Use of Metabolic and Bariatric Surgery Among US Youth.

This cohort study compares trends in use of metabolic and bariatric surgery among US youth and adults before and after publication of a 2019 American Academy of Pediatrics policy statement on access to such surgery.

Comparison of upper gastrointestinal series and symptom questionnaires with intraoperative diagnosis of hiatal hernia during sleeve gastrectomy.

BACKGROUND: Hiatal hernias are common in bariatric surgery patients, but the utility of preoperative hiatal hernia diagnosis prior to sleeve gastrectomy (SG) is debated. OBJECTIVE: This study compared preoperative and intraoperative hiatal hernia detection rates in patients undergoing laparoscopic SG. SETTING: University hospital, United States. METHODS: As part of a randomized trial evaluating the role of routine crural inspection during SG, an initial cohort was prospectively studied to assess the correlation between preoperative upper gastrointestinal (UGI) series, reflux and dysphagia symptoms, and intraoperative hiatal hernia diagnosis. Preoperatively, patients completed the Gastroesophageal Reflux Disease Questionnaire (GerdQ), the Brief Esophageal Dysphagia Questionnaire (BEDQ), and a UGI series. Intraoperatively, patients with an anteriorly visible defect underwent hiatal hernia repair followed by SG. All others were randomized to standalone SG or posterior crural inspection with repair of any hiatal hernia identified prior to SG. RESULTS: Between November 2019 and June 2020, 100 patients (72 female patients) were enrolled. Preoperative UGI series identified hiatal hernia in 28% (26 of 93) of patients. Intraoperatively, hiatal hernia was diagnosed during initial inspection in 35 patients. Diagnosis was associated with older age, lower body mass index, and Black race but did not correlate with GerdQ or BEDQ. Using the standard conservative approach, compared with intraoperative diagnosis, sensitivity and specificity of the UGI series were 35.3% and 80.7%, respectively. Hiatal hernia was identified in an additional 34% (10 of 29) of patients randomized to posterior crural inspection. CONCLUSION: Hiatal hernias are highly prevalent in SG patients. However, GerdQ, BEDQ, and a UGI series unreliably identify hiatal hernia in the preoperative setting and should not influence intraoperative evaluation of the hiatus during SG.

Discontinuation and reduction of asthma medications after metabolic and bariatric surgery: A systematic review and meta-analysis.

Obesity is a risk factor for asthma. Metabolic and bariatric surgery (MBS) is a safe and effective treatment option for obesity. Weight reduction via MBS, in turn, may improve asthma outcomes and decrease the need for asthma medications. The aim of the systematic review and meta-analysis is to explore the available evidence focused on the impact of MBS on the improvement of asthma outcomes via the discontinuation and reduction of asthma medications. After a comprehensive search in the PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases, 15 studies, including pre-post MBS data on asthma medication use among adults, were eligible for the systematic review. Thirteen studies reported the proportion of patient who discontinued asthma medication post-MBS and was meta-analyzed using random effects. Results showed 54% patients completely discontinued asthma medications (95% confidence interval 42%-67%, I2  = 86.2%, p < 0.001). The average number of asthma medications was also decreased by approximately 22%-46%. MBS provides strong therapeutic benefits for patients with asthma, as evidenced by the complete discontinuation of asthma medications in over 50% of MBS completers. The inference was limited by the small number, variations in follow-up time and rates, and heterogeneity of studies. Studies that include more ethnically diverse participant samples are needed to improve generalizability.

Long-Term Outcomes after Adolescent Bariatric Surgery.

BACKGROUND: Metabolic and bariatric surgery (MBS) is a safe and effective treatment option for adolescents with severe obesity, but no long-term studies are available with more than10 years of follow-up data to document sustained improved outcomes. METHODS: A total of 96 patients who completed MBS at 21 years of age or younger in a tertiary academic center 2002 to 2010 were contacted for a telehealth visit. Body weight, comorbidity status, social/physical function status, and long-term complications were evaluated 10 to 18 years after surgery. RESULTS: Mean participant (83% female, 75% Hispanic) age at MBS was 18.8 (±1.6) years (median age 19 years, range 15-21 years), and median pre-MBS BMI was 44.7 kg/m 2 (SD 6.5). At follow-up (mean 14.2 [±2.2] years) post-MBS (90.6% Roux-en-Y gastric bypass [RYGB] or 8.3% laparoscopic adjustable gastric banding [LAGB]) mean total body weight decreased by 31.3% (interquartile range [IQR] 20.0% to 38.9%); 32.0% (IQR, 21.3% to 40.1%) among RYGB participants and 22.5% (IQR, 0.64% to 28.3%) among LAGB participants. Patients with pre-MBS hyperlipidemia (14.6%), asthma (10.4%), and diabetes/hyperglycemia (5.2%) reported 100% remission at follow-up (p < 0.05 for all). Pre-post decrease in hypertension (13.5% vs 1%, p = 0.001), sleep apnea (16.7% vs 1.0%, p < 0.001), gastroesophageal reflux disease (13.5% vs 3.1%, p = 0.016), anxiety (7.3% vs 2.1%, p = 0.169), and depression (27.1% vs 4.2%, p < 0.001) were also found. CONCLUSIONS: Significant sustained reductions in weight and comorbidities, and low rates of long-term complications, a decade or more after completing MBS as an adolescent were found. These findings have important implications for adolescents who may be considering MBS for weight reduction and overall health improvements that extend into adulthood.

Impact of the COVID-19 Pandemic on Metabolic and Bariatric Surgery Utilization and Safety in the United States.

BACKGROUND: Metabolic and bariatric surgery (MBS) is a safe and effective treatment option for severe obesity. The utilization and health and safety outcomes of MBS in the United States (US) during the COVID-19 pandemic versus 2015-2019 among adolescent and adult populations and by ethnic group is largely unknown. METHODS: The 2015-2020 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) longitudinal (30-day) cohort data was used to compare adolescent and adult (N = 1,134,522) post-operative outcomes and to calculate MBS utilization pre-pandemic (2015-2019) versus pandemic (2020). Cochran-Armitage trend tests compared MBS utilization and safety outcomes over time from 2015 to 2020. Logistic regression analysis compared the odds of hospital readmission and MBS completion pre-pandemic versus pandemic by key characteristics. RESULTS: MBS utilization increased by 8.1% among youth (from 970 to 1140 procedures) and decreased by 10.2% among adults (from 205,232 to 167,384) from 2019 to 2020, respectively. MBS increased by 18.5% during the pandemic for youth who identified as other/multiracial (P trend < 0.001). Among US youth, the number of reoperations and reinterventions significantly decreased over the 6-year time frame (P trend < .001). Among US adults, 30-day post MBS mortality, reoperations, readmissions, and reinterventions all showed a significant decrease over time (P trend < .001) while septic shock and sepsis increased from pre-pandemic to the first year of the pandemic (P trend < 0.001). CONCLUSION: In comparison to 2019 (or to previous years), US MBS utilization increased for youth but decreased for adults during the first year of the COVID-19 pandemic. Safety outcomes were comparable to those of the pre-pandemic years.

Five Year Trends in the Utilization of Robotic Bariatric Surgery Procedures, United States 2015-2019.

PURPOSE: Robotic approaches have been steadily replacing laparoscopic approaches in metabolic and bariatric surgeries (MBS); however, their superiority has not been rigorously evaluated. The main goal of the study was to evaluate the 5-year utilization trends of robotic MBS and to compare to laparoscopic outcomes. METHODS: Retrospective analysis of 2015-2019 MBSAQIP data. Kruskal-Wallis test/Wilcoxon and Fisher's exact/chi-square were used to compare continuous and categorical variables, respectively. Generalized linear models were used to compare surgery outcomes. RESULTS: The use of robotic MBS increased from 6.2% in 2015 to 13.5% in 2019 (N= 775,258). Robotic MBS patients had significantly higher age, BMI, and likelihood of 12 diseases compared to laparoscopic patients. After adjustment, robotic MBS patients showed higher 30-day interventions and 30-day readmissions alongside longer surgery time (26-38 min). CONCLUSION: Robotic MBS shows higher intervention and readmission even after controlling for cofounding variables.

Does a Laparoscopic Approach to Distal Pancreatectomy for Cancer Contribute to Optimal Adjuvant Chemotherapy Utilization?

BACKGROUND: Although laparoscopic distal pancreatectomy (LDP) versus open approaches (ODP) for pancreatic adenocarcinoma (PDAC) is associated with reduced morbidity, its impact on optimal adjuvant chemotherapy (AC) utilization remains unclear. Furthermore, it is uncertain whether oncologic resection quality markers are equivalent between approaches. METHODS: The National Cancer Database (NCDB) was queried between 2010 and 2016 for PDAC patients undergoing DP. Effect of LDP vs ODP and institutional case volumes on margin status, hospital stay, 30-day and 90-day mortality, administration of and delay to AC, and 30-day unplanned readmission were analyzed using binary and linear logistic regression. Cox multivariable regression was used to correct for confounders. RESULTS: The search yielded 3411 patients; 996 (29.2%) had LDP and 2415 (70.8%) had ODP. ODP had higher odds of readmission [odds ratio (OR) 1.681, p = 0.01] and longer hospital stay [ß 1.745, p = 0.004]. No difference was found for 30-day mortality [OR 1.689, p = 0.303], 90-day mortality [OR 1.936, p = 0.207], and overall survival [HR 1.231, p = 0.057]. The highest-volume centers had improved odds of AC [OR 1.275, p = 0.027] regardless of approach. LDP conferred lower margin positivity [OR 0.581, p = 0.005], increased AC use [3rd quartile: OR 1.844, p = 0.026; 4th quartile; OR 2.144, p = 0.045], and fewer AC delays [4th quartile: OR 0.786, p = 0.045] in higher-volume centers. CONCLUSIONS: In selected patients, LDP offers an oncologically safe alternative to ODP for PDAC independent of institutional volume. However, additional oncologic benefit due to optimal AC utilization and lower positive margin rates in higher volume centers suggests that LDP by experienced teams can achieve best possible cancer outcomes.

Intersection of smoking, e-cigarette use, obesity, and metabolic and bariatric surgery: a systematic review of the current state of evidence.

BACKGROUND: Millions of Americans qualify for metabolic and bariatric surgery (MBS) based on the proportion of the population with severe obesity. Simultaneously, the use of electronic nicotine/non-nicotine delivery systems (ENDS) has become epidemic. OBJECTIVE: We conducted a timely systematic review to examine the impact of tobacco and ENDS use on post-operative health outcomes among MBS patients. METHODS: PRISMA guidelines were used as the search framework. Keyword combinations of either "smoking," "tobacco," "e-cigarette," "vaping," or "ENDS" and "bariatric surgery," "RYGB," or "sleeve gastrectomy" were used as search terms in PUBMED, Science Direct, and EMBASE. Studies published in English between January 1990 and June 2020 were screened. RESULTS: From the 3251 articles found, a total of 48 articles were included in the review. No articles described a relationship between ENDS and post-operative health outcomes in MBS patients. Seven studies reported smokers had greater post-MBS weight loss, six studies suggested no relationship between smoking and post-MBS weight loss, and one study reported smoking cessation pre-MBS was related to post-MBS weight gain. Perioperative use of tobacco is positively associated with several post-surgery complications and mortality in MBS patients. CONCLUSIONS: Combustible tobacco use among MBS patients is significantly related to higher mortality risk and complication rates, but not weight loss. No data currently is available on the impact of ENDS use in these patients. With ENDS use at epidemic levels, it is imperative to determine any potential health effects among patients with severe obesity, and who complete MBS.

Type 2 Diabetes and HbA1c Predict All-Cause Post-Metabolic and Bariatric Surgery Hospital Readmission.

OBJECTIVE: The main goal of this analysis was to determine whether type 2 diabetes and hemoglobin A1c (HbA1c) predict all-cause 30-day hospital readmission after metabolic and bariatric surgery (MBS). It was hypothesized that a diagnosis of type 2 diabetes or high HbA1c values would predict all-cause hospital readmission rates post MBS. METHODS: A retrospective analysis from the 2015-2018 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) cohort was completed (N = 744,776); 30,972 participants were readmitted during the 30 days post MBS. RESULTS: Mean age of the MBSAQIP sample was 45.1 (11.5) years, and the majority were female (80.7%) and non-Hispanic White (59.4%). The all-cause hospital readmission rate was 4.2% and increased by 10% in those with uncontrolled type 2 diabetes (HbA1c > 7.5% [> 58 mmol/mol]); after adjustment, diabetes was not associated with increased readmission. Uncontrolled type 2 diabetes, type 2 diabetes, and prediabetes resulted in less weight loss 30 days post MBS. CONCLUSIONS: These results based on a national MBS cohort showed that uncontrolled type 2 diabetes is associated with a greater likelihood of all-cause hospital readmission and reduced weight loss 30 days post MBS. Both type 2 diabetes and prediabetes were also associated with decreased weight loss 30 days post MBS. These findings highlight the need to classify and optimize glycemic control prior to MBS.

A Preliminary Study on the Influence of Cannabis and Opioid Use on Weight Loss and Mental Health Biomarkers Post-weight Loss Surgery.

PURPOSE: A subpopulation of weight loss surgery (WLS) patients endorse cannabis and/or opioid use; however, impact on post-WLS anxiety and depression is unclear. This study examined the influence of the independent and combined use of cannabis and opioids on (1) depression and anxiety, (2) duodenum serotonin and cortisol, and (3) total percent weight loss. MATERIALS AND METHODS: A cross-sectional analysis was conducted among patients (N = 18) who had biomarkers of serotonin and cortisol collected from the duodenum during WLS. Cannabis and opioid use was determined by self-reported lifetime, past-year, and past 30-day use. The Beck Anxiety Inventory and Depression Inventory-II assessed depression and anxiety symptoms. Total percent weight loss was calculated from pre-WLS and post-WLS weight (kg). Chi-squared analyses and t tests were conducted. RESULTS: Over a quarter (27.8%) were cannabis-only users and 16.7% used a combination of cannabis and opioids. None reported using only opioids in this sample. Combination users presented with greater depressive symptoms (22.7%, p = 0.01) and greater total percent weight loss (34.1%, p = 0.04) than cannabis users (7.8, 23.2%, respectively). Cannabis users had greater serotonin (p = 0.02) and cortisol (p = 0.01) levels than combination users and never users. CONCLUSIONS: Cannabis users had greater cortisol levels than never users and combination users. Combination users had greater weight loss and depression symptoms than cannabis users. Future studies should consider a larger sample size, utilization of a cohort design to address causality, and examination of the type, dose, and route of cannabis and opioid administration to further understand the impact of the combined use of cannabis and opioids post-WLS.

Resistance Training in Post-Metabolic and Bariatric Surgery Patients: a Systematic Review.

Resistance exercise guidelines exist for obesity but not for post-metabolic and bariatric surgery (MBS) patients. Therefore, the main goal of the present study is to provide evidence to support resistance exercise guidelines for this population. A secondary goal is to evaluate the available evidence to identify gaps for future research. Nine studies evaluating the effect of resistance exercise post-MBS on strength and body composition were included. Resistance training consistently prevented strength loss and when performed by younger population (~ 35 years) also prevented lean mass loss. Combined exercise, but not strength training independently, was found to promote body fat mass loss. Resistance training should be added to post-MBS exercise programs. Sufficiently powered studies using higher volume resistance training with supportive protein consumption and diverse populations are needed.

Comparison of methodological approaches to human gut microbiota changes in response to metabolic and bariatric surgery: A systematic review.

Substantial differences in the response of gut microbial composition to metabolic and bariatric surgery have been reported. Therefore, the goal of the present review is to evaluate if methodological differences could be driving this lack of consistency. A search was conducted using PUBMED, Web of Science, Science Direct and COCHRANE using the following inclusion criteria: human studies written in English with a baseline sampling point, using gut microbiota as an outcome and either Roux-n-Y gastric bypass or sleeve gastrectomy. Sixteen articles were selected (total 221 participants). Roux-n-Y gastric bypass caused more alterations in gut microbial composition in comparison with sleeve gastrectomy. Substantial variability was found in study designs, data collection and analyses across studies. Increases in several families and genera from the phylum Proteobacteria and Bacteroidetes, the family Streptococcaceae, the species Akkermansia muciniphila and Streptococcus salivarius and a decrease in the phylum Firmicutes and the family Bifidobacteriaceae were reported. There is a need for standardization not only of microbial analysis but also of study designs when analysing the effect of bariatric surgery on the human gut microbiome. In addition, outcomes from different surgical procedures should not be combined as they produce distinctive effects on gut microbial composition.

Application and effectiveness of eHealth strategies for metabolic and bariatric surgery patients: A systematic review.

OBJECTIVE: To date the application of eHealth strategies among adults and adolescents undergoing metabolic and bariatric surgery (MBS) has not been systematically reviewed. This study comprehensively examines eHealth intervention studies among MBS patients within the RE-AIM framework to assess reach, effectiveness, adoption, implementation and maintenance of these efforts. METHODS: A search was conducted using PubMed, EMBASE, CINAHL, PsycNET and SCOPUS of original research relating to eHealth strategies for MBS patients published in peer-reviewed journals and revealed 38 published articles between 2011 and 2019. RESULTS: Studies varied widely in terms of design (qualitative to randomized controlled trials) and eHealth delivery method (telemedicine to blog post content) with a balance of pre- or post-MBS use. No studies included adolescents and very few reported (1) a conceptual framework to support study design/outcomes; and (2) race/ethnicity composition. CONCLUSIONS: Although some studies report that eHealth strategies/interventions are effective in producing post-MBS weight loss and other positive health outcomes, most are pilot studies or have study design limitations. There is an opportunity for development of (1) tailored eHealth interventions to support pre- and post-MBS sustained behavior change and improved outcomes; and (2) rigorous studies that employ robust conceptual frameworks so dissemination and implementation efforts can be mapped to construct-driven outcomes.

Short- and long-term safety and efficacy of bariatric surgery for severely obese adolescents: a narrative review.

The selection criteria, safety, and efficacy of bariatric surgery are well established in adults but are less well defined for severely obese adolescents. The number of severely obese adolescents who could benefit from weight loss surgery is increasing, although referral rates have plateaued. Surgical options for these adolescents are controversial and raise several questions. Recent studies, including the prospective Teen-Longitudinal Assessment of Bariatric Surgery Study and the Adolescent Morbid Obesity Surgery Study, help answer these questions. Early bariatric surgical intervention improves body mass index but, more importantly, improves cardiovascular and metabolic co-morbidities of severe obesity. A review of the medical, psychosocial, and economic risks and benefits of bariatric surgery in severely obese adolescents is a step toward improving the management of a challenging and increasing population. We describe the current knowledge of eligibility criteria, preoperative evaluation, surgical options, outcomes, and referral barriers of adolescents for bariatric surgery.

Roux-en-Y gastric bypass is an effective bridge to kidney transplantation: Results from a single center.

Body mass index (BMI) > 35-40 kg/m2 is often a contraindication, while Roux-en-Y gastric bypass (RYGB) is performed to enable kidney transplantation. This single-center retrospective study evaluated pre- and post-transplant outcomes of 31 morbidly obese patients with end-stage renal disease having RYGB before kidney transplantation between July 2009 and June 2014. Fourteen RYGB patients were subsequently transplanted. Nineteen recipients not having GB with a BMI ≥ 36 kg/m2 at transplantation were used as historical controls. Mean BMI (±SE) before RYGB was 43.5 ± 0.7 kg/m2 (range: 35.4-50.5 kg/m2 ); 87.1% (27/31) achieved a BMI < 35 kg/m2 . The percentage having improved diabetes/hypertension control was 29.0% (9/31); 25.8% (8/31) had complications (mostly minor) after RYGB. Among transplanted patients, blacks/Hispanics comprised 78.6% (11/14) and 84.2% (16/19) of RYGB and controls; 57.1% (8/14) and 63.2% (12/19) had a (mostly long-standing) pretransplant history of diabetes. While biopsy-proven acute rejection (BPAR) occurred significantly higher among RYGB vs control patients (6/14 vs 3/19, P = .03), patients developing T-cell BPAR were also significantly more likely to have a tacrolimus (TAC) trough level < 4.0 ng/mL within 3 weeks of T-cell BPAR (P = .0007). In Cox's model, the impact of having a TAC level < 4.0 ng/mg remained significant (P = .007) while the effect of RYGB was no longer significant (P = .13). Infections, graft, and patient survival were not significantly different. Despite obvious effectiveness in achieving weight loss, RYGB will need more careful post-transplant monitoring given the observed higher BPAR rate.

A Qualitative Examination of Increased Alcohol Use after Bariatric Surgery among Racially/Ethnically Diverse Young Adults.

INTRODUCTION: Mounting evidence suggests that bariatric surgery, or weight loss surgery (WLS), patients might be vulnerable to developing post-operative alcohol use problems. While the majority of published research offers information concerning the prevalence of problematic alcohol use post-WLS, the literature lacks comprehensive, qualitative explorations examining why alcohol misuse might emerge after WLS. Such data-driven hypotheses are needed to effectively target this emerging concern. Additionally, young adults and racial/ethnic minorities are both increasingly undergoing WLS and are at heightened risk for problems related to alcohol use. To date, these groups have been under-represented in study samples. METHODS: To address these important gaps in the literature, racially/ethnically diverse, young adult WLS patients who indicated a post-WLS increase in alcohol use (n = 12) participated in an individual, semi-structured qualitative interview. Data were analyzed through two coding cycles; an external audit of the emerging themes was also conducted to further ensure the trustworthiness of the data. RESULTS: Interviews revealed four major themes prompting an increase in alcohol use after WLS: (1) increased sensitivity to alcohol intoxication, (2) utilizing alcohol as a replacement self-soothing mechanism for food, (3) increase in socialization, and (4) utilizing alcohol as a coping mechanism. CONCLUSIONS: By understanding the drivers of increases in alcohol use after WLS, precision-targeted pre- and post-surgical counseling interventions can be developed to address this emerging concern.

Assessing risk factors, presentation, and management of portomesenteric vein thrombosis after sleeve gastrectomy: a multicenter case-control study.

BACKGROUND: Portomesenteric vein thrombosis (PMVT) is a rare complication of laparoscopic sleeve gastrectomy. OBJECTIVES: To identify incidence, patient factors, diagnosis, and treatment of PMVT after laparoscopic sleeve gastrectomy in a large administrative data registry. SETTING: Academic Hospitals and Private Practices, United States. METHODS: A retrospective chart review of 5538 sleeve gastrectomy patients between January 1, 2008 and September 30, 2016 was performed at 5 bariatric centers in the United States. A total of 11 patients were identified as developing PMVT, and 3 controls for each patient were selected by matching age, sex, preoperative body mass index, and center. RESULTS: After adjusting for confounding variables, 2 patient factors significantly impacted the risk of PMVT after sleeve gastrectomy including personal history of malignancy (odds ratio 62, 95% confidence interval (CI) 1.4-99.9), and type 2 diabetes (odds ratio 12.7, 95% CI 1.2-137.3) compared with controls. Mean period from laparoscopic sleeve gastrectomy to presentation of PMVT was 19.3 ± 15.11 days (range, 8-62). All patients except 1 complained of abdominal pain as the main presenting symptom. Other complaints included nausea and vomiting, no bowel movement, decreased appetite, diarrhea, and dehydration, and leukocytosis was present in 45.5% of the patients. All diagnoses were made by using computed tomography. All initial treatments were anticoagulation, heparin drip being the most common method (90.9%). Of patients, 9 (81.8%) required a secondary anticoagulation therapy, and 1 (9.1%) patient required a reoperation. CONCLUSION: Incidence of PMVT is low after sleeve gastrectomy. A personal history of malignancy and type 2 diabetes increase the risk of PMVT. Increasing abdominal pain in a context of dehydration is common presenting symptoms with diagnosis confirmed by computed tomography. Anticoagulation is the standard treatment. There was no mortality associated with the occurrence of PMVT in this cohort.

Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial.

OBJECTIVE: Evaluate safety and efficacy of the pose™ procedure for obesity treatment. METHODS: Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events. RESULTS: Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068. CONCLUSIONS: The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.