Safety and Risk in Airway Management During Bariatric Air Medical Retrieval.

OBJECTIVE: Bariatric anatomy and physiology present added clinical challenges to the provision of safe critical care and patient transport. LifeFlight Retrieval Medicine provides air medical retrieval services in Queensland, Australia, and performs over 6,000 retrieval missions annually using rotary wing, fixed wing, and ground ambulance platforms. METHODS: Bariatric patient retrievals were identified from the LifeFlight Retrieval Medicine electronic patient database. These cases were interrogated to quantify and describe adverse events during patient transport. RESULTS: Over the study period from July 2019 to December 2021 11,096 patient retrievals were completed. Of these patients, 816 (7.3%) had a body weight ≥ 120 kg (range, 120-246 kg; median = 146 kg). Bariatric patients were more likely to be male (70%) and to require critical care interventions than nonbariatric patients (25.9% vs. 19.9%). There was an absolute 1.5% increase of high-interest events during patient retrieval, corresponding to a 1.9-fold increased relative risk. Five hundred eleven of 11,096 patients were intubated by the retrieval team, and 61 of these weighed ≥ 120 kg. Bariatric patients undergoing intubation were of similar age and sex, weighed significantly more, had nonsignificant trends toward poorer airway visualization by Cormack-Lehane laryngoscopic grade, and tended toward reduced first-attempt success compared with nonbariatric patients. Rates of airway adverse events (AAEs) were significantly increased for the bariatric group (30/61, 49.2%) compared with the nonbariatric group (135/450, 30.0%) (χ2 likelihood ratio, P = .004). Postintubation desaturation was the most common AAE and was the only criterion significantly increased when comparing bariatric (26%) versus nonbariatric (12%) patients (χ2 likelihood ratio, P = .005). Using patient weight as a continuous variable, nominal logistic regression revealed a significant effect of increasing weight on AAEs (χ2 = 12.9, P = .0003) with a threshold of 105 kg providing an optimal 88% sensitivity for predicting AAEs. The odds of AAEs were increased significantly for those weighing 105 to 119 kg versus those weighing < 105 kg (odds ratio [OR] = 3.4; 95% confidence interval [CI], 1.6-7.5) and for those weighing ≥ 120 kg versus those weighing < 105 kg (OR = 2.5; 95% CI, 1.4-4.3). There was no difference between those weighing ≥ 120 kg versus those weighing 105 to 119 kg (OR = 0.73; 95% CI, 0.3-1.8). CONCLUSION: Air medical retrieval of bariatric patients is safe despite an increased risk of adverse events. Strategies to optimize emergency anesthesia should be used to maximize safe intubation in bariatric patients.

Bariatrics and endoscopic therapies for the treatment of metabolic disease: Past, present, and future.

The burden of chronic metabolic diseases such as obesity, type 2 diabetes mellitus (T2DM), and metabolic dysfunction-associated steatotic liver disease (MASLD) and the urgency of the epidemiological situation necessitate the development of therapies that enhance metabolic health and alter the trajectory of metabolic disease in society. Certain bariatric-metabolic surgeries have proven to be effective approaches for treating metabolic dysfunction, showing remission or significant improvements in obesity, T2DM, and MASLD-related outcomes, suggesting that these interventions might be able to "reset" a pathologically calibrated metabolic setpoint. However, considering the challenges and invasiveness of surgery, endoscopic bariatric metabolic therapies (EBMTs) have emerged with a primary focus to reconstruct or mimic anatomical and/or functional changes observed with bariatric surgery in a more broadly accessible manner. These innovative approaches offer a potentially promising solution to address significant unmet medical need in the large segment of society, which remains at risk for the consequences of metabolic diseases. In this review, we discuss therapeutic options within the EBMT space in the context of the metabolic setpoint intellectual model and provide a brief overview of current knowledge surrounding their mechanisms of action and impact on metabolic health. Finally, we explore future perspectives and directions in this exciting field.

Evaluation of Dietary Assessment Tools Used in Bariatric Population.

Severe obesity is associated with major health issues and bariatric surgery is still the only treatment to offer significant and durable weight loss. Assessment of dietary intakes is an important component of the bariatric surgery process. OBJECTIVE: To document the dietary assessment tools that have been used with patients targeted for bariatric surgery and patients who had bariatric surgery and explore the extent to which these tools have been validated. METHODS: A literature search was conducted to identify studies that used a dietary assessment tool with patients targeted for bariatric surgery or who had bariatric surgery. RESULTS: 108 studies were included. Among all studies included, 27 used a dietary assessment tool that had been validated either as part of the study per se (n = 11) or in a previous study (n = 16). Every tool validated per se in the cited studies was validated among a bariatric population, while none of the tools validated in previous studies were validated in this population. CONCLUSION: Few studies in bariatric populations used a dietary assessment tool that had been validated in this population. Additional studies are needed to develop valid and robust dietary assessment tools to improve the quality of nutritional studies among bariatric patients.

Metabolic shift precedes the resolution of inflammation in a cohort of patients undergoing bariatric and metabolic surgery.

Bariatric and metabolic surgery has shown to promote weight loss and reduce systemic inflammation. However, the sequence and timing of events regarding metabolic improvement and inflammation resolution has been rarely explored. Furthermore, data on inflammatory markers of Th17 and Th1 cell responses after bariatric surgery is scarce. We conducted a prospective study in subjects with obesity that underwent bariatric and metabolic surgery, with follow-ups at 3 and 6 months. Anthropometric and metabolic markers such as insulin levels, HOMA-IR, and lipid parameters declined significantly 3 months after surgery; while hs-CRP, TNF-α, IL-1ß, IL-6, and IL-8 serum concentrations decreased 6 months after the procedure. Concentrations of Th1 signature and driver cytokines, particularly IFN-γ, IL-12, and IL-18, and of Th17 driver IL-23 also decreased significantly after 6 months. Significant positive correlations between triglyceride levels and hs-CRP, IL-1ß, and IFN-γ concentrations, and between Apo B and IFN-γ levels were observed 6 months after bariatric and metabolic surgery. In addition, BMI was associated with hs-CRP and TNF-α concentrations. Fat mass correlated with hs-CRP, TNF-α, and IL-12. Analysis of the temporality of metabolic and inflammatory events suggests that improvement in the metabolic status occurs before resolution of systemic inflammation and may be a requisite for the later event.

Evaluation of the histological variability of core and wedge biopsies in nonalcoholic fatty liver disease in bariatric surgical patients.

BACKGROUND: Liver biopsy remains the gold standard for characterizing and evaluating treatment response in nonalcoholic fatty liver disease (NAFLD). Liver heterogeneity and sampling variability can affect the reliability of results. This study aimed to compare histological variability of intraoperative wedge and core liver biopsies from different lobes in bariatric patients, to better inform surgeons on biopsy method and guide interpretation of results. METHODS: We prospectively recruited bariatric surgical patients. Intraoperative core biopsies were taken from the left and right lobe, with a wedge biopsy taken from the left. All biopsies were graded by a specialist liver pathologist, blinded to clinical details and biopsy site. Concordance of histological findings between sites was evaluated. RESULTS: There were 91 participants (72.2% female), mean age 46.8 ± 12.0 years, body mass index 45.9 ± 9.4 kg/m2. There was no significant pattern for up- or down-grading disease dependent on biopsy technique. Moderate to strong agreement was seen in the presence of NAFLD and nonalcoholic steatohepatitis (NASH, κ = 0.609-0.865, p < 0.001) between biopsy sites. Individual components (steatosis, inflammation, ballooning) showed weaker agreement (κ = 0.386-0.656, p < 0.01). Fibrosis showed particularly poor agreement (κ = 0.223-0.496, p < 0.01). Detection of pathology improved with a combination of biopsy techniques, compared to a single biopsy method. CONCLUSION: Overall diagnosis of NAFLD or NASH shows good agreement between biopsy sites, but individual components, particularly fibrosis stage, vary significantly. Clinicians should consider biopsies from varied sites, to better assess liver disease severity. These data have important implications in fibrosis assessment of NAFLD and are relevant in the interpretation of histological efficacy of investigational pharmacotherapies. TRIAL REGISTRATION: ACTRN12615000875505 (Australian Clinical Trials Register).

The influence of patient's age on metabolic and bariatric results of laparoscopic sleeve gastrectomy in 2-year observation.

BACKGROUND: The incidence of obesity has been constantly growing and bariatric procedures are considered to be the most effective treatment solution for morbidly obese patients. The results of laparoscopic sleeve gastrectomy (LSG) may differ depending on patient's age, gender, preoperative body mass index (BMI) and physical activity. METHODS: The aim of this study was to evaluate age-related differences in the outcome of LSG in terms of weight loss parameters, lipid and carbohydrate profile. The retrospective analysis of 555 patients who had undergone LSG was performed to compare the metabolic outcomes of surgery in individuals < 45 and ≥ 45 years old. Evaluation of weight loss parameters along with selected laboratory data was performed to demonstrate the results of LSG in 2 years follow-up. RESULTS: Overall, 238 males and 317 females (43%/57%) with median age of 43 years and median preoperative BMI of 46.41 (42.06-51.02) kg/m2 were analyzed. Patients in both groups presented significant weight loss at 24 months after the surgery with comparable percentage of total weight loss (40.95% in < 45 years old group and 40.44% in ≥ 45 years old group). The percentage of excess weight loss (78.52% vs. 74.53%) and percentage of excess BMI loss (91.95% vs. 88.01%) were higher in patients < 45 years old. However, the differences were not statistically significant (p = 0.662, p = 0.788 respectively). Patients under 45 years old experienced faster decrease in fasting glucose level that was observed after only 3 months (109 mg/dl to 95 mg/dl in < 45 years old group vs. 103.5 mg/dl to 99.5 mg/dl in ≥ 45 years old group, p < 0.001). Both groups presented improvement of lipid parameters during the observation. However, patients < 45 years old achieved lower values of LDL at 3 and 12 months follow-up (115 mg/dl vs. 126 mg/dl, p = 0.010; 114.8 mg/dl vs. 122 mg/dl, p = 0.002). Younger group of patients also showed superior improvement of triglycerides level. CONCLUSIONS: LSG results in significant weight loss in all patients regardless age. In turn, superior and faster improvement in lipid and carbohydrate profile is achieved in patients under 45 years old.

Endobariatrics and Metabolic Endoscopy: Can We Solve the Obesity Epidemic with Our Scope?

PURPOSE OF REVIEW: Obesity is a chronic relapsing disease that results in cardiovascular disease, diabetes mellitus, and non-alcoholic fatty liver disease. Currently, surgery represents the most effective treatment. However, the advent of minimally invasive endoscopic bariatric therapy (EBT) has shifted the treatment paradigm to less invasive, cost-effective procedures with minimal complications and recovery time that are preferred by patients. In this review, we will describe current and future EBTs, focusing on outcomes and safety. RECENT FINDINGS: The endoscope has provided an incisionless portal into the gastrointestinal tract for placement of space-occupying devices and intraluminal procedures. EBTs are no longer solely manipulating anatomic alterations; instead, they aim to improve metabolic parameters such as glycated hemoglobin, low-density lipoprotein, cholesterol, and hepatic indices by targeting the mucosal layer of the gastrointestinal tract. The endoscope has succeeded in facilitating clinically meaningful weight loss and improvement of metabolic parameters. Future, solutions to the obesity epidemic will likely entail genetic testing, evaluation of the microbiome, and delivery of personalized therapy, utilizing combination endoscopic modalities that change the anatomy and physiology of individual patients, with new targets such as the abnormal metabolic signal.

ASSESSMENT OF WEIGHT LOSS AFTER NON-ADJUSTABLE AND ADJUSTABLE INTRAGASTRIC BALLOON USE.

BACKGROUND: Intragastric balloon (IGB) use is indicated for patients whose BMI precludes the option of bariatric surgery or who need to lose weight prior to undergoing surgery. It is a minimally invasive procedure and currently there are two main models of IGBs in use, the non-adjustable intragastric balloon (NIB), implanted for six months, and the adjustable intragastric balloon (AIB), implanted for up to 12 months. OBJECTIVE: Analyze clinical characteristics between patients receiving non-adjustable gastric balloon and the adjustable (prolonged implantation) intragastric balloon. METHODS: This was a cross-sectional study of 470 patients diagnosed as obese or overweight who had balloon implantation from October 2011 to July 2018. The associations between percentage excess weight loss versus clinical and demographic variables were calculated using the chi-squared test. Independent samples were submitted to the Student's t test to determine the quantitative variables, with a confidence interval of 95%. Calculation of excess weight was based on an estimated ideal weight that would correspond to a BMI of 24.99 kg/m2. RESULTS: A total of 414 patients completed the treatment achieving an average total body weight loss (%TBWL) of 15.4±7 with the NIB and 15.5±9.6 with the AIB. Overweight patients achieved higher excess weight loss (%EWL) values using AIBs (157.2±82.5) and obese patients did so with NIB use (56±29.7). Women achieved higher %EWL values (65.6±62.2) than men (48±27.1). Individuals who attended >4 consultations with a nutritionist (60.8%) achieved TBWL >18%. All of those P-values were <0.001. CONCLUSION: Obese individuals and women registered the greatest weight losses. Overweight patients achieved greater losses using AIB and obese patients did so using NIBs. NIB use was associated with higher EWL percentages. Nutritional accompaniment had a positive impact on the %TBWL.

Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures - 2019 Update: Cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, The Obesity Society, American Society for Metabolic and Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists.

OBJECTIVE: The development of these updated clinical practice guidelines (CPGs) was commissioned by the American Association of Clinical Endocrinologists (AACE), The Obesity Society (TOS), American Society for Metabolic and Bariatric Surgery (ASMBS), Obesity Medicine Association (OMA), and American Society of Anesthesiologists (ASA) Boards of Directors in adherence with the AACE 2017 protocol for standardized production of CPGs, algorithms, and checklists. METHODS: Each recommendation was evaluated and updated based on new evidence from 2013 to the present and subjective factors provided by experts. RESULTS: New or updated topics in this CPG include: contextualization in an adiposity-based chronic disease complications-centric model, nuance-based and algorithm/checklist-assisted clinical decision-making about procedure selection, novel bariatric procedures, enhanced recovery after bariatric surgery protocols, and logistical concerns (including cost factors) in the current health care arena. There are 85 numbered recommendations that have updated supporting evidence, of which 61 are revised and 12 are new. Noting that there can be multiple recommendation statements within a single numbered recommendation, there are 31 (13%) Grade A, 42 (17%) Grade B, 72 (29%) Grade C, and 101 (41%) Grade D recommendations. There are 858 citations, of which 81 (9.4%) are evidence level (EL) 1 (highest), 562 (65.5%) are EL 2, 72 (8.4%) are EL 3, and 143 (16.7%) are EL 4 (lowest). CONCLUSIONS: Bariatric procedures remain a safe and effective intervention for higher-risk patients with obesity. Clinical decision-making should be evidence based within the context of a chronic disease. A team approach to perioperative care is mandatory, with special attention to nutritional and metabolic issues.

Use of autologous dermal flap as mesh coverage in the treatment of large abdominal-wall defect in patients following massive weight loss: presentation of a novel surgical technique.

PURPOSE: Reconstruction of large abdominal-wall defects (AWD) in patients after massive weight loss (MWL) can be challenging. Patients are left with a sizeable amount of excess skin and subcutaneous tissue which can serve as a natural and readily available source of mesh coverage. In this article, we present our experience in the reconstruction of large AWD in patients after MWL, using autogenous dermal flaps combined with a synthetic mesh. METHOD: All patients with large AWD and MWL, diagnosed between January 2012 and December 2016, were considered to be candidates for the procedure. During the operation, an attempt was made to attain full closure of the defect above the mesh. In those patients for whom such closure was not possible, a dermal flap technique was used. Patients were closely monitored for at least 1 year. Outcome measures included early and late postoperative complications. Data are presented as mean ± standard deviation (SD). RESULTS: Over the study period, a total of 14 patients underwent a surgery involving combined mesh and dermal flap technique. Early post-operative complications included three patients who suffered from minor wound disruption and were treated with local dressings. One patient had an abdominal-wall hematoma that required an evacuation. Two patients suffered from an epidermal cyst and chronic sinuses that required surgical debridement. None of the patients experienced intra-abdominal complication, respiratory failure, or required ICU treatment. No mesh contamination or hernia recurrence was observed during the follow-up period of 22.25 ± 6.4 months. CONCLUSION: Autologous dermal flap combined with mesh technique may serve as an effective surgical alternative in patients after MWL with large AWD for whom full muscular coverage of the underlying prosthesis is not possible.

Avaliação de perda de peso após o uso de balão intragástrico não ajustável e ajustável / Assessment of weight loss after non-adjustable and adjustable intragastric balloon use

ABSTRACT BACKGROUND: Intragastric balloon (IGB) use is indicated for patients whose BMI precludes the option of bariatric surgery or who need to lose weight prior to undergoing surgery. It is a minimally invasive procedure and currently there are two main models of IGBs in use, the non-adjustable intragastric balloon (NIB), implanted for six months, and the adjustable intragastric balloon (AIB), implanted for up to 12 months. OBJECTIVE: Analyze clinical characteristics between patients receiving non-adjustable gastric balloon and the adjustable (prolonged implantation) intragastric balloon. METHODS: This was a cross-sectional study of 470 patients diagnosed as obese or overweight who had balloon implantation from October 2011 to July 2018. The associations between percentage excess weight loss versus clinical and demographic variables were calculated using the chi-squared test. Independent samples were submitted to the Student's t test to determine the quantitative variables, with a confidence interval of 95%. Calculation of excess weight was based on an estimated ideal weight that would correspond to a BMI of 24.99 kg/m2. RESULTS: A total of 414 patients completed the treatment achieving an average total body weight loss (%TBWL) of 15.4±7 with the NIB and 15.5±9.6 with the AIB. Overweight patients achieved higher excess weight loss (%EWL) values using AIBs (157.2±82.5) and obese patients did so with NIB use (56±29.7). Women achieved higher %EWL values (65.6±62.2) than men (48±27.1). Individuals who attended >4 consultations with a nutritionist (60.8%) achieved TBWL >18%. All of those P-values were <0.001. CONCLUSION: Obese individuals and women registered the greatest weight losses. Overweight patients achieved greater losses using AIB and obese patients did so using NIBs. NIB use was associated with higher EWL percentages. Nutritional accompaniment had a positive impact on the %TBWL.

RESUMO CONTEXTO: O uso do balão intragástrico (BIG) é indicado para pacientes cujo IMC contraindica a cirurgia bariátrica ou que necessitam perder peso antes da cirurgia. É um procedimento minimamente invasivo e atualmente existem dois modelos principais de BIG - o balão intragástrico não ajustável (BINA), implantado por seis meses, e o balão intragástrico ajustável (BIA), por até 12 meses. OBJETIVO: Analisar os fatores associados aos resultados clínicos comparando o uso de balão intragástrico não ajustável com o uso de balão intragástrico ajustável. MÉTODOS: Estudo transversal em 470 pacientes, com sobrepeso ou obesidade, submetidos ao tratamento entre outubro 2011 e julho de 2018. A associação entre as porcentagens da perda de excesso de peso (%PEP) e da perda do peso total (%PPT) com as variáveis demográficas e clínicas foram calculados com o teste qui-quadrado (P<0,05). Foi utilizado o teste t de Student para amostras independentes para comparar variáveis quantitativas, com IC 95%. O cálculo do excesso de peso foi estimado em peso ideal correspondente a um IMC de 24.99 kg/m2. RESULTADOS: Um total de 414 pacientes realizaram o tratamento até o final, com %PPT média de 15,4±7 no BINA e 15,5±9,6 no BIA. Os com sobrepeso apresentaram maiores %PEP no BIA (157,2±82,5) e os obesos maiores %PEP no BINA (56±29,7), com P<0,001. Mulheres (65,6±62,2) apresentaram maiores %PEP do que homens (48±27,1), com P<0,001. Os indivíduos que atenderam a >4 consultas com nutricionista obtiveram %PPT >18% (60,8%), com P<0,001. CONCLUSÃO: Obesos e mulheres tiveram maiores perdas ponderais. Maior perda de peso foi identificada em pacientes com sobrepeso que utilizaram BIA e em obesos os quais utilizaram BINA. O BINA esteve associado com maiores taxas de %PEP. O acompanhamento nutricional impactou positivamente na %PPT.

Bariatric interventions in obesity treatment and prevention in pediatric acute lymphoblastic leukemia: a systematic review and meta-analysis.

Most children are surviving acute lymphoblastic leukemia (ALL) today. Yet, the emergence of cardiometabolic comorbidities in this population may impact long-term outcomes including the quality of life and lifespan. Obesity is a major driver of cardiometabolic disorders in the general population, and in ALL patients it is associated with increased risk of hypertension, dysglycemia, and febrile neutropenia when compared with lean ALL patients undergoing therapy. This systematic review aims to assess the current evidence for bariatric interventions to manage obesity in children with ALL. The primary outcome for this systematic review was the change in BMI z-score with implementation of the interventions studied. Literature searches were conducted in several databases. Ten publications addressing the study question were included in this review, and five studies were used in the meta-analysis to assess the impact of the bariatric interventions on obesity. The BMI z-score did not change significantly with the interventions. However, the quality of evidence was low, which precluded the recommendation of their use. In conclusion, prospective, rigorous, adequately powered, and high-quality longitudinal studies are urgently needed to deliver effective lifestyle interventions to children with ALL to treat and prevent obesity. These interventions, if successful, may improves cardiometabolic health outcomes and enhance the quality of life and life expectancy in children with ALL.

Comparative analysis on the effect of low-thermal plasma dissection device (PEAK PlasmaBlade) versus conventional electro surgery in post-bariatric body-contouring procedures: A retrospective randomised clinical study.

Postoperative wound-healing problems are relatively high in post-bariatric body-contouring procedures, partly because of electrosurgery and the associated thermal tissue damage. This study is a retrospective randomised evaluation of the effect of a low-thermal plasma dissection device (PEAK PlasmaBlade, Medtronic, Minneapolis, Minnesota) in comparison with conventional electrosurgery. A total of 24 patients undergoing upper arm or medial thigh lifting were randomised to PEAK PlasmaBlade on one side and to monopolar electrosurgery on the other side of the same patient. Wounds of 10 patients were examined histologically for acute thermal injury depth. Significantly lower total volume of drain output (61,1 ± 70,2 mL versus 95,1 ± 176,0 mL; P = .04) was found on the PEAK PlasmaBlade side compared with the electrosurgery side. Furthermore, the PEAK PlasmaBlade side showed fewer seromas (no case of seroma versus three seromas in the electrosurgery group) and less thermal damage (40% versus 70%; P = .26). Acute thermal injury depth from the PEAK PlasmaBlade was less than from monopolar electrosurgery (425 ± 171 µm versus 686 ± 1037 µm; P = .631). PEAK PlasmaBlade appears to be superior to traditional monopolar electrosurgery for post-bariatric body-contouring procedures because it demonstrated less tissue damage, lower total volume of drain output, and fewer postoperative seromas resulting in faster wound healing.

Anthropometrical phenotypes are important when explaining obstructive sleep apnea in female bariatric cohorts.

Central obesity is the main risk factor for obstructive sleep apnea (OSA). Whether there exists a central-obesity anthropometric that better explains apnea-hypopnea index (AHI) variability in the general population and in sleep cohorts is unknown, and this is even less explored among increasing grades of obesity. The objective of the study is to investigate whether there is an anthropometric that better explains AHI variability in a sample of morbidly obese women awaiting bariatric surgery (BS). A prospective multicentre cross-sectional study was conducted in consecutive women before BS. Demographic and anthropometric characteristics included age, body mass index (BMI), neck circumference (NC), waist circumference (WC), hip circumference (HC) and waist-to-hip ratio (WHR). OSA was diagnosed by polysomnography. The capacity of anthropometrics to explain AHI variance was investigated using regression linear models. A total of 115 women were evaluated: age, 44 ± 10 years; BMI, 46 ± 5 kg/m2 ; AHI, 35 ± 26 events/hr. AHI was associated with all anthropometrics except weight, height and HC. The best univariate predictor was WHR, which accounted for 15% of AHI variance. The simplest model (age + BMI) accounted for 9%, which increased to 20% when applying more complex measurements (age + BMI + NC + WC + HC). The explanatory capacity did not change significantly when applying a simpler model (age + WHR + NC, 19%). In this female morbidly obese cohort, anthropometrics explained one-fifth of AHI variability. WHR is the best univariate parameter and models including waist and neck data provide more information than BMI when explaining AHI variability. Thus, even in young women with extreme obesity, OSA seems to be linked to a specific central-obesity phenotype rather than to a whole-obesity pattern.

Metabolic improvement in obese patients after duodenal-jejunal exclusion is associated with intestinal microbiota composition changes.

BACKGROUND: Intestinal microbiota have been suggested to play an important role in the pathogenesis of obesity and type 2 diabetes. Bariatric surgery improves both conditions and has been associated with changes in intestinal microbiota composition. We investigated the effect of a nonsurgical bariatric technique on intestinal microbiota composition in relation to metabolic improvement. METHODS: Seventeen patients with obesity and type 2 diabetes were treated with the nonsurgical duodenal-jejunal bypass liner, which excludes the proximal 60 cm small intestine from food. Fecal samples as well as metabolic parameters reflecting obesity and type 2 diabetes were obtained from the patients at baseline, after 6 months with the device in situ, and 6 months after explantation. RESULTS: After 6 months of treatment, both obesity and type 2 diabetes had improved with a decrease in weight from 106.1 [99.4-123.5] to 97.4 [89.4-114.0] kg and a decrease in HbA1c from 8.5% [7.6-9.2] to 7.2% [6.3-8.1] (both p < 0.05). This was paralleled by an increased abundance of typical small intestinal bacteria such as Proteobacteria, Veillonella, and Lactobacillus spp. in feces. After removal of the duodenal-jejunal bypass liner, fecal microbiota composition was similar to that observed at baseline, despite persistent weight loss. CONCLUSION: Improvement of obesity and type 2 diabetes after exclusion of the proximal 60 cm small intestine by treatment with a nonsurgical duodenal-jejunal bypass liner may be promoted by changes in fecal microbiota composition.

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population.

BACKGROUND & AIMS: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. METHODS: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. RESULTS: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (ß = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05). CONCLUSIONS: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

A prospective pilot study of the efficacy and safety of Elipse intragastric balloon: A single-center, single-surgeon experience.

BACKGROUND: Elipse™ is the least invasive IGB for weight loss that needs no sedation or endoscopy. It is a swallowable capsule filled with 550 mL of fluid, which stays in the stomach for 16 weeks and is excreted from the gastrointestinal tract. Kuwait is one of the first countries to start using Elipse™ as a weight loss device. This study aims to evaluate the efficacy and safety of Elipse™ intragastric balloon (IGB). MATERIALS AND METHODS: This is a single-center prospective pilot study of 51 Elipse™ insertions at our clinic. The patients were followed for 4 months to monitor their weight and body mass index (BMI) at 1, 2, and 4 months. Total weight loss, % excess weight loss (%EWL), % total body weight loss (%TBWL), and change in BMI and waist circumference (WC) were recorded at the end of the study. A short survey was administered to evaluate symptoms, complications, and overall satisfaction. RESULTS: Fifty-one patients participated, of which five had Elipse™ removed because of intolerance. One case vomited the balloon; one had early deflation. The total weight loss was 8.84 kg, %TBWL 10.44%, %EWL 40.84%, change in BMI 3.42 kg/m2, and the total WC reduction 8.62 cm. Symptoms after insertion were severe, whereas those during excretion were mild and self-limiting. No serious complications were recorded, and the overall satisfaction was above average. CONCLUSION: Our data proves that Elipse™ is a safe and effective device for weight loss. Nevertheless, some limitations were observed that need to be overcome for better outcomes. Larger studies are needed to support our findings.

Precision Bariatrics: Toward a New Paradigm of Personalized Devices in Obesity Therapeutics.

The prevalence and complexity of obesity and its associated metabolic complications highlight the importance of building a rigorous investigative framework for the development of novel weight loss therapies. Device-based interventions in particular constitute a market poised for rapid expansion in the coming years. Optimizing outcomes for this new class of therapies requires attention to an evolving taxonomy of subdivisions within the broader obesity phenotype and a means for stratifying patients toward maximally effective interventions. Extant bariatric devices implicitly prioritize anatomic variables as surrogates for physiology, a somewhat arbitrary assumption that merits empiric validation. Utilizing the governing principles of systems biology and recent innovations in clinical trial design, a robust and precise research infrastructure can and should be developed to more effectively mitigate this contemporary epidemic.