Health Expenditures After Bariatric Surgery: A Retrospective Cohort Study.

OBJECTIVE: Bariatric surgery leads to substantial improvements in weight and weight-related conditions, but prior literature on post-surgical health expenditures is equivocal. In a retrospective cohort study, we compared expenditures between surgical and matched non-surgical patients. SUMMARY BACKGROUND DATA AND METHODS: In a retrospective study, total, outpatient, inpatient and medication expenditures 3 years before and 5.5 years after surgery were compared between 22,698 bariatric surgery (n=7,127 RYGB, 15,571 sleeve gastrectomy) patients from 2012-2019 and 66,769 matched non-surgical patients, using generalized estimating equations. We also compared expenditures between patients receiving the two leading surgical procedures in weighted analyses. RESULTS: Surgical and non-surgical cohorts were well matched, 80-81% female, with mean body mass index (BMI) of 44, and mean age of 47 (RYGB) and 44 (SG) years. Estimated total expenditures were similar between surgical and non-surgical groups 3 years before surgery ($27 difference, 95% confidence interval (CI): -42, 102)), increased 6 months prior to surgery for surgical patients, and decreased below pre-period levels for both groups after 3-5.5 years to become similar (difference at 5.5 y=-$61, 95% CI: -166, 52). Long-term outpatient expenditures were similar between groups. Surgical patients' lower long-term medication expenditures ($314 lower at 5.5 y, 95% CI: -419, -208) were offset by a higher risk of hospitalization. Total expenditures were similar between RYGB and SG patients 3.5 to 5.5 years after surgery. CONCLUSIONS: Bariatric surgery translated into lower medication expenditures than matched controls, but not lower overall long-term expenditures. Expenditure trends appear similar for the two leading bariatric operations.

Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes.

Importance: Randomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration. Objective: To determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes. Design, Setting, and Participants: ARMMS-T2D (Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes) is a pooled analysis from 4 US single-center randomized trials conducted between May 2007 and August 2013, with observational follow-up through July 2022. Intervention: Participants were originally randomized to undergo either medical/lifestyle management or 1 of the following 3 bariatric surgical procedures: Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding. Main Outcome and Measures: The primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 7 years for all participants. Data are reported for up to 12 years. Results: A total of 262 of 305 eligible participants (86%) enrolled in long-term follow-up for this pooled analysis. The mean (SD) age of participants was 49.9 (8.3) years, mean (SD) body mass index was 36.4 (3.5), 68.3% were women, 31% were Black, and 67.2% were White. During follow-up, 25% of participants randomized to undergo medical/lifestyle management underwent bariatric surgery. The median follow-up was 11 years. At 7 years, HbA1c decreased by 0.2% (95% CI, -0.5% to 0.2%), from a baseline of 8.2%, in the medical/lifestyle group and by 1.6% (95% CI, -1.8% to -1.3%), from a baseline of 8.7%, in the bariatric surgery group. The between-group difference was -1.4% (95% CI, -1.8% to -1.0%; P < .001) at 7 years and -1.1% (95% CI, -1.7% to -0.5%; P = .002) at 12 years. Fewer antidiabetes medications were used in the bariatric surgery group. Diabetes remission was greater after bariatric surgery (6.2% in the medical/lifestyle group vs 18.2% in the bariatric surgery group; P = .02) at 7 years and at 12 years (0.0% in the medical/lifestyle group vs 12.7% in the bariatric surgery group; P < .001). There were 4 deaths (2.2%), 2 in each group, and no differences in major cardiovascular adverse events. Anemia, fractures, and gastrointestinal adverse events were more common after bariatric surgery. Conclusion and Relevance: After 7 to 12 years of follow-up, individuals originally randomized to undergo bariatric surgery compared with medical/lifestyle intervention had superior glycemic control with less diabetes medication use and higher rates of diabetes remission. Trial Registration: ClinicalTrials.gov Identifier: NCT02328599.

Acute Care Utilization and Costs Up to 4 Years After Index Sleeve Gastrectomy or Roux-en-Y Gastric Bypass: A National Claims-based Study.

OBJECTIVE: To compare acute care utilization and costs following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). SUMMARY BACKGROUND DATA: Comparing postbariatric 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, sex, calendar-time, diabetes, and baseline acute care use. We used adjusted Cox proportional hazards to compare acute care utilization and 2-part logistic regression models to compare annual associated costs (odds of any cost, and odds of high costs, defined as ≥80th 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 [adjusted hazard ratio (aHR): 0.90; 95% confidence interval (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 (eg, year-1 acute costs adjusted odds ratio (aOR) 0.77; 95% CI: 0.66,0.90) in early follow-up. However, observed cost differences decreased by years 3 and 4 (eg, 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.

Out-of-pocket Costs for Commercially-insured Patients in the Years Following Bariatric Surgery: Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass.

OBJECTIVE: To compare out-of-pocket (OOP) costs for patients up to 3 years after bariatric surgery in a large, commercially-insured population. SUMMARY OF BACKGROUND DATA: More information on OOP costs following bariatric surgery may affect patients' procedure choice. METHODS: 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. RESULTS: 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% confidence interval [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. CONCLUSIONS: 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.

Births After Bariatric Surgery in the United States: Incidence, Obstetric Outcomes, and Reinterventions.

OBJECTIVE: To characterize incidence and outcomes for bariatric surgery patients who give birth. BACKGROUND: Patients of childbearing age comprise 65% of bariatric surgery patients in the United States, yet data on how often patients conceive and obstetric outcomes are limited. METHODS: Using the IBM MarketScan database, we performed a retrospective cohort study of female patients ages 18 to 52 undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass from 2011 to 2017. We determined the incidence of births in the first 2 years after bariatric surgery using Kaplan-Meier estimates. We then restricted the cohort to those with a full 2-year follow-up to examine obstetric outcomes and bariatric-related reinterventions. We reported event rates of adverse obstetric outcomes and delivery type. Adverse obstetric outcomes include pregnancy complications, severe maternal morbidity, and delivery complications. We performed multivariable logistic regression to examine associations between birth and risk of reinterventions. RESULTS: Of 69,503 patients who underwent bariatric surgery, 1464 gave birth. The incidence rate was 2.5 births per 100 patients in the 2 years after surgery. Overall, 85% of births occurred within 21 months after surgery. For 38,922 patients with full 2-year follow-up, adverse obstetric event rates were 4.5% for gestational diabetes and 14.2% for hypertensive disorders. In all, 48.5% were first-time cesarean deliveries. Almost all reinterventions during pregnancy were biliary. Multivariable logistic regression analysis showed no association between postbariatric birth and reintervention rate (odds ratio: 0.93, 95% confidence interval: 0.78-1.12). CONCLUSIONS: In this first national US cohort, we find giving birth was common in the first 2 years after bariatric surgery and was not associated with an increased risk of reinterventions. Clinicians should consider shifting the dialogue surrounding pregnancy after surgery to shared decision-making with maternal safety as one component.

Bariatric Surgery and Suicide Risk in Patients With Obesity.

OBJECTIVE: In a large multisite cohort of Veterans who underwent Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy, we compared the 5-year suicidal ideation and attempt rates with matched nonsurgical controls. BACKGROUND: Bariatric surgery has significant health benefits but has also been associated with adverse mental health outcomes. METHODS: Five-year rates of suicidal ideation and suicide attempts of Veterans who underwent Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy from the fiscal year 2000-2016 to matched nonsurgical controls using sequential stratification using cumulative incidence functions (ideation cohort: n=38,199; attempt cohort: n=38,661 after excluding patients with past-year outcome events). Adjusted differences in suicidal ideation and suicide attempts were estimated using a Cox regression with a robust sandwich variance estimator. RESULTS: In the matched cohorts for suicidal ideation analyses, the mean age was 53.47 years and the majority were males (78.7%) and White (77.7%). Over 40% were treated for depression (41.8%), had a nonrecent depression diagnosis (40.9%), and 4.1% had past suicidal ideation or suicide attempts >1 year before index. Characteristics of the suicide attempt cohort were similar. Regression results found that risk of suicidal ideation was significantly higher for surgical patients (adjusted hazard ratio=1.21, 95% CI: 1.03-1.41), as was risk of suicide attempt (adjusted hazard ratio=1.62, 95% CI: 1.22-2.15). CONCLUSIONS: Bariatric surgery appears to be associated with a greater risk of suicidal ideation and attempts than nonsurgical treatment of patients with severe obesity, suggesting that patients need careful monitoring for suicidal ideation and additional psychological support after bariatric surgery.

Reduction in Long-term Mortality After Sleeve Gastrectomy and Gastric Bypass Compared to Nonsurgical Patients With Severe Obesity.

OBJECTIVE: To separately compare the long-term risk of mortality among bariatric surgical patients undergoing either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (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 RYGB operation and there is less long-term data on the SG. METHODS: In this retrospective, matched cohort study, patients with a body mass index ≥35 kg/m 2 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 tradeoffs between long-term benefits and risks of bariatric surgery.

Preoperative Depression Status and 5 Year Metabolic and Bariatric Surgery Outcomes in the PCORnet Bariatric Study Cohort.

OBJECTIVE: To examine whether depression status before metabolic and bariatric surgery (MBS) influenced 5-year weight loss, diabetes, and safety/utilization outcomes in the PCORnet Bariatric Study. SUMMARY OF BACKGROUND DATA: Research on the impact of depression on MBS outcomes is inconsistent with few large, long-term studies. METHODS: Data were extracted from 23 health systems on 36,871 patients who underwent sleeve gastrectomy (SG; n=16,158) or gastric bypass (RYGB; n=20,713) from 2005-2015. Patients with and without a depression diagnosis in the year before MBS were evaluated for % total weight loss (%TWL), diabetes outcomes, and postsurgical safety/utilization (reoperations, revisions, endoscopy, hospitalizations, mortality) at 1, 3, and 5 years after MBS. RESULTS: 27.1% of SG and 33.0% of RYGB patients had preoperative depression, and they had more medical and psychiatric comorbidities than those without depression. At 5 years of follow-up, those with depression, versus those without depression, had slightly less %TWL after RYGB, but not after SG (between group difference = 0.42%TWL, P = 0.04). However, patients with depression had slightly larger HbA1c improvements after RYGB but not after SG (between group difference = - 0.19, P = 0.04). Baseline depression did not moderate diabetes remission or relapse, reoperations, revision, or mortality across operations; however, baseline depression did moderate the risk of endoscopy and repeat hospitalization across RYGB versus SG. CONCLUSIONS: Patients with depression undergoing RYGB and SG had similar weight loss, diabetes, and safety/utilization outcomes to those without depression. The effects of depression were clinically small compared to the choice of operation.

Bariatric Surgery in Medicare Patients: Examining Safety and Healthcare Utilization in the Disabled and Elderly.

OBJECTIVE: To compare safety and healthcare utilization after sleeve gastrectomy versus Roux-en-Y gastric bypass in a national Medicare cohort. SUMMARY BACKGROUND DATA: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Bariatric surgery is safe, and healthcare utilization benefits of sleeve over bypass are preserved across both Medicare elderly and disabled subpopulations.

Comparative Safety of Sleeve Gastrectomy and Gastric Bypass: An Instrumental Variables Approach.

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.

The Effect of Bariatric Surgery on Long-term Depression Treatment in Patients With Obesity.

OBJECTIVE: In a large multisite cohort of Veterans who underwent Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG), initiation of (ie, incident) and persistence of (ie, continuation of preoperative) depression treatment are compared with matched nonsurgical controls. BACKGROUND: Bariatric surgery has been associated with short-term improvements in depression but less is known about longer term outcomes. METHODS: In a retrospective cohort study, we matched 1713 Veterans with depression treatment who underwent bariatric surgery in Veterans Administration bariatric centers from fiscal year 2001 to 2016 to 15,056 nonsurgical controls using sequential stratification and examined the persistence of depression treatment via generalized estimating equations. Incidence of depression treatment was compared using Cox regression models between 2227 surgical patients and 20,939 matched nonsurgical controls without depression treatment at baseline. RESULTS: In surgical patients with depression treatment at baseline, the use of postsurgical depression treatment declined over time for both surgical procedures, but postsurgical patients had greater use of depression treatment at 5 years [RYGB: odds ratio=1.24, 95% confidence interval (CI): 1.04-1.49; LSG: odds ratio=1.27, 95% CI: 1.04-1.56] compared with controls. Among those without depression treatment at baseline, bariatric surgery was associated with a higher incidence of depression treatment compared with matched controls (RYGB: hazard ratio=1.34, 95% CI: 1.17-1.53; LSG: hazard ratio at 1-5 years=1.27, 95% CI: 1.10-1.47). CONCLUSIONS: Bariatric surgery was associated with a greater risk of postoperative incident depression treatment and greater persistence of postoperative depression treatment. Depression may worsen for some patients after bariatric surgery, so clinicians should carefully monitor their patients for depression postoperatively.

Bariatric Surgery and Risk of Death in Persons With Chronic Kidney Disease.

OBJECTIVE: A retrospective cohort study investigated the association between having surgery and risk of mortality for up to 5 years and if this association was modified by incident ESRD during the follow-up period. Summary of Background Data: Mortality risk in individuals with pre-dialysis 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 January 1, 2006 and September 30, 2015 (n = 802) were matched to patients who did not have surgery (n = 4933). 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 body mass index > 40kg/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 (hazard ratio = 0.21; 95% confidence interval: 0.14-0.32; P < 0.001). Incident ESRD did not moderate the observed association between surgery and mortality (hazard ratio = 1.59; 95% confidence interval: 0.31-8.23; P =0.58). 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.

Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D): Study rationale, design, and methods.

AIMS: Long-term data from randomized clinical trials comparing metabolic (bariatric) surgery versus a medical/lifestyle intervention for treatment of patients with obesity/overweight and type 2 diabetes (T2D) are lacking. The Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) is a consortium of four randomized trials designed to compare long-term efficacy and safety of surgery versus medical/lifestyle therapy on diabetes control and clinical outcomes. MATERIALS AND METHODS: Patients with T2D and body mass index (BMI) of 27-45 kg/m2 who were previously randomized to metabolic surgery (Roux-en-Y gastric bypass, adjustable gastric band, or sleeve gastrectomy) versus medical/lifestyle intervention in the STAMPEDE, SLIMM-T2D, TRIABETES, or CROSSROADS trials have been enrolled in ARMMS-T2D for observational follow-up. The primary outcome is change in glycated haemoglobin after a minimum 7 years of follow-up, with additional analyses to determine rates of diabetes remission and relapse, as well as cardiovascular and renal endpoints. RESULTS: In total, 302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS-T2D observational study. Participant demographics were 71% white, 27% African-American and 68% female. At baseline: age, 50 ± 8 years; BMI, 36.5 ± 3.5 kg/m2 ; duration of diabetes, 8.8 ± 5.6 years; glycated haemoglobin, 8.6% ± 1.6%; and fasting glucose, 168 ± 64 mg/dl. More than 35% of patients had a BMI <35 kg/m2 . CONCLUSIONS: ARMMS-T2D will provide the largest body of long-term, level 1 evidence to inform clinical decision-making regarding the comparative durability, efficacy and safety of metabolic surgery relative to a medical/lifestyle intervention among patients with T2D, including those with milder class I obesity or mere overweight.

Comparative effectiveness of sleeve gastrectomy vs Roux-en-Y gastric bypass in patients giving birth after bariatric surgery: reinterventions and obstetric outcomes.

BACKGROUND: Women of childbearing age comprise approximately 65% of all patients who undergo bariatric surgery in the USA. Despite this, data on maternal reintervention and obstetric outcomes after surgery are limited especially with regard to comparative effectiveness between sleeve gastrectomy and Roux-en-Y gastric bypass, the most common procedures today. METHODS: Using IBM MarketScan claims data, we performed a retrospective cohort study of women ages 18-52 who gave birth after undergoing laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass with 2-year continuous follow-up. We balanced the cohort on observable characteristics using inverse probability weighting. We utilized multivariable logistic regression to examine the association between procedure selection and outcomes, including risk of reinterventions (revisions, enteral access, vascular access, reoperations, other) or adverse obstetric outcomes (pregnancy complications, severe maternal morbidity, and delivery complications). In all analyses, we controlled for age, U.S. state, and Elixhauser or Bateman comorbidities. RESULTS: From 2011 to 2016, 1,079 women gave birth within the first two years after undergoing bariatric surgery. Among these women, we found no significant difference in reintervention rates among those who had gastric bypass compared to sleeve gastrectomy (OR 1.41, 95% CI 0.91-2.21, P = 0.13). We then examined obstetric outcomes in the patients who gave birth after bariatric surgery. Compared to patients who underwent sleeve gastrectomy, those who had Roux-en-Y gastric bypass were not significantly more likely to experience any adverse obstetric outcomes. CONCLUSION: In this first national cohort of females giving birth following bariatric surgery, no significant difference was observed in persons who underwent Roux-en-Y gastric bypass versus sleeve gastrectomy with respect to either reinterventions or obstetric outcomes. This suggests possible equipoise between these two procedures with regards to safety within the first two years following a bariatric procedure among women who may become pregnant, but more research is needed to confirm these findings in larger samples.

Volume-outcome relationships for Roux-en-Y gastric bypass patients in the sleeve gastrectomy era.

BACKGROUND: Sleeve gastrectomy is now the most common bariatric operation performed. With lower volumes of Roux-en-Y gastric bypass (RYGB), it is unclear whether decreasing surgeon experience has led to worsening outcomes for this procedure. METHODS: We used State Inpatient Databases from Florida, Iowa, New York, and Washington. Bariatric surgeons were designated as those who performed ten or more bariatric procedures yearly. Patients who had RYGB were included in our analysis. Using multi-level logistic regression, we examined whether surgeon average yearly RYGB volume was associated with RYGB patient 30-day complications, reoperations, and readmissions and 1-year revisions and readmissions. RESULTS: From 2013 to 2017 there were 27,714 patients who underwent laparoscopic RYGB by 311 surgeons. Median surgeon volume was 77 RYGBs per year. The distribution was 10 bypasses yearly at the 5th percentile, 16 bypasses at the 10th percentile, 38 bypasses at the 25th percentile, and 133 bypasses at the 75th percentile. Multi-level regression revealed that patients of surgeons with lower RYGB volumes had small but statistically significant increased risks of 30-day complications and 1-year readmissions. At 30 days, risk for any complication was 6.71%, 6.43%, and 5.55% at 10, 38, and 133 bypasses per year, respectively (p = 0.01). Risk for readmission at 1 year was 13.90%, 13.67%, and 12.90% at 10, 38, and 133 bypasses per year, respectively (p = 0.099). Of note, volume associations with complications and reoperations due to hemorrhage and leak were not statistically significant. There was also no significant association with revisions. CONCLUSION: This is the first study to examine the association of surgeon RYGB volume with patient outcomes as the national experience with RYGB diminishes. Overall, surgeon RYGB volume does not appear to have a large effect on patient outcomes. Thus, patients can safely pursue RYGB in this early phase of the sleeve gastrectomy era.

Comparative Effectiveness of Vertical Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Diabetes Treatment: A Claims-based Cohort Study.

OBJECTIVE: The aim of the study was to compare diabetes outcomes following vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB). BACKGROUND: There are few comparative studies on diabetes outcomes after VSG and RYGB. METHODS: We used a US-wide commercial insurance claims database to identify adults with diabetes undergoing VSG or RYGB in 2010 to 2016. We matched patients on baseline insulin use, total diabetes medication burden, age, presence of diabetes complications, and follow-up duration, and used adjusted Cox proportional hazards models to compare diabetes medication discontinuation between procedures. We used difference-in-differences analyses to compare changes in medication use intensity up to 2 years after surgery. RESULTS: The matched cohort included 1111 VSG and 922 RYGB patients: 16% were younger than 40 years, 11% were 60 years or older, 67% were women, 67% had a body mass index of 40 kg/m2 or higher, and 23% were on insulin at the time of surgery. Thirteen percent were lost to follow-up at 1 year, and 30% at 2 years after surgery. Patients with VSG were less likely than matched RYGB patients to discontinue all diabetes medications (hazard ratio 0.80, 95% confidence interval 0.72-0.88). Although both groups had substantial decreases in medication use after surgery, RYGB patients had an 86% (32%, 140%) lower total diabetes medication dose than VSG by the second half of postoperative year 2. CONCLUSIONS: In a large claims-based, nationwide cohort of bariatric patients with diabetes, those undergoing RYGB were more likely to come off all medications than those undergoing VSG. Patients with diabetes should consider this potential benefit of RYGB when making informed decisions about obesity treatments.

Weight Outcomes of Sleeve Gastrectomy and Gastric Bypass Compared to Nonsurgical Treatment.

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/m2 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.

Development and Pilot Testing of a Patient-Centered Web-Based Reproductive Decision Support Tool for Primary Care.

BACKGROUND: Patient-centered counseling to help women achieve their reproductive goals is an essential yet often absent component of primary care. OBJECTIVE: We developed and piloted MyPath, a novel web-based decision support tool integrating reproductive goals assessment, information about optimizing health before pregnancy, and contraceptive decision support, for use prior to primary care visits in the Veterans Administration (VA). DESIGN: We created MyPath using best practices for decision tool development, including a conceptual framework informed by theory and user-centered design with input from patients, providers, and scientific experts. We conducted a non-randomized pilot in two VA Women's Health primary care clinics. A control group (n = 28) was recruited prior to and intervention group (n = 30) recruited after introduction of MyPath into clinics. PARTICIPANTS: Women Veterans ages 18-44 with an upcoming visit scheduled with one of eight providers. INTERVENTIONS: After recruitment of controls, providers and staff received a brief introduction to MyPath. Patients scheduled to see providers in the intervention phase used MyPath on an iPad in the waiting room prior to their visit. MAIN MEASURES: Acceptability, feasibility, discussions about pregnancy and/or contraceptive needs, and contraceptive decision quality by a survey of participants and providers. KEY RESULTS: Nearly all participants who used MyPath reported they learned new information (97%) and would recommend it to other Veterans (93%). No providers reported that MyPath significantly increased workload. A greater proportion of intervention participants reported having discussions about reproductive needs in their visit compared to controls (93% vs 68%; p = 0.02). Intervention participants also experienced greater increases in pre-/post-visit knowledge and communication self-efficacy and a trend towards greater reduction in contraceptive decision conflict compared to controls. CONCLUSIONS: MyPath was highly acceptable to women, increased the proportion of primary care visits addressing reproductive needs, and improved decision quality without increasing providers' perceived workload. A larger randomized evaluation of effectiveness is warranted.

Bariatric Surgical Alterations in Tolerability, Enjoyment and Cravings in the Diet (BSATED) instrument: A new scale to measure food preferences following bariatric surgery.

Bariatric surgery is associated with changing food preferences, but it is not known whether these changes differ by type of operation or are associated with weight loss. The current study presents validation results for a new 27-item scale, Bariatric Surgical Alterations in Tolerability, Enjoyment and Cravings in the Diet (BSATED). This scale measured enjoyment, craving, and intolerance changes for nine food and beverage categories common to dietary habits in the Southern California region of the U.S. one year following bariatric surgery in the Bariatric Experience Long Term (BELONG) study. Validation of BSATED was done using exploratory factor analyses, construct validity with other conceptually related survey instruments, and criterion validity using hypothesized differences for operation type and percent total weight loss (%TWL) at 12-18 months after surgery. Participants (n = 999) were 86% female, 41% non-Hispanic White, with a mean age of 43.1 ± 11.3 years and a body mass index (BMI) of 43.4 ± 6.8 kg/m2 at the time of surgery. Participants reported less enjoyment and craving for high-fat meats (62%), grains (54%), candy and other desserts (e.g. candy bars, chocolate, ice cream) (52%), and sweet baked goods (48%) 12 months after surgery. These changes were more common among participants undergoing Roux-en-Y gastric bypass (RYGB) compared to those receiving sleeve gastrectomy (SG). Participants who reported decreased enjoyment and craving for foods and beverages that post-bariatric patients are counseled to reduce or avoid had greater %TWL at 12-18 months following surgery (p < .001 and p = .003 respectively). The foods and beverages in BSATED that post-bariatric patients are counseled to reduce or avoid could be used to understand how changes in enjoyment, craving and tolerability of these foods/beverages contribute to weight loss following surgery.

Bariatric Surgery is Associated With Reduced Risk of Breast Cancer in Both Premenopausal and Postmenopausal Women.

OBJECTIVE: This retrospective cohort study examined whether bariatric surgery is associated with reduced risk of breast cancer among pre- and postmenopausal women. BACKGROUND: Obesity is associated with increased risk of breast cancer, but the impact of weight loss on breast cancer risk has been difficult to quantify. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.