Comparative analysis of hospitalization risk for incident heart failure in non-Hispanic Black versus non-Hispanic White individuals with type 2 diabetes on empagliflozin (Empa-AA): Insights from real-world data.

AIM: There are limited data to evaluate hospitalization for heart failure (hHF) in non-Hispanic Black (hereafter Black) or non-Hispanic White (hereafter White) individuals without previous hHF. Our goal was to evaluate the risk of hHF among Black versus White patients with type 2 diabetes (T2DM) who were initially prescribed empagliflozin using real-world data. METHODS: This multicentre retrospective cohort study included participants aged ≥18 years who had T2DM, were either Black or White, had no previous hHF, and were prescribed empagliflozin between August 2014 and December 2019. Our primary outcome was time to first hHF after the initial prescription of empagliflozin. A propensity-score (PS)-weighted analysis was performed to balance characteristics by race. The inverse probability treatment weighting method based on PS was used to make treatment comparisons. To compare Black with White, a PS-weighted Cox's cause-specific hazards model was used. RESULTS: In total, 8789 participants were eligible for inclusion (Black = 3216 vs. White = 5573). The Black cohort was significantly younger, had a higher proportion of females, and had a higher prevalence of chronic kidney disease, hypertension and diabetic retinopathy, while the White cohort had a higher prevalence of coronary artery disease. After adjustment for confounding factors such as age, gender, coronary artery disease, hypertension and diabetic retinopathy, the hazard ratio for first-time hHF was not significantly different between the two racial groups [hazard ratio (95% confidence interval) = 1.09 (0.84-1.42), p = .52]. CONCLUSION: This study showed no significant difference in incident hHF among Black versus White individuals with T2DM following a prescription for empagliflozin.

Racial Differences in Stage IV Colorectal Cancer Molecular Profiling and Mutation Rates.

INTRODUCTION: Despite advances in colorectal cancer (CRC) treatment, racial disparities persist. The primary aims of the study were to: evaluate differences in molecular testing rates over time by race; and measure the incidence of tumor mutations by race in patients with metastatic CRC. METHODS: A retrospective cohort study was performed of all adult patients with stage IV CRC (2008-2018) identified within the cancer registry of a large regional health system. Demographic/clinical characteristics were collected through primary data abstraction of the electronic health record. Molecular profiling results were obtained directly from Caris Molecular Intelligence and electronic health record. RESULTS: Three hundred eighty-three patients were included: 40.5% (n = 155) were Black and 59.5% (n = 228) were White. Significant increases were observed in microsatellite instability (MSI), KRAS, and BRAF testing rates during the study period (P < 0.0001). The odds of testing over time increased more significantly in Black compared to White patients for MSI testing (White: odds ratio [OR] 1.26 [95% confidence interval [CI] 1.12-1.41], Black: OR 1.69 [95% CI 1.41-2.02], P = 0.005) and BRAF testing (White: OR 1.42 [95% CI 1.26-1.62], Black: OR 1.89 [95% CI 1.51-2.36], P = 0.027). An increase in KRAS testing over time was observed for both cohorts and was independent of race (P = 0.58). Mutation rates did not differ by race: KRAS (Black 55.8% versus White 45.6%, P = 0.13) and BRAF (Black 4.8% versus White 10.0%, P = 0.33). CONCLUSIONS: Within a large regional health system, molecular testing rates in patients with metastatic CRC increased significantly following National Comprehensive Cancer Network guideline changes for both Black and White patients. Black and White patients who underwent molecular testing had similar rates of MSI, KRAS, and BRAF mutations.

A Novel Approach to Analyze Disparities in Colorectal Cancer Screening and Mortality.

INTRODUCTION: Reducing disparities in colorectal cancer (CRC) screening rates and mortality remains a priority. Mitigation strategies to reduce these disparities have largely been unsuccessful. The primary aim is to determine variables in models of healthcare utilization and their association with CRC screening and mortality in North Carolina. METHODS: A cross-sectional analysis of publicly available data across North Carolina using variable reduction techniques with clustering to evaluate association of CRC screening rates and mortality was performed. RESULTS: Three million sixty-five thousand five hundred thirty-seven residents (32.1%) were aged 50 y or more. More than two-thirds (68.8%) were White, while 20.5% were Black. Approximately 61% aged 50 y or more underwent CRC screening (range: 44.0%-80.5%) and had a CRC mortality of 44.8 per 100,000 (range 22.8 to 76.6 per 100,000). Cluster analysis identified two factors, designated social economic education index (factor 1) and rural provider index (factor 2) for inclusion in the multivariate analysis. CRC screening rates were associated with factor 1, consisting of socioeconomic and education variables, and factor 2, comprised of the number of providers per 10,000 individuals aged 50 y or more and rurality. An increase in both factors 1 and 2 by one point would result in an increase in CRC screening rated by 6.8%. CRC mortality was associated with factor 2. An increase in one point in factor 1 results in a decrease in mortality risk by 10.9%. CONCLUSIONS: In North Carolina, using variable reduction with clustering, CRC screening rates were associated with the inter-relationship of the number of providers and rurality, while CRC mortality was associated with the inter-relationship of social, economic, and education variables.

Early outcomes associated with de novo once-daily extended-release versus twice-daily immediate-release tacrolimus in a predominantly African American kidney transplant population: A single-center observational study.

INTRODUCTION: The purpose of this study was to compare early outcomes of de novo LCPT (once-daily extended-release tacrolimus) to IR TAC (twice-daily immediate-release tacrolimus) in a predominantly African American (AA) adult kidney transplant population. METHODS: This is a single center, retrospective cohort study. Patients were divided into two cohorts: IR TAC (administered between January 1, 2017, and January 31, 2019) and LCPT (administered between February 1, 2019, and May 31, 2020). Primary endpoints were changes in tacrolimus trough levels (ng/mL) and estimated glomerular filtration rate up to 12 months post-transplantation. Clinical endpoints included graft survival, delayed graft function, biopsy-proven rejection, CMV viremia, and BK. A propensity score weighted generalized linear mixed effects model was used for analysis. RESULTS: The rate of change in tacrolimus levels was significantly higher in the LCPT cohort compared to the IR TAC cohort at 14 days post-discharge (.2455 ng/mL per day vs. .1073 ng/mL, respectively; p < .001). Subsequently, the LCPT cohort had a slightly higher rate of decline (-.015 ng/mL per day vs. -.010 ng/mL with IR TAC; p = .0894) up to 12 months post-discharge. Although eGFR was similar between the two cohorts at 12 months post-transplant, the rate of increase was slower in the LCPT cohort (.1371 mL/min per day vs. .1852 mL/min per day, p = .0314). No significant differences were found in graft survival, DGF, BPAR, CMV, or BK infection. CONCLUSION: This study demonstrates that despite higher early trough levels with immediate post-transplant LCPT use, clinical outcomes are comparable to IR TAC at one-year post-transplant. Notably, LCPT use does not increase the incidence of DGF and that this formulation of CNI can be used as first line therapy post-transplant.

Association of Rural Residence and Receipt of Guideline-Concordant Care for Locoregional Colon Cancer.

BACKGROUND: Incidence and mortality rates of colon cancer (CC) are higher in rural populations. This study aimed to determine whether rural residence is associated with differences in guideline-concordant care for patients with locoregional CC. METHODS: Patients with stages I-III CC from 2006 to 2016 were identified in the National Cancer Database. Guideline-concordant care (GCC) was defined as resection with negative margins, adequate nodal harvest, and receipt of adjuvant chemotherapy for patients with high-risk stage II or III disease. Multivariable logistic regression (MVR) was performed to evaluate the association between rural residence and the odds of receiving GCC. Effect modification was evaluated using a two-way interaction for rurality by insurance status. RESULTS: Of 320,719 identified patients, 6191 (2%) were rural. The rural patients had lower income and lower educational status than the urban patients and were more often Medicare-insured (p < 0.001). The rural patients traveled farther (44.5 vs. 7.5 miles; p < 0.001), although time to surgery was similar (8 vs. 9 days). The two cohorts had similar resection rates (98.8% vs. 98.0%), margin positivity (5.4% vs. 4.8%), adequate lymphadenectomy (80.9% vs. 83.0%), adjuvant chemotherapy (stage III: 69.2% vs. 68.7%), and receipt of GCC (66.5% vs. 68.3%). In the MVR, the odds of receiving GCC did not differ between the rural and urban patients (odds ratio, 0.99; 95% confidence interval, 0.94-1.05%). Insurance status did not differentially influence the receipt of GCC by the rural versus the urban patients (interaction: p = 0.83). CONCLUSIONS: Rural and urban patients with locoregional CC are equally likely to receive GCC, suggesting that differences in cancer care delivery may not explain rural-urban disparities.

Association of distance traveled on receipt of surgery in patients with locally advanced rectal cancer.

PURPOSE: Studies have shown patients residing in rural settings have worse cancer-related outcomes than those in urban settings. Specifically, rural patients with colorectal cancer have lower rates of screening and longer time to treatment. However, physical distance traveled has not been as well studied. This study sought to determine disparities in receipt of surgery in patients by distance traveled for care. METHODS: A retrospective cohort study of patients with AJCC stage II/III rectal adenocarcinoma was identified within the National Cancer Database (2004-2017). Primary outcome was correlation of distance traveled to receipt of surgery. Multi-variable logistic regression was used to adjust for confounding factors. RESULTS: 65,234 patients were included in the analysis. 94.6% resided in urban-metro areas while 2.2% resided in rural areas. Patients were predominantly non-Hispanic White (NHW) (75.2%) with an overall median age at diagnosis of 61 (IQR 52-71). Overall, 82.6% of patients received surgery. NHW patients were more likely to receive surgery than non-Hispanic Black patients (OR 0.67; 95% CI 0.61-0.73, p < 0.001), as were patients who were privately insured (OR 1.90, 95% CI 1.67-2.15, p < 0.001) or had Medicare (OR 1.68, 95% CI 1.47-1.92, p < 0.001) compared to uninsured patients. Patients traveling distances in the 4th quartile (median 47.9 miles) were more likely to receive surgery than those traveling the shortest distances (1st quartile: median 2.5 miles) (OR 1.37, 95% CI 1.24-1.50, p < 0.001). CONCLUSION: Patients traveling farther distances were more likely to receive surgery than those traveling shorter distances. Shorter distance traveled does not appear to be associated with higher rates of surgical resection in patients with stage II/III rectal cancer.

Body mass index and risk of mortality in patients undergoing bariatric surgery.

BACKGROUND: Prior literature has demonstrated that bariatric surgery is a safe approach for patients with morbid obesity. However, the relationship between body mass index (BMI) and risk of mortality in these patients has not been fully elucidated. Primary objective of this study was to evaluate the relationship between BMI and risk of mortality using data obtained from a national database, with a special focus on patients with BMI ≥ 70.0 kg/m2. METHODS: A retrospective cohort study of patients with morbid obesity (BMI ≥ 40 kg/m2) undergoing first-time bariatric surgery between 2015 and 2018 was performed using data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program. Primary outcome was intra-operative death or death within 30 days post-operatively. Patients were categorized into quartiles according to BMI. Multivariable analysis was performed to evaluate the association of BMI with risk of mortality. Relative risk (RR) and 95% confidence interval (CI) are provided as measures of strength of association and precision, respectively. RESULTS: A total of 463, 436 patients were included with a 30-day mortality rate of 0.11%. Mean BMI (SD) was 48.2 (7.3) kg/m2; 1.5% of patients had BMI ≥ 70.0 kg/m2. On multivariable analysis, highest quartile patients had a significantly higher risk of mortality than lowest quartile patients. For patients with BMI ≥ 70.0 kg/m2, the risk of mortality was more pronounced with an eightfold increase compared to the lowest quartile. In patients with BMI ≥ 70.0 kg/m2, although sleeve gastrectomy (SG) was the most common procedure, the risk of mortality was significantly higher in patients undergoing Roux-en-Y gastric bypass (RYGB). CONCLUSIONS: BMI is associated with increased risk of 30-day mortality. The effect of BMI is more pronounced in patients with BMI ≥ 70.0 kg/m2. In these patients, RYGB is associated with increased risk of mortality compared to SG.

Correction: Association of race and health insurance in treatment disparities of colon cancer: A retrospective analysis utilizing a national population database in the United States.

[This corrects the article DOI: 10.1371/journal.pmed.1003842.].

Risk aversion in the use of complex kidneys in paired exchange programs: Opportunities for even more transplants?

This retrospective review of the largest United States kidney exchange reports characteristics, utilization, and recipient outcomes of kidneys with simple compared to complex anatomy and extrapolates reluctance to accept these kidneys. Of 3105 transplants performed, only 12.8% were right kidneys and 23.1% had multiple renal arteries. 59.3% of centers used fewer right kidneys than expected and 12.1% transplanted zero right kidneys or kidneys with more than 1 artery. Five centers transplanted a third of these kidneys (35.8% of right kidneys and 36.7% of kidneys with multiple renal arteries). 22.5% and 25.5% of centers currently will not entertain a match offer for a left or right kidney with more than one artery, respectively. There were no significant differences in all-cause graft failure or death-censored graft loss for kidneys with multiple arteries, and a very small increased risk of graft failure for right kidneys versus left of limited clinical relevance for most recipients. Kidneys with complex anatomy can be used with excellent outcomes at many centers. Variation in use (lack of demand) for these kidneys reduces the number of transplants, so systems to facilitate use could increase demand. We cannot know how many donors are turned away because perceived demand is limited.

A population health assessment of screening mammography on breast cancer mortality in North Carolina.

PURPOSE: To identify predictors of screening mammography use and the effect of screening mammography on breast cancer mortality in North Carolina. METHODS: This cross-sectional study integrated publicly available data from government and private data repositories to model predictors of screening mammography and breast cancer mortality in North Carolina. RESULTS: In North Carolina during 2008-2010, on average, 68.1% of women aged 40-74 years underwent a screening mammogram in the previous two years (range: 38.7%-82.1). The ordinary least squares (OLS) regression demonstrated counties experiencing persistent poverty have mammography screening rates that are 4.3% less, on average, than counties without persistent poverty (estimate (SE) = - 4.283 (2.105), p = 0.045). As the percentage of women with a college education increases, the mammography screening rates increase by approximately 0.3% (estimate (SE) = 0.319 (0.078), P < .001) and as the health literacy score increases, the mammography screening rate decreases by 0.3% (estimate (SE) = - 0.318 (0.104), p = 0.003). These variables explain 7.0% of the variability in mammographic screening rates. The OLS regression analysis demonstrated that age-adjusted breast cancer incidence (Estimate (SE) = 0.074 (0.024), p = 0.003) and health literacy score (estimate (SE) = - 0.175 (0.083), p = 0.039) are significantly related to breast cancer mortality. CONCLUSIONS: Demographic, socioeconomic, and environmental variables explain only a small percentage of the variability in the rates of screening mammography and breast cancer mortality in North Carolina. Advances in the available treatments are likely the major contributor to improving breast cancer mortality.

Disparate Access to Surgery for Operable Carcinoma of the Lung in North Carolina.

PURPOSE: Disparities in access to surgical care are associated with poorer outcomes in patients with cancer. We sought to determine whether vulnerable populations undergo an expected rate of surgery for Stage I-IIIA lung cancer in North Carolina (NC). METHODS: We calculated the proportional surgical ratio (PSR) to identify a potential disparity in surgery rates for early stage (I-IIIA) lung cancer, first in the five counties with the worst health outcomes (LRC) and subsequently the entire state. The reference was the five healthiest counties (HRC), initially, and then the single county with the best health outcomes. RESULTS: In 2016, 3,452 individuals with Stage I-IIIA lung cancer were diagnosed in NC of which 246,854 resided in LRC, whereas 1,865,588 resided in HRC. A total of 453 operable lung cancers were diagnosed in the HRC and 107 in the LRC. The observed lobectomy rate in HRC was 40.1% (range 20.2-58.3%) of early-stage lung cancer and 19% (range 12-36%) for LRC. The PSR was 0.65 (95% confidence interval [CI] = 0.35, 0.90). For all 99 counties across NC, the PSR ranged from 0.33 to 0.96 (mean = 0.49, standard deviation [SD] = 0.10). In a multivariable model, only other primary care provider ratio (relative rate per 100 increase = 0.997; 95% CI = 0.994, 0.999) was significantly associated with PSR. CONCLUSIONS: Individuals residing in LRC in NC are 42% less likely to undergo surgery for operable lung cancer than patients living in HRC. Understanding how factors impact access is key to designing informed interventions.

Changes in the Proportion of Patients Presenting With Early Stage Colon Cancer Over Time Among Medicaid Expansion and Nonexpansion States: A Cross-sectional Study.

BACKGROUND: The 2010 Patient Protection and Affordable Care Act mandated preventive screening coverage and provided support to participating states for Medicaid coverage. The association of Medicaid expansion with colon cancer stage at diagnosis is unknown. OBJECTIVE: This study aimed to determine whether the proportion of patients diagnosed with early stage colon cancer changed over time within states that expanded Medicaid compared with nonexpansion states. DESIGN: This is a cross-sectional cohort study. SETTING: This study evaluated multicenter registry data from the National Cancer Database (2006-2016). PATIENTS: There were 25,462 uninsured or Medicaid-insured patients with newly diagnosed colon cancer who resided in 2014 Medicaid expansion or nonexpansion states. MAIN OUTCOME MEASURES: This study assessed the annual proportion of patients with early stage (I-II) versus late stage (III-IV) colon cancer. RESULTS: A total of 10,289 patients were identified in expansion states and 15,173 patients in nonexpansion states. Cohorts were similar in age (median 55 years) and sex (46.7% female). A greater proportion of patients in nonexpansion states were Black (33.4% vs 24.0%) and resided in a zip code with median income <$38,000 (39.7% vs 28.2%) and lower educational status (37.4% vs 28.1%). In 2006, the proportions of patients with early stage colon cancer in expansion and nonexpansion cohorts were similar (33.2% vs 32.5%). The proportion of patients with early stage colon cancer within nonexpansion states declined by 0.8% per year after 2014, whereas the proportion within expansion states increased by 0.9% per year after 2014 ( p < 0.05). By 2016, the absolute difference in the propensity-adjusted proportion of early stage colon cancer was 8.8% (39.7% vs 30.9%, p < 0.001). LIMITATIONS: National Cancer Database data are obtained only from Commission on Cancer-accredited sites and are not population based. CONCLUSIONS: After Medicaid expansion in 2014, the proportion of patients diagnosed and treated at Commission on Cancer-accredited facilities with early stage colon cancer increased within expansion states and decreased in nonexpansion states. Increase in insurance coverage may have facilitated earlier diagnosis among patients in expansion states. See Video Abstract at http://links.lww.com/DCR/B804 . CAMBIOS EN LA PROPORCIN DE PACIENTES QUE PRESENTAN CNCER DE COLON EN ESTADIO TEMPRANA A LO LARGO DEL TIEMPO ENTRE LOS ESTADOS DE EXPANSIN Y NO EXPANSIN DE MEDICAID UN ESTUDIO TRANSVERSAL: ANTECEDENTES:La Ley del Cuidado de Salud a Bajo Precio del 2010 ordenó la cobertura de exámenes preventivos y brindó apoyo a los estados participantes para la cobertura de Medicaid. Se desconoce la asociación de la expansión de Medicaid con el estadio del cáncer de colon en el momento del diagnóstico.OBJETIVO:Determinar si la proporción de pacientes diagnosticados con cáncer de colon en estadio temprano cambió con el tiempo dentro de los estados que expandieron Medicaid en comparación con los estados sin expansión.DISEÑO:Estudio de cohorte transversal.ENTORNO CLINICO:Datos de registro multicéntrico de la Base de datos nacional de cáncer (2006-2016).PACIENTES:Había 25,462 pacientes sin seguro o asegurados por Medicaid con cáncer de colon recién diagnosticado. Exposición: Residencia en estados de expansión o no expansión de Medicaid en el 2014.PRINCIPALES MEDIDAS DE RESULTADO:Proporción anual de pacientes con cáncer de colon en estadio temprano (I-II) versus tardío (III-IV).RESULTADOS:Se identificaron un total de 10.289 pacientes en estados de expansión y 15.173 pacientes en estados de no expansión. Las cohortes fueron similares en edad (mediana de 55 años) y sexo (46,7% mujeres). Una mayor proporción de pacientes en estados sin expansión eran de raza negra (33,4% vs 24,0%) y residían en un código postal con ingresos medios <$38 000 (39,7% vs 28,2%) y un nivel educativo más bajo (37,4% vs 28,1%). En el 2006, las proporciones de pacientes con cáncer de colon en estadio temprano en cohortes en expansión y sin expansión fueron similares (33,2% vs 32,5%). La proporción de pacientes con estadio temprano dentro de los estados sin expansión disminuyó en un 0,8% por año después del 2014, mientras que la proporción dentro de los estados de expansión aumentó en un 0,9% por año después del 2014 (p <0,05). Para el 2016, la diferencia absoluta en la proporción ajustada por propensión de cáncer de colon en estadio temprano fue de 8.8% (39.7% vs 30.9%, p <0.001).LIMITACIONES:Los datos de la Base de datos nacional de cáncer se obtienen únicamente de los sitios acreditados por la Comisión de cáncer y no se basan en la población.CONCLUSIONES:Después de la expansión de Medicaid en el 2014, la proporción de pacientes diagnosticados y tratados en instalaciones acreditadas por la Comisión de Cáncer en pacientes con cáncer de colon en estadio temprano aumentó dentro de los estados de expansión y disminuyó en los estados de no expansión. El aumento de la cobertura del seguro puede haber facilitado un diagnóstico más temprano entre los pacientes en estados de expansión. Consulte Video Resumen en http://links.lww.com/DCR/B804 . (Traducción- Dr. Francisco M. Abarca-Rendon ).

Differential effects of the Affordable Care Act on the stage at presentation and receipt of treatment for pancreatic adenocarcinoma.

BACKGROUND AND OBJECTIVES: For pancreatic ductal adenocarcinoma (PDAC) which lacks a recommended screening modality, the benefit of the Affordable Care Act (ACA) may not be an earlier diagnosis, but rather improved rates of treatment. The objective of this study was to examine change in the stage of PDAC presentation and treatment disparities following the ACA. METHODS: A retrospective cohort study of patients with primary PDAC identified in the 2004-2017 National Cancer Database was divided into pre- and post-ACA, for which the primary outcomes of a stage of presentation, receipt of surgical resection, and systemic therapy (termed multimodality) (Stage I-II), and receipt of systemic therapy (Stage III-IV) were compared by multivariable analysis. RESULTS: 228,015 patients were included. Odds of presenting with Stage I-II PDAC were significantly higher in 2011-2017 versus 2004-2010 (odds ratio 1.44, 95% confidence interval 1.40-1.47). Black patients with early-stage disease had a lower likelihood of multimodality therapy and those with advanced disease were less likely to receive systemic therapy, before and after the ACA. Uninsured patients were less likely to receive any therapy compared with insured patients; this disparity increased in the post-ACA period. CONCLUSIONS: An earlier presentation of PDAC increased following the ACA. However, racial, insurance, and socioeconomic treatment disparities persist.

Differences in receipt of multimodality therapy by race, insurance status, and socioeconomic disadvantage in patients with resected pancreatic cancer.

BACKGROUND AND METHODS: Racial and socioeconomic disparities in receipt of adjuvant chemotherapy affect patients with pancreatic cancer. However, differences in receipt of neoadjuvant chemotherapy among patients undergoing resection are not well-understood. A retrospective cross-sectional cohort of patients with resected AJCC Stage I/II pancreatic ductal adenocarcinoma was identified from the National Cancer Database (2014-2017). Outcomes included receipt of neoadjuvant versus adjuvant chemotherapy, or receipt of either, defined as multimodality therapy and were assessed by univariate and multivariate analysis. RESULTS: Of 19 588 patients, 5098 (26%) received neoadjuvant chemotherapy, 9624 (49.1%) received adjuvant chemotherapy only, and 4757 (24.3%) received no chemotherapy. On multivariable analysis, Black patients had lower odds of neoadjuvant chemotherapy compared to White patients (OR: 0.80, 95% CI: 0.67-0.97) but no differences in receipt of multimodality therapy (OR: 0.89, 95% CI: 0.77-1.03). Patients with Medicaid or no insurance, low educational attainment, or low median income had significantly lower odds of receiving neoadjuvant chemotherapy or multimodality therapy. CONCLUSIONS: Racial and socioeconomic disparities persist in receipt of neoadjuvant and multimodality therapy in patients with resected pancreatic adenocarcinoma. DISCUSSION: Policy and interventional implementations are needed to bridge the continued socioeconomic and racial disparity gap in pancreatic cancer care.

Extended systemic antibiotic prophylaxis in ventricular assist device recipients, an infectious disease perspective.

OBJECTIVES: To evaluate whether mediastinitis/deep sternal wound infection (Med/DSWI) is more common in ventricular assist device (VAD) with delayed sternal closure (DSC) compared to VAD with primary sternal closure (PSC). METHODS: A literature search was done over the last four decades for studies that addressed this comparison. RESULTS: Two studies met our inclusion criteria, and their results are contradictory. The first study compared 184 VAD recipients with PSC to 180 VAD recipients with DSC. There was no difference in VAD-related infections between DSC and PSC (15% vs. 16%, respectively; odds ratio = 0.965, 95% confidence interval [CI] = 0.525-1.635). The second study compared 464 VAD recipients with PSC to 94 VAD recipients with DSC. The rate of surgical site infection was higher in the DSC patients (12.5% vs. 1.4%, respectively; odds ratio = 10.1; 95% CI = 3.8-27.0). DSC was identified as an independent risk factor for postoperative mortality, but no detailed infection information was given. CONCLUSIONS: There is no clear evidence of the association between DSC, compared to PSC, and Med/DSWI. Therefore, DSC is not an absolute indication for extended systemic antibiotic prophylaxis. The decision to extend the duration of systemic antibiotic prophylaxis should be made on a case-by-case basis, in collaboration with an infectious disease specialist.

Association of race and health insurance in treatment disparities of colon cancer: A retrospective analysis utilizing a national population database in the United States.

BACKGROUND: Both health insurance status and race independently impact colon cancer (CC) care delivery and outcomes. The relative importance of these factors in explaining racial and insurance disparities is less clear, however. This study aimed to determine the association and interaction of race and insurance with CC treatment disparities. STUDY SETTING: Retrospective cohort review of a prospective hospital-based database. METHODS AND FINDINGS: In this cross-sectional study, patients diagnosed with stage I to III CC in the United States were identified from the National Cancer Database (NCDB; 2006 to 2016). Multivariable regression with generalized estimating equations (GEEs) were performed to evaluate the association of insurance and race/ethnicity with odds of receipt of surgery (stage I to III) and adjuvant chemotherapy (stage III), with an additional 2-way interaction term to evaluate for effect modification. Confounders included sex, age, median income, rurality, comorbidity, and nodes and margin status for the model for chemotherapy. Of 353,998 patients included, 73.8% (n = 261,349) were non-Hispanic White (NHW) and 11.7% (n = 41,511) were non-Hispanic Black (NHB). NHB patients were less likely to undergo resection [odds ratio (OR) 0.66, 95% confidence interval [CI] 0.61 to 0.72, p < 0.001] or to receive adjuvant chemotherapy [OR 0.83, 95% CI 0.78 to 0.87, p < 0.001] compared to NHW patients. NHB patients with private or Medicare insurance were less likely to undergo resection [OR 0.76, 95% CI 0.63 to 0.91, p = 0.004 (private insurance); OR 0.59, 95% CI 0.53 to 0.66, p < 0.001 (Medicare)] and to receive adjuvant chemotherapy [0.77, 95% CI 0.68 to 0.87, p < 0.001 (private insurance); OR 0.86, 95% CI 0.80 to 0.91, p < 0.001 (Medicare)] compared to similarly insured NHW patients. Although Hispanic patients with private and Medicare insurance were also less likely to undergo surgical resection, this was not the case with adjuvant chemotherapy. This study is mainly limited by the retrospective nature and by the variables provided in the dataset; granular details such as continuity or disruption of insurance coverage or specific chemotherapy agents or dosing cannot be assessed within NCDB. CONCLUSIONS: This study suggests that racial disparities in receipt of treatment for CC persist even among patients with similar health insurance coverage and that different disparities exist for different racial/ethnic groups. Changes in health policy must therefore recognize that provision of insurance alone may not eliminate cancer treatment racial disparities.

Effects of Belapectin, an Inhibitor of Galectin-3, in Patients With Nonalcoholic Steatohepatitis With Cirrhosis and Portal Hypertension.

BACKGROUND & AIMS: Increased levels of galectin 3 have been associated with nonalcoholic steatohepatitis (NASH) and contribute to toxin-induced liver fibrosis in mice. GR-MD-02 (belapectin) is an inhibitor of galectin 3 that reduces liver fibrosis and portal hypertension in rats and was safe and well tolerated in phase 1 studies. We performed a phase 2b, randomized trial of the safety and efficacy of GR-MD-02 in patients with NASH, cirrhosis, and portal hypertension. METHODS: Patients with NASH, cirrhosis, and portal hypertension (hepatic venous pressure gradient [HVPG] ≥ 6 mm Hg) from 36 centers were randomly assigned, in a double-blind manner, to groups that received biweekly infusions of belapectin 2 mg/kg (n = 54), 8 mg/kg (n = 54), or placebo (n = 54) for 52 weeks. The primary endpoint was change in HVPG (Δ HVPG) at the end of the 52-week period compared with baseline. Secondary endpoints included changes in liver histology and development of liver-related outcomes. RESULTS: We found no significant difference in ΔHVPG between the 2 mg/kg belapectin group and placebo group (-0.28 mm HG vs 0.10 mm HG, P = 1.0) or between the 8 mg/kg belapectin and placebo group (-0.25 mm HG vs 0.10 mm HG, P = 1.0). Belapectin had no significant effect on fibrosis or nonalcoholic fatty liver disease activity score, and liver-related outcomes did not differ significantly among groups. In an analysis of a subgroup of patients without esophageal varices at baseline (n = 81), 2 mg/kg belapectin was associated with a reduction in HVPG at 52 weeks compared with baseline (P = .02) and reduced development of new varices (P = .03). Belapectin (2 mg/kg) was well tolerated and produced no safety signals. CONCLUSIONS: In a phase 2b study of 162 patients with NASH, cirrhosis, and portal hypertension, 1 year of biweekly infusion of belapectin was safe but not associated with significant reduction in HVPG or fibrosis compared with placebo. However, in a subgroup analysis of patients without esophageal varices, 2 mg/kg belapectin did reduce HVPG and development of varices. ClinicalTrials.gov number: NCT02462967.

Refining breast cancer prognosis by incorporating age at diagnosis into clinical prognostic staging: introduction of a novel online calculator.

PURPOSE: American Joint Committee on Cancer (AJCC) clinical staging is used to estimate breast cancer prognosis, but individual patient survival within each stage varies considerably by age at diagnosis. We hypothesized that the addition of age at diagnosis to the staging schema will enable more refined risk stratification. METHODS: We performed a retrospective population analysis of adult women diagnosed with invasive breast cancer between 2010 and 2015 registered in SEER. Multivariable Cox hazards models were used to evaluate the association of AJCC 8th edition clinical prognostic stage (CPS) and age with risk of overall mortality. Separate hierarchical models were fit to the data: Model 1: CPS alone; Model 2: CPS + age + age2; and Model 3: CPS + age + age2 + CPS x age + CPS x age2. Models were compared by the Akaike information criterion (AIC), the c-statistic for time-dependent receiver operator characteristic curves, and category-free net reclassification improvement (NRI). Internal validation was performed using bootstrapping samples. RESULTS: Among 86,637 women, the median follow-up was 36 months and 3-year overall survival was 91.9% ± 0.1%. Age significantly modified the effect of CPS on survival (p < 0.0001). Model 3 was the most precise, with the lowest AIC (126,619.63), the highest c-statistic (0.8212, standard error 0.0187), and superior NRI indices. CONCLUSION: Age at diagnosis is a highly prognostic variable that warrants consideration for inclusion in future editions of the AJCC Breast Cancer Staging Manual.

The need for future coronary access following surgical or transcatheter aortic valve replacement.

The aim of the study was to estimate the percentage of Medicare patients needing coronary access for percutaneous coronary intervention (PCI) or coronary angiography following aortic valve replacement (AVR). Indications for TAVR have expanded to include younger and low-risk patients, raising the question of coronary access for future procedures. Medicare patients <80 years old with an AVR between 2011 and 2018 were included. Time-to-event analyses were conducted using Cox hazard models to estimate risk of coronary access up to 7 years after AVR. Model adjustments included age, sex, race, region, comorbidity, concomitant CABG, and smoking. A total of 13,469 Medicare patients (mean age 70.6) met inclusion criteria. Models estimated that 2.5% of patients at 1-year post-index and 17% at over 7 years would need coronary access. For patients who had SAVR (with or without CABG), estimates for coronary access were similar and over 15% after 6.5 years. For TAVR patients, with a previous PCI, 28% at 4.5 years required coronary access, which was higher than TAVR patients without a previous PCI. SAVR patients with and without CAD at baseline were similar; however, TAVR patients with CAD had a 22% rate of coronary access versus 7% for those without at 3 years. Approximately half of patients who needed coronary access returned to the same hospital as their initial AVR. Coronary access is required in a substantial portion of AVR patients especially those with PCI or a history of CAD undergoing TAVR. The need for coronary access may increase as transcatheter AVR becomes accessible to younger patients with a longer life expectancy.

Lymphocyte depletion and risk of acute rejection in renal transplant recipients at increased risk for delayed graft function.

Delayed graft function (DGF) is a risk factor for acute rejection (AR) in renal transplant recipients, and KDIGO guidelines suggest use of lymphocyte-depletion induction when DGF is anticipated. We analyzed the United Network for Organ Sharing/Organ Procurement and Transplantation Network (UNOS/OPTN) database to assess the impact of induction immunosuppression on the risk of AR in deceased kidney recipients based on pretransplant risk of DGF using a validated model. Recipients were categorized into 4 groups based upon the induction immunosuppression: (1) Rabbit anti-thymocyte globulin (rATG); (2) Alemtuzumab (C1H); (3) IL2-receptor antagonists (IL2-RA; basiliximab or daclizumab), and (4) No antibody induction. The primary endpoint for analysis was a composite endpoint of treated AR or graft failure by 1-year posttransplantation. Compared to no antibody induction, rATG and C1H had consistently lower adjusted odds of the composite endpoint across all risk strata for DGF risk, whereas IL2-Ra was associated with increased adjusted odds of the composite endpoint with increasing DGF risk. When the induction agents were compared, rATG and C1H were associated with decreasing adjusted odds for the composite endpoint with increasing risk of DGF, especially at the higher risk spectrum of DGF. Consideration must be given to use of lymphocyte-depletion induction when the anticipated risk of DGF is increased.