Participant User File Research Articles

Changes in Surgical Outcomes in a Statewide Quality Improvement Collaborative with Introduction of Simultaneous, Comprehensive Interventions.

Surgical quality improvement collaboratives (QICs) aim to improve patient outcomes through coaching, benchmarked data reporting, and other activities. Although other regional QICs have formed organically over time, it is unknown whether a comprehensive quality improvement program implemented simultaneously across hospitals at the formation of a QIC would improve patient outcomes. Patients undergoing surgery at 48 hospitals in the Illinois Surgical Quality Improvement Collaborative (ISQIC) were included. Risk-adjusted rates of postoperative morbidity and mortality were compared from baseline to year 3. Difference-in-differences analyses compared ISQIC hospitals with hospitals in the NSQIP Participant Use File (PUF), which served as a control. There were 180,582 patients who underwent surgery at ISQIC-participating hospitals. Inpatient procedures comprised 100,219 (55.5%) cases. By year 3, risk-adjusted rates of death or serious morbidity decreased in both ISQIC (relative reduction 25.0%, p < 0.001) and PUF hospitals (7.8%, p < 0.001). Adjusted difference-in-differences analysis revealed that ISQIC participation was associated with a significantly greater reduction in death or serious morbidity (odds ratio 0.94, 95% CI 0.90 to 0.99, p = 0.01) compared with PUF hospitals. Relative reductions in risk-adjusted rates of other outcomes were also seen in both ISQIC and PUF hospitals (morbidity 22.4% vs 6.4%; venous thromboembolism 20.0% vs 5.0%; superficial surgical site infection 27.3% vs 7.7%, all p < 0.05), although these difference-in-differences did not reach statistical significance. Although complication rates decreased at both ISQIC and PUF hospitals, participation in ISQIC was associated with a significantly greater improvement in death or serious morbidity. These results underscore the potential of QICs to improve patient outcomes.

Response to: Association of Intraoperative Red Blood Cell Transfusions With Venous Thromboembolism and Adverse Outcomes After Cardiac Surgery.

We are grateful for the interest and comments of Butt et al1 with regard to our recently published study.2 First, Butt et al1 noted that the overall exposure rate to intraoperative packed red blood cells (PRBCs) was 17.8% in our study compared to the reported rate of 12.8% to 60.3% in previous studies in similar patients. They then speculated that the relatively lower rate of intraoperative PRBC transfusion observed in our study was due to our decision to label missing information on intraoperative PRBC transfusion as “no transfusion.” In support of their argument, they cited a retrospective study of 8141 patients from 10 centers who had cardiac surgery between 2011 and 2014; these patients underwent either isolated coronary artery bypass grafting (CABG) surgery or aortic valve replacement, and Butt et al1 did not cite the risk-adjusted rate for intraoperative PRBC transfusion, which was found to be 4% to 59%.3 Thus, our reported rate of 17.8% is likely reflective of the more contemporary and average national rate of intraoperative PRBC transfusion for isolated CABG surgery. Furthermore, Butt et al1 highlighted that labeling missing data for intraoperative PRBC transfusions as “no transfusion” as justified in the methodology section of our manuscript, and omission of any postoperative transfusion before any hospital-acquired venous thromboembolic (HA-VTE) complications might have biased the association between intraoperative PRBC transfusion and HA-VTE complications. To address this, we performed a sensitivity analysis which indicated that after removing patients with missing data for intraoperative PRBC transfusion the association between intraoperative PRBC transfusion and HA-VTE remained (odds ratios [ORs] for 1, 2, 3, and ≥4 units of PRBC versus none: 1.16 [1.09 to 1.23], 1.19 [1.12 to 1.26], 1.59 [1.49 to 1.68], 1.49 [1.40 to 1.58]). Postoperative transfusion before any HA-VTE complications was not collected by the Society of Thoracic Surgeons Adult Cardiac Surgery Database and was not available for analysis. Second, Butt et al1 also indicated that a causality relationship between intraoperative PRBC transfusion and HA-VTE complications was not supported by the lower odds of HA-VTE complications in women. To address this comment, we reiterate the following: i) given the retrospective nature of our study it was not meant to definitively ascertain a causality, but rather reinforce a previously described association between intraoperative PRBC transfusion and HA-VTE complications in a large-scale national registry; ii) our propensity score-weighted, and covariate-adjusted analysis including adjusting for sex indicated that intraoperative PRBC transfusion was independently associated with HA-VTE complications after isolated CABG surgery; iii) only a small proportion of patients had missing data for height (0.03%) and weight (0.02%), and thus, the calculated body mass index (BMI) was observed in nearly all patients (missing, 0.03%). Therefore, our conditional imputation for 0.03% of the missing BMI is highly unlikely that it may have impacted the association of BMI and intraoperative PRBC transfusion in the development of the propensity score. We agree with Butt et al1 that it would have been potentially valuable to study the impact of geographic location on our selected patient- and procedure-related characteristics, but this information was not available through the participant user file research mechanism via which our study was approved. Third, we agree with the comment that delayed thromboprophylaxis during a prolonged hospital length of stay may also exacerbate HA-VTE complications independently or in combination with intraoperative and postoperative PRBC transfusions. As indicated by Butt and colleagues1 the Society of Thoracic Surgeons Adult Cardiac Surgery Database does not capture data on delayed thromboprophylaxis during a prolonged hospital length of stay, and thus we were not able to study its respective association with prolonged length of stay. Butt et al1 speculate that our approach of implementing a propensity score-weighted method using matching inverse probability of treatment weighting to account for potential confounding of the association between intraoperative PRBC transfusion and our outcomes may have been impacted by handling of extreme weights.4 To address the possibility of residual confounding, we considered the evidence for causality (E value),5 which is considered as an alternative approach to sensitivity analyses for potential unmeasured confounding, and were able to demonstrate that there was a low potential for unmeasured confounding significantly influencing the association between intraoperative PRBC transfusion and our primary outcome of HA-VTE. Finally, we agree with Butt et al1 that there is a need to better predict HA-VTE. We also strongly believe that there is a potentially unmet need for current and future “studies to explore interventions aimed at improving perioperative anemia and blood management while maintaining appropriate postoperative thromboprophylaxis, thereby significantly decreasing the need for PRBC transfusions in this setting and potentially decreasing the incidence of postoperative venous thromboembolism after cardiac surgery.”2

Alcohol withdrawal syndrome in trauma patients: a study using the Trauma Quality Program Participant User File

ObjectiveTo identify the rates and possible predictors of alcohol withdrawal syndrome (AWS) among adult trauma patients.MethodsThis is a retrospective review of all adult patients (18 years or older) included in...

Impact of cytoreductive nephrectomy (CRN) on overall survival (OS) in metastatic non–clear cell renal cancer (nccRCC).

730 Background: Non-clear cell renal cell carcinoma (nccRCC) accounts for 25% of kidney cancer diagnoses and encompasses a diverse group of kidney tumors with distinct biology for which treatment in the metastatic setting is evolving. The role of CRN for nccRCC population in the current treatment landscape remains unclear. Methods: We retrospectively identified patients (pts) with nccRCC from The National Cancer Database (NCDB) participant user file (PUF) for Kidney and Renal Pelvis Tumors. Pts with de novo metastatic disease diagnosed between 2006 and 2017, received systemic treatment (trt) with immunotherapy (IO) or non-immunotherapy (NIO) and either underwent or could have undergone a CRN were selected. Demographic and disease characteristics were summarized using descriptive statistics. The cumulative incidence of CRN with death without CRN as a competing risk, was estimated using the Nelson-Aalen estimator. The association of each demographic and disease characteristic on the cumulative incidence of CRN was evaluated using univariate Fine-Gray regression. The effect of CRN on survival was visualized using a Simon-Makuch plot. P values were based on Mantel-Byar test. Cox regression with a time-dependent predictor was used to estimate the change in the hazard of death after CRN. Results: We identified 3644 pts, 72% male, mean age 61 ±13 years. Nearly 40% of pts (n=1453) had sarcomatoid histology, followed by 30% with papillary (n=1075). Most pts, 96% (n=3489) received NIO systemic trt and only 9% were treated with IO (n=319). Nearly half of the study population (45%) underwent CRN (n=1642). Of these, 95% received NIO trt (n=1564) and 9% received IO (n=152). Pts who underwent CRN were younger and less likely to have bone, brain or liver metastases. Minority pts were less likely to undergo CRN. Mean time from dx to surgery was 1.1 ±1.7 months. For all pts, mOS was 9 months (95% CI: 8.6-9.4). OS was improved for pts who underwent CRN vs those who did not (11.3 vs 7.5 months, p&lt;0.0001). In multivariate analysis, cytoreductive nephrectomy was associated with a reduction in the risk of death, HR 0.73 (95% CI: 0.68, 0.80, p&lt;.0001). Conclusions: For pts with de novo metastatic nccRCC, CRN is associated with improved outcomes. Further analysis regarding the effect of treatment regimens on survival outcomes is warranted and planned. Prospective randomized trials in the modern treatment era are needed to further assess the timing and impact of CRN on outcomes in pts with metastatic nccRCC. [Table: see text]

Comparative real-world survival outcomes of muscle-invasive bladder cancer treated with bladder-only vs. whole-pelvis concurrent chemoradiation.

488 Background: Elective nodal irradiation for patients with muscle-invasive bladder cancer (MIBC) undergoing trimodal therapy (TMT) is controversial. In patients with node-negative (N0) MIBC, the benefit of elective whole-pelvis concurrent chemoradiotherapy (WP-CCRT) compared to bladder-only (BO)-CCRT has not been demonstrated. Currently, the National Comprehensive Cancer Network (NCCN) guidelines do not recommend whether to include pelvic nodes in the radiation field. Using real-world data from the National Cancer Database (NCDB), we sought to compare the overall survival (OS) between BO-CCRT and WP-CCRT for MIBC. Methods: Using the 2019 NCDB Participant User File, we identified cases of MIBC diagnosed between 2017 and 2018. We selected patients with clinical T2-T4N0M0 disease receiving TMT as first-line treatment. TMT was defined as transurethral resection of bladder tumor followed by CCRT: 60–65 Gy of RT delivered to the bladder with concurrent single- or multiple-agent chemotherapy. Patients were stratified into BO-CCRT vs. WP-CCRT. Overall survival (OS) analysis was performed using Kaplan-Meier estimates and multivariable Cox proportional hazards regression analysis. The variables included in the multivariable Cox regression model were age, sex, race, comorbidity burden (as per the Charlson-Deyo comorbidity index), facility type, insurance status, median income quartile, rurality, distance from facility, and clinical T stage. Results: A total of 605 patients receiving TMT for MIBC were identified: 162 (26.8%) BO-CCRT and 443 (73.2%) WP-CCRT. The median follow-up time was 25.6 months (interquartile range [IQR]: 4.8-42.6) and 28.7 months (IQR: 3.0-51.6) for BO-CCRT and WP-CCRT, respectively. The median OS was 32.9 months (95% confidence interval [CI] 30.8 – not reached) and 48.3 months (95% CI 39.6 – not reached) for BO-CCRT and WP-CCRT, respectively. However, multivariable Cox regression analysis failed to find an association between WP-CCRT (hazard ratio [HR] 1.08, 95% CI 0.76-1.54) and improved OS, compared to BO-CCRT. Conclusions: Elective nodal-irradiation (WP-CCRT) in the setting of TMT for MIBC was not associated with a benefit in OS compared to BO-CCRT.

Abstract B114: The absolute need for impartial care: Aggressive surgery and local therapy provide equitable care across diverse patient populations for advanced colorectal cancer

Abstract Introduction: Survival for patients with peritoneal metastasis from colorectal cancer is poor, but can be improved in highly selected patients with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Advanced cancer states tend to create racial/ethnic disparities. Little is known about racial/ethnic disparities in patients with colorectal cancer peritoneal metastasis managed with CRS/HIPEC. In this study we examine the impact of race/ethnicity of patient outcomes and overall survival after CRS/HIPEC. Methods: Data were extracted from the National Cancer Database 2019 Participant User File for adult patients with colorectal cancer managed with CRS/HIPEC from 2006-2018. Patients were classified by racial/ethnic groups: non-Hispanic White, non-Hispanic Black, Hispanic, and Other. Differences in sociodemographics, treatment course, tumor characteristics, and postoperative outcomes were evaluated using Χ2 and Kruskal-Wallis tests. Kaplan-Meier survival analysis and Log-rank tests were used to assess for differences in survival. Cox Regression was used for evaluating predictors of overall survival. Results: 732 patients with colorectal cancer underwent CRS/HIPEC, of which 573 (78.3%) were White, 91 (12.4%) were Black, 39 (5.3%) were Hispanic, and 29 (4.0%) were Other. There were significant differences by race/ethnicity in patient sex, insurance payor, distance traveled to facility, location, education level, and income. There was, however, no difference in patient age, cancer treatment facility type, or year of diagnosis. Patients had similar amounts of comorbidities with the majority of patients having a Charlson-Deyo score of 0 (p=0.6882). Surgical management with CRS/HIPEC was similar across all groups in terms of median days from diagnosis to surgery. Tumor grade and surgical margins were also similar. Postoperative outcomes including hospital length of stay, rates of readmission, 30 and 90-day mortality were not different. Patients had similar lengths of follow-up. Median overall survival was 40.1 months for White patients, 45.5 months for Black patients, 44.1 months for Hispanic patients, and 64.1 months for Other patients. Overall survival was not statistically different between racial/ethnic groups (p=0.1922). Multivariate survival analysis showed that race/ethnicity was not a predictor of survival; however, tumor grade (Poorly differentiated: HR 2.031 [1.309, 3.151], p=0.0016; Undifferentiated: HR 2.284 [1.297, 4.021], p=0.0042) and surgical margins (R2 resection: HR 1.954 [1.186, 3.221], p=0.0086) were significant predictors of survival. Conclusions: Advanced colorectal disease with peritoneal involvement can be managed aggressively with CRS/HIPEC and improve patient overall survival. Similar outcomes are possible for different racial/ethnic groups despite differences in patient sociodemographic factors. CRS/HIPEC for colorectal peritoneal disease should be viewed as an equitable management option for diverse patient populations. Citation Format: Devon C. Freudenberger, Luke Wolfe, Andrea N. Riner, Vignesh Vudatha, Kelly M. Herremans, Leopoldo J. Fernandez, Jose G. Trevino. The absolute need for impartial care: Aggressive surgery and local therapy provide equitable care across diverse patient populations for advanced colorectal cancer [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B114.

Abstract B113: Equal opportunity for all? Does race/ethnicity predict overall survival after aggressive surgical therapy for appendiceal carcinoma?

Abstract Introduction: In select patients, appendiceal cancer with peritoneal surface involvement is managed aggressively with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). There is limited to no data on the management and outcomes of this advanced disease across diverse patient populations. Here we report the first large-scale study evaluating the influence of racial/ethnic differences in outcomes for patients with appendiceal cancer undergoing CRS/HIPEC. Methods: The National Cancer Database (NCDB) 2019 Participant User File was queried for adult patients 18-89 years old, diagnosed with appendiceal cancer that underwent CRS/HIPEC from 2006-2018. Patients were stratified by racial/ethnic groups: non-Hispanic White, non-Hispanic Black, Hispanic, and Other. Differences in sociodemographics, treatment course, tumor characteristics, and postoperative outcomes were determined using Χ2 and Kruskal-Wallis tests. Kaplan-Meier survival analysis and Log-rank tests were conducted to assess for differences in survival. Cox Regression was used to evaluate for predictors of overall survival. Results: In total 2,532 patients were identified, of which 2,098 (82.9%) identified as White, 186 (7.3%) as Black, 127 (5.0%) as Hispanic, and 121 (4.8%) as Other. There were statistically significant differences for all sociodemographic factors across groups, including patient age, sex, insurance payor, distance traveled, treatment facility type, geographic location, and median income. There was no difference in year of diagnosis or burden of comorbidities shared by racial/ethnic group. Days from diagnosis to surgery, tumor grade, surgical margins, hospital length of stay, and rates of readmission were similar between all groups. There was also no difference in 30-day or 90-day mortality with similar lengths of follow-up. However, overall survival was found to be significantly different between all groups (p=0.0029) with Black patients having the shortest median survival of 106.7 months compared to Hispanic patients of 145.9 months (p=0.0093). Median survival for White patients was higher at 136.3 months. On multivariate analysis, race/ethnicity was found to be an independent significant predictor of overall survival. Black and White patients compared to Hispanic patients have increased risk of death after CRS/HIPEC for appendiceal cancer (HR: 2.117 [1.306, 3.431], p=0.0023 and HR: 1.549 [1.007, 2.383], p=0.0463, respectively). Conclusions: Racial/ethnic disparities are strikingly apparent in sociodemographics and overall survival for patients with appendiceal cancer that undergo CRS/HIPEC. Despite having similar tumor and treatment characteristics, long-term survival diverged with Hispanic patients having a survival advantage, whereas non-Hispanic Black individuals had worse overall survival. Disparities in survivorship are not fully explained by social determinants of health, thus different underlying biologic and genomic influences that have yet to be determined may be at play in how this disease progresses. Citation Format: Devon C. Freudenberger, Luke Wolfe, Andrea N. Riner, Vignesh Vudatha, Kelly M. Herremans, Leopoldo J. Fernandez, Jose G. Trevino. Equal opportunity for all? Does race/ethnicity predict overall survival after aggressive surgical therapy for appendiceal carcinoma? [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B113.

Robotic-Assisted Minimally Invasive Esophagectomy: Postoperative Outcomes in a Nationwide Cohort

IntroductionRobotic-assisted minimally invasive esophagectomy (RAMIE) in clinical trials has demonstrated improved outcomes compared to open esophagectomy (OE). However, outcomes after national implementation remain unknown. The aim of this study was to evaluate postoperative outcomes after RAMIE. MethodsPatients who underwent elective esophagectomy between 2016 and 2020 were identified from the American College of Surgeons-- National Surgical Quality Improvement Program esophageal targeted participant user files and categorized by operative approach, with patients who underwent hybrid procedures excluded. Outcomes were compared between OE and minimally invasive esophagectomy (MIE)/RAMIE, with subset analyses by minimally invasive operative approach. Primary outcomes included pulmonary complications, anastomotic leak requiring reintervention, all-cause morbidity, and 30-d mortality. ResultsIn total 2786 patients were included, of which 58.3% underwent OE, 33.2% underwent MIE, and 8.4% underwent RAMIE. In the entire cohort, Ivor Lewis esophagectomy was the most common technique (64.6%), followed by transhiatal (22.0%), and a McKeown technique (13.4%). Comparing OE and MIE/RAMIE, pulmonary complications (21.5% versus 16.1%, P < 0.01) and all-cause morbidity (40.9% versus 32.3%, P < 0.01) were both reduced in the MIE/RAMIE group. When directly comparing MIE to RAMIE, there was no difference in the rate of pulmonary complications, anastomotic leak, all-cause morbidity, and mortality. However, RAMIE was associated with decreased all-cause morbidity compared to OE (40.9% versus 33.3%, P = 0.03). ConclusionsRAMIE was associated with decreased morbidity compared to OE, with similar outcomes to MIE. The national adoption of RAMIE in this select cohort appears safe.

Are IBD Patients Underscored when Determining Postoperative VTE Risk?

BackgroundPatients with inflammatory bowel disease (IBD) have an increased risk of venous thromboembolism (VTE) following colorectal surgery and there is currently no consensus on post-surgical VTE prevention or specific VTE risk assessment tools. We sought to evaluate VTE risk after colorectal surgery and determine if known risk factors used in risk assessment tools adequate correlate with VTE risk in IBD patients. MethodsRetrospective cohort study using the National Surgical Quality Improvement Project (NSQIP) Participant User File from 2010 to 2018. ResultsA total of 27,679 patients were included; 19,015 (68.7%) had Crohn’s disease (CD) and 8664 (31.3%) ulcerative colitis (UC). Of these, 16,749 (60.5%) underwent abdominopelvic procedures, 10,178 (36.8%) complex pelvic procedures, and 752 (2.7%) small bowel operations. The overall VTE rate was 2.3%. The VTE rate in patients with CD and UC was 1.8% and 3.6% (p < 0.001) respectively. Overall median time to VTE was 9 days after surgery. VTE rate was highest in patients who underwent complex pelvic procedures (3.6%; 361/10,178). A risk score was calculated using 16/40 available variables from the Caprini VTE Risk Assessment tool; risk score ranged from 3 to 12 points. Most patients that developed a VTE had a score between 3 and 5 points (75.6%), and only 24.5% had a score of 6 or higher. Patients with higher risk scores did not have a higher VTE incidence. ConclusionPost-surgical VTE rates are high in IBD patients. Over half of the events occurred following discharge and in patients with an apparent low-risk score. Additional studies are warranted to define a recommended postoperative VTE prophylaxis regimen for patients with IBD.

Abstract 9278: No Improvement in the Operative Outcomes of Women Undergoing Coronary Artery Bypass Surgery in the United States, 2011-2020

Background: Women undergoing coronary artery bypass grafting (CABG) have significantly higher mortality and morbidity compared to men. While on a national level overall mortality after CABG has significantly decreased over the last decade, it is unclear if this trend of improvement applies to women. Objective: The aim of this analysis was to evaluate trends in outcomes of women undergoing CABG in the United States over the course of the last decade. Methods: The data for this study was provided through the STS Participant User File research program. Patients were included in the analysis if they underwent primary isolated CABG during the study period. Patients requiring resuscitation prior to surgery, emergent/salvage operations, and reoperation were excluded. The primary outcome was operative (30-day) mortality. The secondary outcome was the composite of operative mortality and morbidity (including operative mortality, stroke, renal failure, reoperation, deep sternal wound infection, prolonged mechanical ventilation, prolonged hospital stay). For all the outcomes, the STS definitions were used. The attributable risk (the effect of female sex on CABG outcomes) for the primary and secondary outcomes was calculated. Results: Between 2011 and 2020, 1,297,204 patients underwent multivessel CABG, 317,716 (24.5%) of which were women. The proportion of women decreased from 26.2% in 2011 to 22.7% in 2020 (P for trend &lt;0.001). Women had a higher unadjusted operative mortality (2.8% vs 1.7%, P &lt;0.001) and overall unadjusted incidence of the composite of operative mortality and morbidity (22.9% vs 16.7%, P &lt;0.001) compared to men. The attributable risk of female sex for operative mortality varied from 1.28 in 2011 to 1.41 in 2020, with no significant change over the study period (P for trend=0.37). The attributable risk for the composite of operative mortality and morbidity was 1.08 in 2011 and 2020, with no significant change over the study period (P for trend=0.71). Conclusion: Female sex remains an independent risk factor for adverse outcomes following CABG and no significant improvement has been seen over the course of the last decade. Further investigation into the determinants of operative outcomes in women is urgently needed.

Effect of Intraoperative Neuromonitoring on the Risks of Recurrent Laryngeal Nerve Injury During Thyroidectomy: A Doubly Robust Approach.

To evaluate the relationship between the use intraoperative neuromonitoring (IONM) during thyroidectomy and the risk of recurrent laryngeal nerve (RLN) injury. The role of IONM in reducing RLN injury during thyroidectomy remains controversial. Several studies on this topic apply conventional multivariable regression to adjust for confounding. However, estimates from this method may be biased due to model misspecification, especially with a rare outcome such as RLN injury. We used a pooled dataset created by linking the 2016-2019 National Surgical Quality Improvement Project General Participant User File with the corresponding Targeted-Thyroidectomy file. The primary outcome was RLN injury rates, and the secondary outcomes were operating time and postoperative length of stay. A doubly robust (DR) estimator, in the form of an inverse-probability-weighted regression adjustment model, was used to estimate the effect of the use of IONM on the risk of RLN injury. Sensitivity analyses was performed. Twenty-four thousand three hundred seventy patients were evaluated, out of which 15,836 (70%) patients had IONM during thyroidectomy, and RLN injury occurred in 1498 (6.2%) cases. Rates of RLN injury increase with increasing age and BMI and are higher in patients with a cancer diagnosis, previous neck operation, total thyroidectomy, and node dissection. Doubly robust model suggests that the use of IONM was associated with a significant reduction in overall rate of RLN injury [risk ratio 0.77, confidence interval (CI), 0.68-0.87, P <0.001], and postoperative length of stay [-2.5 hours (CI, -4.18 to -0.81h), P =0.004]. However, IONM use was associated with an increase in operating time [15.41 minutes (CI, 13.29-17.54 minutes), P <0.0001]. Sensitivity analyses revealed that our estimates are largely robust to confounding. In a balanced cohort of patients undergoing thyroidectomy from multiple sites and surgeons participating in National Surgical Quality Improvement Project, the use of IONM during thyroidectomy was associated with reduction in RLN injury.

Knee ligament injuries in U.S. pedestrian crashes

Objective Projectile legform tests are used to evaluate pedestrian lower extremity injury risk, including risk of injury to the cruciate and collateral ligaments. However, it has been suggested that cruciate ligament injuries rarely occur without collateral ligament injuries, making a cruciate ligament injury requirement unnecessary in pedestrian test procedures. Therefore, the current study examines cruciate ligament injuries among U.S. pedestrians with and without other injuries that are evaluated in pedestrian test procedures. Methods Injury data for pedestrians treated in U.S. trauma centers from 2007 to 2017 were drawn from the National Trauma Data Bank (NTDB) Research Data Set (RDS) and from its successor, the Trauma Quality Program (TQP) Participant User Files (PUF). Crash and demographic details for individual cases with documented knee ligament injuries were obtained from the Pedestrian Crash Data Study (PCDS). Results Among pedestrians aged 16 and older with knee ligament injuries, 38% had only collateral injuries, 31% had only cruciate injuries and 31% were documented with injuries to both. Younger pedestrians also sustained cruciate injuries without collateral injuries, with 36% of the 0–15 year-old pedestrians diagnosed with knee ligament injuries having isolated cruciate injuries. Given that injuries to the left and right knee could not be distinguished in NTDB cases, these estimates of isolated ligament injuries are likely conservative, so that at least 31% of pedestrians aged 16 and older and at least 36% of younger pedestrians sustained cruciate ligament injuries without collateral ligament injuries in the same knee. A PCDS case study illustrated how cruciate injury can occur without collateral injury in a lateral bumper impact below the knee. Conclusions Cruciate ligament injuries can occur in pedestrian crashes, with or without other injuries that are evaluated in pedestrian test procedures. Isolated cruciate injuries may be more likely in impacts above or below the knee and in impacts with a component of anterior-posterior loading. The frequency of cruciate injury in the absence of collateral injury in lateral and non-lateral impact supports inclusion of injury measures correlating to cruciate injury risk in pedestrian legform test procedures.

Assessing the Race, Ethnicity, and Gender Inequities in Blood Alcohol Testing After Trauma.

Alcohol use remains a significant contributing factor in traumatic injuries in the United States, resulting in substantial patient morbidity and societal cost. Because of this, the American College of Surgeons Verification, Review, and Consultation Program requires the screening of 80% of trauma admissions. Multiple studies suggest that patients who use alcohol are subject to stigma by health care providers and may ultimately face legal and financial ramifications of a positive alcohol screening test. There is also evidence that sociodemographic factors may dictate drug and alcohol screening patterns among patients. Because this screening target is often not uniformly achieved among all patients presenting with injury, we sought to investigate whether there are any discrepancies in screening across sociodemographic groups. We investigated the Trauma Quality Program Participant User File for all trauma cases admitted during 2017 and compared the rates of the serum alcohol screening test across different demographic factors, including race and ethnicity. We then performed an adjusted multivariable logistic regression to determine the odds ratio (OR) for receiving a test based on these demographic factors adjusted for hospital and clinical factors. There were 729,174 traumas included in the study. Of this group, 345,315 (47.4%) were screened with a serum alcohol test. Screening rates varied by injury mechanism and were highest among motorcycle crashes (66.0% of patients screened) and lowest among falls (32.8% of patients screened). Overall, Asian and Pacific Islander (52.5% screened), Black (57.7% screened), and other race (58.4% screened) had higher rates of alcohol screening than White patients (43.7% screened, P<0.001). Similarly, Hispanic patients were screened at higher rates than non-Hispanic patients (56.4% screening versus 46.2% screening, P<0.001). These differences persisted across nearly all injury categories. In multivariable logistic regression, Asian and Pacific Islanders were associated with the highest odds of being screened (OR 1.34, P<0.001) followed by other race (OR 1.25, P<0.001) in comparison to White patients. There are consistent and significant differences in alcohol screening rates across race and ethnicity, despite accounting for injury mechanism and comorbidities.

Contemporary Axillary Management in cT1-2N0 Breast Cancer with One or Two Positive Sentinel Lymph Nodes: Factors Associated with Completion Axillary Lymph Node Dissection Within the National Cancer Database.

Management of the axilla in patients with cT1-2N0 breast cancer with one or two positive (+) sentinel lymph nodes (SLNs) is often debated, especially in patients undergoing mastectomy. In 2018, the National Cancer Database (NCDB) began collecting the number of +SLNs, enabling identification of patients with one or two +SLNs for the first time. From the 2018 NCDB participant user file (PUF), all cT1-2N0M0 patients with one or two +SLNs were identified. The rates of completion axillary lymph node dissection (cALND) after breast-conserving surgery (BCS) and mastectomy were determined, and logistic regression was used to assess factors associated with cALND. Of 10,531 patients with one or two +SLNs, cALND was performed in 807/6498 (12.4%) BCS patients and 1845/4033 (45.7%) mastectomy patients (p < 0.001). Factors associated with cALND in BCS were cT2 versus cT1 (16.0% versus 11.1%, p < 0.001), two versus one positive SLN (20.7% versus 10.8%, p < 0.001), and higher tumor grade (grade 3: 15.4% versus grade 1-2: 11.7%, p = 0.002). Factors associated with cALND among mastectomy were cT2 versus cT1 (48.2% versus 43.7%, p = 0.004), two versus one positive SLN (56.6% versus 42.8%, p < 0.001), younger age (age < 50 years: 49.0%, age 50+ years: 44.1%, p = 0.004), and Hispanic ethnicity (55.7% versus 45.1%, p = 0.001). After adjusting for pN category, adjuvant radiation was significantly less likely after mastectomy if cALND was performed (odds ratio (OR) 0.51, p < 0.001). Omission of cALND with one or two +SLNs in BCS is common. Deescalation of axillary therapy in mastectomy is slower, with a cALND rate of 45.7% in 2018. With the recent updates to the National Cancer Care Network (NCCN) guidelines, we anticipate continued deescalation of axillary therapy in mastectomy patients.

An Evaluation of Pediatric Gastrocutaneous Fistula Closure Through the Punch Excision of Epithelized Tract Procedure.

Persistent gastrocutaneous fistulae frequently complicate gastrostomy tube placement. A minimally invasive technique for tract closure employing balloon catheter retraction and punch excision of the epithelized tract (PEET) was recently reported. We hypothesized the PEET technique of closure would lead to decreased complications without an increased incidence of recurrence. We conducted a single-center retrospective cohort study evaluating children who underwent gastrocutaneous fistula (GCF) closure 1/1/2018-12/31/2021, comparing patients who underwent the PEET procedure to those repaired with layered closure. Procedure duration and outcomes were additionally compared to the 2018-2019 National Surgical Quality Improvement Program (NSQIP) Participant Use File (PUF) database. Sixty-two children underwent operative GCF closure, including 25 with PEET and 37 traditional layered closure. Procedural time was significantly decreased employing PEET (14 vs 26minutes, P < .0001), less than half the national median by the NSQIP PUF database of 292 GCF closures (14 vs 34.5minutes, P < .0001). Those repaired with the PEET method experienced no episodes of recurrence, surgical site infection, readmission, reoperation, or mortality within 30days of the procedure. Conversely, in traditional closure, there was a 24.3% complication rate, including 7 surgical site infections, 1 readmission, and 2 unplanned reoperations. National procedural complication rate by NSQIP PUF was 5.5%, with a 4.8% rate of surgical site infection, .3% reoperation incidence, and .3% mortality. Our study suggests GCF closure employing the PEET procedure is a safe, more efficient method of tract closure than the traditional layered closure technique.

Abstract P3-14-10: Breast cancer patterns, behavior and survival among American Indians in the west north central region and the other regions of the U.S.

Abstract Purpose: American Indians (AIs) constitute the single largest racial minority in North Dakota and South Dakota. There are no studies looking at what sociodemographic or biological factors may play a role in affecting outcomes and mortality of breast cancer (BC) among AIs in the United States. Our study compared the BC patterns, behavior, and survival of AIs living in the West North Central Region (WNCR) of the U.S (which includes ND, SD, MN, NE, IO, KS, MO) to the AI BC patients in the remainder of the country. Methods: We used the records of all AI BC patients diagnosed between the years 2004-2016 from The National Cancer Database participant user files. All analyses were conducted using SPSS software (version 25). Results: Records were available for 6,466 AI BC patients, 798 were in the WNCR. There was no difference between WNCR and other regions in the stage distribution, mean age at diagnosis, morphology, hormonal/HER2 status, tumor size, lymph node status, or second cancers. The WNCR patients had less private insurance, lived in zip codes with lower median income, had more co-morbidities, and traveled longer distances for care (p&amp;lt;0.001 for each). They had higher grade cancers (p&amp;lt;0.001) at diagnosis. The WNCR patients were less likely to have received radiation therapy (p=0.015) but more likely to have received chemotherapy (p&amp;lt;0.001) and hormonal therapy (p=0.009) and had longer inpatient stay days after surgery (p&amp;lt;0.001). Time to first treatment and first treatment within 90 days (88.0% vs. 79.7%, p&amp;lt;0.001) was significantly better in the WNCR than in other regions of the country. Five year mortality rate was higher (16.3% vs. 11.1%, p&amp;lt;0.001) and cumulative survival was lower (p&amp;lt;0.001) in the WNCR as compared to AIs in other regions of the country. Univariate/multivariate analysis failed to identify variables that could explain the differences in 5 year mortality or cumulative survival between WNCR and other regions. Conclusion:AIs with BC in the WNCR had worse 5 year mortality and cumulative survival as compared to AIs in other regions in the US. Our analysis could not identify variables that explained the differences in mortality or cumulative survival between WNCR and other regions. Citation Format: Anu G Gaba, Li Cao, Rebecca Renfrew, Deann Witte, Janet Wernisch, Denise Lutkemeier, Kristi Egland, Ross Crosby. Breast cancer patterns, behavior and survival among American Indians in the west north central region and the other regions of the U.S. [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-14-10.

Axillary surgery and complication rates after mastectomy and reconstruction for breast cancer: an analysis of the NSQIP database.

Some series have shown increased complications with extended nodal surgery and immediate breast reconstruction (IBR) with implants. We aim to explore complications associated with axillary dissection compared to sentinel lymph node biopsy at a population level. American College of Surgeons National Surgical Quality Improvement Program participant user files from 2008-2018 were searched to create a cohort of female patients undergoing unilateral mastectomy with IBR and axillary surgery for non-metastatic breast cancer. Patients were classified as having sentinel lymph node biopsy (SLNB), axillary dissection (ALND), or sentinel lymph node biopsy and axillary dissection (SLNB + ALND). Baseline demographics were compared, and multivariable logistic regression was to assess for independent predictors of the primary outcome of 30-day morbidity. Between 2008 and 2018, 18,232 patients had mastectomy and IBR with axillary surgery; 12,632 patients underwent SLNB, 3727 had ALND and 1,873 underwent SLNB + ALND. Mean age of patients in the cohort was 52.5 (SD 11). There was no difference in 30-day morbidity between groups (SLNB: 4.3%, ALND: 4.9%, SLNB + ALND: 4.2%, p = 0.207). Multivariable regression showed that type of axillary surgery was not an independent predictor of 30-day complications (OR 0.78 (95% CI 0.52-1.15) for ALND, and OR 0.87 (95% CI 0.52-1.45) for ALND + SLNB vs SLNB alone). Significant independent predictors for complications were increased BMI (OR 1.06 (95%CI 1.04-1.08)) and increased operative time (OR 1.003 (95% CI 1.001-1.005)). ALND does not increase 30-day morbidity in patients undergoing IBR when compared to SLNB. This supports concurrent axillary dissection for IBR patients when indicated.

A Comparison of Revised Frailty Score Range Association With National Lower Extremity Bypass Outcomes By Gender

INTRODUCTION AND OBJECTIVES The Risk Assessment Index (RAI) frailty scoring system, developed in an all-male veteran cohort, has recently undergone revision and validation using a general surgical sample from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. We set forth to investigate the association between RAI-rev scores and lower extremity bypass outcomes by gender in the NSQIP database. METHODS All elective cases recorded from 2015-2019 in the NSQIP Targeted Lower Extremity Open database were paired with the Participant User File using Case IDs. Cohorts were defined by EMR-recorded gender. Top quartile postoperative length of stay was defined as extended. Aggregate cohort demographics, perioperative factors, and 30-day outcomes were compared using unpaired t-test and Fisher's exact test. Adjusted odds-ratios for outcomes were generated with a multivariate binary logistic regression model utilizing prior ipsilateral bypass versus percutaneous intervention, graft utilization, dirty/infected wound, smoking, hypertension, diabetes, and steroid use as covariates. Calculated RAI-rev scores <25 were defined as the non-frail reference range. RESULTS 8,155 bypass cases were recorded in NSQIP from 2015-2019 including 2,498 (31%) performed in women who had slightly lower RAI-rev scores on average (22.1 ± 5.8 vs 24.2 ±5.1; p=0.0001). While univariate trends suggested increasing incidence for most outcomes across both represented genders, there were more non-significant aOR for women than men (Table). Analysis of 4 patients with RAI-rev scores >45 resulted in no significant aOR. CONCLUSIONS Our study is the first to find that outcomes other than mortality are significantly predicted by RAI-rev score ranges in lower extremity bypass. Stratification of aOR by gender suggests that additional validation of frailty scores may be warranted as these systems gain wider use. The Risk Assessment Index (RAI) frailty scoring system, developed in an all-male veteran cohort, has recently undergone revision and validation using a general surgical sample from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database. We set forth to investigate the association between RAI-rev scores and lower extremity bypass outcomes by gender in the NSQIP database. All elective cases recorded from 2015-2019 in the NSQIP Targeted Lower Extremity Open database were paired with the Participant User File using Case IDs. Cohorts were defined by EMR-recorded gender. Top quartile postoperative length of stay was defined as extended. Aggregate cohort demographics, perioperative factors, and 30-day outcomes were compared using unpaired t-test and Fisher's exact test. Adjusted odds-ratios for outcomes were generated with a multivariate binary logistic regression model utilizing prior ipsilateral bypass versus percutaneous intervention, graft utilization, dirty/infected wound, smoking, hypertension, diabetes, and steroid use as covariates. Calculated RAI-rev scores <25 were defined as the non-frail reference range. 8,155 bypass cases were recorded in NSQIP from 2015-2019 including 2,498 (31%) performed in women who had slightly lower RAI-rev scores on average (22.1 ± 5.8 vs 24.2 ±5.1; p=0.0001). While univariate trends suggested increasing incidence for most outcomes across both represented genders, there were more non-significant aOR for women than men (Table). Analysis of 4 patients with RAI-rev scores >45 resulted in no significant aOR. Our study is the first to find that outcomes other than mortality are significantly predicted by RAI-rev score ranges in lower extremity bypass. Stratification of aOR by gender suggests that additional validation of frailty scores may be warranted as these systems gain wider use.

Risk Factors and Consequences of Acute Kidney Injury After Noncardiac Surgery in Children.

Postoperative acute kidney injury (AKI) is a serious complication that is associated with prolonged hospital stay, high risk of short-term postsurgical mortality, need for dialysis, and possible progression to chronic kidney disease. To date, very little data exist on the risk of postoperative AKI among children undergoing noncardiac surgical procedures. We used data from a large multicenter cohort to determine the factors associated with AKI among children who underwent inpatient noncardiac surgical procedures and its impact on the postoperative course. We utilized the National Surgical Quality Improvement Program Pediatric participant user files to identify a cohort of children who underwent inpatient surgery between 2012 and 2018 (n = 257,439). We randomly divided the study population into a derivation cohort of 193,082 (75%) and a validation cohort of 64,357 (25%), and constructed a multivariable logistic regression model to identify independent risk factors for AKI. We defined AKI as the occurrence of either acute renal failure or progressive renal insufficiency within the 30 days after surgery. The overall rate of postoperative AKI was 0.10% (95% confidence interval [CI], 0.09-0.11). In a multivariable model, operating times longer than 140 minutes, preexisting hematologic disorder, and preoperative sepsis were the strongest independent predictors of AKI. Other independent risk factors for AKI were American Society of Anesthesiologists (ASA) physical status ≥III, preoperative inotropic support, gastrointestinal disease, ventilator dependency, and corticosteroid use. The 30-day mortality rate was 10.1% in children who developed AKI and 0.19% in their counterparts without AKI ( P < .001). Children who developed AKI were more likely to require an extended hospital stay (≥75th percentile of the study cohort) relative to their peers without AKI (77.4% vs 21.0%; P < .001). Independent preoperative risk factors for AKI in children undergoing inpatient noncardiac surgery were hematologic disorder, preoperative sepsis, ASA physical status ≥III, inotropic support, gastrointestinal disease, ventilator dependency, and steroid use. Children with AKI were 10 times more likely to die and nearly 3 times more likely to require an extended hospital stay, relative to their peers without AKI.

Does the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) accurately predict mortality for patients with elevated MELD scores?

BackgroundThe Model for End Stage Liver Disease (MELD) predicts mortality for liver disease patients. The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) estimates mortality risk for surgical patients; however, NSQIP does not collect data regarding liver disease. This study's aim was to examine the accuracy of NSQIP mortality estimates for patients with elevated MELD scores. MethodsNSQIP participant user files from 2005 to 2016 were queried. MELD scores were calculated and patients with scores ≥10 included. NSQIP-predicted mortality was compared to actual mortality. Results268,873 patients met inclusion criteria. Predicted and observed number of 30-day postoperative deaths were 20,644 (7.7%) and 21,764 (8.1%). For patients with MELD ≥24, NSQIP-predicted 30-day mortality underestimated actual mortality. For patients with MELD ≤22, predicted and actual risks were similar. ConclusionNSQIP predicts 30-day mortality risk well for patients with MELD scores from 10 to 22, but underestimates risk for patients with higher MELD scores.