VIDAS D-dimer in combination with clinical pre-test probability to rule out pulmonary embolism. A systematic review of management outcome studies

Author(s):  
Marc Carrier ◽  
Marc Righini ◽  
Reza Karami Djurabi ◽  
Menno V. Huisman ◽  
Arnaud Perrier ◽  
...  
Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1811-1811
Author(s):  
Marc Carrier ◽  
Marc Righini ◽  
Reza Karami Djurabi ◽  
Menno Huisman ◽  
Arnaud Perrier ◽  
...  

Abstract Background: Clinical outcome studies have shown that it is safe to withhold anticoagulant therapy in patients with suspected pulmonary embolism (PE) who have a negative D-dimer result and a low pre-test probability (PTP) either using a PTP model or clinical gestalt. Purpose: To assess the safety of the combination of a non-high PTP using the Wells or Geneva models with a negative VIDAS© D-dimer result to exclude PE. Data Source: A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews. Study Selection: Seven studies (6 prospective management studies and 1 randomized controlled trial) reporting failure rates at three months were included in the analysis. Non-high PTP was defined has “unlikely” or “low/intermediate” PTP using either, the Wells’ score, the Geneva, Revised Geneva Score, or gestalt estimation. Data extraction: Two reviewers independently extracted data onto standardized forms. Data Synthesis: A total of 5,622 patients with non-high PTP were assessed using the VIDAS© D-dimer. PE was ruled out by a negative VIDAS© D-dimer test in 40% (95% confidence intervals (CI) 38.7 to 41.2%) of patients. The three-month thromboembolic risk in patients left untreated was 0.14% (95% CI 0.05 to 0.4%). Table 1. Accuracy Indices Total non-high PTP and negative VIDAS© D-Dimer Wells’ “unlikely” PTP and negative VIDAS© D-dimer Geneva* “low/intermediate” and negative VIDAS© D-dimer Number of patients 5,622 2,017 3,208 Sensitivity (%, 95% CI) 99.7 (99.0– 99.9) 98.7 (96.2– 99.6) 100.0 (99.4–100) Specificity (%, 95% CI) 47.4 (46.0– 48.9) 57.3 (55.0– 59.6) 40.8 (38.9– 42.7) NPV (%, 95% CI) 99.9 (99.6– 100) 99.7 (99.1– 99.9) 100.0 (99.6– 100) Conclusion: The combination of a non-high PTP with a negative VIDAS© D-dimer result, effectively and safely exclude PE in an important proportion of outpatients with suspected PE.


2009 ◽  
Vol 101 (05) ◽  
pp. 886-892 ◽  
Author(s):  
Marc Carrier ◽  
Marc Righini ◽  
Reza Karami Djurabi ◽  
Menno Huisman ◽  
Arnaud Perrier ◽  
...  

SummaryClinical outcome studies have shown that it is safe to withhold anticoagulant therapy in patients with suspected pulmonary embolism (PE) who have a negative D-dimer result and a low pre-test probability (PTP) either using a PTP model or clinical gestalt. It was the objective of the present study to assess the safety of the combination of a negative VIDAS© D-dimer result in combination with a non-high PTP using the Wells or Geneva models to exclude PE. A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews. Seven studies (6 prospective management studies and 1 randomised controlled trial) reporting failure rates at three months were included in the analysis. Non-high PTP was defined as “unlikely” using the Wells’ model, or “low/intermediate” PTP using either the Geneva score, the Revised Geneva Score, or clinical gestalt. Two reviewers independently extracted data onto standardised forms. A total of 5,622 patients with low/intermediate or unlikely PTP were assessed using the VIDAS D-dimer. PE was ruled out by a negative D-dimer test in 2,248 (40%, 95% confidence intervals [CI] 38.7 to 41.3%) of them. The three-month thromboembolic risk in patients left untreated on the basis of a low/intermediate or unlikely PTP and a negative D-dimer test was 3/2,166 (0.14%, 95% CI 0.05 to 0.41%). In conclusion, the combination of a negative VIDAS D-dimer result and a non-high PTP effectively and safely excludes PE in an important proportion of outpatients with suspected PE.


2008 ◽  
Vol 1 (2) ◽  
pp. 11
Author(s):  
DAMIAN MCNAMARA
Keyword(s):  
D Dimer ◽  

1994 ◽  
Vol 72 (01) ◽  
pp. 089-091 ◽  
Author(s):  
P de Moerloose ◽  
Ph Minazio ◽  
G Reber ◽  
A Perrier ◽  
H Bounameaux

SummaryD-dimer (DD), when measured by a quantitative enzyme-linked immunosorbent assay (ELISA), is a valuable test to exclude venous thromboembolism (VTE). However, DD ELISA technique is not appropriate for emergency use and the available agglutination latex assays are not sensitive enough to be used as an alternative to rule out the diagnosis of VTE. Latex assays could still be used as screening tests. We tested this hypothesis by comparing DD levels measured by ELISA and latex assays in 334 patients suspected of pulmonary embolism. All but one patient with a positive (DD ≥500 ng/ml) latex assay had DD levels higher than 500 ng/ml with the ELISA assay. Accordingly, ELISA technique could be restricted to patients with a negative result in latex assay. This two-step approach would have spared about 50% of ELISA in our cohort. In conclusion, our data indicate that a latex test can be used as a first diagnostic step to rule out pulmonary embolism provided a negative result is confirmed by ELISA and the performance of the latex assay used has been assessed properly.


2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S5-S5
Author(s):  
Ridin Balakrishnan ◽  
Daniel Casa ◽  
Morayma Reyes Gil

Abstract The diagnostic approach for ruling out suspected acute pulmonary embolism (PE) in the ED setting includes several tests: ultrasound, plasma d-dimer assays, ventilation-perfusion scans and computed tomography pulmonary angiography (CTPA). Importantly, a pretest probability scoring algorithm is highly recommended to triage high risk cases while also preventing unnecessary testing and harm to low/moderate risk patients. The d-dimer assay (both ELISA and immunoturbidometric) has been shown to be extremely sensitive to rule out PE in conjunction with clinical probability. In particularly, d-dimer testing is recommended for low/moderate risk patients, in whom a negative d-dimer essentially rules out PE sparing these patients from CTPA radiation exposure, longer hospital stay and anticoagulation. However, an unspecific increase in fibrin-degradation related products has been seen with increase in age, resulting in higher false positive rate in the older population. This study analyzed patient visits to the ED of a large academic institution for five years and looked at the relationship between d-dimer values, age and CTPA results to better understand the value of age-adjusted d-dimer cut-offs in ruling out PE in the older population. A total of 7660 ED visits had a CTPA done to rule out PE; out of which 1875 cases had a d-dimer done in conjunction with the CT and 5875 had only CTPA done. Out of the 1875 cases, 1591 had positive d-dimer results (>0.50 µg/ml (FEU)), of which 910 (57%) were from patients older than or equal to fifty years of age. In these older patients, 779 (86%) had a negative CT result. The following were the statistical measures of the d-dimer test before adjusting for age: sensitivity (98%), specificity (12%); negative predictive value (98%) and false positive rate (88%). After adjusting for age in people older than 50 years (d-dimer cut off = age/100), 138 patients eventually turned out to be d-dimer negative and every case but four had a CT result that was also negative for a PE. The four cases included two non-diagnostic results and two with subacute/chronic/subsegmental PE on imaging. None of these four patients were prescribed anticoagulation. The statistical measures of the d-dimer test after adjusting for age showed: sensitivity (96%), specificity (20%); negative predictive value (98%) and a decrease in the false positive rate (80%). Therefore, imaging could have been potentially avoided in 138/779 (18%) of the patients who were part of this older population and had eventual negative or not clinically significant findings on CTPA if age-adjusted d-dimers were used. This data very strongly advocates for the clinical usefulness of an age-adjusted cut-off of d-dimer to rule out PE.


Author(s):  
Eyal Fuchs ◽  
Emilia Hardak ◽  
Anat Keren-Politansky ◽  
Ron Hoffman ◽  
Inna Tzoran
Keyword(s):  
D Dimer ◽  

2019 ◽  
Author(s):  
Nadav Granat ◽  
Evan Avraham Alpert

Pulmonary embolism is caused by a blood clot that travels from the deep veins through the heart and then lodges in the pulmonary vasculature. Common symptoms include pleuritic chest pain, dyspnea, or palpitations. Clinical scores such as the Wells score and Revised Geneva score can be used to assess the pretest probability of pulmonary embolism (PE) and guide work-up such as deciding to order D-dimer testing or imaging. However, clinical gestalt can also accurately assess the pretest probability of PE. The Pulmonary Embolism Rule-out Criteria is a decision rule that can be used to rule out PE without further testing. Imaging modalities include computed tomography pulmonary angiogram or ventilation/perfusion scanning. Novel or new oral anticoagulants are becoming the mainstay of treatment for the hemodynamically stable patient with pulmonary embolism. For the patient who is hemodynamically unstable, treatment modalities include intravenous alteplase, catheter-directed thrombolysis, surgical embolectomy, and catheter-directed embolectomy. A subset of patients with PE can be treated as outpatients. This review contains 1 figure, 4 tables, and 55 references. Key Words: anticoagulants, antithrombins, D-dimer, low-molecular-weight heparin, mechanical thrombolysis, multidetector computed tomography, radionuclide imaging, unfractionated heparin, pulmonary embolism, tissue plasminogen activator, warfarin


2020 ◽  
Vol 4 (18) ◽  
pp. 4296-4311
Author(s):  
Parth Patel ◽  
Payal Patel ◽  
Meha Bhatt ◽  
Cody Braun ◽  
Housne Begum ◽  
...  

Abstract Pulmonary embolism (PE) is a common, potentially life-threatening yet treatable condition. Prompt diagnosis and expeditious therapeutic intervention is of paramount importance for optimal patient management. Our objective was to systematically review the accuracy of D-dimer assay, compression ultrasonography (CUS), computed tomography pulmonary angiography (CTPA), and ventilation-perfusion (V/Q) scanning for the diagnosis of suspected first and recurrent PE. We searched Cochrane Central, MEDLINE, and EMBASE for eligible studies, reference lists of relevant reviews, registered trials, and relevant conference proceedings. 2 investigators screened and abstracted data. Risk of bias was assessed using Quality Assessment of Diagnostic Accuracy Studies-2 and certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. We pooled estimates of sensitivity and specificity. The review included 61 studies. The pooled estimates for D-dimer sensitivity and specificity were 0.97 (95% confidence interval [CI], 0.96-0.98) and 0.41 (95% CI, 0.36-0.46) respectively, whereas CTPA sensitivity and specificity were 0.94 (95% CI, 0.89-0.97) and 0.98 (95% CI, 0.97-0.99), respectively, and CUS sensitivity and specificity were 0.49 (95% CI, 0.31-0.66) and 0.96 (95% CI, 0.95-0.98), respectively. Three variations of pooled estimates for sensitivity and specificity of V/Q scan were carried out, based on interpretation of test results. D-dimer had the highest sensitivity when compared with imaging. CTPA and V/Q scans (high probability scan as a positive and low/non-diagnostic/normal scan as negative) both had the highest specificity. This systematic review was registered on PROSPERO as CRD42018084669.


CJEM ◽  
2018 ◽  
Vol 20 (S1) ◽  
pp. S107-S107
Author(s):  
A. Sinclair ◽  
K. Peprah ◽  
T. Quay ◽  
S. Mulla ◽  
L. Weeks

Introduction: Pulmonary embolism (PE) is a diagnostic challenge, since it shares symptoms with other conditions. Missed diagnosis puts patients at a risk of a potentially fatal outcome, while false positive results leave them at risk of side effects (bleeding) from unnecessary treatment. Diagnosis involves a multi-step pathway consisting of clinical prediction rules (CPRs), laboratory testing, and diagnostic imaging, but the best strategy in the Canadian context is unclear. Methods: We carried out a systematic review of the diagnostic accuracy, clinical utility, and safety of diagnostic pathways, CPRs, and diagnostic imaging for the diagnosis of PE. Clinical prediction rules were studied by an overview of systematic reviews, and pathways and diagnostic imaging by a primary systematic review. Where feasible, a diagnostic test meta-analysis was conducted, with statistical adjustment for the use of variable and imperfect reference standards across studies. Results: The Wells CPR rule showed greater specificity than the Geneva, but the relative sensitivities were undetermined. Application of a CPR followed by with D-dimer laboratory testing can safely rule out PE. In diagnostic test accuracy meta-analysis, computed tomography (CT) (sensitivity 0.973, 95% CrI 0.921 to 1.00) and ventilation/perfusion single-photon emission CT (VQ-SPECT) (sensitivity 0.974, 95% CrI 0.898 to 1.00) had the highest sensitivity) and CT the highest specificity (0.987, 95% CrI 0.958 to 1.00). VQ and VQ-SPECT had a higher proportion of indeterminate studies, while VQ and VQ-SPECT involved lower radiation exposure than CT. Conclusion: CPR and D-dimer testing can be used to avoid unnecessary imaging. CT is the most accurate single modality, but radiation risk must be assessed. These findings, in conjunction with a recent health technology assessment, may help to inform clinical practice and guidelines.


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