scholarly journals Comparison of Diagnostic Accuracies in Outpatients and Hospitalized Patients of D-Dimer Testing for the Evaluation of Suspected Pulmonary Embolism

2003 ◽  
Vol 49 (9) ◽  
pp. 1483-1490 ◽  
Author(s):  
John E Schrecengost ◽  
Robin D LeGallo ◽  
James C Boyd ◽  
Karel G M Moons ◽  
Steven L Gonias ◽  
...  

Abstract Background: The ability of various D-dimer assays to exclude the diagnosis of thromboembolic diseases is controversial. We examined the diagnostic accuracy of two D-dimer methods in hospitalized patients and outpatients. Methods: We studied consecutive patients for whom D-dimer testing was ordered for investigation of suspected pulmonary embolism. We measured D-dimer by an ELISA (VIDAS D-dimer) and an enhanced microlatex immunoassay method (Diagnostica Stago STA Liatest D-di). Patient diagnoses were based on imaging studies or, when these were not performed, on follow-up by review of medical records 3 months later. Results: We examined 233 hospitalized patients and 234 outpatients with a mean age of 58 years (range, 1–92 years) and a female-to-male ratio of 1.4 to 1. Thromboembolism was present in 8% of outpatients and 12% of hospitalized patients. In outpatients, the negative predictive values were 98% [95% confidence interval (CI), 93–100%] and 99% (94–100%) for the microlatex and ELISA methods, respectively, at the recommended cutoffs. Areas under the ROC curves were similar for the two methods [0.77 (95% CI, 0.67–0.87) and 0.81 (0.73–0.89), respectively]. By contrast, in hospitalized patients, the confidence intervals for the areas under the ROC curves included 0.5 [0.60 (95% CI, 0.50–0.71) and 0.56 (0.44–0.67)]. Conclusions: For hospitalized patients, in contrast to outpatients, the diagnostic accuracy of D-dimer testing for pulmonary embolism is poor in a tertiary care setting, presumably reflecting thrombosis and comorbidities, other than pulmonary embolism, that increase the D-dimer concentrations in these patients. The patient population studied appears more important than assay method in studies of the diagnostic accuracy of D-dimer testing.

1992 ◽  
Vol 67 (04) ◽  
pp. 408-412 ◽  
Author(s):  
Christine Demers ◽  
Jeffrey S Ginsberg ◽  
Marilyn Johnston ◽  
Patrick Brill-Edwards ◽  
Akbar Panju

SummaryOne hundred and fifty-six consecutive patients with clinically suspected pulmonary embolism (PE) had blood drawn to measure levels of D-dimer and thrombin-antithrombin (TAT) complexes and underwent ventilation/perfusion (V/Q) lung scanning and bilateral impedance plethysmography (IPG); pulmonary angiography was performed in 10 patients. Patients were classified as: PE-positive (positive pulmonary angiography or high probability lung scan or non-high probability lung scan and abnormal IPG) or, PE-negative (normal lung scan or normal pulmonary angiography) or PE-unlikely (non-high probability lung scan and normal serial IPG and absence of venous thromboembolism in follow-up). Thirty patients were classified as PE-positive, 64 as PE-negative and 62 patients as PE-unlikely. PE-positive patients were treated with anticoagulants, whereas PE-negative and PE-unlikely patients were not. PE-unlikely patients were followed for 3 months with repeat IPG and clinical evaluation for the occurrence of venous thromboembolism. The sensitivities, specificities, positive predictive values and negative predictive values of the D-dimer and TAT complex assays were calculated for patients classified as PE-positive and PE-negative. In addition, the prevalences of normal D-dimer and TAT complex assays were calculated for PE-unlikely patients.Cutoffs of 300 ng/ml for D-dimer and 3.5 μg/ml for TAT complexes provided sensitivities of 96% for both assays, negative predictive values of 97% for D-dimer and 96% for TAT complexes and specificities of 52% for D-dimer and 51% for TAT complexes. The specificities of the assays were higher in patients without comorbid conditions and in outpatients. Among PE-unlikely patients, 14 had normal D-dimer levels and 5 had normal levels of TAT complexes. None of these patients developed venous thromboembolism in follow-up.Our study indicates that: 1) PE is highly unlikely in patients who have D-dimer levels of less than 300 ng/ml and/or levels of TAT complexes below 3.5 μg/ml, and 2), because of their relatively low positive predictive values, further investigation is required if levels of D-dimer and/or TAT complexes are above these cutoffs. These results should be confirmed in future clinical management trials.


2021 ◽  
Vol 5 (8) ◽  
pp. 2237-2244
Author(s):  
Parth Patel ◽  
Payal Patel ◽  
Meha Bhatt ◽  
Cody Braun ◽  
Housne Begum ◽  
...  

Abstract Prompt evaluation and therapeutic intervention of suspected pulmonary embolism (PE) are of paramount importance for improvement in outcomes. We systematically reviewed outcomes in patients with suspected PE, including mortality, incidence of recurrent PE, major bleeding, intracranial hemorrhage, and postthrombotic sequelae. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase for eligible studies, reference lists of relevant reviews, registered trials, and relevant conference proceedings. We included 22 studies with 15 865 patients. Among patients who were diagnosed with PE and discharged with anticoagulation, 3-month follow-up revealed that all-cause mortality was 5.69% (91/1599; 95% confidence interval [CI], 4.56-6.83), mortality from PE was 1.19% (19/1597; 95% CI, 0.66-1.72), recurrent venous thromboembolism (VTE) occurred in 1.38% (22/1597; 95% CI: 0.81-1.95), and major bleeding occurred in 0.90% (2/221%; 95% CI, 0-2.15). In patients with a low pretest probability (PTP) and negative D-dimer, 3-month follow-up revealed mortality from PE was 0% (0/808) and incidence of VTE was 0.37% (4/1094; 95% CI: 0.007-0.72). In patients with intermediate PTP and negative D-dimer, 3-month follow-up revealed that mortality from PE was 0% (0/2747) and incidence of VTE was 0.46% (14/3015; 95% CI: 0.22-0.71). In patients with high PTP and negative computed tomography (CT) scan, 3-month follow-up revealed mortality from PE was 0% (0/651) and incidence of VTE was 0.84% (11/1302; 95% CI: 0.35-1.34). We further summarize outcomes evaluated by various diagnostic tests and diagnostic pathways (ie, D-dimer followed by CT scan).


2010 ◽  
Vol 56 (11) ◽  
pp. 1758-1766 ◽  
Author(s):  
Geert-Jan Geersing ◽  
Diane B Toll ◽  
Kristel JM Janssen ◽  
Ruud Oudega ◽  
Marloes JC Blikman ◽  
...  

BACKGROUND Point-of-care D-dimer tests have recently been introduced to enable rapid exclusion of deep venous thrombosis (DVT) without the need to refer a patient for conventional laboratory-based D-dimer testing. Before implementation in practice, however, the diagnostic accuracy of each test should be validated. METHODS We analyzed data of 577 prospectively identified consecutive primary care patients suspected to have DVT, who underwent 5 point-of-care D-dimer tests—4 quantitative (Vidas®, Pathfast™, Cardiac®, and Triage®) and 1 qualitative (Clearview Simplify®)—and ultrasonography as the reference method. We evaluated the tests for the accuracy of their measurements and submitted a questionnaire to 20 users to assess the user-friendliness of each test. RESULTS All D-dimer tests showed negative predictive values higher than 98%. Sensitivity was high for all point-of-care tests, with a range of 0.91 (Clearview Simplify) to 0.99 (Vidas). Specificity varied between 0.39 (Pathfast) and 0.64 (Clearview Simplify). The quantitative point-of-care tests showed similar and high discriminative power for DVT, according to calculated areas under the ROC curves (range 0.88–0.89). The quantitative Vidas and Pathfast devices showed limited user-friendliness for primary care, owing to a laborious calibration process and long analyzer warm-up time compared to the Cardiac and Triage. For the qualitative Clearview Simplify assay, no analyzer or calibration was needed, but interpretation of a test result was sometimes difficult because of poor color contrast. CONCLUSIONS Point-of-care D-dimer assays show good and similar diagnostic accuracy. The quantitative Cardiac and Triage and the qualitative Clearview Simplify D-dimer seem most user-friendly for excluding DVT in the doctor's office.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1619-1619 ◽  
Author(s):  
David R. Anderson ◽  
Philip S. Wells ◽  
Susan Kahn ◽  
Marc Rodger ◽  
Michael J. Kovacs ◽  
...  

Abstract Ventilation-perfusion (VQ) lung scanning and computerized tomographic pulmonary angiography (CTPA) have been validated as imaging procedures for the evaluation of patients with suspected pulmonary embolism and are used widely. To compare the safety and utility of VQ scanning and CTPA we performed a multi-centre randomized controlled trial in patients presenting with clinically suspected acute pulmonary embolism. All patients were evaluated using an explicit clinical model to determine pretest probability (Wells score) and with D-dimer. Patients considered at low likelihood of pulmonary embolism (score < 4.5 and negative D-dimer) did not undergo further testing and were followed as a separate cohort. The remaining patients were randomized to undergo either VQ scanning or CTPA. Patients diagnosed with pulmonary embolism on the basis of a high probability VQ scan or a positive CTPA were treated. Other patients underwent bilateral venous ultrasound imaging of the proximal veins of lower extremities and those confirmed to have DVT were treated. Physicians were able to refer patients for traditional pulmonary angiography or serial ultrasonography after initial testing but switching of patients to have the alternative pulmonary imaging procedure was not permitted by the protocol. Patients in whom pulmonary embolism was considered excluded did not receive antithrombotic therapy and were followed for a three month period. The primary outcome was the development of symptomatic pulmonary embolism or proximal deep vein thrombosis in the follow-up period in patients in whom the diagnosis of pulmonary embolism had initially been excluded. 1577 patients were enrolled in the study of whom 172 entered the low risk cohort. 1405 patients were randomized, 694 to CTPA and 711 to VQ scanning. 19.2% (133) of patients in the CTPA versus 14.2% (101) were diagnosed with pulmonary embolism in the initial evaluation period (difference 5.0%, 95% CI 1.1% to 8.9%). Of those in whom pulmonary embolism was considered excluded 0.4% (2/561) patients undergoing CTPA versus 1.0% (6/610) patients undergoing VQ scanning developed venous thromboembolism in follow-up (difference −0.6%, 95% CI −1.6% to 0.3%) including one with fatal pulmonary embolism in the VQ group. All cause mortality was higher in the three month follow-up for patients undergoing VQ scanning (30/610, 4.9%) than for CTPA (17/694, 2.4%) in whom pulmonary embolism was considered excluded. Most of these deaths were from cancer. Management practices using bilateral ultrasonography with either VQ scanning or CTPA to exclude the diagnosis of pulmonary embolism resulted in low rates of venous thromboembolic complications. More patients were diagnosed intitally with pulmonary embolism using the CTPA approach and fewer patients died in this cohort in the three month follow-up period.


2014 ◽  
Vol 63 (2) ◽  
pp. 411-417 ◽  
Author(s):  
Abdel Rahem I. Youssf ◽  
Mohammed F.M. Ismail ◽  
Reda ElGhamry ◽  
Mahmoud R. Reyad

1993 ◽  
Vol 70 (03) ◽  
pp. 408-413 ◽  
Author(s):  
Edwin J R van Beek ◽  
Bram van den Ende ◽  
René J Berckmans ◽  
Yvonne T van der Heide ◽  
Dees P M Brandjes ◽  
...  

SummaryTo avoid angiography in patients with clinically suspected pulmonary embolism and non-diagnostic lung scan results, the use of D-dimer has been advocated. We assessed plasma samples of 151 consecutive patients with clinically suspected pulmonary embolism. Lung scan results were: normal (43), high probability (48) and non-diagnostic (60; angiography performed in 43; 12 pulmonary emboli). Reproducibility, cut-off values, specificity, and percentage of patients in whom angiography could be avoided (with sensitivity 100%) were determined for two latex and four ELISA assays.The latex methods (cut-off 500 μg/1) agreed with corresponding ELISA tests in 83% (15% normal latex, abnormal ELISA) and 81% (7% normal latex, abnormal ELISA). ELISA methods showed considerable within- (2–17%) and between-assay Variation (12–26%). Cut-off values were 25 μg/l (Behring), 50 μg/l (Agen), 300 μg/l (Stago) and 550 μg/l (Organon). Specificity was 14–38%; in 4–15% of patients angiography could be avoided.We conclude that latex D-dimer assays appear not useful, whereas ELISA methods may be of limited value in the exclusion of pulmonary embolism.


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