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Compare adverse outcomes up to 5 years after sleeve gastrectomy and gastric bypass in patients with Medicaid.Sleeve gastrectomy is the most common bariatric operation among patients with Medicaid, however its long-term safety in this population is unknown.Using Medicaid claims, we performed a retrospective cohort study of adult patients who underwent sleeve gastrectomy or gastric bypass from January 1, 2012 to December 31, 2018. Instrumental variables survival analysis was used to estimate the cumulative incidence and heterogeneity of outcomes up to 5 years after surgery.Among 132,788 patients with Medicaid, 84,717 (63.8%) underwent sleeve gastrectomy and 48,071 (36.2%) underwent gastric bypass. 69,225 (52.1%) patients were White, 33,833 (25.5%) were Black, and 29,730 (22.4%) were Hispanic. Compared to gastric bypass, sleeve gastrectomy was associated with a lower 5-year cumulative incidence of mortality (1.29% vs. 2.15%), complications (11.5% vs. 16.2%), hospitalization (43.7% vs. 53.7%), ED use (61.6% vs. 68.2%), and reoperation (18.5% vs. 22.8%), but a higher cumulative incidence of revision (3.3% vs. 2.0%). Compared to White patients, the magnitude of the difference between sleeve and bypass was smaller among Black patients for ED use (5-year aHR 1.01 [95% CI 0.94-1.08] vs. 0.94 [95% CI 0.88-1.00], P0.001) and Hispanic patients for reoperation (5-year aHR 0.95 [95% CI 0.86-1.05] vs. 0.76 [95% CI 0.69-0.83], P0.001).Among patients with Medicaid undergoing bariatric surgery, sleeve gastrectomy was associated with a lower risk of mortality, complications, hospitalization, ED use, and reoperations, but a higher risk of revision compared to gastric bypass. Although the difference between sleeve and bypass was generally similar among White, Black, and Hispanic patients, the magnitude of this difference was smaller among Black patients for ED use and Hispanic patients for reoperation.

To compare safety and healthcare utilization after sleeve gastrectomy versus Roux-en-Y gastric bypass in a national Medicare cohort.Though bariatric surgery is increasing among Medicare beneficiaries, no long-term, national studies examining comparative effectiveness between procedures exist. Bariatric outcomes are needed for shared decision-making and coverage policy concerns identified by the cMS Medicare Evidence Development and Coverage Advisory Committee.Retrospective instrumental variable analysis of Medicare claims (2012-2017) for 30,105 bariatric surgery patients entitled due to disability or age. We examined clinical safety outcomes (mortality, complications, and reinterventions), healthcare utilization [Emergency Department (ED) visits, rehospitalizations, and expenditures], and heterogeneity of treatment effect. We compared all outcomes between sleeve and bypass for each entitlement group at 30 days, 1 year, and 3 years.Among the disabled (n = 21,595), sleeve was associated with lower 3-year mortality [2.1% vs 3.2%, absolute risk reduction (ARR) 95% confidence interval (CI): -2.2% to -0.03%], complications (22.2% vs 27.7%, ARR 95%CI: -8.5% to -2.6%), reinterventions (20.1% vs 27.7%, ARR 95%CI: -10.7% to -4.6%), ED utilization (71.6% vs 77.1%, ARR 95%CI: -8.5% to -2.4%), and rehospitalizations (47.4% vs 52.3%, ARR 95%Ci: -8.0% to -1.7%). Cumulative expenditures were $46,277 after sleeve and $48,211 after bypass (P = 0.22). Among the elderly (n = 8510), sleeve was associated with lower 3-year complications (20.1% vs 24.7%, ARR 95%CI: -7.6% to -1.7%), reinterventions (14.0% vs 21.9%, ARR 95%CI: -10.7% to -5.2%), ED utilization (51.7% vs 57.2%, ARR 95%CI: -9.1% to -1.9%), and rehospitalizations (41.8% vs 45.8%, ARR 95%Ci: -7.5% to -0.5%). Expenditures were $38,632 after sleeve and $39,270 after bypass (P = 0.60). Procedure treatment effect significantly differed by entitlement for mortality, revision, and paraesophageal hernia repair.Bariatric surgery is safe, and healthcare utilization benefits of sleeve over bypass are preserved across both Medicare elderly and disabled subpopulations.

To compare out-of-pocket (OOP) costs for patients up to 3 years after bariatric surgery in a large, commercially-insured population.More information on OOP costs following bariatric surgery may affect patients' procedure choice.Retrospective study using the IBM MarketScan commercial claims database, representing patients nationally who underwent laparoscopic sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) January 1, 2011 to December 31, 2017. We compared total OOP costs after the surgical episode between the 2 procedures using difference-in-differences analysis adjusting for demographics, comorbidities, operative year, and insurance type.Of 63,674 patients, 64% underwent SG and 36% underwent RYGB. Adjusted OOP costs after SG were $1083, $1236, and $1266 postoperative years 1, 2, and 3. For RYGB, adjusted OOP costs were $1228, $1377, and $1369. In our primary analysis, SG OOP costs were $122 (95%CI: -$155 to -$90) less than RYGB year 1. This difference remained consistent at -$119 (95%CI: -$158 to -$79) year 2 and -$80 (95%CI: -$127 to -$35) year 3. These amounts were equivalent to relative differences of -7%, -7%, and -5% years 1, 2, and 3. Plan features contributing the most to differences were co-insurance years 1, 2, and 3.. The largest clinical contributors to differences were endoscopy and outpatient care year 1, outpatient care year 2, and emergency department use year 3.Our study is the first to examine the association between bariatric surgery procedure and OOP costs. Differences between procedures were approximately $100 per year which may be an important factor for some patients deciding whether to pursue SG or gastric bypass.

Objective To separately compare the long-term risk of mortality among bariatric surgical patients undergoing either RYGB or SG to large, matched, population-based cohorts of patients with severe obesity who did not undergo surgery. Background Bariatric surgery has been associated with reduced long-term mortality compared to usual care for severe obesity which is particularly relevant in the COVID-19 era. Most prior studies involved the Roux-en-Y gastric bypass (RYGB) operation and there is less long-term data on the sleeve gastrectomy (SG). Methods In this retrospective, matched cohort study, patients with a body mass index ≥35 kg/m2 who underwent bariatric surgery from January 2005 to September 2015 in three integrated health systems in the United States were matched to nonsurgical patients on site, age, sex, body mass index, diabetes status, insulin use, race/ethnicity, combined Charlson/Elixhauser comorbidity score, and prior health care utilization, with follow-up through September 2015. Each procedure (RYGB, SG) was compared to its own control group and the two surgical procedures were not directly compared to each other. Multivariable-adjusted Cox regression analysis investigated time to all-cause mortality (primary outcome) comparing each of the bariatric procedures to usual care. Secondary outcomes separately examined the incidence of cardiovascular-related death, cancer related-death, and diabetes related-death. Results Among 13,900 SG, 17,258 RYGB, and 87,965 nonsurgical patients, the 5-year follow-up rate was 70.9%, 72.0%, and 64.5%, respectively. RYGB and SG were each associated with a significantly lower risk of all-cause mortality compared to nonsurgical patients at 5-years of follow-up (RYGB: HR = 0.43; 95% CI: 0.35,0.54; SG: HR = 0.28; 95% CI: 0.13,0.57) Similarly, RYGB was associated with a significantly lower 5-year risk of cardiovascular- (HR = 0.27; 95% CI: 0.20, 0.37), cancer- (HR = 0.54; 95% CI: 0.39, 0.76), and diabetes-related mortality (HR = 0.23; 95% CI:0.15, 0.36). There was not enough follow-up time to assess 5-year cause-specific mortality in SG patients, but at 3-years follow up, there was significantly lower risk of cardiovascular- (HR = 0.33; 95% CI:0.19, 0.58), cancer- (HR = 0.26; 95% CI:0.11, 0.59), and diabetes-related (HR = 0.15; 95% CI:0.04, 0.53) mortality for SG patients. Conclusion This study confirms and extends prior findings of an association with better survival following bariatric surgery in RYGB patients compared to controls and separately demonstrates that the SG operation also appears to be associated with lower mortality compared to matched control patients with severe obesity that received usual care. These results help to inform the trade-offs between long-term benefits and risks of bariatric surgery.

Weight loss is an effective strategy for the management of hypertension, and bariatric surgery is the most effective weight loss and maintenance strategy for obesity. The importance of bariatric surgery in the long-term management of hypertension and which operation is most effective is less clear. We compared the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB) for remission and relapse of hypertension after surgery in the ENGAGE CVD cohort study (Effectiveness of Gastric Bypass Versus Gastric Sleeve for Cardiovascular Disease). Operations were done by 23 surgeons across 9 surgical practices. Hypertension remission and relapse were assessed in each year of follow-up beginning 30 days and up to 5 years postsurgery. We used a local instrumental variable approach to account for selection bias in the choice of VSG or RYGB. The study population included 4964 patients with hypertension at the time of surgery (n=3186 VSG and n=1778 RYGB). At 1 year, 27% of patients with RYGB and 28% of patients with VSG achieved remission. After 5 years, without accounting for relapse, 42% of RYGB and 43% of VSG patients had experienced hypertension remission. After accounting for relapse, only 17% of RYGB and 18% of VSG patients remained in remission 5 years after surgery. There were no statistically significant differences between VSG and RYGB for hypertension remission, relapse, or mean systolic and diastolic blood pressure at any time during follow-up.

OBJECTIVE: To compare acute care utilization and costs following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). SUMMARY BACKGROUND DATA: Comparing post-bariatric emergency department (ED) and inpatient care use patterns could assist with procedure choice and provide insights about complication risk. METHODS: We used a national insurance claims database to identify adults undergoing SG and RYGB between 2008 and 2016. Patients were matched on age, gender, calendar-time, diabetes, and baseline acute care use. We used adjusted Cox proportional hazards to compare acute care utilization and two-part logistic regression models to compare annual associated costs (odds of any cost, and odds of high costs, defined as ≥80(th) percentile), between SG and RYGB, overall and within several clinical categories. RESULTS: The matched cohort included 4263 SG and 4520 RYGB patients. Up to 4 years after surgery, SG patients had slightly lower risk of ED visits (aHR: 0.90; 95% CI: 0.85,0.96) and inpatient stays (aHR: 0.80; 95% CI: 0.73,0.88), especially for events associated with digestive-system diagnoses (ED aHR: 0.68; 95% CI:0.62,0.75; inpatient aHR: 0.61; 95% CI: 0.53,0.72). SG patients also had lower odds of high ED and high total acute costs (e.g., year-1 acute costs aOR 0.77; 95% CI: 0.66,0.90) in early follow-up. However, observed cost differences decreased by years 3 and 4 (e.g., year-4 acute care costs aOR 1.10; 95% CI: 0.92,1.31). CONCLUSIONS: SG may have fewer complications requiring emergency care and hospitalization, especially as related to digestive system disease. However, any acute care cost advantages of SG may wane over time.

OBJECTIVE: A retrospective cohort study investigated the association between having surgery and risk of mortality for up to five years and if this association was modified by incident End Stage Renal Disease (ESRD) during the follow-up period. SUMMARY BACKGROUND DATA: Mortality risk in individuals with pre-dialysis chronic kidney disease (CKD) is high and few effective treatment options are available. Whether bariatric surgery can improve survival in people with CKD is unclear. METHODS: Patients with class II and III obesity and pre-dialysis CKD stages 3 – 5 who underwent bariatric surgery between 1/1/2006 and 9/30/2015 (n = 802) were matched to patients who did not have surgery (n = 4,933). Mortality was obtained from state death records and ESRD was identified through state-based or healthcare system-based registries. Cox regression models were used to investigate the association between bariatric surgery and risk of mortality and if this was moderated by incident ESRD during the follow-up period. RESULTS: Patients were primarily women (79%), non-Hispanic White (72%), under 65 years old (64%), who had a BMI ≥ 40 kg/m(2) (59%), diabetes (67%) and hypertension (89%). After adjusting for incident ESRD, bariatric surgery was associated with a 79% lower 5-year risk of mortality compared to matched controls (HR = 0.21; 95% CI: 0.14-0.32; p < .001). Incident ESRD did not moderate the observed association between surgery and mortality (HR = 1.59; 95% CI 0.31-8.23; p = .58). CONCLUSIONS: Bariatric surgery is associated with a reduction in mortality in pre-dialysis patients regardless of developing ESRD. These findings are significant because patients with CKD are at relatively high risk for death with few efficacious interventions available to improve survival.

Missing data is common in electronic health records (EHR)-based obesity research. To avoid bias, it is critical to understand mechanisms that underpin missingness. We conducted a survey among bariatric surgery patients in three integrated health systems to (i) investigate predictors of disenrollment and (ii) examine differences in weight between disenrollees and enrollees at 5 years. We identified 2883 patients who had bariatric surgery between 11/2013 and 08/2014. Patients who disenrolled before their 5-year anniversary were invited to participate in a survey to ascertain reasons for disenrollment and current weight. Logistic regression was used to investigate predictors of disenrollment. Five-year percent weight change distributions were estimated using inverse-probability weighting to adjust for (un)availability of EHR weight data at 5 years among enrollees and survey (non-)response among disenrollees. Among 536 disenrolled patients, 104 (19%) completed the survey. Among 2347 patients who maintained enrollment, 384 (16%) had no weight measurement in the EHR near 5 years. Insurance, age, Hispanic ethnicity, and site predicted disenrollment. Disenrollees had slightly greater weight loss than enrollees. We found little evidence of weight loss differences by enrollment status. Collecting information through surveys can be an effective tool to investigate and adjust for missingness in EHR-based studies.

OBJECTIVE To compare the safety of sleeve gastrectomy and gastric bypass in a large cohort of commercially insured bariatric surgery patients from the IBM MarketScan claims database, while accounting for measurable and unmeasurable sources of selection bias in who is chosen for each operation. SUMMARY OF BACKGROUND DATA Sleeve gastrectomy has rapidly become the most common bariatric operation performed in the United States, but its longer-term safety is poorly described, and the risk of worsening gastroesophageal reflux requiring revision may be higher than previously thought. Prior studies comparing sleeve gastrectomy to gastric bypass are limited by low sample size (in randomized trials) and selection bias (in observational studies). METHODS Instrumental variables analysis of commercially insured patients in the IBM MarketScan claims database from 2011 to 2018. We studied patients undergoing bariatric surgery from 2012 to 2016. We identified re-interventions and complications at 30 days and 2 years from surgery using Comprehensive Procedural Terminology and International Classification of Disease (ICD)-9/10 codes. To overcome unmeasured confounding, we use the prior year's sleeve gastrectomy utilization within each state as an instrumental variable-exploiting variation in the timing of payers' decisions to cover sleeve gastrectomy as a natural experiment. RESULTS Among 38,153 patients who underwent bariatric surgery between 2012 and 2016, the share of sleeve gastrectomy rose from 52.6% (2012) to 75% (2016). At 2 years from surgery, patients undergoing sleeve gastrectomy had fewer re-interventions (sleeve 9.9%, bypass 15.6%, P < 0.001) and complications (sleeve 6.6%, bypass 9.6%, P = 0.001), and lower overall healthcare spending ($47,891 vs $55,213, P = 0.003), than patients undergoing gastric bypass. However, at the 2-year mark, revisions were slightly more common in sleeve gastrectomy than in gastric bypass (sleeve 0.6%, bypass 0.4%, P = 0.009). CONCLUSIONS AND RELEVANCE In a large cohort of commercially insured patients, sleeve gastrectomy had a superior safety profile to gastric bypass up to 2 years from surgery, even when accounting for selection bias. However, the higher risk of revisions in sleeve gastrectomy merits further exploration.

Background Opioid analgesics are often prescribed to manage pain after bariatric surgery, which may develop into chronic prescription opioid use (CPOU) in opioid-naive patients. Bariatric surgery may affect opioid use in those with or without presurgical CPOU. Objective To compare CPOU persistence and incidence in a large multisite cohort of veterans undergoing bariatric surgery (open Roux-en-Y gastric bypass, laparoscopic RYGB, or laparoscopic sleeve gastrectomy) and matched nonsurgical controls. Setting Veterans Administration hospitals. Methods In a retrospective cohort study, we matched 1117 surgical patients with baseline CPOU to 9531 nonsurgical controls, and 2822 surgical patients without CPOU at baseline to 26,392 nonsurgical controls using sequential stratification. CPOU persistence in veterans with baseline CPOU was estimated using generalized estimating equations by procedure type. CPOU incidence in veterans without baseline CPOU was estimated in Cox regression models by procedure type because postoperative pain, complications, and absorption may differ by procedure. Results In veterans with baseline CPOU, postsurgical CPOU declined over time for each surgical procedure; these trends did not differ between surgical patients and nonsurgical controls. In veterans without baseline CPOU, compared with nonsurgical controls, bariatric patients had higher CPOU incidence within 5 years after open Roux-en-Y gastric bypass (hazard ratio=1.19; 95% confidence interval: 1.06–1.34) or laparoscopic open Roux-en-Y gastric bypass (hazard ratio=1.22, 95% confidence interval: 1.06–1.41). Veterans undergoing laparoscopic sleeve gastrectomy had higher CPOU incidence 1 to 5 years after surgery (hazard ratio=1.28; 95% confidence interval: 1.05–1.56) than nonsurgical controls. Conclusions Bariatric surgery was associated with greater risk of CPOU incidence in patients without baseline CPOU but was not associated with greater CPOU persistence.

Sleeve gastrectomy is the most widely used bariatric operation; however, its long-term safety is largely unknown.To compare the risk of mortality, complications, reintervention, and health care use 5 years after sleeve gastrectomy and gastric bypass.This retrospective cohort study included adult patients in a national Medicare claims database who underwent sleeve gastrectomy or gastric bypass from January 1, 2012, to December 31, 2018. Instrumental variables survival analysis was used to estimate the cumulative incidence of outcomes up to 5 years after surgery.Laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass.The main outcome was risk of mortality, complications, and reinterventions up to 5 years after surgery. Secondary outcomes were health care use after surgery, including hospitalization, emergency department (ED) use, and total spending.Of 95 405 patients undergoing bariatric surgery, 57 003 (60%) underwent sleeve gastrectomy (mean [SD] age, 57.1 [11.8] years), of whom 42 299 (74.2%) were women; 124 (0.2%) were Asian; 10 101 (17.7%), Black; 1951 (3.4%), Hispanic; 314 (0.6%), North American Native; 43 194 (75.8%), White; 534 (0.9%), of other race or ethnicity; and 785 (1.4%), of unknown race or ethnicity. A total of 38 402 patients (40%) underwent gastric bypass (mean [SD] age, 55.9 [11.7] years), of whom 29 050 (75.7%) were women; 109 (0.3%), Asian; 6038 (15.7%), Black; 1215 (3.2%), Hispanic; 278 (0.7%), North American Native; 29 986 (78.1%), White; 373 (1.0%), of other race or ethnicity; and 404 (1.1%), of unknown race or ethnicity. Compared with patients undergoing gastric bypass, at 5 years after surgery, patients undergoing sleeve gastrectomy had a lower cumulative incidence of mortality (4.27%; 95% CI, 4.25%-4.30% vs 5.67%; 95% CI, 5.63%-5.69%), complications (22.10%; 95% CI, 22.06%-22.13% vs 29.03%; 95% CI, 28.99%-29.08%), and reintervention (25.23%; 95% CI, 25.19%-25.27% vs 33.57%; 95% CI, 33.52%-33.63%). Conversely, patients undergoing sleeve gastrectomy had a higher cumulative incidence of surgical revision at 5 years (2.91%; 95% CI, 2.90%-2.93% vs 1.46%; 95% CI, 1.45%-1.47%). The adjusted hazard ratio (aHR) of all-cause hospitalization and ED use was lower for patients undergoing sleeve gastrectomy at 1 year (hospitalization, aHR, 0.83; 95% CI, 0.80-0.86; ED use, aHR, 0.87; 95% CI, 0.84-0.90) and 3 years (hospitalization, aHR, 0.94; 95% CI, 0.90-0.98; ED use, aHR, 0.93; 95% CI, 0.90-0.97) after surgery but similar between groups at 5 years (hospitalization, aHR, 0.99; 95% CI, 0.94-1.04; ED use, aHR, 0.97; 95% CI, 0.92-1.01). Total health care spending among patients undergoing sleeve gastrectomy was lower at 1 year after surgery ($28 706; 95% CI, $27 866-$29 545 vs $30 663; 95% CI, $29 739-$31 587), but similar between groups at 3 ($57 411; 95% CI, $55 239-$59 584 vs $58 581; 95% CI, $56 551-$60 611) and 5 years ($86 584; 95% CI, $80 183-$92 984 vs $85 762; 95% CI, $82 600-$88 924).In a large cohort of patients undergoing bariatric surgery, sleeve gastrectomy was associated with a lower long-term risk of mortality, complications, and reinterventions but a higher long-term risk of surgical revision. Understanding the comparative safety of these operations may better inform patients and surgeons in their decision-making.

OBJECTIVE There are few studies testing the amount of weight loss necessary to achieve initial remission of type 2 diabetes mellitus (T2DM) following bariatric surgery and no published studies with use of weight loss to predict initial T2DM remission in sleeve gastrectomy (SG) patients. RESEARCH DESIGN AND METHODS With Cox proportional hazards models we examined the relationship between initial T2DM remission and percent total weight loss (%TWL) after bariatric surgery. Categories of %TWL were included in the model as time-varying covariates. RESULTS Of patients (N = 5,928), 73% were female; mean age was 49.8 ± 10.3 years and BMI 43.8 ± 6.92 kg/m2, and 57% had Roux-en-Y gastric bypass (RYGB). Over an average follow-up of 5.9 years, 71% of patients experienced initial remission of T2DM (mean time to remission 1.0 year). With 0–5% TWL used as the reference group in Cox proportional hazards models, patients were more likely to remit with each 5% increase in TWL until 20% TWL (hazard ratio range 1.97–2.92). When categories >25% TWL were examined, all patients had a likelihood of initial remission similar to that of 20–25% TWL. Patients who achieved >20% TWL were more likely to achieve initial T2DM remission than patients with 0–5% TWL, even if they were using insulin at the time of surgery. CONCLUSIONS Weight loss after bariatric surgery is strongly associated with initial T2DM remission; however, above a threshold of 20% TWL, rates of initial T2DM remission did not increase substantially. Achieving this threshold is also associated with initial remission even in patients who traditionally experience lower rates of remission, such as patients taking insulin.

To compare the long-term risks of reintervention following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) in a large surgical cohort.The use of SG has increased dramatically relative to RYGB for the treatment of obesity. However, long-term risks following SG compared with RYGB have not been adequately defined in a large population-based study.A retrospective longitudinal cohort study of all adult health-plan members undergoing SG or RYGB for obesity in a multistate integrated health care system from January 2005 through September 2015. The risks of nutritional, endoscopic, radiologic, and surgical reintervention as well as the overall risk of any reinterventions at 1, 3, and 5 years were identified using diagnosis and procedure codes from comprehensive electronic medical records.The study included 15,319 patients who underwent SG and 19,954 patients who underwent RYGB with a follow-up of 79.2%. The overall risk of any reintervention at 5 years was 21.3% for SG and 28.3% for RYGB (P0.0001). After adjustment, SG was associated with fewer reinterventions through 5 years than RYGB (hazard ratio, 0.78; 95% confidence interval, 0.74-0.84). When comparing subcategories, SG also had a lower risk of nutritional, endoscopic, radiologic, and surgical reinterventions when examined versus RYGB. The findings for risks of reinterventions were consistent across clinical subgroups.SG has significantly lower risk of reintervention in all categories studied when compared with RYGB at 5-year follow-up. The long-term safety profile of LSG compared with RYGB should be an essential part of the discussion in patient-centered decision making when choosing between bariatric procedure options.

This retrospective cohort study examined whether bariatric surgery is associated with reduced risk of breast cancer among pre- and postmenopausal women.Obesity is associated with increased risk of breast cancer, but the impact of weight loss on breast cancer risk has been difficult to quantify.The cohort included obese (body mass index ≥35 kg/m) patients enrolled in an integrated health care delivery system between 2005 and 2012 (with follow-up through 2014). Female bariatric surgery patients (N = 17,998) were matched on body mass index, age, study site, and comorbidity index to 53,889 women with no bariatric surgery. Kaplan-Meier curves and Cox proportional hazards models were used to examine incident breast cancer up to 10 years after bariatric surgery. Pre- and postmenopausal women were examined separately, and further classified by estrogen receptor (ER) status.The analysis included 301 premenopausal and 399 postmenopausal breast cancer cases. In multivariable adjusted models, bariatric surgery was associated with a reduced risk of both premenopausal (HR = 0.72, 95% CI, 0.54-0.94) and postmenopausal (HR = 0.55, 95% CI, 0.42-0.72) breast cancer. Among premenopausal women, the effect of bariatric surgery was more pronounced among ER-negative cases (HR = 0.36, 95% CI, 0.16-0.79). Among postmenopausal women, the effect was more pronounced in ER-positive cases (HR = 0.52, 95% CI, 0.39-0.70).Bariatric surgery was associated with a reduced risk of breast cancer among severely obese women. These findings have significant public health relevance because the prevalence of obesity continues to rise, and few modifiable breast cancer risk factors have been identified, especially for premenopausal women.

To determine the impact of an intensive perioperative nutritional and lifestyle support protocol on long-term outcomes of bariatric surgery. A retrospective observational study was conducted of 955 patients who underwent gastric bypass surgery between 2005 and 2015. Patients were divided into two cohorts: (1) 2005 through August 2013: these 767 patients were required to participate in the intensive telephone-based nutritional support program from 8 weeks preoperative through 44 weeks postoperative; (2) after August 2013, the program was discontinued and 188 patients did not have intensive telephonic nutritional support. Inverse probability weighting was used to obtain weight loss estimates at 1 and 3 years postoperative. Time-to-event analyses were used to investigate hospitalization rates postoperative. Poisson models were used to investigate healthcare utilization. Patients who participated in the program exhibited 1.97% (95% CI 0.7, 3.3) greater %TWL at 1 year and 2.2% (95% CI −0.3, 4.1) greater %TWL at 3 years postoperative than patients who did not participate. Secondary analyses indicated participation in the program was associated with 44% shorter time to first hospitalization postoperative (p

Purpose Obesity is a highly prevalent condition with severe clinical burden. Bariatric procedures are an important and expanding treatment option. This study compared short-(30-day composite adverse events) and long-term (intervention/operation, endoscopy, hospitalization, and mortality up to 5 years) safety outcomes associated with three bariatric surgical procedures. Materials and Methods This observational cohort study replicated an electronic health record study comparing short- and long-term problems associated with three bariatric surgical procedures between January 1, 2006, and September 30, 2015, within a Health Plan Research Network. Results Of 95,251 adults, 34,240 (36%) underwent adjustable gastric banding (AGB), 36,206 (38%) Roux-en-Y gastric bypass (RYGB), and 24,805 (26%) sleeve gastrectomy (SG). Median (interquartile range) years of follow-up was 3.3 (1.4–5.0) (AGB), 2.5 (1.0–4.6) (RYGB), and 1.1 (0.5–2.1) (SG). Overall mean (SD) age was 44.2 (11.4) years. The cohort was predominantly female (76%). Thirty-day composite adverse events occurred more frequently following RYGB (3.8%) than AGB (3.1%) and SG (2.8%). Operation/intervention was less likely in SG than in RYGB (adjusted hazard ratio (AHR), 0.87; 95%CI, 0.80–0.96; P=0.003), and more likely in AGB than in RYGB (AHR, 2.10; 95%CI, 2.00–2.21; PP<0.001; SG vs. RYGB, AHR=0.79; 95%CI, 0.76–0.83; PP=0.004; AGB vs. RYGB: AHR, 0.49; 95%CI, 0.43–0.56; P=0.001). Conclusions Interventions, operations, and hospitalizations were more often associated with AGB and RYGB than SG while RYGB had the lowest risk for revision. Graphical abstract

PURPOSE: Bariatric surgery is the most effective treatment for severe obesity but currently only 1-2% of all eligible patients undergo surgery each year. This study examined which factors were associated with a patient receiving bariatric surgery after referral in a real-world healthcare setting. MATERIALS AND METHODS: The current study used the baseline survey and electronic medical record (EMR) data from the Bariatric Experience Long Term (BELONG) study (n = 1,975). Predictors of who did (n = 1,680) and who did not (n = 295) have surgery were analyzed using multivariate logistic regression. RESULTS: Participants (n = 1,975; 42.4% response rate) were primarily women (84%) and either non-Hispanic Black or Hispanic (60%). In the fully adjusted multivariate model, the strongest predictors of having surgery were being a woman (OR = 3.17; 95% CI = 2.15,4.68; p < .001) and losing at least 5% of their body weight in the year before surgery (OR = 3.16; 95% CI = 2.28,4.38; p < .001). The strongest predictors of not having surgery were a BMI ≥ 50 kg/m(2) (OR = .39; 95% CI = .27,.56; p < .001) and having a higher physical comorbidity burden (OR = .84; 95% CI = .75,.94; p = .004). CONCLUSIONS: Practices such as 5%-10% total weight loss before surgery and selection of patients with safer operative risk profiles (younger with lower comorbidity burden) may inadvertently contribute to under-utilization of bariatric surgery among some demographic subpopulations who could most benefit from this intervention.

Bariatric surgery is the most effective treatment for severe obesity (body mass index >40), helping individuals lose, on average, 25%–29% of their body weight over the first year. However, many patients begin to plateau and regain weight within 12–24 months, and 20% of patients begin to regain weight within 6 months postsurgery. As physical activity (PA) is an important predictor of weight loss and maintenance postsurgery, there is a need for scalable, effective lifestyle interventions to help bariatric patients increase PA in order to maximize their weight loss and maintenance. To assess feasibility of using mobile health (mHealth) tools to support PA postsurgery, we conducted a quality-improvement optimization pilot of BariFit, an mHealth intervention that combines commercial devices and custom text messages. Fifty-one bariatric patients enrolled in a 16-week optimization pilot of BariFit. To assess feasibility, pre–post changes in PA were assessed using activPAL. In addition, the pilot randomized, using a 2 × 2 factorial design, two adaptive approaches to daily step goals (variable and 60th percentile goals) and provision of rest days (yes/no), and microrandomized provision of SMS-delivered activity suggestions five times a day for each participant. Adherence to using study equipment was over 95% at 16 weeks. Participants increased PA by 1,866 steps from baseline to end-of-study (p < .007). Participants who received variable step goals averaged 1,141 more steps per day (p = .096) than those who received 60th percentile goals. Activity suggestions had no effect. mHealth interventions are feasible for supporting PA postbariatric surgery.

Objective To investigate weight trajectories among patients with severe obesity undergoing sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and nonsurgical treatment. Background Although bariatric procedures are associated with substantial weight loss, few studies have compared surgical outcomes to nonsurgical treatment, particularly for SG. Methods In this retrospective, matched cohort study, adult patients with body mass index ≥35 kg/m who underwent RYGB or SG procedures from January 2005 through September 2015 were matched to 87,965 nonsurgical patients. Hierarchical linear models were used to investigate percent total weight loss (%TWL) and regain at 5 years among RYGB, SG, and nonsurgical patients, and at 10 years for RYGB and nonsurgical patients. Results Among 13,900 SG, 17,258 RYGB, and 87,965 nonsurgical patients, the 5-year follow-up rate was 70.9%, 72.0%, and 64.5%, respectively. At 1 year, RYGB patients had 28.4%TWL (95% confidence interval: 28.2, 28.5), SG 23.0%TWL (22.8, 23.2), and nonsurgical patients 0.2%TWL (0.1, 0.4). At 5 years, RYGB had 21.7%TWL (21.5, 22.0), SG 16.0%TWL (15.4, 16.6), and nonsurgical patients 2.2%TWL (2.0, 2.5). After 5 years, 3.7% of RYGB and 10.1% of SG patients had regained weight to within 5% of baseline. At 10 years, RYGB patients had 20.2%TWL (19.3, 21.0) and nonsurgical patients 4.8%TWL (4.0, 5.5). Conclusions In this study, patients with severe obesity who underwent SG and RYGB lost significantly more weight at 5 years than nonsurgical patients. Weight regain was common after surgery but regain to within 5% of baseline was rare.

Background Bariatric surgery improves glycemic control in patients with type 2 diabetes mellitus (T2DM), but less is known about microvascular outcomes. Objective To investigate the relationship between bariatric surgery and incident microvascular complications of T2DM. Design Retrospective matched cohort study from 2005 to 2011 with follow-up through September 2015. Setting 4 integrated health systems in the United States. Participants Patients aged 19 to 79 years with T2DM who had bariatric surgery (n = 4024) were matched on age, sex, body mass index, hemoglobin A1c level, insulin use, diabetes duration, and intensity of health care use up to 3 nonsurgical participants (n = 11 059). Intervention Bariatric procedures (76% gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) compared with usual care. Measurements Adjusted Cox regression analysis investigated time to incident microvascular disease, defined as first occurrence of diabetic retinopathy, neuropathy, or nephropathy. Results Median follow-up was 4.3 years for both surgical and nonsurgical patients. Bariatric surgery was associated with significantly lower risk for incident microvascular disease at 5 years (16.9% for surgical vs. 34.7% for nonsurgical patients; adjusted hazard ratio [HR], 0.41 [95% CI, 0.34 to 0.48]). Bariatric surgery was associated with lower cumulative incidence at 5 years of diabetic neuropathy (7.2% for surgical vs. 21.4% for nonsurgical patients; HR, 0.37 [CI, 0.30 to 0.47]), nephropathy (4.9% for surgical vs. 10.0% for nonsurgical patients; HR, 0.41 [CI, 0.29 to 0.58]), and retinopathy (7.2% for surgical vs. 11.2% for nonsurgical patients; HR, 0.55 [CI, 0.42 to 0.73]). Limitation Electronic health record databases could misclassify microvascular disease status for some patients. Conclusion In this large, multicenter study of adults with T2DM, bariatric surgery was associated with lower overall incidence of microvascular disease (including lower risk for neuropathy, nephropathy, and retinopathy) than usual care. Primary funding source National Institute of Diabetes and Digestive and Kidney Diseases.

The purpose of this study was to assess whether publication of clinical evidence was associated with increased utilization of bariatric surgery. We systematically searched the literature (1994 to 2008) to identify studies on bariatric surgery. We sorted the evidence by publication date and citation frequency. We linked the published evidence to data from the Kaiser Permanente Washington (KPWA) on 1421 bariatric surgery cases and 45,665 medically managed patients with severe obesity to assess the association between evidence and use of bariatric surgery. We used an interrupted time series analysis with a control group to estimate the association. In secondary analyses, we examined the association with accumulating major clinical evidence, the type of evidence, and stratification by influential tiers. A total of 9913 papers were identified and the top 100 cited papers were initially selected. After inclusion criteria were applied, 35 papers were selected. We selected the fourth quarter in 2004 as the exposure based on publication for the two studies with the largest number of citations. Compared to the projected secular trend, the publication of those two major articles was associated with 50 additional cases of bariatric surgery performed per 100,000 eligible individuals per quarter. In our secondary analyses, higher quality evidence (e.g., RCTs) and more highly cited evidence were each associated with a greater probability of receiving bariatric surgery. For patient members of the KPWA with severe obesity, publication of clinical evidence was associated with increased use of bariatric surgery. This finding suggests that publication of higher quality positive clinical evidence may influence utilization.

Objective The aim of this study was to compare the cost and health care utilization of patients with obesity and type 2 diabetes mellitus (T2DM) randomized into either Roux-en-Y gastric bypass (RYGB) surgery or an intensive lifestyle and medical intervention (ILMI). Methods This analysis (N = 745) is based on 2-year follow-up of a small randomized controlled trial (RCT); adult patients with obesity and T2DM were recruited between 2011 and 2012 from Kaiser Permanente Washington. Comparisons were made for patients randomized into either RYGB (N = 15) or ILMI (N = 17). Results There were no significant cost savings for RYGB versus ILMI patients through the follow-up years. Pharmacy cost was lower for RYGB versus ILMI patients by about $900 in year 2 versus year 0; however, inpatient and emergency room costs were higher for surgery patients in follow-up years relative to year 0. Median total cost for nonrandomized patients was higher in year 0 and in year 2 compared to randomized patients. Conclusions Bariatric surgery is not cost saving in the short term. Moreover, the costs of patients who enter into RCTs of RYGB may differ from the costs of those who do not enter RCTs, suggesting use of caution when using such data to draw inferences about the general population with obesity.

Objective To compare bariatric surgery outcomes according to preoperative mental illness category. Methods Electronic health record data from several US healthcare systems were used to compare outcomes of four groups of patients who underwent bariatric surgery in 2012 and 2013. These included the following: people with (1) no mental illness, (2) mild-to-moderate depression or anxiety, (3) severe depression or anxiety, and (4) bipolar, psychosis, or schizophrenia spectrum disorders. Groups were compared on weight loss trajectory using generalized estimating equations using B-spline bases and on all-cause emergency department visits and hospital days using zero-inflated Poisson and negative binomial regression up to 2 years after surgery. Models were adjusted for demographic and health covariates, including baseline healthcare use. Results Among 8,192 patients, mean age was 44.3 (10.7) years, 79.9% were female, and 45.6% were white. Fifty-seven percent had preoperative mental illness. There were no differences between groups for weight loss, but patients with preoperative severe depression or anxiety or bipolar, psychosis, or schizophrenia spectrum disorders had higher follow-up levels of emergency department visits and hospital days compared to those with no mental illness. Conclusions In this multicenter study, mental illness was not associated with differential weight loss after bariatric surgery, but additional research could focus on reducing acute care use among these patients.

In 2016, the Patient-Centered Outcomes Research Institute funded the National Patient Centered Clinical Research Network (PCORnet) Bariatric Study (PBS). Understanding the experience of postoperative patients was a key component of this study. Nine focus groups were conducted in Southern California, Louisiana, Pennsylvania, and Ohio and in a national advocacy conference for patients with obesity. Participants were identified and recruited in both clinical and community settings. Focus group transcripts were analyzed using an iterative inductive-deductive approach to identify global overarching themes. There were 76 focus group participants. Participants were mostly women (81.4%), had primarily undergone gastric sleeve (47.0%), were non-Hispanic white (51.4%), had some college education (44.3%), and made $100,000 annual income or less (65.7%). Qualitative findings included negative reactions patients received from friends, family, and co-workers once they disclosed that they had bariatric surgery to lose weight; and barriers to follow-up care included insurance coverage, emotional and situational challenges, and physical pain limiting mobility. These findings confirm the other qualitative findings in this area. The approach to bariatric surgery should be expanded to provide long-term comprehensive care that includes in-depth postoperative lifetime monitoring of emotional and physical health.

Summary The coronavirus disease 2019 pandemic is wreaking havoc on society, especially health-care systems, including disrupting bariatric and metabolic surgery. The current limitations on accessibility to non-urgent care undermine postoperative monitoring of patients who have undergone such operations. Furthermore, like most elective surgery, new bariatric and metabolic procedures are being postponed worldwide during the pandemic. When the outbreak abates, a backlog of people seeking these operations will exist. Hence, surgical candidates face prolonged delays of beneficial treatment. Because of the progressive nature of obesity and diabetes, delaying surgery increases risks for morbidity and mortality, thus requiring strategies to mitigate harm. The risk of harm, however, varies among patients, depending on the type and severity of their comorbidities. A triaging strategy is therefore needed. The traditional weight-centric patient-selection criteria do not favour cases based on actual clinical needs. In this Personal View, experts from the Diabetes Surgery Summit consensus conference series provide guidance for the management of patients while surgery is delayed and for postoperative surveillance. We also offer a strategy to prioritise bariatric and metabolic surgery candidates on the basis of the diseases that are most likely to be ameliorated postoperatively. Although our system will be particularly germane in the immediate future, it also provides a framework for long-term clinically meaningful prioritisation.

This cohort study compares the risk of operative and nonoperative interventions up to 4 years after Roux-en-Y gastric bypass vs vertical sleeve gastrectomy in patient groups matched on US region, year of surgery, body mass index category, and type 2 diabetes status., Key Points Question Do patients have greater risk of subsequent operative intervention after Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG)? Findings Among 13 027 patients in this cohort study, compared with matched counterparts undergoing RYGB, patients undergoing VSG had lower overall risk of subsequent operative and nonoperative interventions, including biliary procedures, abdominal wall hernia repair, other abdominal operations, and endoscopy, up to 4 years after surgery. Meaning Patients deciding between RYGB and VSG should consider not only the clinical effectiveness of these 2 procedures but also the risk for subsequent operative and nonoperative interventions., Importance There are few nationwide studies comparing the risk of reintervention after contemporary bariatric procedures. Objective To compare the risk of intervention after Roux-en-Y gastric bypass (RYGB) vs vertical sleeve gastrectomy (VSG). Design, Setting, and Participants This cohort study used a nationwide US commercial insurance claims database. Adults aged 18 to 64 years who underwent a first RYGB or VSG procedure between January 1, 2010, and June 30, 2017, were matched on US region, year of surgery, most recent presurgery body mass index (BMI) category (based on diagnosis codes), and baseline type 2 diabetes. The prematch pool included 4496 patients undergoing RYGB and 8627 patients undergoing VSG, and the final weighted matched sample included 4476 patients undergoing RYGB and 8551 patients undergoing VSG. Exposures Bariatric surgery procedure type (RYGB vs VSG). Main Outcomes and Measures The primary outcome was any abdominal operative intervention after the index procedure. Secondary outcomes included the following subtypes of operative intervention: biliary procedures, abdominal wall hernia repair, bariatric conversion or revision, and other abdominal operations. Nonoperative outcomes included endoscopy and enteral access. Time to first event was compared using multivariable Cox proportional hazards regression modeling. Results Among 13 027 patients, the mean (SD) age was 44.4 (10.3) years, and 74.1% were female; 13.7% had a preoperative BMI between 30 and 39.9, 45.8% had a preoperative BMI between 40 and 49.9, and 24.2% had a preoperative BMI of at least 50. Patients were followed up for up to 4 years after surgery (median, 1.6 years; interquartile range, 0.7-3.2 years), with 41.9% having at least 2 years of follow-up and 16.3% having at least 4 years of follow-up. Patients undergoing VSG were less likely to have any subsequent operative intervention than matched patients undergoing RYGB (adjusted hazard ratio [aHR], 0.80; 95% CI, 0.72-0.89) and similarly were less likely to undergo biliary procedures (aHR, 0.77; 95% CI, 0.67-0.90), abdominal wall hernia repair (aHR, 0.60; 95% CI, 0.47-0.75), other abdominal operations (aHR, 0.71; 95% CI, 0.61-0.82), and endoscopy (aHR, 0.54; 95% CI, 0.49-0.59) or have enteral access placed (aHR, 0.58; 95% CI, 0.39-0.86). Patients undergoing VSG were more likely to undergo bariatric conversion or revision (aHR, 1.83; 95% CI, 1.19-2.80). Conclusions and Relevance In this nationwide study, patients undergoing VSG appeared to be less likely than matched patients undergoing RYGB to experience subsequent abdominal operative interventions, except for bariatric conversion or revision procedures. Patients considering bariatric surgery should be aware of the increased risk of subsequent procedures associated with RYGB vs VSG as part of shared decision-making around procedure choice.

Importance Bariatric surgery has been associated with improvements in health in patients with severe obesity; however, it is unclear whether these health benefits translate into lower health care expenditures. Objective To examine 10-year health care expenditures in a large, multisite retrospective cohort study of veterans with severe obesity who did and did not undergo bariatric surgery. Design, Setting, and Participants A total of 9954 veterans with severe obesity between January 1, 2000, and September 30, 2011, were identified from veterans affairs (VA) electronic health records. Of those, 2498 veterans who underwent bariatric surgery were allocated to the surgery cohort. Sequential stratification was used to match each patient in the surgery cohort with up to 3 patients who had not undergone bariatric surgery but were of the same sex, race/ethnicity, diabetes status, and VA regional network and were closest in age, body mass index (calculated as weight in kilograms divided by height in meters squared), and comorbidities. A total of 7456 patients were identified and allocated to the nonsurgery (control) cohort. The VA health care expenditures among the surgery and nonsurgery cohorts were estimated using regression models. Data were analyzed from July to August 2018 and in April 2019. Interventions The bariatric surgical procedures (n = 2498) included in this study were Roux-en-Y gastric bypass (1842 [73.7%]), sleeve gastrectomy (381 [15.3%]), adjustable gastric banding (249 [10.0%]), and other procedures (26 [1.0%]). Main Outcomes and Measures The study measured total, outpatient, inpatient, and outpatient pharmacy expenditures from 3 years before surgery to 10 years after surgery, excluding expenditures associated with the initial bariatric surgical procedure. Results Among 9954 veterans with severe obesity, 7387 (74.2%) were men; the mean (SD) age was 52.3 (8.8) years for the surgery cohort and 52.5 (8.7) years for the nonsurgery cohort. Mean total expenditures for the surgery cohort were $5093 (95% CI, $4811-$5391) at 7 to 12 months before surgery, which increased to $7448 (95% CI, $6989-$7936) at 6 months after surgery. Postsurgical expenditures decreased to $6692 (95% CI, $6197-$7226) at 5 years after surgery, followed by a gradual increase to $8495 (95% CI, $7609-$9484) at 10 years after surgery. Total expenditures were higher in the surgery cohort than in the nonsurgery cohort during the 3 years before surgery and in the first 2 years after surgery. The expenditures of the 2 cohorts converged 5 to 10 years after surgery. Outpatient pharmacy expenditures were significantly lower among the surgery cohort in all years of follow-up ($509 lower at 3 years before surgery and $461 lower at 7 to 12 months before surgery), but these cost reductions were offset by higher inpatient and outpatient (nonpharmacy) expenditures. Conclusions and Relevance In this cohort study of 9954 predominantly older male veterans with severe obesity, total health care expenditures increased immediately after patients underwent bariatric surgery but converged with those of patients who had not undergone surgery at 10 years after surgery. This finding suggests that the value of bariatric surgery lies primarily in its associations with improvements in health and not in its potential to decrease health care costs.

Objective The goal of this study was to determine whether the reduction in cancer risk after bariatric surgery is due to weight loss. Methods A retrospective matched cohort study of patients undergoing bariatric surgery was conducted using data from a large integrated health insurance and care delivery system with five sites in four states. The study included 18,355 bariatric surgery subjects and 40,524 nonsurgical subjects matched on age, sex, BMI, site, and Elixhauser comorbidity index. Multivariable Cox proportional hazards models examined the relationship between weight loss at 1 year and incident cancer during up to 10 years of follow-up. Results The study identified 1,196 cases of incident cancer. The average 1-year postsurgical weight loss was 27% among patients undergoing bariatric surgery versus 1% in matched nonsurgical patients. Percent weight loss at 1 year was significantly associated with a reduced risk of any cancer in adjusted models (HR 0.897, 95% CI: 0.832-0.968, P = 0.005 for every 10% weight loss) while bariatric surgery was not a significant independent predictor of cancer incidence. Conclusions Weight loss after bariatric surgery was associated with a lower risk of incident cancer. There was no apparent independent effect of the bariatric surgery itself on cancer risk that was independent of weight loss.

OBJECTIVE To identify and quantify any legacy effect of bariatric surgery on risk of incident microvascular disease in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS We conducted a retrospective observational cohort study (n = 4,683; 40% racial/ethnic minority) of patients with type 2 diabetes who underwent bariatric surgery from 2001 through 2011. The primary outcome measure was incident microvascular disease defined as a composite indicator of the first occurrence of retinopathy, neuropathy, and/or nephropathy. The Cox proportional hazards framework was used to investigate the associations between type 2 diabetes remission/relapse status and time to microvascular disease. RESULTS Covariate-adjusted analyses showed that patients who experienced type 2 diabetes remission had 29% lower risk of incident microvascular disease compared with patients who never remitted (hazard ratio [HR] 0.71 [95% CI 0.60, 0.85]). Among patients who experienced a relapse after remission, the length of time spent in remission was inversely related to the risk of incident microvascular disease; for every additional year of time spent in remission prior to relapse, the risk of microvascular disease was reduced by 19% (HR 0.81 [95% CI 0.67, 0.99]) compared with patients who never remitted. CONCLUSIONS Our results indicate that remission of type 2 diabetes after bariatric surgery confers benefits for risk of incident microvascular disease even if patients eventually experience a relapse of their type 2 diabetes. This provides support for a legacy effect of bariatric surgery, where even a transient period of surgically induced type 2 diabetes remission is associated with lower long-term microvascular disease risk.

Understanding of the long-term clinical outcomes associated with bariatric surgery has recently been advanced. Research related to the sequelae of diabetes—in particular, long-term microvascular and macrovascular complications—in patients who undergo weight-loss surgery is imperative to this pursuit. While numerous randomized control trials have assessed glucose control with bariatric surgery compared with intensive medical therapy, bariatric surgery outcome data relating to microvascular and macrovascular complications have been limited to observational studies and nonrandomized clinical trials. As a result, whether bariatric surgery is associated with a long-term reduction in microvascular and macrovascular complications when compared with current intensive glycemic control therapy cannot be determined because the evidence is insufficient. However, the consistent salutary effects of bariatric surgery on diabetes remission and glycemic improvement support the opportunity (and need) to conduct high-quality studies of bariatric surgery versus intensive glucose control. This review provides relevant background information related to the treatment of diabetes, hyperglycemia, and long-term complications; reports clinical findings (to date) with bariatric surgery; and identifies ongoing research focusing on long-term vascular outcomes associated with bariatric surgery.

Importance Severe obesity and its related diseases, such as type 2 diabetes, hypertension, dyslipidemia, and sleep apnea, are very common in the United States, but currently very few patients with these conditions choose to undergo bariatric surgery. Summaries of the expanding evidence for both the benefits and risks of bariatric surgery are needed to better guide shared decision-making conversations. Observations There are approximately 252 000 bariatric procedures (per 2018 numbers) performed each year in the US, of which an estimated 15% are revisions. The 1991 National Institutes of Health guidelines recommended consideration of bariatric surgery in patients with a body mass index (calculated as weight in kilograms divided by height in meters squared) of 40 or higher or 35 or higher with serious obesity-related comorbidities. These guidelines are still widely used; however, there is increasing evidence that bariatric procedures should also be considered for patients with type 2 diabetes and a body mass index of 30 to 35 if hyperglycemia is inadequately controlled despite optimal medical treatment for type 2 diabetes. Substantial evidence indicates that surgery results in greater improvements in weight loss and type 2 diabetes outcomes, compared with nonsurgical interventions, regardless of the type of procedures used. The 2 most common procedures used currently, the sleeve gastrectomy and gastric bypass, have similar effects on weight loss and diabetes outcomes and similar safety through at least 5-year follow-up. However, emerging evidence suggests that the sleeve procedure is associated with fewer reoperations, and the bypass procedure may lead to more durable weight loss and glycemic control. Although safety is a concern, current data indicate that the perioperative mortality rates range from 0.03% to 0.2%, which has substantially improved since early 2000s. More long-term randomized studies are needed to assess the effect of bariatric procedures on cardiovascular disease, cancer, and other health outcomes and to evaluate emerging newer procedures. Conclusions and Relevance Modern bariatric procedures have strong evidence of efficacy and safety. All patients with severe obesity—and especially those with type 2 diabetes—should be engaged in a shared decision-making conversation about the risks and benefits of surgery compared with continuing usual medical and lifestyle treatment, and the decision about surgery should be driven primarily by informed patient preferences.

Importance Bariatric surgery can lead to substantial improvements in type 2 diabetes (T2DM), but outcomes vary across procedures and populations. It is unclear which bariatric procedure has the most benefits for patients with T2DM. Objective To evaluate associations of bariatric surgery with T2DM outcomes. Design, Setting, and Participants This cohort study was conducted in 34 US health system sites in the National Patient-Centered Clinical Research Network Bariatric Study. Adult patients with T2DM who had bariatric surgery between January 1, 2005, and September 30, 2015, were included. Data analysis was conducted from April 2017 to August 2019. Interventions Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). Main Outcome and Measures Type 2 diabetes remission, T2DM relapse, percentage of total weight lost, and change in glycosylated hemoglobin (hemoglobin A1c). Results A total of 9710 patients were included (median [interquartile range] follow-up time, 2.7 [2.9] years; 7051 female patients [72.6%]; mean [SD] age, 49.8 [10.5] years; mean [SD] BMI, 49.0 [8.4]; 6040 white patients [72.2%]). Weight loss was significantly greater with RYGB than SG at 1 year (mean difference, 6.3 [95% CI, 5.8-6.7] percentage points) and 5 years (mean difference, 8.1 [95% CI, 6.6-9.6] percentage points). The T2DM remission rate was approximately 10% higher in patients who had RYGB (hazard ratio, 1.10 [95% CI, 1.04-1.16]) than those who had SG. Estimated adjusted cumulative T2DM remission rates for patients who had RYGB and SG were 59.2% (95% CI, 57.7%-60.7%) and 55.9% (95% CI, 53.9%-57.9%), respectively, at 1 year and 86.1% (95% CI, 84.7%-87.3%) and 83.5% (95% CI, 81.6%-85.1%) at 5 years postsurgery. Among 6141 patients who experienced T2DM remission, the subsequent T2DM relapse rate was lower for those who had RYGB than those who had SG (hazard ratio, 0.75 [95% CI, 0.67-0.84]). Estimated relapse rates for those who had RYGB and SG were 8.4% (95% CI, 7.4%-9.3%) and 11.0% (95% CI, 9.6%-12.4%) at 1 year and 33.1% (95% CI, 29.6%-36.5%) and 41.6% (95% CI, 36.8%-46.1%) at 5 years after surgery. At 5 years, compared with baseline, hemoglobin A1cwas reduced 0.45 (95% CI, 0.27-0.63) percentage points more for patients who had RYGB vs patients who had SG. Conclusions and Relevance In this large multicenter study, patients who had RYGB had greater weight loss, a slightly higher T2DM remission rate, less T2DM relapse, and better long-term glycemic control compared with those who had SG. These findings can help inform patient-centered surgical decision-making.

Importance Additional data comparing longer-term problems associated with various bariatric surgical procedures are needed for shared decision-making. Objective To compare the risks of intervention, operation, endoscopy, hospitalization, and mortality up to 5 years after 2 bariatric surgical procedures. Design, Setting, and Participants Adults who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) between January 1, 2005, and September 30, 2015, within the National Patient-Centered Clinical Research Network. Data from 33 560 adults at 10 centers within 4 clinical data research networks were included in this cohort study. Information was extracted from electronic health records using a common data model and linked to insurance claims and mortality indices. Analyses were conducted from January 2018 through October 2019. Exposures Bariatric surgical procedures. Main Outcomes and Measures The primary outcome was time until operation or intervention. Secondary outcomes included endoscopy, hospitalization, and mortality rates. Results Of 33 560 adults, 18 056 (54%) underwent RYGB, and 15 504 (46%) underwent SG. The median (interquartile range) follow-up for operation or intervention was 3.4 (1.6-5.0) years for RYGB and 2.2 (0.9-3.6) years for SG. The overall mean (SD) patient age was 45.0 (11.5) years, and the overall mean (SD) patient body mass index was 49.1 (7.9). The cohort was composed predominantly of women (80%) and white individuals (66%), with 26% of Hispanic ethnicity. Operation or intervention was less likely for SG than for RYGB (hazard ratio, 0.72; 95% CI, 0.65-0.79;P Conclusions and Relevance Interventions, operations, and hospitalizations were relatively common after bariatric surgical procedures and were more often associated with RYGB than SG. Trial Registration ClinicalTrials.gov identifier:NCT02741674

Objective This study aims to describe geographic variation in veterans' prevalence of obesity, participation in Veterans Health Administration's behavioral weight management program (MOVE!), and receipt of bariatric surgery in fiscal year (FY) 2016. Methods In this retrospective cohort study of veterans with obesity who received Veterans Health Administration care in FY2016, electronic health record data were obtained on weight, height, outpatient visits to the MOVE! program, and bariatric surgeries. For each Veterans Integrated Service Network (VISN) region, the prevalence rate of veterans with obesity (BMI ≥ 30 kg/m2 ), MOVE! participation rates, and bariatric surgery rates are presented. Results The prevalence of obesity in veterans ranged from 30.5% to 40.5% across VISNs in FY2016. MOVE! participation among veterans with obesity was low (2.8%-6.9%) across all VISNs, but veterans with class II and III obesity (BMI ≥ 35) had higher MOVE! participation rates (4.3%-10.8%) than veterans with class I obesity. There was 20-fold variation across VISNs in receipt of bariatric surgery among veterans with BMI ≥ 35, ranging from 0.01% to 0.2%. Among veterans with BMI ≥ 35 participating in MOVE!, there was 46-fold variation in bariatric surgery provision, ranging from 0.07% to 3.27%. Conclusions Despite veterans' high prevalence of obesity, behavioral and surgical weight management participation is low and varies across regions.

Background Bariatric surgery has been used for treatment of severe obesity in adolescents but most studies have been small and limited in follow-up. Objectives We hypothesized that electronic health record data could be used to compare effectiveness of bariatric procedures in adolescents. Setting Data were obtained from clinical research networks using a common data model to extract data from each site. Methods Adolescents who underwent a primary bariatric procedure from 2005 through 2015 were identified. The percent change in body mass index (BMI) at 1, 3, and 5 years was estimated using random effects linear regression for patients undergoing all operations. Propensity score adjusted estimates and 95% confidence intervals were estimated for procedures with >25 patients at each time period. Results This cohort of 544 adolescents was predominantly female (79%) and White (66%), with mean (±standard deviation) age of 17.3 (±1.6) years and mean BMI of 49.8 (± 7.8) kg/m2. Procedures included Roux-en-Y gastric bypass (RYGB; n = 177), sleeve gastrectomy (SG; n = 306), and laparoscopic adjustable gastric banding (n = 61). For those undergoing RYGB, SG, and laparoscopic adjustable gastric banding, mean (95% confidence interval) BMI changes of −31% (−30% to −33%), −28% (−27% to −29%), and −10% (−8% to −12%), were estimated at 1 year. For RYGB and SG, BMI changes of −29% (−26% to −33%) and −25% (−22% to −28%) were estimated at 3 years. Conclusions Adolescents undergoing SG and RYGB experienced greater declines in BMI at 1- and 3-year follow-up time points, while laparoscopic adjustable gastric banding was significantly less effective for BMI reduction. (Surg Obes Relat Dis 2018;000:1–13.)

To determine whether bariatric surgery is associated with a lower risk of cancer.Obesity is strongly associated with many types of cancer. Few studies have examined the relationship between bariatric surgery and cancer risk.We conducted a retrospective cohort study of patients undergoing bariatric surgery between 2005 and 2012 with follow-up through 2014 using data from a large integrated health insurance and care delivery systems with 5 study sites. The study included 22,198 subjects who had bariatric surgery and 66,427 nonsurgical subjects matched on sex, age, study site, body mass index, and Elixhauser comorbidity index. Multivariable Cox proportional-hazards models were used to examine incident cancer up to 10 years after bariatric surgery compared to the matched nonsurgical patients.After a mean follow-up of 3.5 years, we identified 2543 incident cancers. Patients undergoing bariatric surgery had a 33% lower hazard of developing any cancer during follow-up [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.60, 0.74, P0.001) compared with matched patients with severe obesity who did not undergo bariatric surgery, and results were even stronger when the outcome was restricted to obesity-associated cancers (HR 0.59, 95% CI 0.51, 0.69, P0.001). Among the obesity-associated cancers, the risk of postmenopausal breast cancer (HR 0.58, 95% CI 0.44, 0.77, P0.001), colon cancer (HR 0.59, 95% CI 0.36, 0.97, P = 0.04), endometrial cancer (HR 0.50, 95% CI 0.37, 0.67, P0.001), and pancreatic cancer (HR 0.46, 95% CI 0.22, 0.97, P = 0.04) was each statistically significantly lower among those who had undergone bariatric surgery compared with matched nonsurgical patients.In this large, multisite cohort of patients with severe obesity, bariatric surgery was associated with a lower risk of incident cancer, particularly obesity-associated cancers, such as postmenopausal breast cancer, endometrial cancer, and colon cancer. More research is needed to clarify the specific mechanisms through which bariatric surgery lowers cancer risk.

Background The Obesity Surgery Mortality Risk Score (OS-MRS) was developed using data from 1995 to 2004; it has yet to be validated for more recent patients in integrated delivery system settings. The objective of this study was to validate the OS-MRS using data from electronic health records in a distributed data network. Methods We conducted a retrospective cohort study of 3,817 adults who underwent an open (21.4%) or laparoscopic (78.6%) gastric bypass surgery between 2005 and 2007 in the Scalable Partnering Network. Our main outcome was all-cause mortality during the 90 days after surgery. We scored patients' risk of mortality by adding characteristics according to the OS-MRS (i.e., 1 point for each predictor). Results Sixteen of 3,817 (0.42/100; 95% CI, .24–.68) patients died within 90 days. The OS-MRS discriminated low-risk and high-risk patients effectively: low-risk (2 of 1,654 patients; .12 deaths/100 patients), intermediate-risk (10 of 2,008 patients; .50 deaths/100 patients), and high-risk (4 of 155 patients; 2.58 deaths/100 patients). High-risk patients were 21.3 times more likely to die in the first 90 days after surgery than low-risk patients (risk ratio=21.3; 95% CI, 3.9–115.6). Conclusion In these 10 U.S. healthcare delivery systems, the OS-MRS appears valid—albeit with the caveat that we observed a small number of deaths. The OS-MRS appears useful for identifying the small fraction of patients at high risk for 90-day mortality after open and laparoscopic RYGB.

Background Severely obese patients considering bariatric surgery face a difficult decision given the tradeoff between the benefits and risks of surgery. The objectives of this study was to study the forces driving this decision and improve our understanding of the decision-making process. Methods A 64-item survey was developed to assess factors in the decision-making process for bariatric surgery. The survey included the decisional conflict scale, decision self-efficacy scale, EuroQol 5D, and the standard gamble. Patients were recruited from a regularly scheduled bariatric surgery interest group meeting associated with a large, university-based bariatric practice and administered a survey at the conclusion of the interest group. Logistic regression models were used to predict who pursued or still planned to pursue surgery at 12 months. Results 200 patients were recruited over an 8-month period. Mean age was 45 years; mean BMI was 48 kg/m 2 , and 77% were female. The 12-month follow-up rate was 95%. At 12 months, 33 patients (17.6%) had surgery and 30 (16.0%) still planned to have surgery. There was no association between age, gender, or obesity-associated conditions and surgery or plan to have surgery. Patients having surgery or still planning to have surgery had significantly worse scores for quality of life and better scores for decisional conflict (indicating readiness to make a decision). Conclusion The decision to have bariatric surgery is strongly associated with patientsʼ perceptions of their current quality of life. In addition, lower decisional conflict and higher self-efficacy are predictive of surgery. Interestingly, factors that clinicians might consider important, such as gender, age, and the presence of obesity-associated co-morbidities did not influence patientsʼ decisions.

Background Randomized trials of bariatric surgery versus lifestyle treatment likely enroll highly motivated patients, which may limit the interpretation and generalizability of study findings. The objective of this study was to assess the feasibility of a population-based shared decision-making (SDM) approach to recruitment for a trial comparing laparoscopic Roux-en-Y gastric bypass surgery with intensive lifestyle intervention among adults with mild to moderate obesity and type 2 diabetes. Methods Adult members with a body mass index (BMI) between 30 and 45 kg/m 2 taking diabetes medications were identified in electronic databases and underwent a multiphase screening process. Candidates were given a telephone survey, education about treatment options for obesity and diabetes using decision aids, and an SDM phone call with a nurse practitioner, in addition to standard office-based consent. Results We identified 1808 members, and 828 (45.7%) had a BMI of 30–34.9 kg/m 2 . Among these, 1063 (59%) agreed to the telephone survey, 416 (23%) expressed interest in education about treatment options, and 277 (15%) completed the SDM process. The preferred treatment options were surgery (21 [8%]), diet and exercise (149 [53.8%]), pharmacotherapy (5 [2%]), none of the above (8 [3%]), and unsure (94 [34%]). Ultimately, 43 participants were randomly assigned to the trial. Significant differences, mainly related to sex, disease severity, and hypoglycemic medication use, were observed among people who did and did not agree to participate in our trial. Conclusion This population-based, SDM-based recruitment strategy successfully identified, enrolled, and randomly assigned patients who had balanced views of surgery and lifestyle management. Even with this approach, selection biases may remain, highlighting the need for careful characterization of nonparticipants in all future studies.