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Background: The rate or persistent perfusion defects after acute pulmonary embolism (PE) varies from 30 % to 50 % after 6 months of treatment. Moreover, PE patients may suffer from persistent dyspnea and decreased quality of life (QoL). However, it is unknown whether persistent dyspnea results from perfusion defects and if either may affect QoL on the very long term. This study assessed the rate of persistent dyspnea and perfusion defects after PE and their association with long-term QoL. Methods: This observational study included consecutive patients with acute PE. At 6 months, a perfusion scan (Q-scan) was performed, patient-reported dyspnea was assessed, and of both the cumulative incidence rates with 95 % confidence intervals (CI) were calculated. After five years, disease-specific QoL was assessed with the PEmb-QoL questionnaire. Differences in PEmb-QoL between patients with and without dyspnea and between patients with and without persisting perfusion defects were calculated with the Mann-Whitney U test. Results: In 179 PE patients, the rate of persistent dyspnea was 24 % (95 % CI:17–30 %). Of these patients, 57 % (95 % CI:40–72 %) had persistent perfusion defects at 6 months which was significantly related to the persistent dyspnea (OR: 2.3 (95 % CI:1.1–4.9); p = 0.027). Perfusion defects did not result a difference in PEmb-QoL at five years. However, patients with persistent dyspnea had significantly worse PEmb-QoL after 5 years (38 % [18–55 %] versus 11 % [4.2–25 %]; p < 0.001). Conclusion: Persistent dyspnea after acute PE was associated with a lower QoL on the long term, however no relation was found between persistent perfusion defects and a lower QoL.

Background The safety and efficacy of edoxaban and dalteparin is unclear for several cancer groups. Methods We evaluated the occurrence of the primary outcome in large cancer groups. The primary outcome was the composite of recurrent VTE or major bleeding over 12 months. Results In patients with gastrointestinal cancer, the primary outcome occurred in 19.4% patients given edoxaban and in 15.0% given dalteparin (risk difference [RD], 4.4%; 95%-CI, −4.1% to 12.8%). The corresponding rates for edoxaban and dalteparin were 10.4% and 10.7% for lung cancer (RD, −0.3%; 95%-CI, −10.0% to 9.5%), 13.6% and 12.5% for urogenital cancer (RD, 1.1; 95%-CI, −10.1–12.4), 3.1% and 11.7% for breast cancer (RD, −8.6; 95%-CI, −19.3–2.2), 8.9% and 10.9% for hematological malignancies (RD, −2.0; 95%-CI, −13.1–9.1), and 10.4% and 17.4% for gynecological cancer (RD, −7.0; 95%-CI, −19.8–5.7). In the subgroup of gastrointestinal cancer, edoxaban was associated with a 3.5% lower absolute risk of recurrent VTE and a 7.9% higher risk of major bleeding. Conclusion Edoxaban has a similar risk-benefit ratio to dalteparin in most cancer groups. In those with gastrointestinal cancer, the lower risk of recurrent VTE and the advantages of oral therapy need to be balanced against the increased risk of major bleeding.

Background Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. Methods In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support–free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of −1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. Results The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support–free days was 1 (interquartile range, −1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, −1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Venous thromboembolism (VTE) may be the first manifestation of cancer. We aimed at evaluating the performance ofThis was a pre-specified analysis of a systematic review and individual patient data meta-analysis including prospective studies assessing cancer screening in patients with unprovoked VTE. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FDG PET/CT were calculated based on cancer diagnosis during a 1-year follow-up period.Four studies were identified as using FDG PET/CT as part of their extensive screening strategy. Out of the 332 patients who underwent FDG PET/CT, the scan was interpreted as positive in 67 (20.2%), as equivocal in 27 (8.1%), and as negative in 238 (71.7%). Seventeen (5.1%) patients were diagnosed with cancer at inclusion or during the 12-month follow up period. All cancers were diagnosed at initial screening. Pooled sensitivity, specificity, NPV, and PPV were 87.3% (95% CI, 55.3 to 97.4), 70.2% (95% CI, 48.2 to 85.6), 98.9% (95% CI, 94.3 to 99.7), and 17.9% (95% CI, 8.5 to 33.6), respectively.FDG PET/CT appears to have satisfactory accuracy indices for cancer diagnosis in patients with unprovoked VTE. In particular, it exhibits a very high negative predictive value and could be used to rule out the presence of an underlying occult malignancy in this setting.

The authors regret that panel E of Fig. 1 was missing, showing the cumulative incidence of the primary outcome in hematologic cancer. The authors would like to apologise for any inconvenience caused.

Introduction: The procoagulant activity of extracellular vesicles (EV) exposing tissue factor (TF) is a promising biomarker for venous thromboembolism (VTE) in cancer patients. We evaluated an in-house EV-TF activity assay (the fibrin generation test) for the prediction of cancer-associated VTE. We also compared the results with the fibrin generation tests to an EV-TF-dependent factor Xa generation assay in samples from pancreatic cancer patients.Materials and methods: Data collected in a multinational, prospective cohort study were used. Patients with various types of advanced cancer were enrolled if chemotherapy was scheduled or started in the previous 3 months. Patients were followed for 6 months for the occurrence of VTE. The fibrin generation test was performed at baseline to measure EV-TF procoagulant activity.Results: The fibrin generation test was performed in 648 patients with advanced cancer. The mean age was 62 years; 58% had distant metastasis. Forty patients (6.1%) developed VTE. Overall, a high fibrin generation test result was associated with a two-fold increased risk for VTE (HR 2.0; 95%-CI, 1.1-3.6). The association was stronger in patients with pancreatic cancer (HR 4.1; 95%-CI, 0.91-19) than in those with other tumor types (HR 1.5; 95%-CI, 0.72-3.1). Correlation between the FGT and the TF-dependent factor Xa generation assay in patients with pancreatic cancer was poor (Spearman's R = 0.35).Conclusion: This study shows that a high EV-TF procoagulant activity as measured by the fibrin generation test is associated with an increased risk of VTE in cancer patients, in particular in those with pancreatic cancer. Future studies should aim to further improve the feasibility and accuracy of EV-TF activity assays.

Background The Ottawa score was previously developed to predict recurrent venous thromboembolism (VTE) in cancer patients with VTE. The performance of this score in patients with incidental VTE is currently unclear. Aim To evaluate the performance of the Ottawa risk score in cancer patients with incidental pulmonary embolism included in an international, prospective, observational cohort study. Methods The score was used to classify patients as high (≥1), intermediate (0), or low risk (≤−1). The discriminative performance of the score was estimated by calculating the cumulative incidence of recurrent VTE for all groups, the time-dependent c-statistic, and the sub-distribution hazard ratio (SHR), using a competing risk approach. Results Of the 691 patients for which the Ottawa score could be calculated, 25 (3.6%) had recurrent VTE during 6-month follow-up and 38 (5.5%) during 12-month follow-up. The c-statistics of the continuous score at 6 and 12 months were 0.45 (95% CI, 0.36–0.54) and 0.51 (95% CI, 0.46–0.59), respectively. The 6-month cumulative incidences of recurrent VTE for those at low, intermediate, and high risk were 3.9% (95% CI, 1.5–8.4), 3.6% (95% CI, 1.9–6.2), and 3.6% (95% CI, 1.8–6.5), respectively. A sensitivity analysis restricted to the on-treatment period yielded similar results. None of the Ottawa risk score items were significantly associated with recurrent VTE. Conclusion In cancer patients with incidental pulmonary embolism, the Ottawa risk score has a poor predictive value for recurrent VTE, which does not support the use of the score in this patient population.

Background The incidence of upper extremity deep vein thrombosis (UEDVT) is increasing. Information on the clinical course of UEDVT is scarce, especially in cancer patients. Aim To summarize the clinical evidence regarding long-term clinical outcomes of UEDVT, in terms of recurrent venous thromboembolism (VTE), mortality, and anticoagulant-related bleeding, in patients with or without concomitant cancer. Methods A systematic search of the literature was conducted in MEDLINE, EMBASE and BIOSIS Previews. Incidence rates for all outcome variables were calculated. Results In total, 45 studies comprising 4580 patients were included. No randomized controlled trials were identified. In most studies, patients were treated solely with anticoagulants. Among the prospective studies, the incidences of recurrent VTE and bleeding complications averaged 5.1% and 3.1% respectively, during 3 to 59 months of follow-up. In the retrospective studies these figures were 9.8% and 6.7% respectively. Among the prospective studies, the mortality rate was 24% after one year. In the retrospective studies this rate was 35%. Cancer patients were found to have a 2- to 3-fold higher risk of recurrent VTE, an 8-fold increased risk of mortality, and a 4-fold increased risk of bleeding during anticoagulant therapy, compared to non-cancer patients. Conclusions Studies were very heterogeneous in terms of study design, study populations and treatment approaches. Follow-up durations varied greatly, hampering combined analyses of average incidence rates. There is a need for large prospective studies to provide information on the best management of this disease, especially in high risk groups such as those with cancer.

Introduction In a management study, a diagnostic algorithm consisting of a clinical decision rule, D-dimer, and ultrasonography was shown to safely exclude upper extremity deep vein thrombosis (UEDVT). Efficiency may be lower in high-risk subgroups: those with a central venous catheter or pacemaker, inpatients, cancer, and elderly patients. Methods Data of 406 patients with suspected UEDVT enrolled in a prospective management study were used for the present analysis. The aim was to evaluate the efficiency of the algorithm in subgroups, defined as the proportion of patients in whom imaging could be safely withheld based on the combination of a decision rule result indicating “UEDVT unlikely” and a normal D-dimer result. Results The strategy excluded UEDVT in 87 of 406 patients (21%); ultrasonography was withheld in these patients and none developed UEDVT during 3 months of follow-up. In contrast, ultrasonography could be withheld in only 4 of 92 patients with a catheter or pacemaker (4.3%; 95% CI: 1.7% to 11%) and in 4 of 83 inpatients (4.8%; 95% CI: 1.9% to 12%). The efficiency was 11% in patients with cancer and 13% in those older than 75 years. Conclusion Although the combination of a decision rule and D-dimer testing is safe in excluding UEDVT in the overall population of patients with suspected UEDVT, its efficiency appears limited in some subgroups, in particular those with a central venous catheter or pacemaker, and inpatients.

Cancer patients frequently present with suspected pulmonary embolism (PE). The D-dimer (DD) test is less useful in excluding PE in cancer patients due to the lower specificity. In the general population, the age-adjusted cutoff for DD combined with a clinical decision rule (CDR) improved specificity in the diagnosis of PE. To evaluate the safety and efficacy of the age-adjusted cutoff (defined as age∗10μg/L in patients >50years) combined with a CDR for the exclusion of PE in cancer patients. We conducted a prospective study to evaluate the age-adjusted cutoff in patients with suspected PE. Here we report a post-hoc analysis on the performance of the age-adjusted cutoff in patients with and without cancer. The primary outcome was the rate of venous thromboembolic events (VTE) during three-month follow-up. Of 3324 patients with suspected PE, 429 (12.9%) patients had cancer. The prevalence of PE was 25.2% in cancer patients and 18% in patients without cancer (p

Introduction Anticoagulant treatment in patients with liver cirrhosis is challenging. The aim of this systematic review was to evaluate clinical outcomes of direct oral anticoagulant (DOAC) therapy in cirrhosis patients. Materials and methods A systematic search was performed in MEDLINE, Embase, and conference proceedings up to November 7th, 2017, for studies that evaluated the efficacy and safety of DOACs in cirrhosis patients with venous thromboembolism (VTE), splanchnic vein thrombosis (SVT), or atrial fibrillation (AF). Two authors independently screened titles, abstracts, and full-text articles, and assessed risk of bias. A meta-analysis could not be performed due to heterogeneity of the included studies. Results Of the 2927 articles assessed, five retrospective cohort studies were included (n = 239, including 20 patients overlap). All studies had fair methodological quality. Two studies evaluated DOAC treatment only, and three also evaluated vitamin K antagonists (VKAs) or low-molecular-weight heparins (LMWHs). Recurrent VTE (DOAC n = 12, LMWH/VKA n = 8) or ischemic stroke (DOAC n = 37, LMWH/VKA n = 9) occurred in none of the patients. Progression of VTE was 8% with DOACs (n = 12) and 13% with VKAs and LWWH (n = 8). Recurrent SVT occurred in 0 to 4% with DOACs (n = 31). Progression of SVT was 0 to 5% with DOACs (n = 24) and 0 to 47% with VKAs and LMWH (n = 33). Major bleeding risk ranged from 4 to 15% with DOACs (n = 172) and from 7 to 28% with VKAs and LMWH (n = 67). All-cause mortality risk was 6% with DOACs (n = 36). Conclusions There is paucity of data on the efficacy and safety of DOACs in patients with cirrhosis. This analysis suggests that DOACs may be effective and safe for treatment of VTE, SVT, and AF in these patients.

Upper extremity deep vein thrombosis (UEDVT) accounts for 4% to 10% of all cases of deep vein thrombosis. UEDVT may present with localized pain, erythema, and swelling of the arm, but may also be detected incidentally by diagnostic imaging tests performed for other reasons. Prompt and accurate diagnosis is crucial to prevent pulmonary embolism and long-term complications as the post-thrombotic syndrome of the arm. Unlike the diagnostic management of deep vein thrombosis (DVT) of the lower extremities, which is well established, the work-up of patients with clinically suspected UEDVT remains uncertain with limited evidence from studies of small size and poor methodological quality. Currently, only one prospective study evaluated the use of an algorithm, similar to the one used for DVT of the lower extremities, for the diagnostic workup of clinically suspected UEDVT. The algorithm combined clinical probability assessment, D-dimer testing and ultrasonography and appeared to safely and effectively exclude UEDVT. However, before recommending its use in routine clinical practice, external validation of this strategy and improvements of the efficiency are needed, especially in high-risk subgroups in whom the performance of the algorithm appeared to be suboptimal, such as hospitalized or cancer patients. In this review, we critically assess the accuracy and efficacy of current diagnostic tools and provide clinical guidance for the diagnostic management of clinically suspected UEDVT. (C) 2017 Elsevier Ltd. All rights reserved

Patients with unprovoked venous thromboembolism (VTE) should receive anticoagulant treatment for at least 3 to 6months. Thereafter, the decision to extend treatment indefinitely for secondary prevention of recurrent events is based on a personalized assessment of the risks of recurrent VTE and anticoagulant-related bleeding. Whereas there are clinical factors that identify patients at higher risk of recurrent VTE, factors to aid the prediction of major bleeding events during anticoagulant therapy have received much less attention. It is now clear that establishing an accurate estimate of the risk of major bleeding is required in treatment decision making. Several studies aimed at deriving new, or validating existing, clinical prediction scores for major bleeding in patients with VTE have been published. The aim of this review is to provide an overview of the available clinical prediction scores, highlighting the methodological shortcomings with their derivation and validation, summarize their performance, and provide considerations for bleeding risk assessment in clinical practice.