VIDAS D-dimer in combination with clinical pre-test probability to rule out pulmonary embolism

2009 ◽  
Vol 101 (05) ◽  
pp. 886-892 ◽  
Author(s):  
Marc Carrier ◽  
Marc Righini ◽  
Reza Karami Djurabi ◽  
Menno Huisman ◽  
Arnaud Perrier ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Search Strategy ◽  
Controlled Trial ◽  
Thromboembolic Risk ◽  
Literature Search Strategy ◽  
Revised Geneva Score ◽  
Randomised Controlled ◽  
Test Probability ◽  
D Dimer ◽  
Rule Out

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.

VIDAS D-Dimer in Combination with Clinical Pre-Test Probability to Rule out Pulmonary Embolism. A Systematic Review of the Management Outcome Studies.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1811-1811
Author(s):  
Marc Carrier ◽  
Marc Righini ◽  
Reza Karami Djurabi ◽  
Menno Huisman ◽  
Arnaud Perrier ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Data Extraction ◽  
Controlled Trial ◽  
Outcome Studies ◽  
Study Selection ◽  
Number Of Patients ◽  
Wells Score ◽  
Revised Geneva Score ◽  
Test Probability ◽  
D Dimer

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.

D-Dimer and CT Rule Out Pulmonary Embolism

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

D-Dimer Determination to Exclude Pulmonary Embolism: a Two-Step Approach Using Latex Assay as a Screening Tool

1994 ◽  
Vol 72 (01) ◽  
pp. 089-091 ◽  
Author(s):  
P de Moerloose ◽  
Ph Minazio ◽  
G Reber ◽  
A Perrier ◽  
H Bounameaux
Keyword(s):  
Pulmonary Embolism ◽  
Screening Tool ◽  
Screening Tests ◽  
Enzyme Linked Immunosorbent Assay ◽  
Elisa Assay ◽  
Elisa Technique ◽  
Diagnostic Step ◽  
D Dimer ◽  
Rule Out ◽  
Latex Test

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.

Evidence for Age-Adjusted D-Dimer to Rule out Pulmonary Embolism: An Institutional Study

2020 ◽  
Vol 154 (Supplement_1) ◽  
pp. S5-S5
Author(s):  
Ridin Balakrishnan ◽  
Daniel Casa ◽  
Morayma Reyes Gil
Keyword(s):  
Pulmonary Embolism ◽  
False Positive ◽  
False Positive Rate ◽  
Moderate Risk ◽  
Older Population ◽  
Statistical Measures ◽  
Positive Rate ◽  
Risk Patients ◽  
D Dimer ◽  
Rule Out

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.

scholarly journals Therapeutic versus Prophylactic Anticoagulation for Patients Admitted to Hospital with COVID-19 and Elevated D-dimer Concentration (ACTION): An Open-Label, Multicentre, Randomised, Controlled Trial

2021 ◽  
Vol 5 (2) ◽  
pp. 103-108
Author(s):  
Gilson Soares Feitosa-Filho ◽  
Gabriella S. Sodré ◽  
Juliane Penalva C. Serra ◽  
Rhanniel Theodorus-Villar ◽  
Tatiana Otero Mendelez ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Primary Efficacy ◽  
Therapeutic Group ◽  
Open Label ◽  
Safety Outcome ◽  
Therapeutic Anticoagulation ◽  
Efficacy Outcome ◽  
Randomised Controlled ◽  
Prophylactic Anticoagulation ◽  
D Dimer

Background. COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. Methods. We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3–0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. Findings. From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28.899 (34.8%) wins in the therapeutic group and 34.288 (41.3%) in the prophylactic group (win ratio 0.86 [95% CI 0.59–1.22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3.64 [95% CI 1.61–8.27], p=0.0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. Interpretation. In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation.

scholarly journals Randomised controlled trial of the Limit of Detection of Troponin and ECG Discharge (LoDED) strategy versus usual care in adult patients with chest pain attending the emergency department: study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e025339 ◽  
Author(s):  
Edward Carlton ◽  
Sarah Campbell ◽  
Jenny Ingram ◽  
Rebecca Kandiyali ◽  
Hazel Taylor ◽  
...  
Keyword(s):  
Emergency Department ◽  
Chest Pain ◽  
Randomised Controlled Trial ◽  
Limit Of Detection ◽  
Controlled Trial ◽  
High Sensitivity ◽  
Early Discharge ◽  
High Sensitivity Troponin ◽  
Randomised Controlled ◽  
Rule Out

IntroductionObservational data suggest a single high-sensitivity troponin blood test taken at emergency department (ED) presentation could be used to rule out major adverse cardiac events (MACE) in 10%–60% of ED patients with chest pain. This is done using an ‘undetectable’ cut-off (the Limit of Detection: LoD). We combined the LoD cut-off with ECG findings to create the LoDED strategy. We aim to establish whether the LoDED strategy works under real-life conditions, when compared with existing strategies, in a way that is cost-effective and acceptable to patients.Methods and analysisThis is a parallel-group pragmatic randomised controlled trial across UK EDs. Adults presenting to ED with suspected cardiac chest pain will be randomised 1:1. Existing rule-out strategies in current use across study centres, using serial high-sensitivity troponin testing, will be compared with the LoDED strategy. The primary outcome is successful early discharge (discharge from hospital within 4 hours of arrival) without MACE occurring within 30 days. Secondary outcomes include initial length of hospital stay; comparative costs; patient satisfaction and acceptability to patients. To detect a 9% difference between the early discharge rates (assuming an 8% rate in the standard care group) with 90% power, 594 patients need to be recruited, assuming a 95% follow-up rate.Ethics and disseminationThe study has been approved by the Frenchay Research Ethics Committee (reference 18/SW/0038). Results will be published in an international peer-reviewed journal. Lay summaries will be made available to patients.Trial registration numberISRCTN86184521; Pre-results.

The age-adjusted D-dimer cutoff level to rule out pulmonary embolism in patients with syncope

2021 ◽  
Author(s):  
Eyal Fuchs ◽  
Emilia Hardak ◽  
Anat Keren-Politansky ◽  
Ron Hoffman ◽  
Inna Tzoran
Keyword(s):  
Pulmonary Embolism ◽  
D Dimer ◽  
Rule Out

Pulmonary Embolism

2019 ◽  
Author(s):  
Nadav Granat ◽  
Evan Avraham Alpert
Keyword(s):  
Computed Tomography ◽  
Pulmonary Embolism ◽  
Blood Clot ◽  
Pretest Probability ◽  
Treatment Modalities ◽  
Pulmonary Vasculature ◽  
Pulmonary Angiogram ◽  
Catheter Directed Thrombolysis ◽  
D Dimer ◽  
Rule Out

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

scholarly journals Advances in the Diagnosis of Venous Thromboembolism: A Literature Review

Diagnostics ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. 365 ◽  
Author(s):  
Harish Patel ◽  
Haozhe Sun ◽  
Ali N. Hussain ◽  
Trupti Vakde
Keyword(s):  
Pulmonary Embolism ◽  
Venous Thromboembolism ◽  
Valsalva Maneuver ◽  
Imaging Modality ◽  
Diagnostic Algorithm ◽  
Pulmonary Angiography ◽  
Vein Thrombosis ◽  
Compression Ultrasound ◽  
Test Probability ◽  
D Dimer

The incidence of venous thromboembolism (VTE), including lower extremity deep vein thrombosis (DVT) and pulmonary embolism (PE) is increasing. The increase in suspicion for VTE has lowered the threshold for performing imaging studies to confirm diagnosis of VTE. However, only 20% of suspected cases have a confirmed diagnosis of VTE. Development of pulmonary embolism rule-out criteria (PERC) and update in pre-test probability have changed the paradigm of ruling-out patient with low index of suspicion. The D-dimer test in conjunction to the pre-test probability has been utilized in VTE diagnosis. The age appropriate D-dimer cutoff and inclusion of YEARS algorithm (signs of the DVT, hemoptysis and whether PE is the likely diagnosis) for the D-dimer cutoff have been recent updates in the evaluation of suspected PE. Multi-detector computed tomography pulmonary angiography (CTPA) and compression ultrasound (CUS) are the preferred imaging modality to diagnose PE and DVT respectively. The VTE diagnostic algorithm do differ in pregnant individuals. The prerequisite of avoiding excessive radiation has recruited planar ventilation-perfusion (V/Q) scan as preferred in pregnant patients to evaluate for PE. The modification of CUS protocol with addition of the Valsalva maneuver should be performed while evaluating DVT in pregnant individual.

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