Ochsner Health System Research Articles

Direct Oral Anticoagulants Versus Warfarin in Patients With Isolated Heparin-Induced Thrombocytopenia or Heparin-Induced Thrombocytopenia With Thrombosis.

No existing studies compare oral anticoagulants to treat heparin-induced thrombocytopenia with or without thrombosis (HIT/HITT). This retrospective study evaluated thrombotic and bleeding outcomes in adults treated for HIT/HITT with a direct oral anticoagulant (DOAC) or warfarin between 2012 and 2023 within the Ochsner Health System. Patients with mechanical heart valves, valvular atrial fibrillation, antiphospholipid syndrome, active malignancy, or venous thromboembolism (VTE) within the previous 6 months were excluded. The primary outcome was a composite of new or progressive VTE or arterial thromboembolism. Secondary outcomes included major and clinically relevant non-major bleeding, duration of hospitalization, time to platelet recovery, and incidence of skin necrosis, gangrene, and amputation. Forty-nine patients receiving a DOAC and 30 patients receiving warfarin were included. Baseline characteristics were similar between cohorts. There were non-statistically significant increased rates of both the primary outcome (8.9% vs. 4.3%, p = 0.65) and the composite bleeding outcome (32.7% vs. 23.3%, p = 0.37) in the DOAC cohort. Larger, prospective studies are needed to confirm these findings.

Exocrine pancreatic insufficiency as a possible predictor of pancreatic cancer development.

679 Background: Chronic and acute pancreatitis are established risk factors for pancreatic cancer. Chronic pancreatitis and pancreatic cancer are also common causes of exocrine pancreatic insufficiency (EPI), which is characterized by inadequate pancreatic secretion of exocrine digestive enzymes. Although the association between EPI and pancreatic cancer has been thought to be linked by preceding chronic pancreatitis, it is unclear if EPI, regardless of etiology, is a risk factor or early marker for pancreatic cancer or cancer in general. Methods: This is a retrospective observational study utilizing the electronic health records of Ochsner Health System, Louisiana, over a 3-year period from January 2017 to January 2020 to identify patients with a diagnosis of EPI by ICD-10 codes. Two cohorts were reviewed: patients with EPI (n=677) and patients with pancreatitis (n=1852). Both history of acute and/or chronic pancreatitis were included in the pancreatitis cohort. The cohorts were compared based on cancer prevalence at the start and end of the 3 year observation period. Results: In the EPI cohort, the cancer prevalence was 15.95% (108) at start, and 43.9% (297) at end, (p<0.05); and pancreatic cancer prevalence at start was 6.65% (123) and 29.8% (552) at end (p<0.05). In the pancreatitis cohort, the cancer prevalence was 5.4% (100) at start and 15.9% (294) at end (p<0.05); and pancreatic cancer 0.8% at start and 5% at end (p<0.05). Conclusions: Over a 3 year period, the rise in prevalence of general cancer and pancreatic cancer was higher in the EPI cohort compared to the pancreatitis cohort. Additionally, there was a statistically significant 2.8-fold increase in prevalence of cancer diagnosis and 4.5-fold increase in prevalence of pancreatic cancer diagnosis in the EPI cohort over the 3 year observation period. Though this is an observational study, it suggests the possibility that EPI, regardless of etiology, may be an independent predictor/risk factor for the development of future cancer in general and pancreatic cancer in particular. In addition it appears that this risk potential is substantively greater than that from a history of pancreatitis alone.

THU261 Etiologic Factors, Contributors, And Associations For Exocrine Pancreatic Insufficiency

Abstract Disclosure: K.G. Romo: None. A. Noor: None. A. Zia: None. S. Shu: None. S. Bhamre: None. W.A. West: None. B.M. Hoard: None. G.I. Uwaifo: None. Introduction: Exocrine pancreatic insufficiency (EPI) is a clinical condition which though presumed to be uncommon has grown in prominence and recognition in recent years. The fact that pancreatic enzyme replacement therapy (PERT) is available to ameliorate many of the metabolic and gastrointestinal sequelae of EPI makes its early recognition, diagnosis, and treatment very important. Since EPI appears uncommon, improved quantification of its prevalence and identification of associated etiologic factors could inform targeted screening in select patient populations. Our study is a retrospective chart analysis of a large multi-specialty, multi-institutional practice group covering much of Louisiana and seeks to provide needed information regarding EPI prevalence and etiologic factors. Methods: A retrospective review of the entire 1.3 million patient-practice of the Ochsner Health system in Louisiana was performed to cover the period from January 2017 to January 2020. All cases of documented EPI and patients on PERT were identified—these were then further interrogated including individual chart review to identify etiologic factors and obtain relevant cardiometabolic, demographic, vital sign data, and clinical course information. Results: A total of 677 EPI patients were identified with a prevalence of 0.525% among patients with diabetes (DM) and 0.051% in the general outpatient population. EPI, though uncommon, is thus ∼ 10x more prevalent among DM patients. The identified etiologic factors were Type 2 diabetes (T2DM) (44.6% of cases), general cancer (15.9%), secondary diabetes (11.5%), cystic fibrosis (12.9%), Type 1 diabetes (T1DM) (9.6%), pancreatic cancer (6.6%), idiopathic (6.2%), pancreatitis (5%), pancreatic surgery (2.95%), hemochromatosis-hemosiderosis (0.44%), and alpha-1 antitrypsin deficiency (0.15%). Several patients in the cohort had multiple identified etiologic factors. Discussion and Conclusions: While EPI is uncommon in the general population it is at least 10x more prevalent among DM patients. Etiologic factors provide a clinical pathway for targeted clinical and lab screening to enable early diagnosis and treatment. Since T2DM is the most common etiologic factor for EPI in our cohort and other reported series, there is need for further in-depth study to identify potentially modifiable factors and possible predictors in the progression of DM to EPI and whether PERT can ameliorate associated cardio-metabolic and ASCVD risk surrogates. Presentation: Thursday, June 15, 2023

1431-P: Exocrine Pancreatic Insufficiency Is Both a Risk Factor for and Comorbidity of Diabetes Mellitus

Introduction: Exocrine Pancreatic Insufficiency (EPI) is an uncommon but important disease of the exocrine pancreas. Its relationship to endocrine pancreas function and diabetes (DM) remains poorly characterized. To better understand this relationship, a retrospective chart review was performed in a large statewide multispecialty practice. Methods: A retrospective review of the entire 1.3 million patient-practice of Ochsner Health system in Louisiana was performed to cover the period of January 2017 to January 2020. All cases of documented EPI and patients on pancreatic enzyme replacement therapy (PERT) were identified and underwent individual chart review to identify etiologic factors and cardiometabolic, demographic, vital sign data, and clinical course information. Results: 677 EPI patients were identified with DM being the most prevalent etiologic risk factor (44.6% T2DM, 9.6% T1DM and 11.5% secondary DM). EPI patients without DM had a 10.9% prevalence of pre-DM, and 127 new DM cases developed over the observation period among EPI patients initially without DM with an 18.7% incidence rate. EPI patients, compared to the general DM population, were significantly younger with more diverse DM etiology. They also had greater LFT and serum lipase elevations. EPI patients had lower BMIs; 25.6 ± 7.5 vs 32.8 ± 46.9 kg/m2 with greater alcohol use. EPI patients also had better glycemic control (HBAC 6.83 ± 2.1 vs 7.2 ± 1.9) and triglycerides (125.7 ± 104.7 vs 140.6 ± 118.9) though other lipids were similar. Discussion and Conclusions: EPI, though uncommon, is both an important risk factor for onset of DM and comorbidity of diabetes. DM patients with EPI have distinctive etiologic, metabolic, and anthropometric features from DM patients in the general population. Further study of EPI patients to better understand predictors of onset of EPI in DM patients and DM onset in non-DM EPI patients are needed to guide evidence based screening. This would in turn enable early EPI recognition and management. Disclosure K.G.Romo: None. S.Shu: None. A.A.Noor: None. W.A.West: None. S.Bhamre: None. G.I.Uwaifo: None.

Area deprivation index and breast cancer subtypes in young patients.

e18651 Background: Breast cancer (BC) diagnosed under age 40 accounts for approximately 7-9% of all BC diagnoses. Patients diagnosed with BC < age 40 have more aggressive cancers, present at later stages, and poorer outcomes. Socioeconomic status (SES), income, and education have been studied in relation to cancer incidence and prognosis. According to data reviewed from 2008 SEER database, there was no major difference in incidence of female BC among patients of varying poverty levels or annual household income and women with college education had a higher incidence of breast cancer diagnosis compared to those without college education. A composite index of these variables is categorized as Area Deprivation Index (ADI). ADI ranks census bureau neighborhoods by SES and disadvantaged metrics including income, education, employment, and housing. Louisiana and Mississippi have large areas of deprivation in rural and urban areas. Methods: We performed a retrospective chart review and collected data on 746 women diagnosed with BC < age 40 from 2012 to 2022 in single medical system (Ochsner Health System) throughout Louisiana and Mississippi. Data was collected including age at diagnosis, BMI, race, BC subtype, and zip code (to determine ADI). Data was censored for patients without zip codes. We reviewed patients’ BC subtype by ADI to determine if there is a relationship between these young patients’ BC diagnoses and ADI. Cochran-Armitage test was used to determine significance. Results: ADI State Rankings by Quintiles. Conclusions: Young women in regions of lower SES are more likely to be diagnosed with TNBC. As TNBC is an aggressive subtype in a patient population that is predisposed to aggressive BC, this data serves as rationale to increased BC outreach to women in neighborhoods of higher ADI to promote knowledge, risk reduction and early detection. [Table: see text] [Table: see text] [Table: see text]

A System-wide Retrospective Cohort Analysis of the Development of Psychiatric Conditions Following Concussion (P7-1.005)

<h3>Objective:</h3> To determine if mTBI is a risk factor for the development of major depressive disorder and/or general anxiety disorder within one year of injury. <h3>Background:</h3> Minor traumatic brain injury (mTBI; concussion) commonly presents to the health care system. While most mTBI cases recover with complete return to baseline, there are individuals who have persistent symptoms or develop new disorders following brain injury. Despite findings linking psychiatric disorders to traumatic brain injuries, identifying similar pathologies post-mTBI has been lacking until now. <h3>Design/Methods:</h3> An observational, retrospective cohort study of all male and female patients with diagnosed mTBI (concussion) who received care within the Ochsner Health system between January 1, 2010 and December 31, 2020. Relative risk &gt;2.0 was recognized as significant. <h3>Results:</h3> Of the 10,637 mTBI patients presenting over the 10-year period, 7,940 met the inclusion criteria for congruent comparison to National Institute of Mental Health data. Forty-five percent of patients were aged 18–29, 19% were aged 30–44, 16% were aged 45–59, and 20% were older than 60. Gender was also evaluated among the study population – females represented 54.6%, while men made up 45.4%. Across all ages, mTBI within one year increased the risk of GAD development a factor of 2.5. Patients older than 59 years were at nearly four times greater risk of developing GAD. Although males showed lower prevalence of GAD than females, patients with mTBI were twice as likely to develop GAD irrespective of gender. <h3>Conclusions:</h3> Adult patients suffering mTBI demonstrated significant risk of GAD among the total study population, particularly young adults and those of advanced age. Further nuanced evaluation is necessary before development of specific guidelines to protect vulnerable patients. Future work requires greater ethnic diversity, socioeconomic background, and participants of adolescent age. In order to prevent progression to mental health disorders, systematic guidelines should be in place for patient support. <b>Disclosure:</b> Mr. Brown has nothing to disclose. Mr. Kazmer has nothing to disclose. Dr. Posas has nothing to disclose.

Direct Oral Anticoagulants Versus Warfarin for Venous Thromboembolism Prophylaxis in Patients With Nephrotic Syndrome: A Retrospective Cohort Study.

Evidence supporting venous thromboembolism (VTE) prophylaxis with direct oral anticoagulants (DOACs) in patients with nephrotic syndrome (NS) is limited to case reports. The purpose of this study was to compare bleeding and thromboembolic events in this population. A retrospective cohort study was conducted in adults with NS initiated on a DOAC or warfarin for VTE prophylaxis between January 2013 and July 2021 within the Ochsner Health System. Patients with study drug exposure within the preceding 7 days, acute VTE within the preceding 6 months, or ≤7 days of study drug exposure were excluded. The primary outcome was the composite rate of major bleeding and clinically relevant nonmajor bleeding. Secondary outcomes included time to major bleeding and rate of new thromboembolic events. This study was approved by the Ochsner Health System Institutional Review Board. Twenty-five DOAC and 19 warfarin patients were included. The primary outcome occurred in 8% vs 26.3% (P = 0.21) of patients treated with a DOAC or warfarin, respectively, and was driven by major bleeding (4% vs 21%, P = 0.25). Other secondary outcomes were similar between cohorts. The study was limited by a small sample size. Use of DOACs for VTE prophylaxis resulted in a nonstatistically significant, but clinically relevant lower rate of major bleeding compared to warfarin. This study provides comparative data showing safe and effective use of DOACs in patients with NS. Prospective, randomized studies are needed to confirm results.

Rates of Cognitive Decline in 100 Patients With Alzheimer Disease.

Background: In the state of Louisiana, the prevalence of Alzheimer disease (AD) is projected to increase 26.4% by 2025 because of the rapidly increasing geriatric population. While significant research is available on risk factors for developing AD, less data are available regarding AD progression and the rate of change among patients with the disease. To date, no research has established the baseline cognitive decline of patients with AD residing in New Orleans, Louisiana.Methods: We evaluated 100 patients in the Ochsner Health system from September 2013 to December 2019 who had a diagnosis of AD and repeated Mini-Mental State Examination (MMSE) or Montreal Cognitive Assessment (MoCA) scores to determine annual rates of decline. Associated variables that were analyzed included race, age at diagnosis, social factors, and comorbidities.Results: The average annual rates of decline for MMSE and MoCA scores were 2.43 (SD 2.82) points and 2.39 (SD 1.88) points, respectively. Our results were significant for a faster rate of decline in MMSE scores among smokers (3.50 points, SD 3.20) vs nonsmokers (1.54 points, SD 2.07). We found no significant difference in MoCA scores for smokers vs nonsmokers, in addition to other demographic and lifestyle variables.Conclusion: The rate of decline seen in an urban population of patients with AD is lower than the average rate of decline reported in the literature, a finding that can help inform future interventional studies that use rate of decline as a primary outcome.

Direct Oral Anticoagulants Versus Warfarin for Treatment of Thrombosis or Atrial Fibrillation in Patients With Cirrhosis: A Retrospective Cohort Study.

Evidence for direct oral anticoagulants (DOACs) in patients with cirrhosis is limited. Few patients with Child-Turcotte-Pugh (CTP) class B and C cirrhosis have been studied. To compare major bleeding rates in patients with cirrhosis receiving a DOAC versus warfarin. A retrospective cohort study was conducted in adults with cirrhosis receiving a DOAC versus warfarin for venous thromboembolism, portal-vein thrombosis, or atrial fibrillation. The primary outcome was the rate of major bleeding. Secondary outcomes included time to major bleeding, clinically relevant nonmajor bleeding, all bleeding, gastrointestinal bleeding, intracranial bleeding, and new thromboembolic events. The study was approved by the Ochsner Health System Institutional Review Board. A total of 44 patients receiving a DOAC and 41 patients receiving warfarin were included. Major bleeding occurred in 4 patients receiving a DOAC and 6 patients receiving warfarin (9.1% vs 14.6%; P = 0.881). Rates of major bleeding were similar in 24 DOAC and 17 warfarin patients with CTP Class B (4.2% vs 17.6%; P = 0.37) and 8 DOAC and 9 warfarin patients with CTP Class C (37.5% vs 11.1%; P = 0.41) cirrhosis. Secondary bleeding and efficacy outcomes were similar between cohorts. The study was limited by a small sample size. Treatment with DOACs in patients with cirrhosis was associated with a similar rate of major bleeding compared with warfarin. Inclusion of CTP class C patients in future studies remains valuable to evaluate safety and efficacy of DOACs in this population.

PCV45 The Healthcare Effects of the Ochsner Hypertension Digital Medicine Program

To evaluate whether the Ochsner Health System’s Hypertension Digital Medicine Program (HDMP) improved enrollee blood pressure (BP), and utilization. Patients with hypertension (HTN) could enroll in Ochsner’s HDMP. Program benefits include blood pressure tele-monitoring in home, pharmacy management and in-depth education. Patients had to be residents of Louisiana and have no history of a heart or kidney transplant. The treatment group included all patients enrolled in the HDMP and were continuously enrolled in Quality Blue Primary Care at least 6 months before and after the HDMP participation date. Propensity scoring was used to match the treatment group to a control population, not being managed by Ochsner PCPs. Patients were further categorized by whether or not their BP was controlled, defined as less than 140/90 mmHg in the baseline period. Difference-in-difference regression models was used to measure the program effects on BP control, healthcare utilization, medication adherence and costs. After matching, each of the cohorts BP controlled and uncontrolled at baseline had a total of 244 and 167 patient pairs, respectively. Members in the treatment group, regardless of whether or not their BP was controlled at baseline had significantly improved their BP and HTN related medication adherence. Emergency department and specialty visits were also lower for the treatment group who had uncontrolled BP at baseline. Ochsner Health System’s HDMP improved enrollee BP, medication adherence, and healthcare utilization.

Understanding the patient journey to diagnosis of lung cancer

ObjectiveThis research describes the clinical pathway and characteristics of two cohorts of patients. The first cohort consists of patients with a confirmed diagnosis of lung cancer while the second consists of patients with a solitary pulmonary nodule (SPN) and no evidence of lung cancer. Linked data from an electronic medical record and the Louisiana Tumor Registry were used in this investigation.Materials and methodsREACHnet is one of 9 clinical research networks (CRNs) in PCORnet®, the National Patient-Centered Clinical Research Network and includes electronic health records for over 8 million patients from multiple partner health systems. Data from Ochsner Health System and Tulane Medical Center were linked to Louisiana Tumor Registry (LTR), a statewide population-based cancer registry, for analysis of patient’s clinical pathways between July 2013 and 2017. Patient characteristics and health services utilization rates by cancer stage were reported as frequency distributions. The Kaplan-Meier product limit method was used to estimate the time from index date to diagnosis by stage in lung cancer cohort.ResultsA total of 30,559 potentially eligible patients were identified and 2929 (9.58%) had primary lung cancer. Of these, 1496 (51.1%) were documented in LTR and their clinical pathway to diagnosis was further studied. Time to diagnosis varied significantly by cancer stage. A total of 24,140 patients with an SPN were identified in REACHnet and 15,978 (66.6%) had documented follow up care for 1 year. 1612 (10%) had no evidence of any work up for their SPN. The remaining 14,366 had some evidence of follow up, primarily office visits and additional chest imaging.ConclusionIn both cohorts multiple biopsies were evident in the clinical pathway. Despite clinical workup, 70% of patients in the lung cancer cohort had stage III or IV disease. In the SPN cohort, only 66% were identified as receiving a diagnostic work-up.

Abstract PS6-47: Breast cancer and COVID-19: Impact of active treatment on severe outcomes

Abstract Background: Several reports have observed that cancer patients who recently underwent chemotherapy or surgery had a higher risk of severe events compared with patients without cancer. Limited data is available on outcomes in specific cancer types, as well as the impact of non-cytotoxic systemic treatment, such as targeted therapy and hormonal therapy on severe outcomes. We aim to identify whether active treatment impacts severe outcomes (rate of hospitalization, ICU admission, intubation, and death) in breast cancer patients. Methods: We conducted a multicenter study in the state of Louisiana, throughout the Ochsner Health System, in both tertiary and non-tertiary centers. Patients must carry a diagnosis of breast cancer, and have a completed SARS-CoV-2 test between March 1st and April 30th, 2020. Chi-squared and Fisher’s exact tests were performed to compare the proportion of patients experiencing severe outcomes between treatment groups. Results: As of April 30, 2020, a total of 70 patients with breast cancer who had a positive SARS-COV-2 test were identified. Median age 64.5, median BMI 30.8, 62.9% (n=44) black, 27.1% (n=19) current/former smokers, HTN (n=52) and DM2 (n=22) were the most common comorbidities, and 12.9% (n=9) of patients had stage IV disease. Of these patients, 58.6% (n=41) were on hormonal treatment, and another 12.9% (n=9) were receiving other forms of systemic therapy (cytotoxic chemotherapy or targeted therapy). In terms of severe outcomes, 32.9% (n=23) of patients required hospitalization, 8.6% (n=6) required ICU admission with 7.1% (n=5) patients requiring intubation, 11.4% (n=8) of patients died. There was not a statistical difference in rate of severe outcomes (rate of hospitalization, ICU admission, intubation, and death) among breast cancer patients receiving active treatment (chemotherapy, targeted therapy, or hormonal therapy) vs those receiving no active treatment. There was also no difference in terms of severe outcomes by race. Conclusion: With an ongoing global COVID-19 pandemic, it is important to identify how the treatment and management of cancer impacts COVID-19 outcomes. This small cohort does not identify active treatment as a risk factor for increased rate of severe outcomes in patients with breast cancer. Further analyses describing impact of specific hormonal and chemotherapy regimens on risk of hospitalization and death will be completed by time of presentation. Citation Format: Karine Tawagi, Jeff Burton, Michael Lunski, Diana Maslov, John Cole. Breast cancer and COVID-19: Impact of active treatment on severe outcomes [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-47.

Prognosis of first-line tumor directed therapy for hepatocellular carcinoma using a combination of AFP, AFP-L3, and DCP

Presenter: Paul Thevenot PhD | Ochsner Health System Background: The expanded biomarker panel consisting of α-fetoprotein (AFP), AFP-L3%, and des-γ-carboxy prothrombin (DCP) has improved surveillance and early detection of hepatocellular carcinoma (HCC). The biomarkers individually, when elevated, have also been linked to aggressive tumor biology including vascular invasion and advanced staging. With increased clinical utilization on the horizon, we investigated the role of using biomarker combinations at the time of diagnosis and correlating the outcomes at the time of liver transplantation. Methods: This prospective study was conducted at a single-center in HCC patients presenting to a multi-disciplinary tumor board for liver-directed therapy (LDT) and evaluation for bridge to liver transplantation (8/30/16 – 10/16/20). AFP, AFP-L3%, and DCP were assayed on the day of first line LDT using the μTASWako i30 instrument. Additional analyzed parameters were also obtained prior to first-line LDT and monitored for bridge to transplant outcome as the primary study endpoint. Results: Consented for analysis were 140 treatment naïve HCC patients undergoing first line LDT with transarterial chemoembolization, Ytrrium-90, or microwave ablation. The median cohort age was 61 years with majority demographics of male (74%) and hepatitis C etiology (59%). Tumor burden was 82% within Milan with a median MELD-Na prioritization score of 11. Study endpoint breakdown was 29% transplanted, 29% dropout due to tumor progression, 24% censored from study endpoint, and 18% remaining waitlist active at the time of analysis. Median biomarker values were 10 ng/mL AFP, 7% AFP-L3, and 3.1 ng/mL DCP. Forty-four percent of cohort was negative for all three biomarkers while 14% were triple positive. Univariate analysis for each biomarker at threshold were associated with tumor progression (OR 5.6 – AFP > 20 ng/mL, 4.8 – AFP-L3 >10%, 8.8 – DCP >7.5 ng/mL). Analysis of cohort based on biomarker status (triple negative, AFP only, or positive for AFP-L3% and/or DCP) revealed an association between biomarker positivity and largest lesion size (P < 0.001). Univariate analysis showed largest lesion, and each individual biomarker, along with 2 positive biomarkers was associated with bridge to transplant survival. Controlling for tumor burden in separate multivariate analyses, AFP (HR 4.8), and DCP (HR 2.2), or having 2 positive biomarkers (HR 6.0) remained associated with bridge to transplant survival. In endpoint analysis, patients with more than 2 positive biomarkers had significant lower bridge to transplant survival. Biomarker positivity was also associated with response to first line LDT (OR 3.2). Conclusion: The expanded biomarker panel (AFP, AFP-L3%, and DCP) prior to LDT in bridge to transplant HCC can identify patients at high risk of tumor progression following LDT. The expanded biomarker panel may provide an opportunity to optimize treatment modality with outcome based on profile independent of radiographic tumor burden.

Multivariate mortality analyses in COVID-19: Comparing patients with cancer and patients without cancer in Louisiana.

This is the largest and only multivariate study evaluating the difference in mortality from coronavirus disease 2019 (COVID-19) between patients with cancer and patients without cancer in the United States. The objective was to assess COVID-19 mortality rates in patients with cancer versus patients without cancer and uncover possible statistically significant characteristics contributing to mortality. This retrospective study analyzed patients with cancer and patients without cancer who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from March 1 through April 30, 2020. This was a multicenter study in the state of Louisiana throughout the Ochsner Health System in both tertiary and nontertiary centers. Patients older than 18 years were eligible. Three hundred twelve patients with cancer were compared with 4833 patients without cancer. Mortality was found to be higher in the cancer group. Patients of advanced age with cancer had a significant increase in mortality (odds ratio [OR], 5.96; P < .001). Other significant risk factors for increased mortality were male sex (OR, 2.15), a history of chronic kidney disease (OR, 3.84), and obesity (OR, 1.30). In hospitalized patients with cancer, adverse vital signs on admission, decreased absolute lymphocyte counts, thrombocytopenia, elevated creatinine, lactic acidosis, and elevated procalcitonin all seemed to increase the risk of death. Among patients with cancer, active or progressive disease (P < .001) and recent therapy (OR, 2.34; 95% confidence interval, 1.08-5.08) were shown to increase mortality. Patients with cancer have increased mortality in the setting of infection with SARS-CoV-2 in comparison with patients without cancer. Patients with cancer who are 65 years of age or older and those with certain comorbidities have the greatest risk of death. Recent cancer-directed therapy and disease status also seem to play roles in mortality. This is the largest study of patients with cancer versus patients without cancer to date and is the first multivariate analysis study comparing these 2 patient populations. This study confirms the hypothesis that patients with cancer are at increased risk for mortality and that there are multiple characteristics posing the potential to risk-stratify these patients in the setting of a future outbreak.

Abstract PO-083: Prostate cancer and COVID-19: Impact of hormonal therapy on severe outcomes

Abstract Background: Early reports on cancer patients infected with COVID-19 have suggested a high risk of hospitalization and death compared to the general population. Limited data are available on outcomes in specific cancer types. We aim to identify whether hormonal treatment impacts severe outcomes (rate of hospitalization, ICU admission, intubation, and death) in prostate cancer patients. Methods: We conducted a multicenter study in the state of Louisiana, throughout the Ochsner Health System, in both tertiary and nontertiary centers. Patients must carry a diagnosis of prostate cancer and have a completed SARS-CoV-2 test between March 1st and April 30th, 2020. Chi-squared and Fisher’s exact tests were performed to compare the proportion of patients experiencing severe outcomes between treatment groups. Results: As of April 30, 2020, a total of 56 patients with prostate cancer who had a positive SARS-COV-2 test were identified. Median age 69, median BMI 28.8, 78.6% (n=44) black, 58.9% (n=33) current/former smokers, HTN, DM2, and CKD were the most common comorbidities, and 12.5% (n=7) of patients had stage IV disease. Of these patients, 26.8% (n=15) were on hormonal treatment (received within 90 days of COVID+ test). In terms of severe outcomes, 58.9% (n=33) of patients required hospitalization, 17.9% (n=10) required ICU admission with 14.3% (n=8) patients requiring intubation, and 23.2% (n=13) of patients died. There was no statistical difference in rate of severe outcomes (rate of hospitalization, ICU admission, intubation, and death) among prostate cancer patients receiving hormonal therapy vs. those receiving no hormonal therapy. Conclusion: With an ongoing global pandemic of COVID-19, it is important to identify characteristics leading to increased risk of severe events in cohorts of cancer patients. This small cohort does not identify hormonal therapy as a risk factor for increased rate of severe outcomes in patients with prostate cancer. Further analyses describing impact of specific hormonal regimens on risk of hospitalization and death will be completed by time of presentation. Citation Format: Karine Tawagi, Jeff Burton, Diana Maslov, Michael Lunski, Marc Matrana, Daniel Johnson. Prostate cancer and COVID-19: Impact of hormonal therapy on severe outcomes [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-083.

Urinary Sediment Microscopy in Acute Kidney Injury Associated with COVID-19.

AKI has been observed in patients infected with the novel coronavirus severe acute respiratory syndrome coronavirus 2 that causes coronavirus disease 2019 (COVID-19). Recent studies in the United States have reported an incidence of AKI in the context of COVID-19 around 25%–50% of cases requiring hospitalization (1,2; L. Chan, et al, unpublished observations). Nevertheless, data remain scarce about specific characteristics of coronavirus disease 2019–associated AKI (CoV-AKI). Microscopic examination of the urinary sediment (MicrExUrSed) is a reliable clinical tool of diagnostic and prognostic value in the assessment of AKI (3⇓⇓⇓–7). To date, there has been no report comprehensively describing findings of MicrExUrSed in specimens from patients with CoV-AKI. We hypothesized that MicrExUrSed may provide diagnostic information that could help in elucidating the pathogenic mechanisms of kidney injury in CoV-AKI. We conducted a prospective observational study in patients seen in the inpatient nephrology consultation service with a diagnosis of Kidney Disease Improving Global Outcomes AKI stage ≥1 and positive nasopharyngeal swab test for severe acute respiratory syndrome coronavirus 2 RNA over a 1-month period. This study was an ancillary study of a previously reported larger cohort of 161 patients with CoV-AKI (1). Because of concerns of health care worker exposure to infected patients and rationale use of personal protective equipment (PPE), MicrExUrSed was not systematically pursued as it is routinely done outside the context of COVID-19. Nevertheless, MicrExUrSed was attempted whenever there was a suspicion for an intrinsic cause of AKI that could affect medical management and/or in clinical scenarios that were confounded by more than one possible etiology of AKI. Thus, in selected cases, urine specimens were collected and handled with PPE to perform MicrExUrSed under bright-field, dark-field, and phase contrast microscopy. At least three operators inspected each slide. Slides were assessed for …

Racial Disparities in COVID-19: Present from Diagnosis to Death

Many have reported that Black people have been disproportionately affected by COVID-19. Investigators at Ochsner Health System in Louisiana have now

Can automating surgical processes reduce operating room supply costs? A pilot study of a novel OR based technology.

Introduction In the struggling economic post covid era, there will be greater cost containment, efficiency, and quality pressures. How does novel technology to dynamically digitize and automate surgical processes, as an adjunct to existing static workflows, impact surgical supply costs in knee replacement surgeries compared to traditional non automated knee replacement surgeries? Materials/Methods A novel innovative patented technology (SIGHT Medical, Alexandria LA) was created to digitize surgical processes and interface with hospital data systems (EMR- EPIC and ERP- Lawson) within Ochsner health system. Medical Surgical supplies and billable medical supplies were captured by the OR staff using standard hospital EMR and materials management workflows. Outcome measures included costs of surgical supplies, length of stay and number of cases captured using the Ochsner Health system data analytics platform (Tableau, Seattle, WA). Results 1023 knee replacement surgeries were reviewed over 3 years by 3 surgeons at 3 different hospitals within the Ochsner Health system. There was an average of $479/surgery in medical surgical supply costs for automated surgeries and $557/surgery for traditional surgeries. There was an average of $2,444/surgery in billable medical supply costs for automated surgeries and $4,660/surgery for traditional surgeries. Discussion Deploying innovative technology to create a real time dynamic communication and transparency platform can create significant supply cost savings. An average of $78 in medical surgical supply cost savings and $2216 in billable medical supply cost savings can be achieved by automating many of the surgical workflows and processes.

PCN226 LUNG CANCER PATIENT CHARACTERISTICS FROM A DATA LINKAGE STUDY

This research analyzed the clinical pathway of patients from a diagnosis of solitary pulmonary nodule including demographics, diagnostic procedures and lung cancer diagnosis through data linkage. REACHnet is one of 9 clinical research networks (CRNs) in PCORnet®, the National Patient-Centered Clinical Research Network and includes electronic health record for over 8 million patients from multiple partner health systems. Data from Ochsner Health System and Tulane Medical Center were linked to Louisiana Tumor Registry (LTR), a statewide population-based cancer registry, for analysis of patient’s clinical pathways. Index date was diagnosis of solitary pulmonary nodule (SPN), low-dose computer tomography (LDCT) or chest computer tomography (CT) between July 2013 and 2017. Patients with lung biopsy and without SPN diagnosis, SPN with pleural biopsy as first biopsy, secondary lung cancer diagnosis, residence outside of Louisiana, Death Certificate diagnosis, and diagnosis on autopsy were excluded. A total of 30,561 patients with SPN, LDCT or qualifying biopsy were identified and 2,929 (9.58%) had primary lung cancer. 1,496 (51.1%) were documented in LTR. When linking REACHnet and LTR, 94% of 1,496 patients had diagnosis of SPN, 84% had CTs capturing portions of the lung and 89% had 1 or more biopsies. Biopsy distribution was 2.4% surgical, 50.1% bronchoscopy and 47.5% CT guided. Median interval and interquartile from index date to biopsy was 11 days and 28 days respectively. AJCC stage among these patients was Stage 0 (0.53%), Stage I (20.66%), Stage II (7.22%), Stage III (21.86%) Stage IV (47.26%), and Unknown (2.47%). Despite clinical workup, 70% of patients were diagnosed as having stage III or IV disease. Approximately half of lung cancer patients receiving care at Ochsner or Tulane healthcare systems do not appear in the LTR. Reasons for this are not clear but are presumed to be attributable to residence.

Biomarkers Afp In Combination With Afp-L3 And Dcp Predicts Tumor Progression In Treatment Naïve Hcc Patients

Presenter: Kelley Nunez PhD | Ochsner Health System Background: Hepatocellular carcinoma (HCC) treatment with locoregional therapy (LRT) is standard process to downstage or maintain lesions within Milan Criteria. In this study, we retrospectively analyzed early-stage HCC patients undergoing de novo LRT and monitored both recurrence-free survival and intention-to-treat (ITT) survival. We also prospectively monitored a subset of early-stage HCC patients to determine whether additional HCC biomarkers would aid in predicting ITT survival compared to α—fetoprotein (AFP) alone. Methods: All studies were IRB-approved at our institution. A retrospective review of HCC patients transplanted from June 2011 – Feb 2019 that underwent DEB-TACE was performed with patients monitored for 5 year recurrence. In the ITT cohort, HCC patients undergoing de novo DEB-TACE from Aug 2015 – May 2019 were reviewed. Blood was collected from a subset of the ITT cohort (n=52) immediately prior to LRT. Plasma was used to measure HCC biomarkers (AFP, des-λ-carboxy prothrombin (DCP), and Lens culinaris agglutinin-reactive α-fetoprotein (AFP-L3)) in samples with the μTASWako i30 autoanalyzer. ITT endpoint included patients that received liver transplantation or dropout due to tumor progression. Results: In the retrospective transplanted cohort, 268 treatment-naïve patients were analyzed with 75% male and main etiology of Hepatitis C (58%). Recurrence free survival was significantly lower in patients that presented with AFP > 100 (P=0.01). In the ITT cohort, 160 treatment-naïve HCC patients were analyzed with 71% male and 65% Hepatitis C. Milan Criteria and AFP elevation alone was not predicitive ITT survival, however patients with AFP > 100 had significantly lower ITT survival. A subset of the ITT cohort was prospectively monitored with blood collections. Demographic comparsions between two revealed only significant differenecs in sodium and bilirubin levels. Univariate analysis revealed patients with tumor progression had larger lesions (P < 0.0001), cumulative lesion size (P < 0.0001), and higher HCC biomarkers AFP (P=0.39), AFP-L3 (P=0.002), and DCP (P=0.005). ITT survival was significantly lower in patients presenting with elevated single biomarkers [AFP >100 (P < 0.0001), AFP-L3 (P < 0.0001), and DCP (P < 0.0001)], primary lesion >3cm (P < 0.0001), and cumulative lesion size >3cm (P < 0.001). Analysis of patients stratified by HCC biomarkers revealed patients presenting with AFP elevation and an additional biomarker had worse ITT survival and were at greater risk of waitlist dropout. Conclusion: AFP alone can identity patients at risk of waitlist dropout with higher risk of recurrence post transplant. However, the addition of AFP-L3 and DCP biomarkers can identify a patient population prior to LRT intervention at risk of tumor progression from the waitlist.