Low Thromboembolic Risk Research Articles

Predicting Thromboembolism in Hospitalized Patients with Ventricular Thrombus.

Thromboembolism is associated with mortality and morbidity in patients with ventricular thrombus. Early detection of thromboembolism is critical. This study aimed to identify potential predictors of patient characteristics and develop a prediction model that predicted the risk of thromboembolism in hospitalized patients with ventricular thrombus. We performed a retrospective cohort study from the National Center of Cardiovascular Diseases of China between November 2019 and December 2021. Hospitalized patients with an initial diagnosis of ventricular thrombus were included. The primary outcome was the rate of thromboembolism during the hospitalization. The Lasso regression algorithm was performed to select independent predictors and the multivariate logistic regression was further verified. The calibration curve was derived and a nomogram risk prediction model was built to predict the occurrence of thromboembolism. A total of 338 eligible patients were included in this study, which was randomly split into a training set (n = 238) and a validation set (n = 100). By performing Lasso regression and multivariate logistic regression, the prediction model was established including seven factors and the area under the receiving operating characteristic was 0.930 in the training set and 0.839 in the validation set. Factors associated with a high risk of thromboembolism were protuberant thrombus (odds ratio (OR) 5.03, 95% confidential intervals (CI) 1.14-23.83, p = 0.033), and history of diabetes mellitus (OR 6.28, 95% CI 1.59-29.96, p = 0.012), while a high level of left ventricular ejection fraction along with no antiplatelet therapy indicated a low risk of thromboembolism (OR 0.95, 95% CI 0.89-1.01, p = 0.098; OR 0.26, 95% CI 0.05-1.07, p = 0.083, separately). A prediction model was established by selecting seven factors based on the Lasso algorithm, which gave hints about how to forecast the probability of thromboembolism in hospitalized ventricular thrombus patients. For the development and validation of models, more prospective clinical studies are required. NCT05006677.

Low-Voltage Area at the Anterior Wall of the Left Atrium Is Associated With Thromboembolism in Atrial Fibrillation Patients With a Low CHA2DS2-VA Score.

BackgroundNon-valvular atrial fibrillation (NVAF) in patients at low risk of thromboembolism (TE) does not mean “no risk.” We sought to assess the risk factors associated with TE in clinically low-risk AF patients with a non-gender CHA2DS2-VASc score (CHA2DS2-VA score) of 0 or 1.MethodsIn this single-center cross-sectional study, NVAF patients with a CHA2D-VA score of 0 or 1 who underwent index high-density bipolar voltage mapping of the left atrium (LA) and AF ablation were consecutively enrolled from 2017 to 2020. The population was divided into patients with and without TE history before voltage mapping. AF patients with CHA2DS2-VA score of 0 to 1 before TE (TE group) were analyzed and compared with clinically low-risk AF patients without TE history (non-TE group). The association among LA low voltage area (LVA), other clinical factors and TE history was analyzed with logistic regression.ResultsIn the TE group, LVA was more prevalent [15/25 (60%) vs. 105/359 (29.2%), p = 0.003] and more preferentially located at the anterior wall [8/15 (53%) vs. 24/105 (23%), p = 0.025]. Among patients with LVA, the activation time from the sinus node to the left atrial appendage was significantly longer in the TE group (77.09 ± 21.09 vs. 57.59 ± 15.19 ms, p < 0.001). Multivariate analysis demonstrated that LVA at the anterior wall of the LA [OR: 4.17 (95% CI: 1.51 to 11.51); p = 0.006] and being female [OR: 3.40 (95% CI: 1.36 to 8.51); p = 0.009] were associated with TE history.ConclusionsLVA at the anterior wall of the LA is associated with TE history in NVAF patients with a low CHA2DS2-VA score.

Association between Gut Microbiota Dysbiosis and the CHA2DS2-VASc Score in Atrial Fibrillation Patients.

Background In our previous studies, we found a disordered taxonomic composition and function of gut microbiota (GM) in atrial fibrillation (AF) patients. However, direct evidence about the association between dysbiotic microbiota and thromboembolic risk in AF is lacking. Aims In this study, we analyzed the interaction of GM and related functional patterns in AF with different CHA2DS2-VASc scores to assess its potential as a biomarker for predicting stroke risk. Patients and Methods. The CHA2DS2-VASc score was used for thromboembolic risk stratification in AF according to American Heart Association (AHA) guidelines. We investigated the taxonomic and functional annotation of GM based on metagenomic data from 50 AF patients (32 with high thromboembolic risk (CHA2DS2-VASc score ≥2 (males) or CHA2DS2-VASc score ≥3 (females)) and 18 individuals with low thromboembolic risk (CHA2DS2-VASc score <2 (males) or CHA2DS2-VASc score <3 (females))). Results The gut microbial diversity, composition, and function in AF were different in high and low CHA2DS2-VASc score groups. In high thromboembolic risk group, the abundance of Prevotella, Lachnospiraceae, and Eubacterium rectale, related to the production of short-chain fatty acids and anti-inflammatory were reduced (all P < 0.05). Furthermore, annotated by Kyoto Encyclopedia of Genes and Genomes (KEGG), a database of genes and genomes, the KEGG orthology-based scoring approach exhibited a significant association with thromboembolic risk in AF patients. Conclusions Imbalance of GM and microbial dysfunction are involved in aggravated thromboembolic risk of AF.

Therapeutic versus prophylactic anticoagulation in patients with COVID-19: a meta-analysis of randomised controlled trials

Abstract Funding Acknowledgements Type of funding sources: None. Background Several systematic reviews and meta-analyses have been conducted to evaluate the effects of anticoagulation on patients admitted with coronavirus infectious disease 2019 (COVID-19). However, since most of them consist of observational studies, the optimal dose still remains controversial. Purpose The purpose of this study was to investigate the efficacy and safety of therapeutic anticoagulation compared with prophylactic anticoagulation in patients admitted with COVID-19. Methods A meta-analysis was conducted on randomised controlled trials (RCTs) to minimise bias. PubMed and the Cochrane Central Register of Controlled Trials were queried for the terms "covid-19," "(anticoagulation OR thromboprophylaxis)," and "randomised." The same terms or relevant studies were also queried on the website of the ClinicalTrials.gov and relevant reviews. The clinical endpoints of interest were all-cause death, thromboembolism, and major bleeding. Pooled estimates were calculated using a random-effects model. Results A total of 7 RCTs were included in this study. The risk of thromboembolism was lower (odds ratio (OR) 0.54; 95% confidence interval (CI) 0.41-0.73; p &amp;lt; 0.001) and the risk of major bleeding was higher (OR 1.87; 95% CI 1.21-2.90; p = 0.005) in the therapeutic anticoagulation group than in the prophylactic anticoagulation group. On the other hand, the risk of all-cause death was similar (OR 0.92; 95% CI 0.65-1.31; p = 0.65) between the 2 groups. In a subgroup analysis, the risk of thromboembolism was also lower in the therapeutic anticoagulation group compared with the prophylactic anticoagulation group both in moderately and severely ill patients, respectively. However, the risk of major bleeding was more likely to higher (OR 1.85; 95% CI 0.98-3.49; p = 0.06) in the therapeutic anticoagulation group than the prophylactic anticoagulation group only in severely ill patients. Conclusions Therapeutic anticoagulation is associated with a lower risk of thromboembolism and a higher risk of major bleeding compared to prophylactic anticoagulation in patients hospitalised with COVID-19. Therapeutic anticoagulation may be more beneficial for moderately ill patients.

Anticoagulation Therapy After the Fontan Procedure.

The optimum postoperative anticoagulation therapy type and duration after the Fontan procedure remains unclear. This study aimed to evaluate whether our approach of administering only oral antiplatelets without warfarin due to serious bleeding complication risks in children is reasonable. We retrospectively reviewed the data of 249 patients who underwent the Fontan procedure. Total cavopulmonary connection with extracardiac conduit was performed in 230 patients (92%), the lateral tunnel Fontan procedure was performed in 18 patients (8%), and intraatrial conduit Fontan procedure was performed in one patient. Aspirin administration (initial dose: 5mg/kg/day) was continued in all patients. Only 29 patients (11%) received combined administration of aspirin and warfarin for various reasons, and warfarin was discontinued in 20 (71%) of these within a median of 16months postoperatively. Sixteen patients at high risk of thromboembolism were started on warfarin. Hospital mortality was 0%, with no thromboembolic or bleeding event-related early death. Nine late deaths, not associated with bleeding nor thromboembolism, occurred except one resulting from cardiac infarction 1.9years after the procedure. During hospitalization, five patients experienced graft thromboembolism, two of which underwent graft exchange, and the others were started on warfarin. In the late phase (3.1 ± 6.6years), cerebral infarction (n = 3), peripheral pulmonary artery occlusion (n = 2), gastrointestinal bleeding (n = 5), and respiratory hemorrhage (n = 4) occurred. Eight of nine patients with bleeding events received only aspirin. Thromboembolic events occurred in six patients within the first year after the procedure. Bleeding events occurred at 8 ± 5.5years after the procedure. Expected freedom from a thromboembolic event was 99.8% at 1year and 93.4% at 20years. Expected freedom from a bleeding event was 100% at 1year and 88.4% at 20years. In children at low risk of thromboembolism after the Fontan procedure, continuous administration of an oral antiplatelet agent alone without warfarin seems to represent a reasonable prophylactic approach.

Low Risk of Venous Thromboembolism After Robot-assisted Radical Prostatectomy Through Systemic Image Assessment: A Prospective Study.

The aim of the study was to evaluate the risk of venous thromboembolism (VTE) after robot-assisted radical prostatectomy (RARP) and discuss whether a uniform prophylaxis for VTE after radical prostatectomy is also suitable for robotic surgery. On this context, we investigated the incidence and risk factors of VTE, including asymptomatic events, after RARP compared to transurethral resection of bladder tumor (TUR-BT). The participants were 209 patients with localized prostate cancer who underwent RARP, and 93 patients who underwent TUR-BT as controls. The incidence and risk factors of VTE, including deep vein thrombosis and pulmonary embolism, were systemically investigated seven days after surgery using contrast-enhanced computed tomography. Of the 209 RARP patients, 5.7% (12/209) patients had VTE. All events were asymptomatic and the incidence of VTE was not significantly different between the two surgeries (p=0.90). In multivariate analyses, neoadjuvant androgen deprivation therapy (ADT) (p=0.006), D-dimer value on postoperative day 1 (p=0.001) and lymphocele formation (p=0.043) were significantly associated with VTE after RARP. The risk of VTE after RARP might not be so high and uniform prophylaxis might not be suitable for RARP because it might be the same as that after transurethral resection for bladder tumors. However, neoadjuvant ADT, high D-dimer levels after surgery and lymphocele formation should be noted as risk factors of VTE after RARP.

Experimental and computational models for tissue-engineered heart valves: a narrative review.

ABSTRACTValvular heart disease is currently a common problem which causes high morbidity and mortality worldwide. Prosthetic valve replacements are widely needed to correct narrowing or backflow through the valvular orifice. Compared to mechanical valves and biological valves, tissue-engineered heart valves can be an ideal substitute because they have a low risk of thromboembolism and calcification, and the potential for remodelling, regeneration, and growth. In order to test the performance of these heart valves, various animal models and other models are needed to optimise the structure and function of tissue-engineered heart valves, which may provide a potential mechanism responsible for substantial enhancement in tissue-engineered heart valves. Choosing the appropriate model for evaluating the performance of the tissue-engineered valve is important, as different models have their own advantages and disadvantages. In this review, we summarise the current state-of-the-art animal models, bioreactors, and computational simulation models with the aim of creating more strategies for better development of tissue-engineered heart valves. This review provides an overview of major factors that influence the selection and design of a model for tissue-engineered heart valve. Continued efforts in improving and testing models for valve regeneration remain crucial in basic science and translational researches. Future research should focus on finding the right animal model and developing better in vitro testing systems for tissue-engineered heart valve.

Evaluation of Real-World Patient Volume for a Low Risk Pulmonary Embolism Outpatient Clinic at a Large, Public Medical Center

Introduction: Guidelines from the American Society of Hematology recommend consideration of outpatient management, rather than hospitalization, for patients with pulmonary thromboembolism (PTE) with low risk of complication. The simplified Pulmonary Embolism Severity Index (sPESI) is frequently used for PTE risk stratification and selection for outpatient management, where an sPESI of 0 is associated with a low risk of recurrent thromboembolism, non-fatal bleeding, and death. Prior to developing an outpatient care pathway for low risk PTE at a large, public academic medical center, we sought to assess the potential clinic volume by determining the number of patients seen at our institution with low risk acute PTE. We also sought to capture other features that may preclude outpatient management including renal impairment, thrombocytopenia, and obesity, which may prevent direct oral anticoagulant (DOAC) use, and lack of insurance, which may impede access to affordable anticoagulation and clinic follow-up.Methods: We retrospectively identified patients with acute PTE by reviewing computed tomography (CT) of the chest with contrast or CT angiography performed during a one-year period (Oct 1, 2018 to Sept 30, 2019) using CPT codes. Imaging reports were manually reviewed to determine if acute PTE was present. sPESI variables were collected: age >80, history of cancer, history of cardiopulmonary disease, heart rate (HR) ≥110bpm, systolic blood pressure (SBP) <100mmHg, and oxygen saturation (O 2) <90%. Medical history variables were identified using ICD-10 codes. Vital sign values were determined by identifying peak or nadir as appropriate within 24 hours of encounter initiation. Additional demographic and clinical variables collected included sex, weight, body mass index (BMI), insurance status, serum creatinine, platelet count, and length of stay for admitted patients. Readmission was determined by reviewing documentation within 30 days of initial encounter. Values were reported using frequencies with percentages and means with standard deviation and/or range. Comparisons were performed using chi squared tests and t tests as appropriate.Results: Of 587 CT chest imaging studies identified, 199 (34%) demonstrated acute PTE (Figure 1). The majority (n=174, 87%) had an sPESI of 1 or greater. Points were more frequently gained due to SBP <100mmHg (n=109, 63%), HR ≥110bpm (n=105, 60%), and O 2 ≤90% (n=90, 52%). History of cancer was present in 54 patients (31%) and history of cardiopulmonary disease in 81 patients (47%), with a total of 113 patients (65%) having a history of either. Only 25 patients (13%) had a low risk sPESI score of 0. Two patients with sPESI of 0 were excluded from further analysis due to age <18 and transfer to an outside hospital. Table 1 includes a comparison of the demographic and clinical features of all patients with acute PTE versus those with sPESI of 0.Of those patients with a low risk sPESI, 3 patients (13%) had another indication for hospital admission aside from acute PTE (Figure 1). Three patients (13%) had a BMI greater than 40kg/m 2 and a weight greater than 120 kilograms. No patients had significant renal impairment, with a serum creatinine ranging between 0.5-1.5mg/dL. No patients had significant thrombocytopenia. Three patients (13%) were uninsured, 1 of whom was admitted for another indication.The majority of patients with sPESI of 0 were admitted (n=19, 83%) with an average length of stay of 1.8 days (SD 1.6, range 0.2-7.4). Two patients were discharged from the emergency department (ED), and 2 patients were diagnosed and managed by an outpatient provider without contact with the ED or hospital. Only 1 patient was readmitted to the hospital within 30 days for reasons unrelated to PTE.Conclusions: Our results indicate that the annual volume for a low risk PTE outpatient management pathway at a large, public medical center would be low, with only 20 patients meeting eligibility per sPESI in 12 months. Patients were frequently disqualified for vital sign abnormalities, but over half were ineligible due to comorbidities. This quantification will allow our institution and others that are similar to gauge the potential resource allotment needed for low risk pathway development. In addition, we demonstrate that 10% of eligible patients were uninsured, emphasizing that access to affordable anticoagulation and follow-up is necessary when developing outpatient PTE care models. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Effect of antimicrobial therapy on the embolic events in patients with infective endocarditis

Abstract Background Embolic events (EE) are presented in up to 50% of the cases of infective endocarditis (IE). Main approach in prevention of the embolisms is properly timed surgery and antimicrobial therapy. But specific antimicrobial drug to prevent embolic events is not yet established. Purpose To analyze effect of a distinct group of an antimicrobials on association with embolic events in patients with IE. Methods 255 patients with verified IE (DUKE 2009, 2015), hospitalized and treated from January 2010 to January 2020, were included in the study. Patients underwent clinical investigation including physical examination, laboratory and instrumental studies. Results About one quarter (27.5%) of the patients had an embolic event after initiation of antimicrobial therapy. Embolism localizations include: brain (30%), lungs (47%), kidneys (20%), spleen (14%), coronary (8%) and peripheral arteries (5.7%). Most common causative agent was Staphylococcus aureus (25.5%). There were no clinical association between a certain group of antimicrobials and embolic outcome (table). However, effectiveness of the first-line antimicrobial, eradication of pathogen and abscence of infection persistence was associated with lower rate of embolism Conclusion In correspondence to guidelines adequate antimicrobial therapy (eradication of a pathogen and abscence of infection persistence) is associated with lower thromboembolic risk regardless of certain group of antimicrobials. Funding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): RUDN University Strategic Academic Leadership Program.

Thromboprophylaxis in hospitalized COVID-19 patients: the efficacy and safety of the approved hospital protocol.

Introduction: Prothrombotic coagulopathy in COVID-19 has led to a strong recommendation for thromboprophylaxis in all hospitalized patients, although there are large differences in the dosage regimens among hospitals and their outcomes remain uncertain. Objectives: We aimed to determine the incidence of thrombotic events and bleeding in patients with COVID-19 using the approved local thromboprophylaxis protocol. Patients and methods: We adapted a self-developed pharmacological thromboprophylaxis protocol based on clinical and laboratory risk assessment of thrombosis in 350 consecutive patients (median age, 67 years) with confirmed COVID-19, treated in designated wards at a single center in Kraków, Poland from October 10, 2020, to April 30, 2021. We recorded in-hospital venous and arterial thromboembolic events, major or clinically relevant bleeding, and deaths along with other complications related to heparin administration. Results: Thromboprophylaxis with low-molecular-weight heparin was administered in 99.7% of patients, 57 (16%) were treated in the intensive care unit. As many as 92% of patients followed the protocol for more than 85% of hospitalization time. Thromboembolic events occurred in 16 patients (4.4%): venous thromboembolism (n = 4; 1.1%), ischemic stroke (n = 4; 1.1%), and myocardial infarction (n = 8; 2.2%). Hemorrhagic complications were observed in 31 patients (9%), including fatal bleeds (n = 3; 0.9%). The overall mortality was 13.4%. The prophylactic, intermediate, and therapeutic anticoagulation preventive strategies with heparin were not related to any of the outcomes. Conclusions: The thromboprophylaxis protocol approved in our institution was associated with a relatively low risk of thromboembolism and bleeding, which provides additional evidence supporting the adoption of institutional strategies to improve outcomes in hospitalized patients with COVID-19.

Recurrent bleeding and thrombotic events after resumption of oral anticoagulants following gastrointestinal bleeding: Communication from the ISTH SSC Subcommittee on Control of Anticoagulation

BackgroundGastrointestinal bleeding frequently complicates anticoagulant therapy causing treatment discontinuation. Data to guide the decision regarding whether and when to resume anticoagulation based on the risks of thromboembolism and recurrent bleeding are scarce. ObjectivesWe aimed to retrospectively evaluate the incidence of these events after anticoagulant‐related gastrointestinal bleeding and assess their relationship with timing of anticoagulation resumption. MethodsPatients hospitalized because of gastrointestinal bleeding during oral anticoagulation for any indication were eligible. All patients were followed up to 2 years after the index bleeding for recurrent major or clinically relevant non‐major bleeding, venous or arterial thromboembolism, and mortality. ResultsWe included 948 patients hospitalized for gastrointestinal bleeding occurring during treatment with vitamin K antagonists (n = 531) or direct oral anticoagulants (n = 417). In time‐dependent analysis, anticoagulant treatment was associated with a higher risk of recurrent clinically relevant bleeding (hazard ratio [HR] 1.55; 95% confidence interval [CI] 1.08–2.22), but lower risk of thromboembolism (HR 0.34; 95% CI 0.21–0.55), and death (HR 0.50; 95% CI 0.36–0.68). Previous bleeding, index major bleeding, and lower glomerular filtration rate were associated with a higher risk of recurrent bleeding. The incidence of recurrent bleeding increased after anticoagulation restart independently of timing of resumption. ConclusionsAnticoagulant treatment after gastrointestinal bleeding is associated with a lower risk of thromboembolism and death, but higher risk of recurrent bleeding. The latter seemed to be influenced by patient characteristics and less impacted by time of anticoagulation resumption.

Gastrointestinal Endoscopy in Patients Receiving Antithrombotic Therapy

Gastrointestinal endoscopy is used as a diagnostic and therapeutic tool. Patients receiving antithrombotic agents are at higher risk for bleeding in this procedure. Regarding its thromboembolic versus bleeding risk, physicians should consider to adjust antithrombotic therapy in patients undergoing gastrointestinal endoscopy. Some important factors including the urgency of the procedure, bleeding risk from the procedure and antithrombotic itself, and the risk of thromboembolic events during endoscopy if antithrombotic is to be stopped need to be considered wisely. Based on recommendations of ASGE, ESGE, and BSG, endoscopic procedures were divided based on the level of emergency, namely elective and urgent. In elective endoscopy with high risk of bleeding and thromboembolism, antithrombotic therapy is given in the minimum duration required and then discontinued before the procedure. In elective endoscopy with low risk of bleeding and thromboembolism, antithrombotic can be continued as usual. In urgent endoscopy due to gastrointestinal bleeding, all antithrombotic should be discontinued. Antithrombotic can be restarted within 48 hours after the procedure if no bleeding is evident

Left atrial strain measured by 4D Auto LAQ echocardiography is significantly correlated with high risk of thromboembolism in patients with non-valvular atrial fibrillation.

The 4-dimensional automated left atrial quantification (4D Auto LAQ) tool is a new software for analysis of the structure and function of the left atrium (LA). This study aimed to evaluate the relationship between LA strain (LAS) as measured by 4D Auto LAQ echocardiography and thromboembolism risk in patients with non-valvular atrial fibrillation (NVAF). Eight-five patients with NVAF were recruited from the cardiovascular center of our hospital, including 39 patients at high risk and 46 patients at low risk of thromboembolism. The study participants were assessed by routine echocardiography; 4D images were obtained, after which 4D Auto LAQ assessment was performed. In the thromboembolism high-risk group, the rates of impaired LA reservoir strain, LA contraction strain, LA reservoir circumferential strain, LA conduit circumferential strain, and LA contraction circumferential strain were found to be significantly higher than in the low-risk group. However, there was no significant difference in volume at onset of LA contraction or LA ejection fraction (LAEF) between the 2 groups. LA contraction circumferential strain was found to be an independent high risk factor for thromboembolism [odds ratio (OR): 2.52; P=0.008]. LA contraction circumferential strain >-4.5% was the cut-off for differentiating between participants with high and low risk of thromboembolism, with an area under the curve (AUC) of 0.95 (P<0.0001), a sensitivity of 0.872, and a specificity of 0.978. Sequential analysis revealed that LA contraction circumferential strain had a high diagnostic efficacy for stroke, as well as a specified accuracy in the diagnosis of hypertension and diabetes in patients aged ≥65 years old. However, it was not found to be effective in the diagnosis of heart failure and vascular diseases. LAS is a useful index for the dynamic evaluation of LA function in patients with non-valvular AF, with higher sensitivity and accuracy than LA volume. LA contraction circumferential strain is an independent high risk factor for thromboembolism, and LA contraction circumferential strain >-4.5% is a valuable cut-off to guide the use of anticoagulant therapy in patients with non-valvular AF.

Tissue Factor-Related Biomarkers and Prediction of Cancer-Associated VTE: Correlative Analyses of the Phacs Trial

Background: Cancer patients at high or low risk for venous thromboembolism (VTE) can be predicted by a validated score (Khorana et al, Blood 2008) but the mechanisms underlying this association are not fully understood. We evaluated the association of VTE-related biomarkers with clinical outcomes in patients enrolled in a randomized trial of outpatient prophylaxis in high-risk patients and a control population of low-risk patients.Methods: Cancer patients with risk score ≥3 starting systemic therapy were randomized to dalteparin or observation for 12 weeks; a low-risk group of controls (score=0) was concurrently enrolled. Analyses for tissue factor (TF) using microparticle procoagulant activity, TF pathway inhibitor (TFPI) using ELISA, D-dimer and factor VIIA were conducted on specimens obtained at enrollment and 4-weekly on study as well as at enrollment in control patients.Results: The study populations comprised 89 randomized high-risk patients and 101 low-risk patients. TF MP-PCA levels were more likely to be detectable in high-risk patients (51.7% vs 32.7% of low-risk patients, p=0.01) and levels were elevated at time of enrollment in high-risk compared to low-risk patients (mean 0.67 vs 0.19 pg/mL in low-risk, p=0.002; median 0.03 vs 0 pg/mL, p=0.001). TF levels were particularly high in the subgroup of high-risk patients with pancreatic cancer (N=38, 57.9% detectable, mean 0.87 pg/mL, median 0.13 pg/mL). D-dimer levels were also significantly elevated in high-risk patients (median 1.23 vs 0.92 mg/mL, p=0.006). Levels of F1.2 and FVIIa were not significantly different between the high- and low-risk groups. Patients randomized to dalteparin had a significant decline in median D-dimer levels (median 1.22 mg/mL for timepoint 1 versus 0.7 mg/mL for timepoint 4, p =0.018) whereas there was no significant change over time for patients randomized to observation (median 1.30 vs 1.33 mg/mL, p=0.43). F1.2 levels also declined over time for patients randomized to dalteparin (median 77.17 to 32.37, p=0.01) but not for patients randomized to observation (median 59.06 to 61.63, p=0.99). In multivariate time-dependent Cox analysis in high-risk patients, VTE was associated with both doubling of TF (HR 1.42 95% CI 1.17-1.84, p=0.0003) and doubling of TFPI (HR 3.21, 95% CI 1.14-9.50, p=0.02).Conclusions: Cancer patients at high-risk for VTE are more likely to have increased TF levels at baseline; increased levels of both TF and TFPI were associated with future VTE. Further investigations into the role of TF and TFPI in cancer-associated thrombosis and their roles as predictive biomarkers are warranted. DisclosuresKhorana:Pfizer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Amgen: Consultancy, Research Funding; Leo: Consultancy, Honoraria, Research Funding. Francis:Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Research Funding.

Application of the Caprini Risk Assessment Model for the Assessment of Risk Factors for Postoperative Venous Thromboembolism in the Surgery Department of Anosiala University Hospital

The purpose of this research is to ascertain the prevalence of postoperative venous thromboembolism in the Department of Surgery at Anosiala University Hospital and to identify risk factors for developing postoperative venous thromboembolism using the Caprini Risk Assessment Model. From December 2017 to October 2019, this was a 22-month prospective cohort research conducted at Anosiala University Hospital. It included all adult patients over the age of 18 who were operated on in an emergency or on a planned basis by the Department of Surgery. This research included 662 participants. Within 30 days after surgery, the risk of venous thromboembolism was 0.3 percent. According to the overall Caprini score, 25.2 percent of patients were classified as having a low risk of venous thromboembolism, 25.2 percent as having a moderate risk, 29.5 percent as having a high risk, and 20.1 percent as having the greatest risk. Patients in the highest risk category (scoring 5) had a substantially increased chance of having venous thromboembolism after surgery (p = 0.0007). Only major open surgery was related with a statistically significant increase in postoperative venous thromboembolism (p = 0.028). Age 75 years, elective arthroplasty, and hip, pelvic, or leg fractures were not linked with postoperative venous thromboembolism statistically significantly (p&gt; 0.05). Our findings indicate that the Caprini risk assessment model might be used successfully to avoid postoperative venous thromboembolism in surgical patients in Madagascar, since patients in the highest risk category had a considerably increased chance of developing postoperative venous thromboembolism.

Low bleeding and thromboembolic risk with continued dabigatran during cardiovascular interventions: the GLORIA-AF study

BackgroundProspective data on nonvitamin-K-antagonist oral anticoagulant (NOAC) management during cardiovascular interventions are limited. We therefore evaluated the safety and effectiveness of uninterrupted dabigatran therapy as well as dabigatran management during atrial fibrillation (AF)-cardioversions, AF-ablations, pacemaker implantations and coronary angiography and/or stenting procedures. MethodGLORIA-AF is an international registry programme involving patients with newly diagnosed AF. Dabigatran users were followed for ≤2 years. The primary outcome was occurrence of stroke/systemic embolism and major bleeding ≤8 weeks after a cardiovascular intervention during uninterrupted dabigatran therapy. ResultsDuring the 2-year follow-up, 599 cardiovascular interventions were identified in 479 eligible patients. 412/599 (69%) interventions were performed with uninterrupted dabigatran therapy: 299/354 (84%) AF-cardioversions, 38/89 (43%) AF-ablations, 25/58 (43%) pacemaker implantations, and 50/98 (51%) coronary angiography and/or stenting procedures. During an average follow-up of 8.4 weeks after intervention, one major bleed and one systemic embolic event occurred (risk 0.25% for both outcomes; 95% confidence interval, 0.01%-1.36%). ConclusionsMore than two thirds of the interventions were performed with uninterrupted dabigatran therapy, of which most were AF-cardioversions. Uninterrupted dabigatran therapy was associated with low major bleeding and stroke/systemic embolism risk, supporting the favourable safety and effectiveness profile of dabigatran in clinical practice-based settings.

Screening for venous thromboembolism in patients with COVID-19

Pulmonary thromboembolism and deep venous thrombosis occur frequently in hospitalised patients with COVID-19, the prevalence increases on the intensive care unit (ICU) and is very high in patients on extracorporeal membrane oxygenation (ECMO). We undertook a literature review to assess the usefulness of screening for peripheral venous thrombosis or pulmonary thrombosis in patients admitted with COVID-19. Outside of the ICU setting, D-dimer elevation on presentation or marked increase from baseline should alert the need for doppler ultrasound scan of the lower limbs. In the ICU setting, consideration should be given to routine screening with doppler ultrasound, given the high prevalence of thrombosis in this cohort despite standard anticoagulant thromboprophylaxis. However, absence of lower limb thrombosis on ultrasound does not exclude pulmonary venous thrombosis. Screening with CT pulmonary angiography (CTPA) is not justified in patients on the general wards, unless there are clinical features and/or marked elevations in markers of COVID-19-associated coagulopathy. However, the risk of pulmonary embolism or pulmonary thrombosis in ICU patients is very high, especially in patients on ECMO, where studies that employed routine screening for thrombosis with CT scanning have uncovered up to 100% incidence of pulmonary thrombosis despite standard anticoagulant thromboprophylaxis. Therefore, in patients at low bleeding risk and high clinical suspicion of venous thromboembolism, therapeutic anticoagulation should be considered even before screening, Our review highlights the need for increased vigilance for VTE, with a low threshold for doppler ultrasound and CTPA in high risk in-patient cohorts, where clinical features and D-dimer levels may not accurately reflect the occurrence of pulmonary thromboembolism.

Overuse of Primary Thromboprophylaxis in Medical Inpatients at Low Risk of Venous Thromboembolism.

Overuse of Primary Thromboprophylaxis in Medical Inpatients at Low Risk of Venous Thromboembolism.

Risk of Venous Thromboembolism Following Rhinoplasty.

Although prior studies have identified a low risk of venous thromboembolism (VTE) in rhinoplasty, these studies are limited by small samples and associated risk factors remain unknown. The aim of this study was to discern the incidence of VTE following rhinoplasty in a large patient population through analysis of a nationwide insurance claims database. This study involved a population-based retrospective analysis of insurance claims made by patients who underwent rhinoplasty between 2007 and 2016. Established risk factors for VTE, demographic data, procedural details, and absolute incidence of VTE were collected. We identified a total of 55,287 patients who underwent rhinoplasty from 2007 to 2016. Mean age [standard error of the mean] was 38.74 [0.06] years (range, 18-74 years), and 54% were female. The overall incidence of VTE was 111, of which 70 were DVT and 41 were PE. From multivariate regression analysis, previous VTE (odds ratio [OR], 52.8; 95% confidence interval [CI], 35.2-78.6; P < 0.0001), peripherally inserted central catheter (PICC)/central line placement (OR, 19.6; 95% CI, 9.8-153; P < 0.05), rib graft (OR, 4.6; 95% CI, 2.3-8.5; P < 0.0001), age 41 to 60 years (OR, 2.65; 95% CI, 1.7-4.3; P < 0.01), inflammatory bowel disease (IBD) (OR, 2.6; 95% CI, 1.0-5.5; P < 0.05), and age 61 to 74 years (OR, 2.4; 95% CI, 1.2-4.8; P < 0.05) were associated with an increased risk of VTE. We demonstrate a low overall incidence of VTE in rhinoplasty patients. Previous VTE, PICC/central line, advancing age, IBD, and intraoperative rib graft harvest were most strongly associated with VTE in this population cohort.

Periprocedural edoxaban interruption is associated with low bleeding and thromboembolic risk: the Italian data of the EMIT-AF/VTE study

So far, the only available data for edoxaban periprocedural management come from the ENGAGE AF-TIMI 48 trial. The recently published EMIT-AF/VTE study showed low periprocedural bleeding and thromboembolic risks of edoxaban in a real-world setting in patients undergoing any diagnostic or therapeutic procedures. The aim of this study was to compare descriptively Italian and European data with regard to patient characteristics and outcomes in the EMIT-AF/VTE study. A total of 1155 patients treated with edoxaban for stroke prevention in non-valvular atrial fibrillation and with venous thromboembolism, and undergoing a wide range of diagnostic and therapeutic procedures were enrolled in 326 centers across Europe. Of these patients, 246 were from 43 Italian centers. The periprocedural interruption of edoxaban was at the physician's discretion. All the procedures were classified into minor, low, and high bleeding procedural risk according to the European Heart Rhythm Association (EHRA) definition. The primary outcome was the incidence of major bleeding. Secondary outcomes included thromboembolic events. Patients were older in Italy in comparison with the rest of Europe with a mean age of 74.2 vs 71.3 years. Also, the rate of comorbidities was higher in Italy (e.g. diagnosed cancer and vascular disease) than in Europe. In Italy, there was a higher rate of high bleeding risk procedures than in other European countries (37.8% vs 20.6%) and a more homogeneous distribution of all types of procedures (while in Europe 44.1% were vascular access and transcatheter diagnostic procedures and interventions). In Italy, a higher proportion of patients did not interrupt edoxaban (32.9% vs 29% in Europe). The number of major bleeding events (2 in Italy, 3 in Europe) as well as of thromboembolic events (4 in Italy, 3 in Europe) was overall low. In the EMIT-AF/VTE study, the number of bleeding and thromboembolic events in patients treated with edoxaban undergoing elective or unplanned procedures was low either in Italy or in the rest of Europe. The safety and efficacy of edoxaban was confirmed in Italy even if patients were older, presented more frequently with cancer, and there was a higher rate of high bleeding risk procedures by EHRA definition.