <b><br>Importance:</b> 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.</br>.

Changes in Food Preferences Before and After Intragastric Balloon Placement.

BACKGROUNDS: In recent years, numerous studies have tried to decode the way bariatric surgery works toward weight reduction by the use of food preference questionnaires. The intragastric balloon has gained popularity, mainly due to its limited invasiveness, in patients with obesity not fulfilling criteria for bariatric surgery. However, there is no study assessing the changes in food preferences [FP]. We decided to analyze the FP of individuals prior to intragastric balloon insertion and following its removal, on the strict condition that participants must complete the 6-month treatment period and attend at least 4 of the 7 follow-up interviews. METHODS: Patients were asked to rate the frequency of consumption of 63 food items before balloon insertion, at monthly intervals and after balloon removal. The food categories were protein, carbohydrates, fruit and vegetables, and sweets and fats. RESULTS: The questionnaires of 320 participants were analyzed. A reduced frequency in consumption of meat and meat products, high-fat, and high-carbohydrate/sugary products and an increase in raw vegetables and fruit was found in all individuals. CONCLUSION: The intragastric balloon seems to exert analogically similar mechanisms to bariatric surgery for weight loss, both functioning through alterations in FP. These are dictated by the anatomical re-configuration of the stomach, but mainly by counseling of dieticians and the self-education of the patient after experiencing unpleasant postprandial discomfort.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Intragastric Balloon as a Noninvasive Method for Obesity Treatment: A Single-Center Retrospective Study.

BACKGROUND: The incidence of obesity is increasing globally, with approximately 1 in 3 adults either overweight or obese. Surgery provides the most effective treatment for advanced obesity; however, endoscopic treatment, including intragastric balloon therapy, is commonly used in patients who do not meet the indications for surgery. Our study aimed to evaluate short- and mid-term weight changes of patients who had intragastric balloon therapy. MATERIAL AND METHODS: In this single-center retrospective study, we enrolled 320 patients with body mass index (BMI) values between 30 and 40 kg/m2 and without comorbidities, who underwent intragastric balloon treatment. 284 patients successfully underwent the operation. All patients were followed-up at 6 months after treatment, balloons were removed, and BMIs were recorded. Further follow-up was performed 6 months after balloon removal, and patients' BMI and demographic data were recorded again. RESULTS: Overall, 320 patients were enrolled in this study. In this cohort, 82 returned to their preprocedural weight at 1 year postprocedure, whereas 260 had BMI lower than the preprocedural values, but higher than the values at 6 months postprocedure. None of the patients had lower BMI compared to their 6-month postprocedural values. CONCLUSIONS: Balloon therapy typically helps patients lose 10% of body weight. Intragastric balloons are effective when used as weight loss tools, but are ineffective at maintaining weight loss. An intragastric device placed for 6 months may also be expected to help the patients develop better eating habits; however, we did not encounter this lifestyle change in our series.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Clinical validation of the VIPUN™ gastric monitoring system versus manometry for the evaluation of gastric motility.

BACKGROUND: Gastrointestinal dysmotility is frequently suspected in patients with gastroparesis, functional dyspepsia, and ileus, and in the intensive care unit. Monitoring of gastric motility in clinical practice remains challenging. A novel technology was developed to meet the medical need for a widely available bedside tool to monitor gastric motility continuously. The VIPUN™ Gastric Monitoring System (GMS) comprises a nasogastric feeding tube with intragastric balloon to allow for measuring gastric contractions. AIMS: To compare the performance of the VIPUN GMS versus a reference technique (manometry). METHODS: In this validation study in healthy subjects, the investigational catheter and a solid-state manometry catheter were placed in the stomach concomitantly. Motility was recorded for 2.5 h: 2 h in a fasting state, followed by a 400-kcal liquid meal, and monitoring of the fed state for the remaining half hour. The performance of both systems was compared by automated recognition and manual identification of the contractile activity. Data are presented as mean (standard deviation). KEY RESULTS: The analysis set comprised 13 healthy subjects (6 women, age: 27.5 (8.1) years, BMI: 22.2 (2.46) kg/m2). Automatically-recognized contractility was strongly correlated between the two techniques (endpoint: contraction duration; Spearman ρ = 0.96, p < 0.001). A correlation was also observed between the number of individual contractions identified by expert gastroenterologists on both technologies independently (ρ = 0.71, p = .007) and between the contractions identified by the experts and by the GMS software (ρ = 0.87, p = 0.001). No serious or unanticipated adverse events occurred. CONCLUSIONS & INFERENCES: The observed strong correlations with the gold standard, manometry, validate the performance of the VIPUN GMS as a gastric monitoring system.

Economic Evaluations of Anti-obesity Interventions in Obese Adults: An Umbrella Review.

This umbrella review amalgamates the outcomes of economic evaluations pertaining to bariatric surgeries, pharmacotherapy, and gastric balloon for adult obesity treatment. Six databases were systematically searched. The inclusion criteria were established following the Patient/population Intervention Comparison and Outcomes (PICO) statement. Fifteen reviews met all the inclusion criteria. Eight studies focused on surgical interventions, four on pharmacotherapy, and three on both interventions. No systematic review of the economic evaluation of gastric balloons was identified. The majority of reviews advocated bariatric surgery as a cost-effective approach; however, there was discordance in the interpretation of pharmacological cost-effectiveness. Most of the economic evaluations were conducted from the payer and the healthcare system perspectives. We propose that future economic evaluations assessing weight loss interventions in adults adopt a societal perspective and longer-term time horizons.

Emergent Management of Gastric Outlet Obstruction Post-Intragastric Balloon: A Case Report Highlighting the Importance of Preoperative Assessments and Postoperative Monitoring in Obesity Management.

BACKGROUND Obesity is a global epidemic often managed through surgical interventions, such as intragastric balloons. Despite the minimally invasive appeal of intragastric balloons, severe complications, such as gastric outlet obstruction, can occur with their use. The most recent guidelines recommend metabolic and bariatric surgery for specific body mass index categories but rarely discuss the potential complications and required postoperative monitoring. Guidelines encourage metabolic and bariatric surgery for patients with a body mass index of 30-34.9 kg/m² and presence of metabolic disease, or body mass index ≥35 kg/m², regardless of co-morbidities. CASE REPORT We report a case of a 35-year-old woman with severe nausea, vomiting, electrolyte imbalance, and chest pain, leading to ICU admission just 2 weeks after intragastric balloon placement in Mexico. Testing and diagnostics were concerning for metabolic imbalance and heart rhythm changes. Imaging and endoscopic investigations confirmed gastric outlet obstruction, necessitating emergent endoscopic balloon deflation and removal. Following the procedure, her symptoms resolved, and she was discharged with appropriate medication and scheduled follow-up. CONCLUSIONS Given the increasing prevalence of obesity and a corresponding surge in surgical interventions, this case serves as a cautionary tale. Selection of a type of metabolic and bariatric surgery should be patient specific, with the patient involved in the decision making. Rigorous preoperative assessments and sustained postoperative monitoring are imperative. This study aims to guide future research toward enhanced patient selection and prevention of severe complications, thus influencing practice and policy in obesity management.

Torsade de pointes secondary to long QT syndrome after intragastric balloon placement. A rare but severe complication

The obesity pandemic is becoming one of the most prevalent diseases nowadays. There is a wide spectrum of treatment, ranging from hygienic-dietary measures to bariatric surgery. Endoscopic intragastric balloon placement is becoming increasingly more frequent, due to its technical simplicity, safety and short-term success(1). Although complications are rare some can be severe, so pre-endoscopic evaluation must be carried out carefully. A 43-year-old woman with a history of grade I obesity (BMI 32.7) had an Orbera® intragastric balloon implanted successfully. After the procedure she presented frequent nausea and vomiting, partially controlled with antiemetics. She attended the Emergency Department(ED) with a persistent emetic syndrome - oral intolerance and short-term loss of consciousness(syncope), for which she was admitted. Lab tests showed metabolic alkalosis with severe hypokalemia(K+ 1.8mmol/L), so fluid therapy was initiated for hydroelectrolytic replacement. During the patient’s stay in the ED, two episodes of polymorphic ventricular tachychardia “Torsades de Pointes” (PVT-TDP) occurred, leading to cardiac arrest and requiring electrical cardioversion to restore sinus rhythm, in addition to a temporary pacemaker placement. Telemetry showed a corrected QT interval of >500ms, compatible with Long QT Syndrome(LQTS). Once the patient was hemodynamically stabilized a gastroscopy was performed. The intragastric balloon located in the fundus was removed using an extraction kit, puncturing and aspirating 500ml of saline solution, and extracting the collapsed balloon without any complications. The patient achieved an adequate oral intake afterwards, and no recurrence of emetic episodes were noticed. Previous ECGs revealed a prolonged QT interval and a genetic study confirmed a congenital type 1 LQTS. Treatment was initiated with beta-blockers and a bicameral automatic defibrillator was implanted in order to prevent recurrences. ... (AU)