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.

Left digit bias in selection and acceptance of deceased donor organs.

BACKGROUND: Organs suitable for donation are a scarce resource and maximizing the use of available organs is a priority. We aimed to determine whether there is a supply restricting left digit bias in organs offered and accepted for donors entering a new decade of age. METHODS: Potential deceased organ donors (n = 105,387) who had any organs offered for transplantation from 2010 to 2019 Organ Procurement and Transplantation Network data were analyzed. Donors were identified 1 year before and after a decade altering birthday. RESULTS: At age 70 there was a 5.4% decrease in the probability of any organ placement compared to 69 (95% CI 1.1-9.7). There was a decrease of 0.25 organs (95% CI 0.13-0.37) after age 70. CONCLUSIONS: There was a significant left digit bias in the acceptance of any organs for transplantation at ages 60 and 70 as well as in the acceptance of a kidney at age 70.

Population-based Trends in Obesity and Kidney Transplantation Among Patients With End-stage Kidney Disease.

Obesity is a barrier to transplant, reducing access and leading to worse outcomes versus nonobese adults. Most transplant centers in the United States maintain body mass index (BMI) cutoffs to listing for kidney transplantation of 35 to 40 kg/m2. There is little contemporary data on the prevalence of obesity among patients with end-stage kidney disease (ESKD) despite its impact on clinical outcomes and healthcare expenditures. METHODS: We utilized data from the US Renal Data System from 2008 to 2016 to identify a prevalent cohort of 1 079 410 patients with ESKD. Linear regression determined trends in the proportion of patients within each category of BMI. We also evaluated geographic variation in rates of obesity and transplantation across the United States. RESULTS: Among the 1 079 410 ESKD patients, the largest cohort of patients were those with obesity (n = 423 270; 39.2%). There were 309 707 (28.7%) patients with an overweight BMI and 274 683 (25.4%) with a normal BMI. The proportion of patients with obesity increased significantly from 36.8% in 2008 to 40.2% in 2016 (trend 0.28; 95% confidence interval, 0.05-0.51). There was significant geographic variation by state with rates of obesity ranging from 32.3% to 45.4% and state transplant rates among those obese patients ranging from 22.5% to 46.8%. There is a weak correlation between states with increased rates of obese ESKD patients and states with an increased obesity transplant rate as indicated with r = 0.40 (P = 0.003). CONCLUSIONS: Beneficiaries with obesity are now the largest and fastest growing demographic among patients with ESKD in the United States.

Associations Among Different Domains of Quality Among US Liver Transplant Programs.

Importance: US liver transplant programs have traditionally been evaluated on 1-year patient and graft survival. However, there is concern that a narrow focus on recipient outcomes may not incentivize programs to improve in other ways that would benefit patients with end-stage liver disease. Objective: To determine the correlation among different potential domains of quality for adult liver transplant programs. Design, Setting, and Participants: This retrospective cohort study was conducted from 2014 to 2019 among adult liver transplant programs included in the United Network for Organ Sharing and Scientific Registry of Transplant Recipients program-specific reports. Liver transplant programs in the United States completing at least 10 liver transplants per year were included. Data were analyzed from March 2 to August 13, 2020. Main Outcomes and Measures: The potential domains of quality examined included recipient outcomes (1-year graft and patient survival), aggressiveness (ie, marginal graft use, defined as the rate of use of donors with body mass index [calculated as weight in kilograms divided by height in meters squared] greater than 40, age older than 65 years, or deceased by cardiac death), and waiting list management (ie, waiting list mortality). The correlation among measures, aggregated at the center level, was evaluated using linear regression to control for mean Model for End Stage Liver Disease-Sodium score at organ allocation. The extent to which programs were able to achieve high quality across multiple domains was also evaluated. Results: Among 114 transplant programs that performed a total of 44 554 transplants, the mean (SD) 1-year graft and patient survival was 90.3% (3.0%) with a total range of 75.9% to 96.6%. The mean (SD) waiting list mortality rate was 16.7 (6.1) deaths per 100 person-years, with a total range of 6.3 to 53.0 deaths per 100 person years. The mean (SD) marginal graft use rate was 15.8 (8.8) donors per 100 transplants, with a total range of 0 to 49.3 donors. There was no correlation between 1-year graft and patient survival and waiting list mortality (ß = -0.053; P = .19) or marginal graft use (ß = -0.007; P = .84) after correcting for mean allocation Model for End Stage Liver Disease-Sodium scores. There were 2 transplant programs (1.8%) that performed in the top quartile on all 3 measures, while 4 transplant programs (3.6%) performed in the bottom quartile on all 3 measures. Conclusions and Relevance: This cohort study found that among US liver transplant programs, there were no correlations among 1-year recipient outcomes, measures of program aggressiveness, or waiting list management. These findings suggest that a program's performance in one domain may be independent and unrelated to its performance on others and that the understanding of factors contributing to these domains is incomplete.

Changes in Dialysis Center Quality Associated With the End-Stage Renal Disease Quality Incentive Program : An Observational Study With a Regression Discontinuity Design.

BACKGROUND: In 2012, the Centers for Medicare & Medicaid Services started levying performance-based financial penalties against outpatient dialysis centers under the mandatory End-Stage Renal Disease Quality Incentive Program. OBJECTIVE: To determine whether penalization was associated with improvement in dialysis center quality. DESIGN: Leveraging the threshold for penalization (total performance score < 60), a regression discontinuity design was used to examine the effect of penalization on quality over 2 years. Publicly available Medicare data from 2015-2018 were used. The effect of penalization at dialysis centers with different characteristics (for example, size or chain affiliation) was also examined. SETTING: United States. PARTICIPANTS: Outpatient dialysis centers (n = 5830). MEASUREMENTS: Dialysis center total performance scores (a composite metric ranging from 0 to 100 based on clinical quality and adherence to reporting requirements) and individual measures that contribute to the total performance score. RESULTS: There were 1109 (19.0%) outpatient dialysis centers that received penalties in 2017 on the basis of performance in 2015. Penalized centers were located in ZIP codes with a higher average proportion of non-White residents (36.4% vs. 31.2%; P < 0.001) and residents with lower median income ($49 290 vs. $51 686; P < 0.001). Penalization was not associated with improvement in total performance scores in 2017 (0.4 point [95% CI, -2.5 to 3.2 points]) or 2018 (0.3 point [CI, -2.8 to 3.4 points]). This was consistent across dialysis centers with different characteristics. There was also no association between penalization and improvement in specific measures. LIMITATION: The study could not account for how centers respond to penalization. CONCLUSION: Penalization under the End-Stage Renal Disease Quality Incentive Program was not associated with improvement in the quality of outpatient dialysis centers. PRIMARY FUNDING SOURCE: None.

Comparative Effectiveness of Neoadjuvant Therapy and Upfront Resection for Patients with Resectable Pancreatic Adenocarcinoma: An Instrumental Variable Analysis.

BACKGROUND: Neoadjuvant therapy (NAT) is increasingly being used in the management of patients with resectable pancreatic ductal adenocarcinoma (PDAC); however, there is a lack of evidence regarding the benefit among these patients. OBJECTIVE: The aim of this study was to evaluate overall survival (OS) in PDAC patients with resectable disease treated with NAT or upfront resection through instrumental variable (IV) analysis. DESIGN: A national cohort study of resectable PDAC patients in the National Cancer Data Base (2007-2015) treated with either upfront surgery or resection after NAT. Using multivariable modeling and IV methods, OS was compared between those treated with NAT and upfront resection. The IV was hospital-level NAT utilization in the most recent year prior to treatment. RESULTS: The cohort included 16,666 patients (14,012 upfront resection; 2654 NAT) treated at 779 hospitals. Among those treated with upfront resection, 59.9% received any adjuvant therapy. NAT patients had higher median (27.9 months, 95% confidence interval [CI] 26.2-29.1) and 5-year OS (24.1%, 95% CI 21.9-26.3%) compared with those treated with upfront surgery (median 21.2 months, 95% CI 20.7-21.6; 5-year survival 20.9%, 95% CI 20.1-21.7%). After multivariable modeling, NAT was associated with an approximately 20% decrease in the risk of death (hazard ratio [HR] 0.78, 95% CI 0.73-0.84), and this effect was magnified in the IV analysis (HR 0.61, 95% CI 0.47-0.79). CONCLUSIONS: In patients with resectable PDAC, NAT is associated with improved survival relative to upfront resection. Given the benefits of multimodality therapy and the challenges in receiving adjuvant therapy, consideration should be given to treating all PDAC patients with NAT.

Wide Variation in Surgical Spending Within Hospital Systems: A Missed Opportunity for Bundled Payment Success.

OBJECTIVE: We sought to measure the extent of variation in episode spending around total hip replacement within and across hospital systems. SUMMARY OF BACKGROUND DATA: Bundled payment programs are pressuring hospitals to reduce spending on surgery. Meanwhile, many hospitals are joining larger health systems with the stated goal of improved care at lower cost. METHODS: Cross-sectional study of fee-for-service Medicare patients undergoing total hip replacement in 2016 at hospital systems identified in the American Hospital Association Annual Survey. We calculated risk- and reliability-adjusted average 30-day episode payments at the hospital and system level. RESULTS: Average episode payments varied nearly as much within hospital systems ($2515 between the lowest- and highest-cost hospitals, 95% confidence interval $2272-$2,758) as they did between the lowest- and highest-cost quintiles of systems ($2712, 95% confidence interval $2545-$2879). Variation was driven by post-acute care utilization. Many systems have concentrated hip replacement volume at relatively high-cost hospitals. CONCLUSIONS: Given the wide variation in surgical spending within health systems, we propose tailored strategies for systems to maximize savings in bundled payment programs.

Variation in colectomy rates for benign polyp and colorectal cancer.

BACKGROUND: Removal of pre-cancerous polyps on screening colonoscopy is a mainstay of colorectal cancer (CRC) prevention. Complex polyps may require surgical removal with colectomy, an operation with a 17% morbidity and 1.5% mortality rate. Recently, advanced endoscopic techniques have allowed some patients with complex polyps to avoid the morbidity of colectomy. However, the rate of colectomy for benign polyp in the United States is unclear, and variation in this rate across geographic regions has not been studied. We compared regional variation in colectomy rates for CRC versus benign polyp. METHODS: We performed a retrospective population-based study of Medicare beneficiaries undergoing colectomy for CRC or benign polyp, using the 100% Medicare Provider Analysis and Review files from 2010 to 2015. We used multivariable linear regression to obtain population-based colectomy rates for CRC and benign polyp at the hospital referral region (HRR) level, adjusted for age, sex, and race. RESULTS: Of 280,815 patients, 157,802 (65.8%) underwent colectomy for CRC compared to 81,937 (34.2%) for benign polyp. Across HRRs, colectomy rates varied 5.8-fold for cancer (0.32-1.84 per 1000 beneficiaries). However, there was a 69-fold variation for benign polyp (0.01-0.69). While the rate of colectomy for CRC was correlated with the rate of colectomy for benign polyp (slope = 0.61, 95% CI 0.48-0.75), HRRs with the lowest or highest rates of colectomy for CRC did not necessarily have similarly low or high rates for benign polyp. CONCLUSIONS: The use of colectomy for benign polyp is much more variable compared to CRC, suggesting overuse of colectomy for benign polyp in some regions. This variation may stem from provider-level differences, such as endoscopists' referral practice or skill or surgeons' decision to perform colectomy, or from limited access to advanced endoscopists. Interventions to increase endoscopic resection of benign polyps may spare some patients the morbidity and cost of surgery.

Association of Medicaid Eligibility With Surgical Readmission Among Medicare Beneficiaries.

Importance: The Centers for Medicare & Medicaid Services is beginning to consider adjusting for social risk factors, such as dual eligibility for Medicare and Medicaid, when evaluating hospital performance under value-based purchasing programs. It is unknown whether dual eligibility represents a unique domain of social risk or instead represents clinical risk unmeasured by variables available in traditional Medicare claims. Objective: To assess how dual eligibility for Medicare and Medicaid is associated with risk-adjusted readmission rates after surgery. Design, Setting, and Participants: A retrospective cohort study was conducted of 55 651 Medicare beneficiaries undergoing general, vascular, and gynecologic surgery at 62 hospitals in Michigan between January 1, 2014, and December 1, 2016. Representative cohorts were derived from traditional Medicare claims (n = 29 710) and the Michigan Surgical Quality Collaborative (MSQC) clinical registry (n = 25 941), which includes additional measures of clinical risk. Statistical analysis was conducted between April 10 and July 15, 2019. The association between dual eligibility and risk-adjusted 30-day readmission rates after surgery was compared between models inclusive and exclusive of additional measurements of clinical risk. The study also examined how dual eligibility is associated with hospital profiling using risk-adjusted readmission rates. Exposures: Dual eligibility for Medicare and Medicaid. Main Outcomes and Measures: Risk-adjusted all-cause 30-day readmission after surgery. Results: There were a total of 3986 dual-eligible beneficiaries in the Medicare claims cohort (2554 women; mean [SD] age, 72.9 [6.9] years) and 1608 dual-eligible beneficiaries in the MSQC cohort (990 women; mean [SD] age, 72.9 [6.8] years). In both data sets, higher proportions of dual-eligible beneficiaries were younger, female, and nonwhite than Medicare-only beneficiaries (Medicare claims cohort: female, 2554 of 3986 [64.1%] vs 12 879 of 25 724 [50.1%]; nonwhite, 1225 of 3986 [30.7%] vs 2783 of 25 724 [10.8%]; MSQC cohort: female, 990 of 1608 [61.6%] vs 12 578 of 24 333 [51.7%]; nonwhite, 416 of 1608 [25.9%] vs 2176 of 24 333 [8.9%]). In the Medicare claims cohort, dual-eligible beneficiaries were more likely to be readmitted (15.5% [95% CI, 13.7%-17.3%]) than Medicare-only beneficiaries (13.3% [95% CI, 12.7%-13.9%]; difference, 2.2 percentage points [95% CI, 0.4-3.9 percentage points]). In the MSQC cohort, after adjustment for more granular measures of clinical risk, dual eligibility was not significantly associated with readmission (difference, 0.6 percentage points [95% CI, -1.0 to 2.2 percentage points]). In both the Medicare claims and MSQC cohorts, adding dual eligibility to risk-adjustment models had little association with hospital ranking using risk-adjusted readmission rates. Conclusions and Relevance: This study suggests that dual eligibility for Medicare and Medicaid may reflect unmeasured clinical risk of readmission in claims data. Policy makers should consider incorporating more robust measures of social risk into risk-adjustment models used by value-based purchasing programs.

Bariatric Surgery and Long-term Survival in Patients With Obesity and End-stage Kidney Disease.

Importance: Obesity rates in patients with end-stage kidney disease are rising, contribute to excess morbidity, and limit access to kidney transplant. Despite this, there continues to be controversy around the use of bariatric surgery in this patient population. Objective: To determine whether bariatric surgery is associated with improvement in long-term survival among patients with obesity and end-stage kidney disease. Design, Setting, and Participants: Retrospective cohort study and secondary analysis of previously collected data from the United States Renal Data System registry (2006-2015). We used Cox proportional hazards analysis to evaluate differences in outcomes for patients receiving bariatric surgery (n = 1597) compared with a matched cohort of nonsurgical patients (n = 4750) receiving usual care. Data were analyzed between September 3, 2019, and November 13, 2019. Exposure: Receipt of bariatric surgery. Main Outcomes and Measures: All-cause mortality at 5 years. Secondary outcomes included disease-specific mortality and incidence of kidney transplant. Results: Surgical and nonsurgical control patients had similar age, demographics, and comorbid disease burden. The mean (SD) age was 49.8 (11.2) years for surgical patients vs 51.7 (11.1) years for nonsurgical patients. Six hundred fifteen surgical patients (38.5%) were black vs 1833 nonsurgical patients (38.6%). Surgery was associated with lower all-cause mortality at 5 years compared with usual care (cumulative incidence, 25.6% vs 39.8%; hazard ratio, 0.69, 95% CI, 0.60-0.78). This was driven by lower mortality from cardiovascular causes at 5 years for patients undergoing bariatric surgery compared with nonsurgical control patients (cumulative incidence, 8.4% vs 17.2%; hazard ratio, 0.51; 95% CI, 0.41-0.65). Bariatric surgery was also associated with an increase in kidney transplant at 5 years (cumulative incidence, 33.0% vs 20.4%; hazard ratio, 1.82; 95% CI, 1.58-2.09). However, at 1 year, bariatric surgery was associated with higher all-cause mortality compared with usual care (cumulative incidence, 8.6% vs 7.7%; hazard ratio, 1.45; 95% CI, 1.13-1.85). Conclusions and Relevance: Among patients with obesity and end-stage kidney disease, bariatric surgery was associated with lower all-cause mortality compared with usual care. Bariatric surgery was also associated with an increase in kidney transplant. Bariatric surgery may warrant further consideration in the treatment of patients with obesity and end-stage kidney disease.