Exclusion of venous thromboembolism: evaluation of D-Dimer PLUS for the quantitative determination of D-dimer.
ABSTRACT The objective of this study was to evaluate if D-Dimer PLUS (Dade Behring, USA), a rapid fully automated assay, could be used as an initial screening test in the diagnosis of venous thromboembolism (VTE). Samples from 274 consecutive symptomatic patients with suspected pulmonary embolism (n=229; 79% outpatients, 21% inpatients), deep venous thrombosis (n=37; 84% outpatients, 16% inpatients) or suspected for both complications (n=8) were tested with this D-dimer assay with a Sysmex CA-1500 Coagulation Analyzer. Clinical probability for pulmonary embolism (PE) or deep venous thrombosis (DVT) was staged according to a pretest risk score proposed by Wells. Final diagnosis of PE and/or DVT was established by spiral-computed tomography of the pulmonary arteries or compression ultrasonography, respectively. PE was diagnosed in 13.5% of the patients, whereas DVT was confirmed in 17.7% of the patients. The optimal cut-off value for exclusion of venous thromboembolism was 130 mug/l, and sensitivity, specificity and negative predictive value (NPV) were 95.0% (95% CI: 92.4-97.6), 30.4% (95% CI: 25.0-35.8) and 97.2% (95% CI: 95.2-99.2), respectively. In fact, two patient with PE were missed using D-Dimer PLUS; both cases were outpatients. In conclusion, this assay appears to be safe when implemented in an algorithm based on clinical assessment, D-dimer concentration, and radiological diagnostic techniques to stratify the risk for PE or DVT. However, higher sensitivities and negative predictive values were claimed in the scarce published reports for the D-Dimer PLUS assay than found in this study.
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ABSTRACT: Wells score has been validated for estimation of pretest probability in patients with suspected deep vein thrombosis (DVT). In clinical practice, many clinicians prefer to use empirical estimation rather than Wells score. However, which method is better to increase the accuracy of clinical evaluation is not well understood. Our present study compared empirical estimation of pretest probability with the Wells score to investigate the efficiency of empirical estimation in the diagnostic process of DVT. Five hundred and fifty-five patients were enrolled in this study. One hundred and fifty patients were assigned to examine the interobserver agreement for Wells score between emergency and vascular clinicians. The other 405 patients were assigned to evaluate the pretest probability of DVT on the basis of the empirical estimation and Wells score, respectively, and plasma D-dimer levels were then determined in the low-risk patients. All patients underwent venous duplex scans and had a 45-day follow up. Weighted Cohen's κ value for interobserver agreement between emergency and vascular clinicians of the Wells score was 0.836. Compared with Wells score evaluation, empirical assessment increased the sensitivity, specificity, Youden's index, positive likelihood ratio, and positive and negative predictive values, but decreased negative likelihood ratio. In addition, the appropriate D-dimer cutoff value based on Wells score was 175 μg/l and 108 patients were excluded. Empirical assessment increased the appropriate D-dimer cutoff point to 225 μg/l and 162 patients were ruled out. Our findings indicated that empirical estimation not only improves D-dimer assay efficiency for exclusion of DVT but also increases clinical judgement accuracy in the diagnosis of DVT.Blood coagulation & fibrinolysis: an international journal in haemostasis and thrombosis 10/2012; · 1.25 Impact Factor
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ABSTRACT: To develop a convenient screening method that can predict perioperative venous thromboembolism (VTE) and identify patients at risk of fatal perioperative pulmonary embolism (PE). Patients hospitalized for gynecological abdominal surgery (n = 183) underwent hematology tests and multidetector computed tomography (MDCT) to detect VTE. All statistical analyses were carried out using the SPSS software program (PASWV19.0J). THE FOLLOWING RISK FACTORS FOR VTE WERE IDENTIFIED BY UNIVARIATE ANALYSIS: plasmin-alpha2-plasmin inhibitor complex (PIC), thrombin-antithrombin III complex (TAT), and prolonged immobility (all p<0.001); age, neoadjuvant chemotherapy (NAC), malignancy, hypertension, past history of VTE, and hormone therapy (all p<0.01); and hemoglobin, transverse tumor diameter, ovarian disease, and menopause (all p<0.05). Multivariate analysis using these factors revealed that PIC, age, and transverse tumor diameter were significant independent determinants of the risk of VTE. We then calculated the incidence rate of perioperative VTE using PIC and transverse tumor diameter in patient groups stratified by age. In patients aged≦40 years, PIC ≧1.3 µg/mL and a transverse tumor diameter ≧10 cm identified the high-risk group for VTE with an accuracy of 93.6%. For patients in their 50 s, PIC ≧1.3 µg/mL identified a high risk of VTE with an accuracy of 78.2%. In patients aged ≧60 years, a transverse tumor diameter ≧15 cm (irrespective of PIC) or PIC ≧1.3 µg/mL identified the high-risk group with an accuracy of 82.4%. We propose new screening criteria for VTE risk that are based on PIC, transverse tumor diameter, and age. Our findings suggest the usefulness of these criteria for predicting the risk of perioperative VTE and for identifying patients with a high risk of fatal perioperative PE.PLoS ONE 01/2014; 9(2):e89206. · 3.73 Impact Factor
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ABSTRACT: Pulmonary embolism (PE) is diagnosed with increasing frequency nowadays due to advances in the diagnostic methods and the increased awareness of the disease. There is a tendency to use non invasive diagnostic methods for all diseases. D-dimer is a fibrin degradation product. We aimed to detect the relationship between disease severity and the D-dimer levels measured with two different methods. We compared D-dimer levels in cases of massive vs. non-massive PE. A total of 89 patients who were diagnosed between 2006 and 2008 were included in the study. Group 1 included patients whose D-dimer levels were measured with the immunoturbidimetric polyclonal antibody method (D-dimerPLUS®), while Group 2 patients made use of the immunoturbidimetric monoclonal antibody method (InnovanceD-DIMER®). In each group, the D-dimer levels of those with massive and non-massive PE were compared, using the Mann Whitney U test. The mean age of Group 1 (25 F/26 M) was 56.0 ± 17.9 years, and that of Group 2 (22 F/16 M) was 52.9 ± 17.9 years. There was no statistical difference in gender and mean age between the two groups (p > 0.05). In Group 1, the mean D-dimer level of massive cases (n = 7) was 1444.9 ± 657.9 μg/L and that of nonmassive PE (n = 34) was 1304.7 ± 350.5 μg/L (p > 0.05). In Group 2, the mean D-dimer level of massive cases (n = 6) was 9.7 ± 2.2 mg/L and that of non-massive PE (n = 32) was 5.9 ± 1.3 mg/L (p < 0.05). The mean D-dimer levels of massive cases as measured with the immunoturbidimetric monoclonal antibody method were significantly higher. Pulmonary embolism patients whose D-dimer levels are higher (especially higher than 6.6 mg/L) should be considered as possibly having massive embolism. Diagnostic procedures and management can be planned according to this finding.Multidisciplinary respiratory medicine 01/2010; 5(3):168-72. · 0.05 Impact Factor