Surgical Approach and Long-Term Recurrence After Ventral Hernia Repair.

Importance: The prevalence of robotic-assisted anterior abdominal wall (ventral) hernia repair has increased dramatically in recent years, despite conflicting evidence of patient benefit. Whether long-term hernia recurrence rates following robotic-assisted repairs are lower than rates following more established laparoscopic or open approaches remains unclear. Objective: To evaluate the association between robotic-assisted, laparoscopic, and open approaches to ventral hernia repair and long-term operative hernia recurrence. Design, Setting, and Participants: Secondary retrospective cohort analysis using Medicare claims data examining adults 18 years and older who underwent elective inpatient ventral, incisional, or umbilical hernia repair from January 1, 2010, to December 31, 2020. Data analysis was performed from January 2023 through March 2024. Exposure: Operative approach to ventral hernia repair, which included robotic-assisted, laparoscopic, and open approaches. Main Outcomes and Measures: The primary outcome was operative hernia recurrence for up to 10 years after initial hernia repair. To help account for potential bias from unmeasured patient factors (eg, hernia size), an instrumental variable analysis was performed using regional variation in the adoption of robotic-assisted hernia repair over time as the instrument. Cox proportional hazards modeling was used to estimate the risk-adjusted cumulative incidence of operative recurrence up to 10 years after the initial procedure, controlling for factors such as patient age, sex, race and ethnicity, comorbidities, and hernia subtype (ventral/incisional or umbilical). Results: A total of 161 415 patients were included in the study; mean (SD) patient age was 69 (10.8) years and 67 592 patients (41.9%) were male. From 2010 to 2020, the proportion of robotic-assisted procedures increased from 2.1% (415 of 20 184) to 21.9% (1737 of 7945), while the proportion of laparoscopic procedures decreased from 23.8% (4799 of 20 184) to 11.9% (946 of 7945) and of open procedures decreased from 74.2% (14 970 of 20 184) to 66.2% (5262 of 7945). Patients undergoing robotic-assisted hernia repair had a higher 10-year risk-adjusted cumulative incidence of operative recurrence (13.43%; 95% CI, 13.36%-13.50%) compared with both laparoscopic (12.33%; 95% CI, 12.30%-12.37%; HR, 0.78; 95% CI, 0.62-0.94) and open (12.74%; 95% CI, 12.71%-12.78%; HR, 0.81; 95% CI, 0.64-0.97) approaches. These trends were directionally consistent regardless of surgeon procedure volume. Conclusions and Relevance: This study found that the rate of long-term operative recurrence was higher for patients undergoing robotic-assisted ventral hernia repair compared with laparoscopic and open approaches. This suggests that narrowing clinical applications and evaluating the specific advantages and disadvantages of each approach may improve patient outcomes following ventral hernia repairs.

Learning Curve for Robotic-Assisted Cholecystectomy.

This cohort study evaluates the learning curve for robotic-assisted cholecystectomy among US surgeons from 2010 through 2019.

Comparative Safety of Robotic-Assisted vs Laparoscopic Cholecystectomy.

Importance: Robotic-assisted cholecystectomy is rapidly being adopted into practice, partly based on the belief that it offers specific technical and safety advantages over traditional laparoscopic surgery. Whether robotic-assisted cholecystectomy is safer than laparoscopic cholecystectomy remains unclear. Objective: To determine the uptake of robotic-assisted cholecystectomy and to analyze its comparative safety vs laparoscopic cholecystectomy. Design, Setting, and Participants: This retrospective cohort study used Medicare administrative claims data for nonfederal acute care hospitals from January 1, 2010, to December 31, 2019. Participants included 1 026 088 fee-for-service Medicare beneficiaries 66 to 99 years of age who underwent cholecystectomy with continuous Medicare coverage for 3 months before and 12 months after surgery. Data were analyzed August 17, 2022, to June 1, 2023. Exposure: Surgical technique used to perform cholecystectomy: robotic-assisted vs laparoscopic approaches. Main Outcomes and Measures: The primary outcome was rate of bile duct injury requiring definitive surgical reconstruction within 1 year after cholecystectomy. Secondary outcomes were composite outcome of bile duct injury requiring less-invasive postoperative surgical or endoscopic biliary interventions, and overall incidence of 30-day complications. Multivariable logistic analysis was performed adjusting for patient factors and clustered within hospital referral regions. An instrumental variable analysis was performed, leveraging regional variation in the adoption of robotic-assisted cholecystectomy within hospital referral regions over time, to account for potential confounding from unmeasured differences between treatment groups. Results: A total of 1 026 088 patients (mean [SD] age, 72 [12.0] years; 53.3% women) were included in the study. The use of robotic-assisted cholecystectomy increased 37-fold from 211 of 147 341 patients (0.1%) in 2010 to 6507 of 125 211 patients (5.2%) in 2019. Compared with laparoscopic cholecystectomy, robotic-assisted cholecystectomy was associated with a higher rate of bile duct injury necessitating a definitive operative repair within 1 year (0.7% vs 0.2%; relative risk [RR], 3.16 [95% CI, 2.57-3.75]). Robotic-assisted cholecystectomy was also associated with a higher rate of postoperative biliary interventions, such as endoscopic stenting (7.4% vs 6.0%; RR, 1.25 [95% CI, 1.16-1.33]). There was no significant difference in overall 30-day complication rates between the 2 procedures. The instrumental variable analysis, which was designed to account for potential unmeasured differences in treatment groups, also showed that robotic-assisted cholecystectomy was associated with a higher rate of bile duct injury (0.4% vs 0.2%; RR, 1.88 [95% CI, 1.14-2.63]). Conclusions and Relevance: This cohort study's finding of significantly higher rates of bile duct injury with robotic-assisted cholecystectomy compared with laparoscopic cholecystectomy suggests that the utility of robotic-assisted cholecystectomy should be reconsidered, given the existence of an already minimally invasive, predictably safe laparoscopic approach.

Trends in Use of Robotic Surgery for Privately Insured Patients and Medicare Fee-for-Service Beneficiaries.

This cohort study evaluates trends in the adoption of robotic surgery among Medicare beneficiaries and privately insured patients for common general surgical procedures.

The intersection of race and ethnicity, gender, and primary diagnosis on lung transplantation outcomes.

BACKGROUND: Reducing racial disparities in lung transplant outcomes is a current priority of providers, policymakers, and lung transplant centers. It is unknown how the combined effect of race and ethnicity, gender, and diagnosis group is associated with differences in 1-year mortality and 5-year survival. METHODS: This is a longitudinal cohort study using Standard Transplant Analysis Research files from the United Network for organ sharing. A total of 25,444 patients undergoing first time lung transplantation between 2006 and 2019 in the United States. The primary exposures were lung transplant recipient race and ethnicity, gender, and primary diagnosis group at listing. Multivariable regression models and cox-proportional hazards models were used to determine adjusted 1-year mortality and 5-year survival. RESULTS: Overall, 25,444 lung transplant patients were included in the cohort including 15,160 (59.6%) men, 21,345 (83.9%) White, 2,318 (9.1%), Black and Hispanic/Latino (7.0%). Overall, men had a significant higher 1-year mortality than women (11.87%; 95% CI 11.07-12.67 vs 12.82%; 95% CI 12.20%-13.44%). Black women had the highest mortality of all race and gender combinations (14.51%; 95% CI 12.15%-16.87%). Black patients with pulmonary vascular disease had the highest 1-year mortality (19.77%; 95% CI 12.46%-27.08%) while Hispanic/Latino patients with obstructive lung disease had the lowest (7.42%; 95% CI 2.8%-12.05%). 5-year adjusted survival was highest among Hispanic/Latino patients (62.32%) compared to Black (57.59%) and White patients (57.82%). CONCLUSIONS: There are significant differences in 1-year and 5-year mortality between and within racial and ethnic groups depending on gender and primary diagnosis. This demonstrates the impact of social and clinical factors on lung transplant outcomes.

Treatment patterns and survival in older adults with unresected nonmetastatic biliary tract cancers.

INTRODUCTION: The optimal treatment for unresected nonmetastatic biliary tract cancer (uBTC) is not well-established. The objective of this study was to analyze the treatment patterns and compare the differences in overall survival (OS) between different treatment strategies amongst older adults with uBTC. MATERIALS AND METHODS: We identified patients aged ≥65 years with uBTC using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database (2004-2015). Treatments were classified into chemotherapy, chemoradiotherapy, and radiotherapy. The primary outcome was OS. The differences in OS were analyzed using Kaplan-Meier curves and multivariable Cox proportional hazard regression. RESULTS: A total of 4352 patients with uBTC were included. The median age was 80 years and median OS was 4.1 months. Most patients (67.3%, n = 2931) received no treatment, 19.1% chemotherapy (n = 833), 8.1% chemoradiotherapy (n = 354), and 5.4% radiotherapy alone (n = 234). Patients receiving no treatment were older and had more comorbidities. Chemotherapy was associated with significantly longer OS than no treatment in uBTC (hazard ratio [HR] 0.87, 95% confidence interval [CI] 0.79-0.95), but no difference was found in the subgroups of intrahepatic cholangiocarcinoma (iCCA; HR 0.87, 95% CI 0.75-1.00) and gallbladder carcinoma (GBC; HR 1.09, 95% CI 0.86-1.39). In the sensitivity analyses, capecitabine-based chemoradiotherapy showed significantly longer OS in uBTC compared to chemotherapy (adjusted HR 0.71, 95% CI 0.53-0.95). DISCUSSION: A minority of older patients with uBTC receive systemic treatments. Chemotherapy was associated with longer OS compared to no treatment in uBTC, but not in the subgroups of iCCA and GBC. The efficacy of chemoradiotherapy, especially in perihilar cholangiocarcinoma using capecitabine-based chemoradiotherapy, may be further evaluated in prospective clinical trials.

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.

Variation of ventral and incisional hernia repairs in kidney transplant recipients.

INTRODUCTION: As survivorship following kidney transplant continues to improve, so does the probability of intervening on common surgical conditions, such as ventral or incisional hernia, in this population. Ventral hernia management is known to vary across institutions and this variation has an impact on patient outcomes. We sought to evaluate hospital level variation of ventral or incisional hernia repair (VIHR) in the kidney transplant population. METHODS: We performed a retrospective review of 100% inpatient Medicare claims to identify patients who underwent kidney transplant between 2007 and 2018. The primary outcome was 1- and 3-year ventral or incisional risk- and reliability-adjusted VIHR rates. Patient and hospital characteristics were evaluated across risk- and reliability-adjusted VIHR rate tertiles. Models were adjusted for age, sex, race, and Elixhauser comorbidities. RESULTS: Overall, 139,741 patients underwent kidney transplant during the study period with a mean age (SD) of 51.6 (13.7) years. 84,717 (60.6%) were male, and 72,657 (52.0%) were white. Median follow up time was 5.4 years. 2098 (1.50%) patients underwent VIHR. the 1 year risk- and reliability-adjusted hernia repair rates were 0.49% (95% Conf idence Interval (CI) 0.48-0.51, range 0.31-0.59) in tertile 1, 0.63% (95% CI 0.62-0.63, range 0.59-0.68) in tertile 2, and 0.98 (95% CI 0.91-1.05, range 0.68-2.94) in tertile 3. Accordingly, compared to hospitals in tertile 1, the odds of post-transplant hernia repair tertile 2 hospitals were 1.78 (95% CI 1.37-2.31) and at tertile 3 hospitals 3.53 (95% CI 2.87-4.33). CONCLUSIONS: In a large cohort of Medicare patients undergoing kidney transplant, the overall cumulative incidence of hernia repair varied substantially across hospital tertiles. Patient and hospital characteristics varied across tertile, most notably in diabetes and obesity. Future research is needed to understand if program and surgeon level factors are contributing to the observed variation in treatment of this common disease.

One-Year Mortality Is Not a Reliable Indicator of Lung Transplant Center Performance.

BACKGROUND: In the United States, the Organ Procurement and Transplant Network (OPTN) uses 1-year mortality as the primary measure of transplant center quality. We sought to evaluate the reliability of mortality outcomes in lung transplantation and to compare statistical methods of program performance evaluation. METHODS: We used the Standard Transplant Analysis and Research files from the United Network for Organ Sharing to identify lung transplant recipients from 2013 to 2018 in the United States. We stratified hospitals on the basis of 30-day, 1-year, and 5-year survival by risk adjustment, reliability adjustment with empirical Bayes technique, and hierarchical bayesian mixed effects models currently used by the OPTN. We measured variation in mortality rates and identification of performance outliers between techniques. RESULTS: We identified 12,769 recipients in 69 centers. Reliability adjustment reduced variation in hospital outcomes and had a large impact on hospital mortality rankings. For example, with 1-year mortality, 28% (5 hospitals) of the "best" hospitals (top 25%) and 18% (3 hospitals) of the "worst" hospitals (bottom 25%) were reclassified after reliability adjustment. The overall reliability of 1-year mortality was low at 0.42. Compared with the bayesian method used by the OPTN, reliability adjustment identified fewer outliers. The 5-year survival reached a higher reliability plateau with a lower volume of cases required. CONCLUSIONS: The reliability of 1-year mortality in lung transplantation is low, whereas 5-year survival estimates may be more reliable at lower case volumes. Reliability adjustment yielded more conservative measures of center performance and fewer outliers compared with current bayesian methods.

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.

Medication Use for Obesity-Related Comorbidities After Sleeve Gastrectomy or Gastric Bypass.

IMPORTANCE: Sleeve gastrectomy and gastric bypass are the most common bariatric surgical procedures in the world; however, their long-term medication discontinuation and comorbidity resolution remain unclear. OBJECTIVE: To compare the incidence of medication discontinuation and restart of diabetes, hypertension, and hyperlipidemia medications up to 5 years after sleeve gastrectomy or gastric bypass. DESIGN, SETTING, AND PARTICIPANTS: This comparative effectiveness research study of adult Medicare beneficiaries who underwent laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass between January 1, 2012, to December 31, 2018, and had a claim for diabetes, hypertension, or hyperlipidemia medication in the 6 months before surgery with a corresponding diagnosis used instrumental-variable survival analysis to estimate the cumulative incidence of medication discontinuation and restart. Data analyses were performed from February to June 2021. EXPOSURES: Laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass. MAIN OUTCOMES AND MEASURES: The primary outcome was discontinuation of diabetes, hypertension, and hyperlipidemia medication for any reason. Among patients who discontinued medication, the adjusted cumulative incidence of restarting medication was calculated up to 5 years after discontinuation. RESULTS: Of the 95 405 patients included, 71 348 (74.8%) were women and the mean (SD) age was 56.6 (11.8) years. Gastric bypass compared with sleeve gastrectomy was associated with a slightly higher 5-year cumulative incidence of medication discontinuation among 30 588 patients with diabetes medication use and diagnosis at the time of surgery (74.7% [95% CI, 74.6%-74.9%] vs 72.0% [95% CI, 71.8%-72.2%]), 52 081 patients with antihypertensive medication use and diagnosis at the time of surgery (53.3% [95% CI, 53.2%-53.4%] vs 49.4% [95% CI, 49.3%-49.5%]), and 35 055 patients with lipid-lowering medication use and diagnosis at the time of surgery (64.6% [95% CI, 64.5%-64.8%] vs 61.2% [95% CI, 61.1%-61.3%]). Among the subset of patients who discontinued medication, gastric bypass was also associated with a slightly lower incidence of medication restart up to 5 years after discontinuation. Specifically, the 5-year cumulative incidence of medication restart was lower after gastric bypass compared with sleeve gastrectomy among 19 599 patients who discontinued their diabetes medication after surgery (30.4% [95% CI, 30.2%-30.5%] vs 35.6% [95% CI, 35.4%-35.9%]), 21 611 patients who discontinued their antihypertensive medication after surgery (67.2% [95% CI, 66.9%-67.4%] vs 70.6% [95% CI, 70.3%-70.9%]), and 18 546 patients who discontinued their lipid-lowering medication after surgery (46.2% [95% CI, 46.2%-46.3%] vs 52.5% [95% CI, 52.2%-52.7%]). CONCLUSIONS AND RELEVANCE: Findings of this study suggest that, compared with sleeve gastrectomy, gastric bypass was associated with a slightly higher incidence of medication discontinuation and a slightly lower incidence of medication restart among patients who discontinued medication. Long-term trials are needed to explain the mechanisms and factors associated with differences in medication discontinuation and comorbidity resolution after bariatric surgery.

Evaluating the Impact of Surgeon Self-awareness by Comparing Self Versus Peer Ratings of Surgical Skill and Outcomes for Bariatric Surgery.

OBJECTIVE: To evaluate variation in self versus peer-assessments of surgical skill using surgical videos and compare surgeon-specific outcomes with bariatric surgery. SUMMARY BACKGROUND DATA: Prior studies have demonstrated that surgeons with lower peer-reviewed ratings of surgical skill had higher complication rates after bariatric surgery. METHODS: This is a retrospective cohort study of 25 surgeons who voluntarily submitted a video of a typical laparoscopic sleeve gastrectomy (SG) between 2015 and 2016. Videos were self and peer-rated using a validated instrument based on a 5-point Likert scale (5= "master surgeon" and 1= "surgeon-in-training"). Risk adjusted 30-day complication rates were compared between surgeons who over-rated and under-rated their skill based on data from 24,186 SG cases and 12,888 gastric bypass (GBP) cases. RESULTS: individual overall self-rating of surgical skill varied between 2.5 and 5. Surgeons in the top quartile for self:peer ratings (n = 6, ratio 1.58) had lower overall mean peer-scores (2.98 vs 3.79, P = 0.0150) than surgeons in the lowest quartile (n = 6, ratio 0.94). Complication rates between top and bottom quartiles were similar after SG, however leak rates were higher with gastric bypass among surgeons who over-rated their skill with SG (0.65 vs 0.27, P = 0.0181). Surgeon experience was similar between comparison groups. CONCLUSIONS AND RELEVANCE: Self-perceptions of surgical skill varied widely. Surgeons who over-rated their skill had higher leak rates for more complex procedures. Video assessments can help identify surgeons with poor self-awareness who may benefit from a surgical coaching program.

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.

Evaluation of Patient Reported Gastroesophageal Reflux Severity at Baseline and at 1-year After Bariatric Surgery.

OBJECTIVE: To assess patient-reported gastroesophageal reflux disease (GERD) severity before and after SG and Roux-en-Y gastric bypass (RYGB). SUMMARY OF BACKGROUND DATA: Development of new-onset or worsening GERD symptoms after bariatric surgery varies by procedure, but there is a lack of patient-reported data to help guide decision-making. Methods: Retrospective cohort study of patients undergoing bariatric surgery in a statewide quality collaborative between 2013 and 2017. We used a validated GERD survey with symptom scores ranging from 0 (no symptoms) to 5 (severe daily symptoms) and included patients who completed surveys both at baseline and 1-year after surgery (n = 10,451). We compared the rates of improved and worsened GERD symptoms after SG and RYGB. RESULTS: Within our study cohort, 8680 (83%) underwent SG and 1771 (17%) underwent RYGB. Mean baseline score for all patients was 0.94. Patients undergoing SG experienced similar improvement in GERD symptoms when compared to RYGB (30.4% vs 30.8%, P = 0.7015). However, SG patients also reported higher rates of worsening symptoms (17.8% vs 7.5%, P < 0.0001) even though they were more likely to undergo concurrent hiatal hernia repair (35.1% vs 20.0%, P<0.0001). More than half of patients (53.5%) did not report a change in their score. CONCLUSIONS: Although SG patients reported higher rates of worsening GERD symptoms when compared to RYGB, the majority of patients (>80%) in this study experienced improvement or no change in GERD regardless of procedure. Using clinically relevant patient-reported outcomes can help guide decisions about procedure choice in bariatric surgery for patients with GERD.

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.

Relationship Between Health Care Spending and Clinical Outcomes in Bariatric Surgery: Implications for Medicare Bundled Payments.

OBJECTIVE: To evaluate sources of 90-day episode spending variation in Medicare patients undergoing bariatric surgery and whether spending variation was related to quality of care. SUMMARY OF BACKGROUND DATA: Medicare's bundled payments for care improvement-advanced program includes the first large-scale episodic bundling program for bariatric surgery. This voluntary program will pay bariatric programs a bonus if 90-day spending after surgery falls below a predetermined target. It is unclear what share of bariatric episode spending may be due to unnecessary variation and thus modifiable through care improvement. METHODS: Retrospective analysis of fee-for-service Medicare claims data from 761 acute care hospitals providing inpatient bariatric surgery between January 1, 2011 and September 30, 2016. We measured associations between patient and hospital factors, clinical outcomes, and total Medicare spending for the 90-day bariatric surgery episode using multivariable regression models. RESULTS: Of 64,537 patients, 46% underwent sleeve gastrectomy, 22% revisited the emergency department (ED) within 90 days, and 12.5% were readmitted. Average 90-day episode payments were $14,124, ranging from $12,220 at the lowest-spending quintile of hospitals to $16,887 at the highest-spending quintile. After risk adjustment, 90-day episode spending was $11,447 at the lowest quintile versus $15,380 at the highest quintile (difference $3932, P < 0.001). The largest components of spending variation were readmissions (44% of variation, or $2043 per episode), post-acute care (19% or $871), and index professional fees (15% or $450). The lowest spending hospitals had the lowest complication, ED visit, post-acute utilization, and readmission rates (P < 0.001). CONCLUSIONS AND RELEVANCE: In this retrospective analysis of Medicare patients undergoing bariatric surgery, the largest components of 90-day episode spending variation are readmissions, inpatient professional fees, and post-acute care utilization. Hospitals with lower spending were associated with lower rates of complications, ED visits, post-acute utilization, and readmissions. Incentives for improving outcomes and reducing spending seem to be well-aligned in Medicare's bundled payment initiative for bariatric surgery.

Association of Historic Housing Policy, Modern Day Neighborhood Deprivation and Outcomes After Inpatient Hospitalization.

OBJECTIVE: To evaluate the association of historical racist housing policies and modern-day healthcare outcomes. SUMMARY OF BACKGROUND DATA: In 1933 the United States Government Home Owners Loan Corporation (HOLC) used racial composition of neighborhoods to determine creditworthiness and labeled them "Best", "Still Desirable", "Definitely Declining", and "Hazardous." Although efforts have been made to reverse these racist policies that structurally disadvantage those living in exposed neighborhoods, the lasting legacy on modern day healthcare outcomes is uncertain. METHODS: We performed a cross-sectional retrospective review of 212,179 Medicare beneficiaries' living in 171,930 unique neighborhoods historically labeled by the HOLC who underwent 1 of 5 of common surgical procedures - coronary artery bypass, appendectomy, colectomy, cholecystectomy, and hernia repair - between 2012 and 2018. We compared 30-day mortality, complications, and readmissions across HOLC grade and Area Deprivation Index (ADI) of each neighborhood. Outcomes were risk-adjusted using a multivariable logistical regression model accounting for patient factors (age, sex, Elixhauser comorbidities), admission type (elective, urgent, emergency), type of operation, and each neighborhoods ADI; a modern day measure of neighborhood disadvantage that includes education, employment, housing-quality, and poverty measures. RESULTS: Overall, 212,179 Medicare beneficiaries (mean age, 71.2 years; 54.2% women) resided in 171,930 unique neighborhoods historically graded by the HOLC. Outcomes worsened in a stepwise fashion across HOLC neighborhoods. Overall, 30-day postoperative mortality was 5.4% in "Best" neighborhoods, 5.8% in "Still Desirable", 6.1% in "Definitely Declining", and 6.4% in "Hazardous" (Best vs Hazardous Odds Ration: 1.23, 95% CI: 1.13-1.24, P < 0.001). The same stepwise pattern was seen from "Best" to "Hazardous" neighborhoods for complications (30.5% vs 32.2%; OR: 1.12 [95% CI: 1.07-1.17]; P < 0.001) and Readmissions (16.3% vs 17.1%; OR: 1.06 [95% CI: 1.01-1.11]; P = 0.023). After controlling for modern day deprivation using ADI, the patterns persisted with "Hazardous" neighborhoods having higher mortality (OR: 1.17 [95% CI: 1.08-1.27]; P < 0.001) and complications (OR: 1.07 [95% CI: 1.02-1.12]; P = 0.003), but not for readmissions (OR: 1.02 [95% CI: 0.97-1.07]; P = 0.546). CONCLUSIONS: Patients residing in neighborhoods previously "redlined" or labeled "Hazardous" were more likely to experience worse outcomes after inpatient hospitalization compared to those living in "Best" neighborhoods, even after taking into account modern day measures of neighborhood disadvantage.