Changes in Smoking Behavior Before and After Gastric Bypass: A 7-year Study.

OBJECTIVE: To evaluate smoking history and change in smoking behavior, from 1 year before through 7 years after Roux-en-Y gastric bypass (RYGB) surgery, and to identify risk factors for post-surgery smoking. BACKGROUND: Smoking behavior in the context of bariatric surgery is poorly described. METHODS: Adults undergoing RYGB surgery entered a prospective cohort study between 2006 and 2009 and were followed up to 7 years until ≤2015. Participants (N = 1770; 80% female, median age 45 years, median body mass index 47 kg/m2) self-reported smoking history pre-surgery, and current smoking behavior annually. RESULTS: Almost half of participants (45.2%) reported a pre-surgery history of smoking. Modeled prevalence of current smoking decreased in the year before surgery from 13.7% [95% confidence interval (CI) = 12.1-15.4] to 2.2% (95% CI = 1.5-2.9) at surgery, then increased to 9.6% (95% CI = 8.1-11.2) 1-year post-surgery and continued to increase to 14.0% (95% CI = 11.8-16.0) 7-years post-surgery. Among smokers, mean packs/day was 0.60 (95% CI = 0.44-0.77) at surgery, 0.70 (95% CI = 0.62-0.78) 1-year post-surgery and 0.77 (95% CI = 0.68-0.88) 7-years post-surgery. At 7-years, smoking was reported by 61.7% (95% CI = 51.9-70.8) of participants who smoked 1-year pre-surgery (n = 221), 12.3% (95% CI = 8.5-15.7) of participants who formerly smoked but quit >1 year pre-surgery (n = 507), and 3.8% (95% CI = 2.1-4.9) of participants who reported no smoking history (n = 887). Along with smoking history (ie, less time since smoked), younger age, household income <$25,000, being married or living as married, and illicit drug use were independently associated with increased risk of post-surgery smoking. CONCLUSION: Although most adults who smoked 1-year before RYGB quit pre-surgery, smoking prevalence rebounded across 7-years, primarily due to relapse.

Short-term intestinal lipase inhibition in normal-weight individuals does not affect postprandial peptide YY3-36 and glucagon-like peptide-1 levels, hunger or satiety.

Fat malabsorption associated with Roux-en-Y gastric bypass (RYGB) may contribute to elevated postprandial glucagon-like peptide-1 (GLP-1) and peptide YY (PYY) after the procedure, leading to sustained weight loss and appetite reduction. This study investigated whether fat malabsorption via orlistat increases GLP-1 and PYY and if these increases would be proportional to changes in hunger and satiety. Five healthy participants received standardized meals with 120 mg orlistat or placebo in a randomized, double-blinded, crossover design for 3 days. On the final day, glucose, insulin, GLP-1, PYY3-36 and visual analogue scores for hunger and satiety were measured over a 14-hour period that included three meals. Fasting, 14-hour area under the curve (AUC) and meal-related AUC for glucose and insulin were similar, although postprandial increases in peak insulin and glucose were greater with orlistat. PYY3-36 , GLP-1, hunger and satiety were not different. In conclusion, short-term orlistat administration does not enhance postprandial GLP-1 or PYY3-36 or affect hunger or satiety in normal-weight individuals. Furthermore, fat malabsorption from RYGB is unlikely to mediate subsequent postprandial increases in GLP-1 and PYY.

Serum biomarkers of inflammation and adiposity in the LABS cohort: associations with metabolic disease and surgical outcomes.

BACKGROUND: The utility of serum biomarkers related to inflammation and adiposity as predictors of metabolic disease prevalence and outcomes after bariatric surgery are not well-defined. METHODS: Associations between pre- and post-operative serum levels of four biomarkers (C-reactive protein (CRP), cystatin C (CC), leptin, and ghrelin) with baseline measures of adiposity and metabolic disease prevalence (asthma, diabetes, sleep apnea), and weight loss and metabolic disease remission after bariatric surgery were studied in the Longitudinal Assessment of Bariatric Surgery (LABS) cohort. RESULTS: Baseline CRP levels were positively associated with the odds of asthma but not diabetes or sleep apnea; baseline CC levels were positively associated with asthma, diabetes, and sleep apnea; baseline leptin levels were positively associated with asthma and negatively associated with diabetes and sleep apnea; baseline ghrelin levels were negatively associated with diabetes and sleep apnea. Increased weight loss was associated with increased baseline levels of leptin and CRP and decreased baseline levels of CC. Remission of diabetes and asthma was not associated with baseline levels of any biomarker. A higher likelihood of asthma remission was associated with a greater decrease in leptin levels, and a higher likelihood of diabetes remission was predicted by a lesser decrease in CC. Bariatric surgery was associated with decreased post-operative CC, CRP, and leptin levels, and increased post-operative ghrelin levels. CONCLUSION: This is the largest study to date of serum biomarkers of inflammation and adiposity in a bariatric surgery cohort. Biomarker levels correlate with metabolic disease prevalence prior to bariatric surgery, and with weight loss but not metabolic disease remission after surgery. Bariatric surgery regulates serum biomarker levels in a manner consistent with anti-inflammatory and compensatory orexigenic effects. These data contribute to our understanding of the mechanisms underlying the biologic effects of bariatric surgery.

Laparoscopic vagal nerve blocking device explantation: case series and report of operative technique.

BACKGROUND: Vagal nerve blockade with the vBloc device (ReShape Lifesciences, St. Paul, MN) has been shown to provide durable 2-year weight loss in patients with moderate obesity. These devices may require removal. We present a series of patients and report our technique for laparoscopic removal of this device. METHODS: From December 2009 to December 2016, the medical records of patients who underwent laparoscopic explantation of a vagal blocking device at our institution were retrospectively reviewed. All patients initially underwent device placement as part of a multi-center, randomized, controlled trial. The device leads were removed with the application of firm traction in order to safely dissect them away from the stomach and esophagus as the body tended to form a fibrotic capsule surrounding the leads. Operative details, length of stay, 30-day post-operative complications, demographics and reasons for device removal were reported. RESULTS: Thirty patients were identified. Median age was 54 (37-65) years. Average operative time was 227.63 (± 100.21) min. Median time from implantation to removal was 41 (11-96) months. Removal reasons included device malfunction (7 patients, 23.3%), pain at the neuroregulator site (5 patients, 16.7%), retrosternal or epigastric pain (11 patients, 36.7%), weight regain or dissatisfaction with weight loss (15 patients, 50%), and severe nausea (2 patients, 6.7%). Two patients (6.7%) had Clavien-Dindo grade II complications following explantation. Thirteen patients (43.3%) had dense adhesions noted at the time of operation. Seroma formation at the neuroregulator site was the most common complication (7 patients, 23.3%). CONCLUSION: The vagal nerve blocking device can be safely removed laparoscopically with a low 30-day complication rate. Surgeons should be familiar with the details of the device appearance, the typical lead location, and should anticipate dense adhesions surrounding the leads. In addition, experience operating in the region of the gastroesophageal junction is imperative.

Prospective evaluation of insulin and incretin dynamics in obese adults with and without diabetes for 2 years after Roux-en-Y gastric bypass.

AIMS/HYPOTHESIS: In this prospective case-control study we tested the hypothesis that, while long-term improvements in insulin sensitivity (SI) accompanying weight loss after Roux-en-Y gastric bypass (RYGB) would be similar in obese individuals with and without type 2 diabetes mellitus, stimulated-islet-cell insulin responses would differ, increasing (recovering) in those with diabetes but decreasing in those without. We investigated whether these changes would occur in conjunction with favourable alterations in meal-related gut hormone secretion and insulin processing. METHODS: Forty participants with type 2 diabetes and 22 participants without diabetes from the Longitudinal Assessment of Bariatric Surgery (LABS-2) study were enrolled in a separate, longitudinal cohort (LABS-3 Diabetes) to examine the mechanisms of postsurgical diabetes improvement. Study procedures included measures of SI, islet secretory response and gastrointestinal hormone secretion after both intravenous glucose (frequently-sampled IVGTT [FSIVGTT]) and a mixed meal (MM) prior to and up to 24 months after RYGB. RESULTS: Postoperatively, weight loss and SI-FSIVGTT improvement was similar in both groups, whereas the acute insulin response to glucose (AIRglu) decreased in the non-diabetic participants and increased in the participants with type 2 diabetes. The resulting disposition indices (DIFSIVGTT) increased by three- to ninefold in both groups. In contrast, during the MM, total insulin responsiveness did not significantly change in either group despite durable increases of up to eightfold in postprandial glucagon-like peptide 1 levels, and SI-MM and DIMM increased only in the diabetes group. Peak postprandial glucagon levels increased in both groups. CONCLUSIONS/INTERPRETATION: For up to 2 years following RYGB, obese participants without diabetes showed improvements in DI that approach population norms. Those with type 2 diabetes recovered islet-cell insulin secretion response yet continued to manifest abnormal insulin processing, with DI values that remained well below population norms. These data suggest that, rather than waiting for lifestyle or medical failure, RYGB is ideally considered before, or as soon as possible after, onset of type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT00433810.

Insurance status differences in weight loss and regain over 5 years following bariatric surgery.

BACKGROUND: The effectiveness of bariatric surgery among Medicaid beneficiaries, a population with a disproportionately high burden of obesity, remains unclear. We sought to determine if weight loss and regain following bariatric surgery differed in Medicaid patients compared to commercial insurance. SUBJECTS/METHODS: Data from the Longitudinal Assessment of Bariatric Surgery, a ten-site observational cohort of adults undergoing bariatric surgery (2006-2009) were examined for patients who underwent Roux-en-Y Gastric Bypass (RYGB), Laparoscopic Adjustable Band (LAGB), or Sleeve Gastrectomy (SG). Using piecewise spline linear mixed-effect models, weight change over 5 years was modeled as a function of insurance type (Medicaid, N = 190; commercially insured, N = 1448), time, procedure type, and sociodemographic characteristics; additionally, interactions between all time, insurance, and procedure type indicators allowed time- and procedure-specific associations with insurance type. For each time-spline, mean (kg) difference in weight change in commercially insured versus Medicaid patients was calculated. RESULTS: Medicaid patients had higher mean weight at baseline (138.3 kg vs. 131.2 kg). From 0 to 1 year post-operatively, Medicaid patients lost similar amounts of weight to commercial patients following all procedure types (mean weight Δ difference [95% CI]: RYGB: -0.9 [-3.2, 1.4]; LAGB: -1.5 [-6.7, 3.8]; SG: 5.1 [-4.0, 14.2]). From 1 to 3 years post-operatively Medicaid and commercial patients continued to experience minimal weight loss or began to slowly regain weight (mean weight Δ difference [95% CI]: RYGB: 0.9 [0.0, 2.0]; LAGB: -2.1 [-4.2, 0.1]; SG: 0.7 [-3.0, 4.3]). From 3 to 5 years post-operatively, the rate of regain tended to be faster among commercial patients compared to Medicaid patients (mean weight Δ difference [95% CI]: RYGB: 1.1 [0.1, 2.0]; LAGB: 1.5 [-0.5, 3.5]; SG: 1.0 [-2.5, 4.5]). CONCLUSIONS: Although Medicaid patients had a higher baseline weight, they achieved similar amounts of weight loss and tended to regain weight at a slower rate than commercial patients.

Treatment of Obesity: Weight Loss and Bariatric Surgery.

This review focuses on the mechanisms underlying, and indications for, bariatric surgery in the reduction of cardiovascular disease (CVD), as well as other expected benefits of this intervention. The fundamental basis for bariatric surgery for the purpose of accomplishing weight loss is the determination that severe obesity is a disease associated with multiple adverse effects on health, which can be reversed or improved by successful weight loss in patients who have been unable to sustain weight loss by nonsurgical means. An explanation of possible indications for weight loss surgery as well as specific bariatric surgical procedures is presented, along with review of the safety literature of such procedures. Procedures that are less invasive or those that involve less gastrointestinal rearrangement accomplish considerably less weight loss but have substantially lower perioperative and longer-term risk. The ultimate benefit of weight reduction relates to the reduction of the comorbidities, quality of life, and all-cause mortality. With weight loss being the underlying justification for bariatric surgery in ameliorating CVD risk, current evidence-based research is discussed concerning body fat distribution, dyslipidemia, hypertension, diabetes mellitus, inflammation, obstructive sleep apnea, and others. The rationale for bariatric surgery reducing CVD events is discussed and juxtaposed with impacts on all-cause mortalities. Given the improvement of established obesity-related CVD risk factors after weight loss, it is reasonable to expect a reduction of CVD events and related mortality after weight loss in populations with obesity. The quality of the current evidence is reviewed, and future research opportunities and summaries are stated.

The Impact of Different Surgical Techniques on Outcomes in Laparoscopic Sleeve Gastrectomies: The First Report from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP).

OBJECTIVE: Questions remain regarding best surgical techniques to use for a laparoscopic sleeve gastrectomy (LSG) including the use of staple line reinforcement (SLR), bougie size (BS), and distance from the pylorus (DP) where the staple line is initiated. Our objectives were to assess the impact of these techniques on 30-day outcomes and to evaluate the impact of these techniques on weight loss and comorbidities at 1 year. METHODS: Using the MBSAQIP data registry, univariate analyses and hierarchical logistical regression models were developed to analyze outcomes for techniques of LSG at patient and surgeon-level. RESULTS: A total of 189,477 LSG operations were performed by 1634 surgeons at 720 centers from 2012 to 2014. Eighty percent of surgeons used SLR, 20% did not. SLR cases were associated with higher leak rates (0.96% vs 0.65%, odds ratio [OR] 1.20 95% confidence interval [CI] 1.00-1.43) and lower bleed rates (0.75% vs 1.00%, OR 0.74 95% CI 0.63-0.86) compared to no SLR at patient level. At the surgeon level, leak rates remained significant, but bleeding events became nonsignificant. BS ≥38 was associated with significantly lower leak rates compared to BS <38 at patient and surgeon level (patient level: 0.80% vs 0.96%, OR 0.72, 95% CI 0.62-0.94; surgeon level: 0.84% vs 0.95%, OR 0.90, 95% CI 0.80-0.99). BS ≥40 was associated with increased weight loss. DP had no impact on leaks or bleeds but showed an increase in weight loss with increasing DP. CONCLUSION: LSG is a safe procedure with a low morbidity rate. SLR is associated with increased leak rates. A surgeon should consider risks, benefits, and costs of these surgical techniques when performing a LSG and selectively utilize those that, in their hands, minimize morbidity while maximizing clinical effectiveness.

Objectively-measured sedentary time and cardiometabolic health in adults with severe obesity.

It is unknown whether sedentary behavior is independently associated with the cardiometabolic health of adults with severe obesity. Additionally, there is debate regarding how best to derive meaningful indices of sedentary time (ST) from activity monitor data. A convenience sample of adults with severe obesity (N=927; 79% female, median age 45y, median body mass index (BMI) 46kg/m(2)) completed a research assessment at one of ten US hospitals in 2006-2009 prior to bariatric surgery. Cardiometabolic health was assessed via physical measures, fasting blood samples and medication use. Indices of ST were derived from StepWatch™ activity monitor data with minimum bout durations of 1min, 10min and 30min. Cross-sectional associations were examined. Median (25th, 75th percentile) ST was 9.3h/d (8.1, 10.5) in ≥1min bouts, 6.5h/d (5.2, 8.0) in ≥10min bouts, or 3.2h/d (2.1, 4.5) in ≥30min bouts. Associations with ST were generally strongest with the ≥10min bout duration. Independent of moderate-to-vigorous intensity physical activity, BMI and other potential confounders, 1h/day ST in ≥10min bouts was associated with higher odds of diabetes by 15% (95%CI: 1.05-1.26), metabolic syndrome by 12% (95%CI: 1.01-1.24) and elevated blood pressure by 14% (95%CI: 1.02-1.26), and was associated with 1.4cm (95%CI: 0.9-1.9) larger waist circumference. Findings indicate the importance of considering ST as a distinct health risk among adults with severe obesity, and suggest a 10min minimum duration may be preferable to 1min or 30min for establishing ST from activity monitor data.

Distance of the internal central venous catheter tip from the right atrium is positively correlated with central venous thrombosis.

Central venous catheters (CVCs) are associated with occlusive, infectious, and thrombotic complications. The aim of this study was to determine if internal CVC tip position was correlated with subsequent complications. This was an institutional review board approved single-center retrospective review of 169 consecutive patients who underwent placement of 203 semipermanent CVCs. Using post-placement chest X-rays, a de novo scale of internal catheter tip position was developed. Major complications were recorded. A logistic regression analysis was used to determine if catheter tip position predicted subsequent complications. There were 78 men and 91 women with a mean age of 48 ± 11 years. There were 21 catheter tips placed in the subclavian/innominate veins, 32 in the upper superior vena cava, 113 in the atriocaval junction, and 37 in the right atrium. There were 83 complications occurring in 61 (36.1 %) patients, including sepsis in 40 (23.7 %), venous thrombosis in 18 (10.7 %), catheter occlusion in 16 (9.5 %), internal catheter repositioning in 6 (3.6 %), pneumothorax in 2 (1.2 %), and death in 1 (0.6 %). An internal catheter tip position peripheral to the atriocaval junction resulted in a catheter that was more likely to undergo internal repositioning (p < 0.001) and venous thrombosis (p < 0.001). Patients with femoral catheters were more likely to develop sepsis (45 %) than patients whose catheters were inserted through the upper extremity veins (18 %) (p < 0.01). In conclusion, to reduce catheter-associated morbidity and potentially mortality, the internal catheter tip should be positioned at the atriocaval junction or within the right atrium and femoral insertion sites should be avoided whenever possible.

Change in Pain and Physical Function Following Bariatric Surgery for Severe Obesity.

IMPORTANCE: The variability and durability of improvements in pain and physical function following Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB) are not well described. OBJECTIVES: To report changes in pain and physical function in the first 3 years following bariatric surgery, and to identify factors associated with improvement. DESIGN, SETTING, AND PARTICIPANTS: The Longitudinal Assessment of Bariatric Surgery-2 is an observational cohort study at 10 US hospitals. Adults with severe obesity undergoing bariatric surgery were recruited between February 2005 and February 2009. Research assessments were conducted prior to surgery and annually thereafter. Three-year follow-up through October 2012 is reported. EXPOSURES: Bariatric surgery as clinical care. MAIN OUTCOMES AND MEASURES: Primary outcomes were clinically meaningful presurgery to postsurgery improvements in pain and function using scores from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (ie, improvement of ≥5 points on the norm-based score [range, 0-100]) and 400-meter walk time (ie, improvement of ≥24 seconds) using established thresholds. The secondary outcome was clinically meaningful improvement using the Western Ontario McMaster Osteoarthritis Index (ie, improvement of ≥9.7 pain points and ≥9.3 function points on the transformed score [range, 0-100]). RESULTS: Of 2458 participants, 2221 completed baseline and follow-up assessments (1743 [78.5%] were women; median age was 47 years; median body mass index [BMI] was 45.9; 70.4% underwent RYGB; 25.0% underwent LAGB). At year 1, clinically meaningful improvements were shown in 57.6% (95% CI, 55.3%-59.9%) of participants for bodily pain, 76.5% (95% CI, 74.6%-78.5%) for physical function, and 59.5% (95% CI, 56.4%-62.7%) for walk time. Additionally, among participants with severe knee or disability (633), or hip pain or disability (500) at baseline, approximately three-fourths experienced joint-specific improvements in knee pain (77.1% [95% CI, 73.5%-80.7%]) and in hip function (79.2% [95% CI, 75.3%-83.1%]). Between year 1 and year 3, rates of improvement significantly decreased to 48.6% (95% CI, 46.0%-51.1%) for bodily pain and to 70.2% (95% CI, 67.8%-72.5%) for physical function, but improvement rates for walk time, knee and hip pain, and knee and hip function did not (P for all ≥.05). Younger age, male sex, higher income, lower BMI, and fewer depressive symptoms presurgery; no diabetes and no venous edema with ulcerations postsurgery (either no history or remission); and presurgery-to-postsurgery reductions in weight and depressive symptoms were associated with presurgery-to-postsurgery improvements in multiple outcomes at years 1, 2, and 3. CONCLUSIONS AND RELEVANCE: Among a cohort of participants with severe obesity undergoing bariatric surgery, a large percentage experienced improvement, compared with baseline, in pain, physical function, and walk time over 3 years, but the percentage with improvement in pain and physical function decreased between year 1 and year 3. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00465829.

Hepatic pathology among patients without known liver disease undergoing bariatric surgery: observations and a perspective from the longitudinal assessment of bariatric surgery (LABS) study.

Liver biopsy is not routine during bariatric surgery. Alanine aminotransferase (ALT) is widely used to screen for liver disease. We assessed the relationship between ALT and pathology in biopsies from Longitudinal Assessment of Bariatric Surgery (LABS) patients with normal preoperative ALTs. Biopsies from the LABS-1 and LABS-2 studies were scored using the NASH CRN and Ishak systems. Diagnosis and histology were examined in relation to alanine aminotransferase (ALT) values. Six-hundred ninety-three suitable biopsies were evaluated. Biopsied patients had a median age of 45 years; 78.6% were female and 35.1% diabetic; median body mass index was 46 kg/m(2). Six-hundred thirty-five biopsied patients had preoperative ALTs. Median ALT was 25 IU/L (interquartile range [IQR] 19-36 IU/L); 26.6% had an ALT > 35 IU/L and 29.9% exceeded the more restrictive Prati criteria for normal. Using the Prati criteria, 7.9% of participants with normal ALT had steatohepatitis and 5.3% had ≥ stage 2 fibrosis. Logistic regression models were used to predict the probabilities of having bridging fibrosis/cirrhosis or a diagnosis of borderline/definite steatohepatitis in the unbiopsied LABS-2 sample. The proportion of biopsied participants with these findings was very similar to the modeled results from the unbiopsied cohorts. We estimated that 86.0% of participants with advanced fibrosis and 88.1% of participants with borderline/definite steatohepatitis were not biopsied and went undiagnosed. As ALT did not reliably exclude significant obesity-related liver disease in bariatric surgery patients, consideration should be given to routine liver biopsy during bariatric surgery and medical follow-up of significant hepatic pathology.

Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity.

IMPORTANCE: Severe obesity (body mass index [BMI] ≥35) is associated with a broad range of health risks. Bariatric surgery induces weight loss and short-term health improvements, but little is known about long-term outcomes of these operations. OBJECTIVE: To report 3-year change in weight and select health parameters after common bariatric surgical procedures. DESIGN AND SETTING: The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium is a multicenter observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. PARTICIPANTS AND EXPOSURE: Adults undergoing first-time bariatric surgical procedures as part of routine clinical care by participating surgeons were recruited between 2006 and 2009 and followed up until September 2012. Participants completed research assessments prior to surgery and 6 months, 12 months, and then annually after surgery. MAIN OUTCOMES AND MEASURES: Three years after Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), we assessed percent weight change from baseline and the percentage of participants with diabetes achieving hemoglobin A1c levels less than 6.5% or fasting plasma glucose values less than 126 mg/dL without pharmacologic therapy. Dyslipidemia and hypertension resolution at 3 years was also assessed. RESULTS: At baseline, participants (N = 2458) were 18 to 78 years old, 79% were women, median BMI was 45.9 (IQR, 41.7-51.5), and median weight was 129 kg (IQR, 115-147). For their first bariatric surgical procedure, 1738 participants underwent RYGB, 610 LAGB, and 110 other procedures. At baseline, 774 (33%) had diabetes, 1252 (63%) dyslipidemia, and 1601 (68%) hypertension. Three years after surgery, median actual weight loss for RYGB participants was 41 kg (IQR, 31-52), corresponding to a percentage of baseline weight lost of 31.5% (IQR, 24.6%-38.4%). For LAGB participants, actual weight loss was 20 kg (IQR, 10-29), corresponding to 15.9% (IQR, 7.9%-23.0%). The majority of weight loss was evident 1 year after surgery for both procedures. Five distinct weight change trajectory groups were identified for each procedure. Among participants who had diabetes at baseline, 216 RYGB participants (67.5%) and 28 LAGB participants (28.6%) experienced partial remission at 3 years. The incidence of diabetes was 0.9% after RYGB and 3.2% after LAGB. Dyslipidemia resolved in 237 RYGB participants (61.9%) and 39 LAGB participants (27.1%); remission of hypertension occurred in 269 RYGB participants (38.2%) and 43 LAGB participants (17.4%). CONCLUSIONS AND RELEVANCE: Among participants with severe obesity, there was substantial weight loss 3 years after bariatric surgery, with the majority experiencing maximum weight change during the first year. However, there was variability in the amount and trajectories of weight loss and in diabetes, blood pressure, and lipid outcomes. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00465829.

Long-Term Outcomes of Bariatric Surgery in Idiopathic Intracranial Hypertension Patients.

BACKGROUND: Idiopathic intracranial hypertension (IIH), a rare neurological disorder, has limited effective long-term treatments. Bariatric surgery has shown short-term promise as a management strategy, but long-term efficacy has not been evaluated. We investigated IIH-related outcomes 4 to 16 years postsurgery. MATERIALS AND METHODS: This cross-sectional retrospective cohort study included Intracranial Hypertension Registry (IHR) participants with existing medical records that completed a bariatric surgery questionnaire at least 4 years postsurgery. Two physicians independently evaluated the IIH disease course at bariatric surgery and at the time of the questionnaire using detailed medical records. Determinations of improvements were based on within-participant comparisons between the 2 time points. IIH-related outcomes were then combined with bariatric surgery information and outcomes to assess the relationship between weight loss and alterations in IIH. RESULTS: Among participants that underwent bariatric surgery and met study criteria (n=30) the median body mass index (BMI) at the time of surgery was 45.0 [interquartile range (IQR): 39.8-47.0], dropped to a postsurgical nadir of 27.3 (IQR: 22.8-33.1), and rose to 33.4 (IQR: 29.9-41.7) at the time of the questionnaire. Improvements in the IIH disease course at time of the questionnaire occurred in 37% of participants. However, there was a notable association between durable weight loss and IIH improvement as 90% (9 of 10) of participants that attained and maintained a BMI of 30 or below displayed improvement. CONCLUSIONS: Attaining and maintaining a BMI of 30 or below was associated with long-term improvement in the IIH disease course, including improved disease management and amelioration of signs and symptoms of participants of the IHR.

Health change awareness and its association with weight loss following bariatric surgery.

OBJECTIVE: Patients' ability to judge health change over time has important clinical implications for treatment, but is understudied in longitudinal contexts with meaningful health change. We assess patients' awareness of health change for 5 years following bariatric surgery, and its association with weight loss. METHOD: Participants were part of the Longitudinal Assessment of Bariatric Surgery (N = 2,027). Perceived health change for each year was assessed by comparing it to self-reports of health on the SF-36 health survey. Participants were categorized as concordant when perceived and actual self-reported health change corresponded, and as discordant when they did not correspond. RESULTS: Year-to-year concordance between perceived and actual self-reported health change occurred less than 50% of the time. Discordance between perceived and actual health was associated with weight loss following surgery. Discordant-positive participants who perceived their health change as more positive than was warranted lost more weight post-surgery and thus had lower body mass index scores than concordant participants. Conversely, discordant-negative participants who perceived their health as worse than what was warranted lost less weight post-surgery and thus had higher body mass index scores. CONCLUSIONS: These results suggest that recollection of past health is generally poor and can be biased by salient factors during recall. Clinicians are advised to use caution when retrospective judgments of health are utilized. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Obesity and breast cancer: Preventive and therapeutic possibilities for bariatric surgery.

Breast cancer is the most common and second deadliest malignancy in women. With rising obesity rates and building evidence for a strong association with obesity, the incidence of breast cancer can be expected to increase. Weight loss reduces breast cancer risk, the mechanisms of which are still poorly understood. As an effective therapy for obesity, bariatric surgery may be a powerful tool in breast cancer prevention and treatment. This review details the potential physiologic mechanisms that may underlie this association, as well as recently published studies that reinforce the link between bariatric surgery and a reduction in incident breast cancer. The use of bariatric surgery as an adjunct therapy in endometrial cancer also raises the potential for similar use in select breast cancer patients. Despite the expanding potential applications of bariatric surgery in this field, publications to date have been strictly observational, highlighting a need for future clinical trials.

Postbariatric hypoglycemia: symptom patterns and associated risk factors in the Longitudinal Assessment of Bariatric Surgery study.

BACKGROUND: Postbariatric hypoglycemia (PBH) can be a devastating complication for which current therapies are often incompletely effective. More information is needed regarding frequency, incidence, and risk factors for PBH. OBJECTIVES: To examine hypoglycemia symptoms following Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB) and baseline and in-study risk factors. SETTING: Multicenter, at 10 US hospitals in 6 geographically diverse clinical centers. METHODS: A prospective, longitudinal cohort study of adults undergoing RYGB or LAGB as part of clinical care between 2006 and 2009 were recruited and followed until January 31, 2015, with baseline and annual postoperative research assessments. We analyzed baseline prevalence and post-operative incidence and frequency of self-reported hypoglycemia symptoms as well as potential preoperative risk factors. RESULTS: In all groups, postoperative prevalence of hypoglycemia symptoms was 38.5%. Symptom prevalence increased postoperatively from 2.8%-36.4% after RYGB in patients without preoperative diabetes (T2D), with similar patterns in prediabetes (4.9%-29.1%). Individuals with T2D had higher baseline hypoglycemia symptoms (28.9%), increasing after RYGB (57.9%). Hypoglycemia symptoms were lower after LAGB, with 39.1% reported hypoglycemia symptoms at only 1 postoperative visit with few (4.0%) having persistent symptoms at 6 or more annual visits. Timing of symptoms was not restricted to the postprandial state. Symptoms of severe hypoglycemia were reported in 2.6-3.6% after RYGB. The dominant risk factor for postoperative symptoms was preoperative symptoms; additionally, baseline selective serotonin (SSRI) and serotonin-norepinephrine (SNRI) reuptake inhibitor use was also associated with increased risk in multivariable analysis. Weight loss and regain were not related to hypoglycemia symptom reporting. CONCLUSION: Hypoglycemia symptoms increase over time after RYGB, particularly in patients without diabetes. In a small percentage, symptoms can be persistent or severe and require hospitalization. Preoperative hypoglycemia symptoms and SSRI/SNRI use in RYGB patients without diabetes is associated with increased risk of symptoms.

Diabetes Remission Status During Seven-year Follow-up of the Longitudinal Assessment of Bariatric Surgery Study.

CONTEXT: Few studies have examined the clinical characteristics that predict durable, long-term diabetes remission after bariatric surgery. OBJECTIVE: To compare diabetes prevalence and remission rates during 7-year follow-up after Roux-en-Y gastric bypass (RYGB) and laparoscopic gastric banding (LAGB). DESIGN: An observational cohort of adults with severe obesity recruited between 2006 and 2009 who completed annual research assessments for up to 7 years after RYGB or LAGB. SETTING: Ten US hospitals. PARTICIPANTS: A total sample of 2256 participants, 827 with known diabetes status at both baseline and at least 1 follow-up visit. INTERVENTIONS: Roux-en-Y gastric bypass or LAGB. MAIN OUTCOME MEASURES: Diabetes rates and associations of patient characteristics with remission status. RESULTS: Diabetes remission occurred in 57% (46% complete, 11% partial) after RYGB and 22.5% (16.9% complete, 5.6% partial) after LAGB. Following both procedures, remission was greater in younger participants and those with shorter diabetes duration, higher C-peptide levels, higher homeostatic model assessment of ß-cell function (HOMA %B), and lower insulin usage at baseline, and with greater postsurgical weight loss. After LAGB, reduced HOMA insulin resistance (IR) was associated with a greater likelihood of diabetes remission, whereas increased HOMA-%B predicted remission after RYGB. Controlling for weight lost, diabetes remission remained nearly 4-fold higher compared with LAGB. CONCLUSIONS: Durable, long-term diabetes remission following bariatric surgery is more likely when performed soon after diagnosis when diabetes medication burden is low and beta-cell function is preserved. A greater weight-independent likelihood of diabetes remission after RYGB than LAGB suggests mechanisms beyond weight loss contribute to improved beta-cell function after RYGB.Trial Registration clinicaltrials.gov Identifier: NCT00465829.