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.

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. ... (AU)

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.

Obesity Management in Adults: A Review.

Importance: Obesity affects approximately 42% of US adults and is associated with increased rates of type 2 diabetes, hypertension, cardiovascular disease, sleep disorders, osteoarthritis, and premature death. Observations: A body mass index (BMI) of 25 or greater is commonly used to define overweight, and a BMI of 30 or greater to define obesity, with lower thresholds for Asian populations (BMI ≥25-27.5), although use of BMI alone is not recommended to determine individual risk. Individuals with obesity have higher rates of incident cardiovascular disease. In men with a BMI of 30 to 39, cardiovascular event rates are 20.21 per 1000 person-years compared with 13.72 per 1000 person-years in men with a normal BMI. In women with a BMI of 30 to 39.9, cardiovascular event rates are 9.97 per 1000 person-years compared with 6.37 per 1000 person-years in women with a normal BMI. Among people with obesity, 5% to 10% weight loss improves systolic blood pressure by about 3 mm Hg for those with hypertension, and may decrease hemoglobin A1c by 0.6% to 1% for those with type 2 diabetes. Evidence-based obesity treatment includes interventions addressing 5 major categories: behavioral interventions, nutrition, physical activity, pharmacotherapy, and metabolic/bariatric procedures. Comprehensive obesity care plans combine appropriate interventions for individual patients. Multicomponent behavioral interventions, ideally consisting of at least 14 sessions in 6 months to promote lifestyle changes, including components such as weight self-monitoring, dietary and physical activity counseling, and problem solving, often produce 5% to 10% weight loss, although weight regain occurs in 25% or more of participants at 2-year follow-up. Effective nutritional approaches focus on reducing total caloric intake and dietary strategies based on patient preferences. Physical activity without calorie reduction typically causes less weight loss (2-3 kg) but is important for weight-loss maintenance. Commonly prescribed medications such as antidepressants (eg, mirtazapine, amitriptyline) and antihyperglycemics such as glyburide or insulin cause weight gain, and clinicians should review and consider alternatives. Antiobesity medications are recommended for nonpregnant patients with obesity or overweight and weight-related comorbidities in conjunction with lifestyle modifications. Six medications are currently approved by the US Food and Drug Administration for long-term use: glucagon-like peptide receptor 1 (GLP-1) agonists (semaglutide and liraglutide only), tirzepatide (a glucose-dependent insulinotropic polypeptide/GLP-1 agonist), phentermine-topiramate, naltrexone-bupropion, and orlistat. Of these, tirzepatide has the greatest effect, with mean weight loss of 21% at 72 weeks. Endoscopic procedures (ie, intragastric balloon and endoscopic sleeve gastroplasty) can attain 10% to 13% weight loss at 6 months. Weight loss from metabolic and bariatric surgeries (ie, laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass) ranges from 25% to 30% at 12 months. Maintaining long-term weight loss is difficult, and clinical guidelines support the use of long-term antiobesity medications when weight maintenance is inadequate with lifestyle interventions alone. Conclusion and Relevance: Obesity affects approximately 42% of adults in the US. Behavioral interventions can attain approximately 5% to 10% weight loss, GLP-1 agonists and glucose-dependent insulinotropic polypeptide/GLP-1 receptor agonists can attain approximately 8% to 21% weight loss, and bariatric surgery can attain approximately 25% to 30% weight loss. Comprehensive, evidence-based obesity treatment combines behavioral interventions, nutrition, physical activity, pharmacotherapy, and metabolic/bariatric procedures as appropriate for individual patients.

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.

Intra-gastric balloon with lifestyle modification: a promising therapeutic option for overweight and obese patients with metabolic dysfunction-associated steatotic liver disease.

BACKGROUND: Data on effects of intra-gastric balloon (IGB) on metabolic dysfunction-associated steatotic liver disease (MASLD) are scarce, in part with contradictory results, and mainly obtained in tertiary care patients with diabetes and other comorbidities. We here explore effects of IGB in patients with MASLD referred to a first-line obesity clinic. METHODS: In this prospective cohort study, patients with at least significant fibrosis (≥ F2) and/or severe steatosis (S3) according to screening transient elastography (FibroScan®) were offered a second FibroScan® after 6 months lifestyle modification with or without IGB (based on patient preference). RESULTS: 50 of 100 consecutively screened patients (generally non-diabetic) qualified for repeated evaluation and 29 (58%) of those had a second FibroScan®. At baseline, at least significant fibrosis was present in 28% and severe steatosis in 91%. IGB was placed in 19 patients (59%), whereas 10 patients (41%) preferred only lifestyle modification (no differences in baseline characteristics between both groups). After 6 months, liver stiffness decreased markedly in the IGB group (median: from 6.0 to 4.9 kPa, p = 0.005), but not in the lifestyle modification only group (median: from 5.5 to 6.9 kPa, p = 0.477). Steatosis improved in both groups, (controlled attenuation parameter values; IGB, mean ± SD: from 328 ± 34 to 272 ± 62 dB/m, p = 0.006: lifestyle modification only, mean ± SD: from 344 ± 33 to 305 ± 43 dB/m: p = 0.006). CONCLUSION: Both steatosis and fibrosis improve markedly in overweight/obese patients with MASLD after 6 months IGB combined with lifestyle modification. Our results warrant further research into long-term effect of IGB in these patients.

Efficacy of Intragastric Balloon versus Liraglutide as Bridge to Surgery in Super-Obese Patients.

INTRODUCTION: Bariatric surgery is a safe and effective treatment for obesity, although in super-obese patients (BMI ≥50 kg/m2) it can become challenging for anatomical and anesthesiologic issues. Several bridging therapies have been proposed to increase preoperative weight loss and decrease perioperative morbidity and mortality. The aim of this study was to compare the efficacy and safety of different two-stage approaches in super-obese patients: laparoscopic sleeve gastrectomy (LSG) following preoperative liraglutide therapy versus LSG with preoperative intragastric balloon (IGB) during a 1-year follow-up. METHODS: Clinical records of 86 patients affected by super-obesity who underwent two-stage approach between January 2019 and January 2022 were retrospectively reviewed using a prospectively maintained database. Patients were separated into two groups: those managed with preoperative IGB and those with liraglutide 3.0 mg prior to LSG. Weight (kg), BMI (kg/m2), %EWL, and %EBWL were reported and compared between the two groups at the end of bridging therapy, at 6th month and 12th month postoperatively. Postoperative complications were recorded. RESULTS: Forty-four patients underwent IGB insertion prior to LSG, while 42 were treated with liraglutide. There were no statistical differences in baseline weight and BMI. At the end of preoperative treatment, the group treated with IGB reported a significant reduction in BMI (47.24 kg/m2 vs. 53.6 kg/m2; p < 0.391) compared to liraglutide group. There were no differences recorded between the two groups concerning postoperative complications. At 6 months, the liraglutide group had lower %EWL (15.8 vs. 29.84; p < 0.05) and %EBWL (27.8 vs. 55.6; p < 0.05) when compared to IGB group. At 12 months, the IGB preserved with higher %EWL (39.9 vs. 25; p < 0.05) and %EBWL (71.2 vs. 42; p < 0.05). CONCLUSION: A two-stage therapeutic approach with IGB prior to LSG in super-obese patients could be considered an attractive alternative to liraglutide as bridging therapy before bariatric surgery.

Performance Characteristics of Endoscopic Sleeve Gastroplasty in Patients with Prior Intragastric Balloon: Results of a Propensity Score Matched Study.

INTRODUCTION: The performance characteristics of endoscopic sleeve gastroplasty (ESG) for weight recurrence after intragastric balloon (IGB) are unknown. METHODS: This is a retrospective propensity score matched study of ESG after IGB (IGB-to-ESG) vs ESG without prior IGB (ESG-only). The primary outcome was total weight loss (TWL) at 12 months. Secondary outcomes included TWL at 3 and 6 months, 12-month excess weight loss (EWL), procedural characteristics, and safety. RESULTS: Thirty-nine adults underwent ESG from August 2020 to September 2022 after IGB explantation a median of 24 months (range 2-56 months) prior and a median post-IGB nadir weight increase of 100.0% (range 0 to 3200%). An ESG-only 2:1 age- sex- and BMI- propensity score matched cohort was derived from 649 patients (Pearson's goodness-of-fit: 0.86). TWL for IGB-to-ESG vs. ESG-only was 12.3 ± 13.5% vs. 12.4 ± 3.7% at 3 months (p = 0.97), 10.1 ± 7.1% vs. 15.4 ± 4.6% at 6 months (p < 0.001), and 8.7 ± 7.7% vs. 17.1 ± 5.7% at 12 months (p < 0.001). Twelve-month EWL for IGB-to-ESG vs ESG-only was 27.8 ± 46.9% vs 62.0 ± 21.0% (p < 0.001). There was no difference in mean procedural duration of ESG; however, more sutures were used with IGB-to-ESG vs. ESG-only (7 vs. 6, p < 0.0002). There were no serious adverse events in either cohort. CONCLUSION: ESG after IGB produces safe, acceptable weight loss but with an attenuated effect compared to ESG alone. Further study is required to understand the factors driving this discrepancy.

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.

INTRAGASTRIC BALLOON AND IMPACT ON WEIGHT LOSS: EXPERIENCE IN QUITO, EQUADOR.

BACKGROUND: Obesity is associated with different medical conditions, such as cardiologic, respiratory, gastrointestinal, and genitourinary, and constitutes a severe health problem. AIMS: This study aimed to evaluate the use of intragastric fluid-filled balloon in the reduction of weight and other measurements related to body composition. METHODS: This is a retrospective, monocentric study involving all patients who opted for the intragastric balloon Spatz® placement from January 2018 to July 2019, with fulfillment of inclusion and exclusion criteria. The patients were analyzed after 6 and 12 months after the intragastric fluid-filled balloon placed. RESULTS: A total of 121 subjects were included in this study, with 83 (68.6%) females and 38 (31.4%) males. The mean age was 36 years and height was 1.64±0.09. Weight mean and standard deviation was 89.85±14.65 kg, and body mass index was 33.05±4.03; body mass index decreased to 29.4 kg/m2 with a mean weight of 79.83 kg, after 12 months of follow-up. There were statistical differences between body mass index and the 12 months in fat percentage, fat-free mass (kg), visceral fat area, and basal metabolic rate. There was a significant variation according to gender, with males having highest reduction. The percentage of excess weight loss was 46.19, and the total weight loss was 9.24 at the end of the study. CONCLUSIONS: The study demonstrated a benefit of intragastric fluid-filled balloon on weight loss after 12 months. At the end of treatment, body mass index and the measurements of body composition were significantly lower. Men benefited more than women from the treatment.

Brazilian guide to nutrition in bariatric and metabolic surgery.

PURPOSE: Brazilian nutrition recommendations for bariatric and metabolic surgery aim to provide knowledge, based on scientific evidence, on nutritional practices related to different surgical techniques in the surgical treatment of obesity and metabolic diseases. MATERIALS AND METHODS: A systematic literature search was carried out with the appropriate MeSH terms using Medline/Pubmed/LiLACS and the Cochrane database, with the established criteria being based on the inclusion of articles according to the degree of recommendation and strength of evidence of the Classification of Recommendations, Evaluation, Development, and Evaluation System (GRADE). RESULTS: The recommendations that make up this guide were gathered to assist in the individualized clinical practice of nutritionists in the nutritional management of patients with obesity, including nutritional management in the intragastric balloon; pre and postoperative nutritional treatment and supplementation in bariatric and metabolic surgeries (adolescents, adults, elderly, pregnant women, and vegetarians); hypoglycemia and reactive hyperinsulinemia; and recurrence of obesity, gut microbiota, and inflammatory bowel diseases. CONCLUSION: We believe that this guide of recommendations will play a decisive role in the clinical practice of nutritionists who work in bariatric and metabolic surgery, with its implementation in health services, thus promoting quality and safety in the treatment of patients with obesity. The concept of precision nutrition is expected to change the way we understand and treat these patients.