scholarly journals Thromboembolic Outcomes of Hospitalized COVID-19 Patients in the 90-Day Post-Discharge Period: Early Data from the Northwell CORE-19 Registry

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 33-34
Author(s):  
Dimitrios Giannis ◽  
Steven L. Allen ◽  
Anne Davidson ◽  
Galina S. Marder ◽  
Sarah Flint ◽  
...  

Introduction Thromboembolic outcomes have emerged as an important issue in sick hospitalized patients with COVID-19. Multiple pathogenetic mechanisms for thrombosis have been implicated, including endothelial dysfunction, increased von Willebrand factor (vWF), interleukin-6 release, and activation of/interaction between macrophages, monocytes, endothelial cells, platelets and lymphocytes. The actual rate of arterial and venous thromboembolic events (ATE and VTE) in hospitalized patients with COVID-19, especially in the immediate post-hospital discharge period, has not been fully elucidated, with most of the data derived from retrospective studies with small sample sizes. Methods Against this background, we have designed and implemented an ongoing prospective registry (CORE-19) consisting of 11,249 consecutive hospitalized patients with COVID-19 from March 1st 2020 through May 31st 2020 using data derived from the Northwell Health System and the COVID-19 Research Consortium to study through 90-days post-discharge the rate of VTE and ATE, major bleeding, all-cause mortality, and other complications. We are capturing data of interest including demographic characteristics, co-morbidities, relevant medications, hospital setting, in-hospital treatment, thromboprophylaxis usage, key laboratory parameters, and 90-day thromboembolic and other key outcomes. A unified data repository (datamart) of hospitalized COVID-19 patients across multiple datasets from electronic health records, health informatics exchange, a dedicated radiology database, and a standardized data collection tool in REDCap, that includes telephonic calls up to 90 days post-discharge, is being implemented. A common data model (CDM) is utilized to ensure semantic interoperability between data originating from disparate sources. Northwell Health protocols stipulate the use of post-discharge low-molecular weight heparin, direct oral anticoagulants, or baby aspirin in hospitalized COVID-19 patients with high thrombotic risk features. Results Our cohort as of August 7, 2020 consists of complete follow up in 4,100 patients with a mean age of 61.0 years (SD: 17.0) with 54.7% males (Table 1). Preliminary data show an all-cause mortality rate of 4.29%, an overall thromboembolic rate of 3.51% (2.41% VTE and 1.10% ATE), a major bleeding rate of 1.61%, and a rehospitalization rate of 12.85%. Of patients with either DVT or PE post-discharge, 13.43% (9/67) died. The full dataset, including risk factors, comorbidities, key in-hospital and post-discharge medications including anticoagulant and antiplatelet agents, will be available at the time of presentation to the ASH congress. Conclusion Our ongoing registry is a large prospective study evaluating the rate of overall thromboembolic complications and all-cause mortality in hospitalized COVID-19 patients through 90 days post discharge. Current rates of thromboembolic events signify the importance of post-discharge surveillance and, potentially, post-discharge extended thromboprophylaxis, in this acutely ill medical population. Disclosures Allen: Bristol Myers Squibb: Current equity holder in publicly-traded company. Spyropoulos:Janssen, Boehringer Ingelheim, Bayer, BMS, Portola, ATLAS Group: Consultancy; Janssen, Boehringer Ingelheim: Research Funding.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Cordero ◽  
J.M Garcia-Acuna ◽  
M Rodriguez-Manero ◽  
B Cid ◽  
B Alvarez Alvarez ◽  
...  

Abstract Background In 2019 the Academic Research Consortium of high-bleeding risk (ARC-HBR) proposed a new and binary definition of high-bleeding risk (HBR) patients based on the presence of 1 major or 2 minor criteria. Methods Prospective study of all consecutive patients admitted for ACS in two different centers. We analyzed bleeding incidence in patients with 1 major criteria (1MC) vs. 2 minor criteria (2mC) using the 2019 ARC-HBR consensus. Bleeding events were collected according those fitting definitions 3 or 5 of the BARC consortium. Results We included 8,724 patients included and 40.9% we classified as HBR; 20.9% for 1MC and 20.0% for 2mC. In-hospital mayor bleeding rate was 8.6%; no-HBR patients had 0.3%, 2mC 15.1% and 1MC 29.7% (p<0.001 for the comparison). In contrast, the statistically highest in-hospital mortality was observed in patients with 2mC (11.4%), followed by patients with 1MC (8.0%) and no-HBR patients (2.0%). During follow-up (median time 57.8 months) all-cause mortality rate was 21.0% and cardiovascular dead 14.2%. The incidence of post-discharge major bleeding was 10.5%. No-HBR patients had the lowest bleeding rate (7.4%) and no difference was observed in patients with 1MC (14.6%) or 2mC (15.8%) (figure). The multivariate analysis, adjusted by age, gender, medical treatment, atrial fibrillation and revascularization and considering all-cause mortality as competing risk, showed independent association of 1MC (sHR: 1.46, 95% 1.22–1.75) and 2mC (sHR: 1.31, 95% CI 1.05–1.63) with post-discharge major bleeding. Conclusions HBR patients according to the 2019 ARC-HBR containing 2mC or 1MC are at similar and higher risk of in-hospital or post-discharge bleeding events Funding Acknowledgement Type of funding source: None


2021 ◽  
pp. 001857872098714
Author(s):  
S. P. Veeranki ◽  
Z. Xiao ◽  
A. Levorsen ◽  
M. Sinha ◽  
B. Shah

Introduction: Little is known about outcomes associated with enoxaparin versus unfractionated heparin (UFH) for venous thromboembolism (VTE) prophylaxis in abdominal surgery patients in U.S. clinical practice. The purpose of this study was to compare VTE, all-cause mortality, PE-related in-hospital mortality, and hospital costs during abdominal surgery hospitalization and the 90 days post-discharge between patients who received enoxaparin versus UFH prophylaxis. Materials and Methods: Using the Premier Healthcare Database, abdominal surgery patients who received at least 1 day of VTE prophylaxis with enoxaparin or UFH were identified between January 1, 2010 and September 30, 2016. Clinical outcomes were assessed using multivariable logistic regression models and cost outcomes were assessed using generalized linear models. Results: Of 363,669 patients identified, 59% received enoxaparin and 41% UFH. In adjusted analyses, there were statistically significant lower odds of VTE (OR 0.80; 95% CI 0.65-0.97), all-cause mortality (OR 0.67; 95% CI 0.60-0.75), and major bleeding (OR 0.88; 95% CI 0.82-0.94) during the hospitalization for enoxaparin versus UFH, but no differences during the 90-days post-discharge or for PE-related mortality. There was a statistically significant lower total hospital cost with enoxaparin versus UFH during index hospitalization ($8,913 vs $9,017, P < .0001), but not post-discharge ($3,342 vs $3,368, P = .42). Unadjusted rates of heparin-induced thrombocytopenia (index:0.1% vs 0.3%; post-discharge: 0.02% vs 0.06%) were reported for enoxaparin and UFH, respectively. Conclusion: In contemporary U.S. hospital practice, statistically significant lower odds of VTE, all-cause mortality and major bleeding with enoxaparin versus UFH prophylaxis were found during abdominal surgery hospitalizations.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 5069-5069
Author(s):  
Luis S. Noble ◽  
Maria Velazquez ◽  
Anuradha Gupta ◽  
Mark M. Landeros ◽  
Juan Herrada

Abstract Abstract 5069 Background Hereditary spherocytosis (HS) is a spectrum of inherited erythrocyte membrane defects that result in hemolysis and varying degrees of anemia, usually not associated with increased thrombotic risk. However, there is some concern about post-splenectomy thrombocytosis, since both arterial and venous thromboembolic events have been reported in patients splenectomized for HS. A review of the medical literature revealed only a few cases of thrombosis associated with pregnancy and hereditary spherocytosis, and none of them had methyl tetrahydrofolate reductase (MTHFR) mutations or the presence of elevated anticardiolipin antibodies (both considered risk factors for thromboembolic disease). Methods Case report Results A 34-year-old Caucasian female with history of hereditary spherocytosis and splenectomy at age five, underwent evaluation for infertility. The patient was found to have a high titer of anticardiolipin antibodies and the presence of heterozygosity for the MTHFR C677T mutation. She denied any personal or family history of deep venous thrombosis. Subsequently the patient became pregnant. Because the combination of thrombophilic states appears to increase the risk of thromboembolic events, it was decided to start the patient prophyllactically with oral aspirin 81 mg daily, Foltx® (Folic acid 2.5 mg, cyanocobalamin 2000 mcg, and pyridoxine hydrochloride 25 mg), and heparin 5000 mg subcutaneously twice a day. On her most recent evaluation, at 26 weeks of pregnancy, no medical or obstetric problems have been observed. Conclusion Our case illustrates an unusual combination of thrombophilic states. Further studies are needed to evaluate the clinical significance of this association. Disclosures No relevant conflicts of interest to declare.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Elena Salmoirago-Blotcher ◽  
Darleen Lessard ◽  
Joel Gore ◽  
Robert Goldberg

Background: Whether a diagnosis of depression after developing an acute myocardial infarction (AMI) is linked to a worse prognosis remains a matter of debate after several RCTs of interventions to treat post-AMI depression have yielded negative results. A possible explanation is that depressive symptoms after AMI may be part of the normal adjustment to an adverse life event. A pre-admission history of depression could better identify patients who may derive the most benefit from depression treatment. The objective of this study was to evaluate whether a pre-admission history of depression was associated with a worse post-discharge prognosis among patients with AMI. Methods: This was a secondary analysis conducted among patients included (biennial basis between 1999-2009) in the Worcester Heart Attack Study, an ongoing epidemiologic study examining long-term trends in the clinical outcomes of AMI among residents of the Worcester, MA metropolitan area. The exposure was defined as a physician-recorded diagnosis of depression preceding the index hospitalization for AMI based on the review of hospital medical records (MR). The outcome was all-cause death rates in-hospital and 1-year post discharge. Information regarding demographics, medical history, in-hospital treatment, and discharge status was abstracted from the MR by trained study physicians and nurses. Survival status after discharge was obtained from the MR and from death certificates. Univariate and multivariate logistic regression models were used to assess associations between depression and the outcome. Results: This analysis included 5,068 patients (mean age 70 years, 44% women). Approximately 16% of patients had a history of depression pre-admission. No significant differences were found between patients with and without a history of depression with regard to in-hospital mortality (11.5% vs. 9.9%; unadjusted OR=1.18; 95% CI: 0.95, 1.48). At 1 year after discharge all-cause mortality was significantly higher among patients with a pre-admission history of depression (27.5% vs. 18.2%; unadjusted OR=1.71; 95% CI: 1.44, 2.02). While the association between history of depression and in-hospital mortality was largely explained by confounding, the association with 1 year mortality remained significant even after adjustment for demographics, coronary risk factors, co-morbidities, clinical characteristics and medications at discharge (OR=1.57; CI: 1.24, 1.98). Conclusions: In this community-based cohort of patients hospitalized with AMI at different hospitals in central MA, a pre-admission history of depression was an independent predictor of all-cause mortality 1 year after MI. Documentation of a history of depression in the medical record could be a simple tool for cardiologists and primary care physicians to identify high-risk patients who may benefit from depression treatment.


2012 ◽  
Vol 153 (31) ◽  
pp. 1207-1218
Author(s):  
Klára Gadó ◽  
Gyula Domján

Antiphospholipid syndrome is characterized by arterial and venous thromboembolic events and persistent laboratory evidence of antiphospholipid antibodies. Obstetric complications such as recurrent miscarriage, early delivery, oligohydramnios, prematurity, intrauterine growth restriction, fetal distress, fetal or neonatal thrombosis, pre-eclampsia/eclampsia, and HELLP syndrome are also hallmarks of antiphospholipid syndrome. This syndrome is one of the diseases associated with the most severe thrombotic risk. Changes in the hemostatic system during normal pregnancy also result in a hypercoagulable state resulting in elevated thrombotic risk. Thromboembolic events are responsible of the vast majority of maternal and fetal deaths. Administration of appropriate thromboprophylaxis helps prevent thromboembolic complications during pregnancy in women with antiphospholipid syndrome and also give birth to healthy children. It is important to centralize the medication and management of these patients. It helps in the thoughtful care of these pregnant women encountering serious problems. Orv. Hetil., 2012, 153, 1207–1218.


Author(s):  
Niklas Wallvik ◽  
Henrik Renlund ◽  
Anders Själander

Abstract New oral anticoagulants (NOACs) is the preferred treatment in secondary prophylaxis of venous thromboembolic events (VTE). The aim of this study was to investigate possible risk factors associated with major bleeding in VTE-patients treated with NOACs. In this retrospective register-based study we screened the Swedish anticoagulation register Auricula (during 2012.01.01–2017.12.31) to find patients and used other national registers for outcomes. Primary endpoint was major bleeding defined as bleeding leading to hospital care. Multivariate Cox-regression analysis was used to reveal risk factors. 18 219 patients with NOAC due to VTE were included. 85.6% had their first VTE, mean age was 69.4 years and median follow-up time was 183 days. The most common NOAC was rivaroxaban (54.8%), followed by apixaban (42.0%), dabigatran (3.2%) and edoxaban (0.1%). The rate of major bleeding was 6.62 (95% CI 6.19–7.06) per 100 treatment years in all patients and 11.27 (CI 9.96–12.57) in patients above 80 years of age. Statistically independent risk factors associated with major bleeding were age (normalized HR 1.38, CI 1.27–1.50), earlier major bleeding (HR 1.58, Cl 1.09–2.30), COPD (HR 1.28, CI 1.04–1.60) and previous stroke (HR 1.28, Cl 1.03–1.58) or transient ischemic attack (TIA) (HR 1.33, Cl 1.01–1.76). Prior warfarin treatment was protective (HR 0.67, CI 0.58–0.78). This real world cohort shows a high bleeding rate especially among the elderly and in patients with previous major bleeding, COPD and previous stroke or TIA. This should be considered when deciding on treatment duration and NOAC dose in these patients.


2019 ◽  
Vol 57 (5) ◽  
pp. 854-859
Author(s):  
John Agzarian ◽  
Virginia Litle ◽  
Lori-Ann Linkins ◽  
Alessandro Brunelli ◽  
Laura Schneider ◽  
...  

Abstract OBJECTIVES Venous thromboembolic events can be successfully prevented with chemical and/or mechanical prophylaxis measures, but evidence-based guidelines in thoracic surgery are limited, particularly regarding extended post-discharge prophylaxis. This study attempts to gather an international consensus on best practices to inform the development of such guidelines. METHODS A series of 3 surveys was distributed to the ESTS/AATS/ISTH (European Society of Thoracic Surgeons, American Association of Thoracic Surgeons, International Society for Thrombosis and Haemostasis) venous thromboembolic events prophylaxis working group starting January 2017. This iterative Delphi consensus process sought to gather a consensus on (i) risk factors; (ii) preferred agents; (iii) duration; and (iv) perceived barriers to an extended thromboprophylaxis approach. Participant responses were expressed on a 10-point scale, and the results were summarized and circulated to all respondents in subsequent rounds. A coefficient of variance of ≤0.3 was identified pre hoc to identify agreement. RESULTS A total of 21 Working Group members completed the surveys, composed of 19% non-surgeon thrombosis experts, and 48% from North America. Respondents largely saw agreement regarding risk factors that indicate a need for extended thromboprophylaxis. The group agreed that low-molecular-weight heparin is a suitable agent for use post-discharge, but there was a wide variety in response regarding agents, duration and barriers to extended prophylaxis, where no consensus was observed across the three rounds. CONCLUSIONS There is strong agreement around indications for extended venous thromboembolic events thromboprophylaxis after thoracic surgery, but there is little consensus regarding the agents and duration to be employed. Further research is required to better inform guideline development.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3421-3421
Author(s):  
James N. Frame ◽  
Elaine A. Davis ◽  
Ying Wang

Abstract Background: Retrospective studies have reported a correlation of higher ELISA optical density (OD) values for H-PF4 antibodies with occurrence of thrombotic events in patients (pts) with HIT; often with variable prophylactic direct thrombin inhibitor (DTI) use. Objectives: To compare positive OD (≥0.4) values with thrombotic risk and clinical outcome in pts with clinically-suspected or confirmed HIT. Design: Retrospective cohort study. Setting: IRB-approved, CAMC HIT Registry. Patients: 182 HIT pts, age ≥18 yrs with OD values ≥0.40 (EIA, GTI) enrolled from 3/11/05 to 12/27/07. Age 64.5±13.4 yrs; M/F (107/75); caucasian (96.2%); CV surgery (n=120), medical (n=45), gen/vasc surgery (n=17); heparin use: therapeutic (n=160), prophylaxis (n=17), catheter flushes (n=5). Measurements: mean OD±SD; objectively confirmed thrombosis (venous, arterial); all-cause mortality; length of stay (LOS); DTI use; composite outcome (new thrombosis, death, amputation); thrombotic composite outcome (new thrombosis, death from new thrombosis, amputation). Results: At HIT diagnosis, prevalent thrombosis occurred in 82 pts and isolated HIT occurred in 100 pts. Thrombotic presentations (n) included: venous alone (DVT-27, PE-9, DVT + PE-5), arterial alone (single event-28, multiple events-5), and venous plus arterial (8). Prevalent thromboses were symptomatic in 65 pts (79.3%). Fourteen pts developed a new thrombosis; 5 of them had isolated HIT. A total of 87 pts (47.8%) had “ever” thrombosis. The OD of the 182 pts was 1.12±0.76 with a cumulative thrombotic rate of 52.4%, 75.6% and 90.3% in OD ranges of 0.40–0.89, 0.4–1.49 and 0.4–2.29, respectively. No significant difference in rates of prevalent thrombosis was observed in any of 3 categorizations of OD values (% thrombosis): 0.40–0.99 vs. ≥1.00 (42.3% vs. 41.7%; P=0.457), 0.40–1.09 vs. ≥1.10 (47.9% vs. 40.0%; P=0.307) and 0.40–1.19 vs. ≥ 1.20 (47.5% vs. 40.0%; P=0.337). Among pts with “ever” vs. “never” thrombosis, there was no significant difference in OD values (1.14±0.84 vs. 1.10±0.69; P=0.692). Among pts with a new thrombosis, the OD was 1.45±1.36 (min 0.43, max 5.53). The OD was numerically higher in pts with isolated HIT who developed a new thrombosis vs. pts with “never” thrombosis (2.23±2.05 vs. 1.10±0.69; P=0.285). Males developed a higher rate of thrombosis than females (56.1% vs. 36.0%; P=0.008). Surgical pts comprised a higher proportion of “ever” thrombosis than medical pts (54.7% vs. 26.7%); P=0.001). All-cause mortality was significantly higher in the “ever” vs. “never” thrombosis groups (16.1% vs. 5.3%; P=0.017); highest among pts with isolated HIT (80.0%) and prevalent thrombosis who developed a new thrombosis (55.6%). HIT as cause or possible cause of mortality in pts with “never” thrombosis (1.1%) was significantly lower than those with “ever” thrombosis (10.3%, P=0.007) and those with new thrombosis (57.1%, P<0.001). Composite and thrombotic composite outcomes were numerically higher in pts presenting with prevalent thrombosis vs. isolated HIT: 19.5% vs. 10.0% (P=0.068) and 14.6% vs. 6.0% (P=0.052). Among pts with “ever” vs. “never” thrombosis, there was no significant difference in rates of major bleeding (5.8% vs. 2.1%), amputation (2.3% vs. 0.0%), alternative anticoagulant therapy (99.0% vs. 94.7%), DTI use (96.6% vs. 94.7%) and mean LOS (28.1 d vs. 25.1 d). The mean duration of DTI use was longer in pts with “ever” vs. “never” thrombosis (16 d vs. 11.9 d; P=0.029) with a non-significant trend for a longer duration of DTI-warfarin overlap (7.4 d vs. 5.8 d; P=0.064). Conclusions: The occurrence of prevalent thrombosis was not significantly different in any of 3 categorizations of (+) OD values with thresholds at or above vs. lower than 1.0, 1.1 or 1.2. OD values, DTI use, rates of major bleeding and length of stay were similar among pts with “ever” vs. “never” thrombosis. Patients with “ever” thrombosis had significantly higher rates of all-cause and HIT-specific mortality. After HIT presentation, pts who developed a new thrombosis had the highest subpopulation OD values and mortality outcomes. Patients with isolated HIT who did not develop a new thrombosis (“never” thrombosis) had significantly lower rates of all-cause and HIT-specific mortality.


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