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.

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.

Safety and Efficacy of 12-Month Intra-gastric Balloon-Series of over 1100 Patients.

BACKGROUND: Intra-gastric balloons (IGB) are a mainstay of endoscopic treatment of overweight and obesity. In recent years, an IGB which can remain in situ for 12 months has been developed. The current study aimed to analyse the safety and efficacy of this 12-month IGB. METHODS: Consecutive patients receiving the Orbera 365TM IGB (Apollo Endosurgery, TX, USA) between September 2017 and August 2021 were included in a prospective database. Patients received regular follow-up consultations followed by endoscopic removal at 12 months. Demographic data along with weight loss data were collected. All adverse events were recorded. RESULTS: In total, 1149 patients were included in the study. A majority of the patients were female (87.13%). Median body mass index (BMI) prior to insertion was 36.30 kg/m2 (IQR 32.60-40.00 kg/m2). Median absolute weight loss for all patients was 11.36 kg (IQR 6.70-16.82 kg). There was ongoing sustained weight loss until device removal at week 52. For patients with a weight recording at point of IGB removal, median weight loss was greater (15.88 kg, IQR 10.43-21.72) with percentage total body weight loss of 15.38% (IQR 10.99-21.77) and excess weight loss of 53.99% (IQR 32.44-76.30). Increased patient engagement with post-procedural follow-up was associated with increased weight loss (p<0.001). There were 60 total complications (5.22%). Fifty patients required balloon removal due to intolerance. There were eight cases of balloon rupture. There were only two severe complications (0.17%). CONCLUSION: The current study has confirmed safety of this IGB at 12 months with adverse events comparable to published literature. Weight loss increased up until the point of removal at 12 months.

Intragastric balloons for obesity: critical review of device design, efficacy, tolerability, and unmet clinical needs.

INTRODUCTION: Sustaining a healthy weight is a challenge and obesity, with associated risk of co-morbidities, is a major public health concern. Bariatric surgery has shown a great promise for many where pharmacological and lifestyle interventions failed to work. However, challenges and limitations associated with bariatric surgery has pushed the demand for less invasive, reversible (anatomically) interventions, such as intragastric balloons (IGBs). AREAS COVERED: This review critically appraises IGBs used in the past, present, and those in clinical trials, discussing the device designs, limitations, placement and removal techniques, patient eligibility, efficacy, and safety issues. EXPERT OPINION: Several intragastric balloons were developed over the years that brought excitement to patients and healthcare professionals alike. Albeit good efficacy, there had been several safety issues reported with IGBs such as spontaneous deflation, intestinal occlusion, gut perforation, and mucosal ulcerations. This led to evolution of IGBs design; device material, filling mechanism, fluid type, inflation volume, and further innovations to ease ingestion and removal of device. There are some IGB devices under development aimed to swallow like a conventional pill and excrete naturally through defecation, however, how successful they will be in clinical practice in terms of their efficacy and tolerability remains to be seen in the future.

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. Intragastric balloon placement is generally a safe procedure, serious complications present in 0.70% of cases(2). It is essential to have a proper pre-endoscopic evaluation, including patient's medical history and comorbidities. Episodes of PVT-TDP may present precipitated by certain medications (eg. metoclopramide) or hydroelectrolytic imbalances (eg, hypokalemia)(3). A standardized evaluation of ECG before intragastric balloon placement may be useful to prevent these rare but serious complications.

Meta-analysis: Impact of intragastric balloon therapy on NAFLD-related parameters in patients with obesity.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease affecting approximately 25% of adults in the western world. Intragastric balloon (IGB) is an endoscopic bariatric therapy -a therapeutic endoscopic tool that has shown promise in inducing weight loss. Its role in the treatment of NAFLD is yet to be established. AIM: To evaluate the effect of IGB as a treatment option in NAFLD. METHODS: We searched MEDLINE (PubMed) and EMBASE from inception to September 2022. We included studies evaluating the impact of IGB on obesity with the assessment of one or more liver-related outcomes and studies primarily evaluating the impact of IGB on NAFLD. We included comparative and non-comparative studies; primary outcomes were liver-related NAFLD surrogates. RESULTS: We included 19 studies with 911 patients. IGB demonstrated an effect on NAFLD parameters including NAFLD activity score (NAS): mean difference (MD): -3.0 [95% CI: -2.41 to -3.59], ALT: MD: -10.40 U/L [95% CI: -7.31 to -13.49], liver volume: MD -397.9 [95% CI: -212.78 to 1008.58] and liver steatosis: MD: -37.76 dB/m [95% CI: -21.59 to -53.92]. There were significant reductions in non-liver-related outcomes of body weight, BMI, glycated haemoglobin and HOMA-IR. CONCLUSION: Intragastric balloons may play an important role in addressing the treatment gap in NAFLD 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)

The efficacy of liraglutide combined with intragastric balloon on weight loss.

OBJECTIVE: Intragastric balloon placement is an effective method for weight reduction. The aim of this study was to evaluate the efficacy of combining liraglutide with intragastric balloon. METHODS: Initially, demographic data of patients such as age, gender, comorbid diseases, adverse events, initial weight, height, body mass index, percent body fat, and waist-hip ratio were collected. Weight, body mass index, percent body fat, and waist-hip ratio were measured in the second, third, fourth, fifth, and sixth months. Then, intragastric balloon was removed and liraglutide was stopped. RESULTS: A total of 50 patients were included in the study, of whom 28 (56%) were in Group A (intragastric balloon) and 22 (44%) were in Group B (plus liraglutide). Weight change at the time of balloon removal was higher in Group B [median weight change 13.8 (7.8 min to 16.8 max) versus 7.9 (4.8 min to 11.8 max); p<0.01]. When the weight, percent body fat, body mass index, and waist-hip ratio changes were compared according to gender, no significant difference was observed in the groups. Comorbid diseases were hypertension in 7 patients (4 in Group A and 3 in Group B) and diabetes in 9 patients (5 in Group A and 4 in Group B). No statistical significance was found. CONCLUSION: Liraglutide has benefits in terms of weight, percent body fat, and body mass index reduction when administered with intragastric balloon.

Surgical Management of Intra-gastric Balloon Complications, Single-Center Experience, and Literature Review.

INTRODUCTION: In Saudi Arabia, the prevalence of obesity has multiplied in the last decades leading to a surge in bariatric surgery and other endoscopic modalities. The intra-gastric balloon (IGB) is the most used endoscopic modality. Surgical management for IGB complications is required for gastrointestinal perforation and/or obstruction. However, the literature seems to underestimate these complications. MATERIALS AND METHODS: A retrospective descriptive study was conducted in King Fahd University Hospital, Saudi Arabia, from Jan 2017 to Dec 2021, including all patients with complicated IGB who necessitated any surgical procedure. Exclusion criteria were patients with complicated IGBs that were only managed conservatively or endoscopically. RESULTS: A total of 326 patients were admitted with different complications after bariatric procedures. Of them, six patients were referred due to IGB complications that necessitated operative intervention. All patients were young females. Three patients had gastric wall perforation, and were managed by endoscopic removal of the IGBs followed by exploratory laparotomy. One patient had an intestinal obstruction on top of a migrated IGB that was surgically removed. One patient had failed endoscopic retrieval of IGB and required a laparoscopic gastrostomy. Another patient had an esophageal rupture that required left thoracotomy, pleural flap, and insertion of an esophageal stent. All cases were discharged and followed up with no related complications. CONCLUSION: IGB is an endoscopic alternative, within specific indications, for the management of obesity. However, surgical management may be necessary to manage its complications, including gastrointestinal perforation, IGB migration, and failure of endoscopic removal.

Losing weight to achieve joint or hernia surgery: is the intragastric balloon the answer?

BACKGROUND: Obesity is an epidemic, with its accompanying medical conditions putting patients at increased risk of postoperative complications. For patients undergoing elective surgery, preoperative weight loss provides an opportunity to decrease complications. We sought to evaluate the safety and efficacy of an intragastric balloon in achieving a body mass index (BMI) < 35 kg/m2 prior to elective joint replacement or hernia repair. METHODS: Retrospective review of all patients who had intragastric balloon placement at a level 1A VA medical center from 1/2019 to 1/2023. Patients who had a scheduled qualifying procedure (knee/hip replacement or hernia repair) and had a BMI > 35 kg/m2 were offered intragastric balloon placement to achieve 30-50lbs (13-28 kg) weight loss prior to surgery. Participation in a standardized weight loss program for 12 months was required. Balloons were removed 6 months after placement, preferentially concomitant with the qualifying procedure. Baseline demographics, duration of balloon therapy, weight loss and progression to qualifying procedure were recorded. RESULTS: Twenty patients completed intragastric balloon therapy and had balloon removal. Mean age 54 (34-71 years), majority (95%) male. Mean balloon duration was 200 ± 37 days. Mean weight loss was 30.8 ± 17.7lbs (14.0 ± 8.0 kg) with an average BMI reduction of 4.4 ± 2.9. Seventeen (85%) patients were successful, 15 (75%) underwent elective surgery and 2 (10%) were no longer symptomatic after weight loss. Three patients (15%) did not lose sufficient weight to qualify or were too ill to undergo surgery. Nausea was the most frequent side effect. One (5%) patient was readmitted within 30 days for pneumonia. DISCUSSION: Intragastric balloon placement resulted in an average 30lbs (14 kg) weight loss over 6 months allowing more than 75% of patients to undergo joint replacement or hernia repair at an optimal weight. Intragastric balloons should be considered in patients requiring 30-50lbs (13-28 kg) weight loss prior to elective surgery. More study is needed to determine the long-term benefit of preoperative weight loss prior to elective surgery.

The Swallowable Intragastric Balloon Combined with Lifestyle Coaching: Short-Term Results of a Safe and Effective Weight Loss Treatment for People Living with Overweight and Obesity.

BACKGROUND: Some patients with overweight or obesity are not eligible for surgery according to international guidelines or do not wish a surgical intervention. For these patients, different treatment options are being explored. In this study, we examined the effectiveness of the swallowable intragastric balloon (IB) combined with lifestyle coaching, in patients living with overweight and obesity. METHOD: A retrospective data study was conducted on patients with a swallowable IB placement between December 2018 and July 2021, combined with a 12-month coaching program. Before balloon placement, patients underwent multidisciplinary screening. The IB was swallowed and filled with fluid once in the stomach and naturally excreted around 16 weeks. RESULTS: A total of 336 patients, 71.7% female, were included with a mean age of 45.7 (±11.7) years. Mean baseline weight and BMI were 107.54 (±19.16) kg and 36.1 (±5.02) kg/m2. After 1 year, the mean total weight loss was 11.0% (±8.4). The mean placement duration was 13.1 (±2.82) min, and in 43.7%, a stylet was used to facilitate placement. The most common symptoms were nausea (80.4%) and gastric pain (80.3%). In the majority of patients, complaints were resolved within a week. The early deflation of the balloon occurred in 8 patients (2.4%) of which one showed symptoms suggesting a gastric outlet obstruction. CONCLUSION: Given the low rate of long-term complaints while providing a positive effect on weight loss, we conclude that the swallowable intragastric balloon, combined with lifestyle coaching, is a safe and effective treatment option for patients living with overweight and obesity.

Factors of Affecting the Success of Intragastric Balloon.

BACKGROUND: Our aim was to determine the efficacy and safety of intragastric balloon (IGB) application and the factors affecting its success by evaluating the results of patients who underwent IGB. MATERIALS AND METHODS: A total of 277 consecutive patients that underwent IGB between January 2019-September 2020 in our clinic were evaluated. Patients' demographic data, height and weight before the IGB procedure, weight at 6 and 12 months after the procedure, follow-up period, complication status, and whether they received dietician's assistance during the follow-up were recorded. RESULTS: In 5 (1.8%) patients, IGB was removed for various reasons before the standard period of 6 months. The mean age of the patients was 35.6±9.5 years, the mean baseline weight and body mass index (BMI) was 92.6±14 kg and 33.5±5.4 kg/m 2 respectively. The mean follow-up time was 13±4.9 months, whereas in 146(53.6%) patients the follow-up was≥12 months. In the 6-month follow-up, the mean %excess weight loss and %body weight loss were 65.65±25.19% and 14.69±6.96%, respectively, whereas at the 12-month follow-up they were 32.38±24.79% and 6.56±5.31%, respectively. High BMI (odds ratio=1.2, 95% CI=1.0-1.2) and not receiving dietitian's assistance (odds ratio=8.5, 95% CI=3.1-23.7) were independent risk factors for unsuccessful IGB application at both 6-month and 12-month follow-ups. CONCLUSION: IGB application is a relatively effective and safe weight loss treatment for overweight and obese individuals. High BMI and not getting help from a dietician are risk factors for failure of IGB. To increase compliance with dieticians and therefore success of IGB application, patients should undergo psychiatric evaluation before IGB procedure, and receive psychiatric support, if necessary.

Spanish Intragastric Balloon Consensus Statement (SIBC): practical guidelines based on experience of over 20 000 cases.

BACKGROUND: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.