State-of-the-Art-Review : Exclusion and Diagnosis of Pulmonary Embolism by a Rapid ELISA D-dimer Test and Noninvasive Imaging Techniques within the Context of a Clinical Model

2000 ◽  
Vol 6 (1) ◽  
pp. 46-52 ◽  
Author(s):  
Jan Jacques Michiels ◽  
Peter M. T. Pattynama
Keyword(s):  
Pulmonary Embolism ◽  
State Of The Art ◽  
Imaging Techniques ◽  
Noninvasive Imaging ◽  
Clinical Model ◽  
D Dimer

scholarly journals Diagnostic pathways in acute pulmonary embolism: recommendations of the PIOPED II investigators

2013 ◽  
pp. 31-36
Author(s):  
M. Campanini
Keyword(s):  
Pulmonary Embolism ◽  
Imaging Techniques ◽  
High Sensitivity ◽  
Disease Diagnosis ◽  
Complete Evaluation ◽  
Iodinated Contrast Medium ◽  
Clinical Probability ◽  
Iodinated Contrast ◽  
The Right ◽  
D Dimer

BACKGROUND Pulmonary embolism (PE) is a potentially fatal disease. Diagnosis is challenging for clinicians because clinical presentation is variable and there is no diagnostic test that combines sufficiently high sensitivity and specificity to be used alone in clinically suspected PE. AIM OF THE STUDY PIOPED II investigators have formulated recommendations for the diagnostic approach to patients with suspected PE based on randomized trials. METHODS Diagnostic work-up recommendations were formulated based on the results of the Prospective Investigation of Pulmonary Embolism Diagnosis II and outcomes studies. RESULTS In many patients that present the combination of low or moderate clinical probability with negative D-dimer PE can be safely excluded. In other patients with suspected PE and positive D-dimer a CT angiography in combination with CT venography is recommended. PIOPED II investigators have also formulated recommendations for patients with suspected PE and allergy to iodinated contrast medium, with impaired renal function, and for women at fertile age and during pregnancy. In patients with discordant findings between clinical assessment and CTA o CTA/CTV, and with segmental or sub-segmental EP, further evaluation may be necessary and the diagnosis should be re-assessed. DISCUSSION AND CONCLUSIONS PIOPED II recommendations are of particular interest because consider, after the right clinical evaluation necessary for risk stratification of PE, the most recent, sensitive and specific imaging techniques for definitive diagnosis, such as CTA and CTV. D-dimer evaluation is recommended but, however, its low specificity is not underlined. The importance of combining CTA and CTV for a complete evaluation of the deep venous system is stated, but the difficulties of a routinary similar approach are not considered and alternative techniques, like compressive ultrasound and Colour Doppler ultrasound, are not proposed. The study faces also the issue of segmental and sub-segmental embolism, that presents a difficult clinical interpretation: the recommendations are, before starting the therapy, to re-evaluate and confirm the diagnosis, to avoid the risk of overtreatment.

Derivation of a Simple Clinical Model to Categorize Patients Probability of Pulmonary Embolism: Increasing the Models Utility with the SimpliRED D-dimer

2000 ◽  
Vol 83 (03) ◽  
pp. 416-420 ◽  
Author(s):  
David Anderson ◽  
Marc Rodger ◽  
Jeffrey Ginsberg ◽  
Clive Kearon ◽  
Michael Gent ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Scoring System ◽  
Clinical Symptoms ◽  
Prediction Rule ◽  
Scoring Systems ◽  
Clinical Prediction Rule ◽  
Clinical Prediction ◽  
Clinical Model ◽  
Validation Set ◽  
D Dimer

SummaryWe have previously demonstrated that a clinical model can be safely used in a management strategy in patients with suspected pulmonary embolism (PE). We sought to simplify the clinical model and determine a scoring system, that when combined with D-dimer results, would safely exclude PE without the need for other tests, in a large proportion of patients. We used a randomly selected sample of 80% of the patients that participated in a prospective cohort study of patients with suspected PE to perform a logistic regression analysis on 40 clinical variables to create a simple clinical prediction rule. Cut points on the new rule were determined to create two scoring systems. In the first scoring system patients were classified as having low, moderate and high probability of PE with the proportions being similar to those determined in our original study. The second system was designed to create two categories, PE likely and unlikely. The goal in the latter was that PE unlikely patients with a negative D-dimer result would have PE in less than 2% of cases. The proportion of patients with PE in each category was determined overall and according to a positive or negative SimpliRED D-dimer result. After these determinations we applied the models to the remaining 20% of patients as a validation of the results. The following seven variables and assigned scores (in brackets) were included in the clinical prediction rule: Clinical symptoms of DVT (3.0), no alternative diagnosis (3.0), heart rate >100 (1.5), immobilization or surgery in the previous four weeks (1.5), previous DVT/PE (1.5), hemoptysis (1.0) and malignancy (1.0). Patients were considered low probability if the score was <2.0, moderate of the score was 2.0 to 6.0 and high if the score was over 6.0. Pulmonary embolism unlikely was assigned to patients with scores <4.0 and PE likely if the score was >4.0. 7.8% of patients with scores of less than or equal to 4 had PE but if the D-dimer was negative in these patients the rate of PE was only 2.2% (95% CI = 1.0% to 4.0%) in the derivation set and 1.7% in the validation set.Importantly this combination occurred in 46% of our study patients. A score of <2.0 and a negative D-dimer results in a PE rate of 1.5% (95% CI = 0.4% to 3.7%) in the derivation set and 2.7% (95% CI = 0.3% to 9.0%) in the validation set and only occurred in 29% of patients. The combination of a score <4.0 by our simple clinical prediction rule and a negative SimpliRED D-Dimer result may safely exclude PE in a large proportion of patients with suspected PE.

scholarly journals Age-Adjusted D-Dimer Cutoffs for DVT and Pulmonary Embolism: A Comparison of Five Assays

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1419-1419 ◽  
Author(s):  
Maria Farm ◽  
Anwar Siddiqui ◽  
Liselotte Onelöv ◽  
Roza Chaireti ◽  
Margareta Holmström ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Plasma Concentration ◽  
Venous Thrombosis ◽  
False Positive ◽  
Older Patients ◽  
Research Funding ◽  
Imaging Techniques ◽  
Increased Risk ◽  
Positive Results ◽  
D Dimer

Abstract Background: Venous thromboembolism (VTE) is a common but underdiagnosed condition constituted primarily by deep venous thrombosis (DVT, 2/3) and pulmonary embolism (PE, 1/3).Diagnosis of VTE is based on the biomarker D-dimer for excluding low probability VTE, and imaging techniques to verify mid/high probability VTE. D-dimer assays generally have excellent sensitivity, but specificity is kept low by the physiology of the measurand. The plasma concentration of D-dimer increases in thrombosis and activated coagulation, but also in several other conditions such as pregnancy, cancer, trauma, inflammation, infection and with age. Many of these conditions are especially prevalent in VTE-patients, because they are also linked to an increased risk of venous thrombosis. Haase et al. showed that the plasma concentration of D-dimer in a healthy population increases with age, 50% of those ≥70 years old had a positive D-dimer (>0.5 mg/L FEU)1. Age-adjusted decision thresholds have subsequentially been recommended and validated, to increase specificity and reduce the rate of false positive D-dimer results in older patients without decreasing sensitivity. Aims: The study compares age-adjusted D-dimer decision thresholds for different assays in Swedish out-patients with suspected DVT or PE. Methods: Patients (n=940) with clinically suspected PE or DVT in a lower limb were recruited from the medical emergency department (ED) of Karolinska University Hospital, and fresh citrated plasma samples were analyzed for D-dimer within 30 minutes. D-dimer concentrations were measured by four immunoturbidimetric assays using the instruments Sysmex CS2100i and Stago CompactMax. VTE was verified by imaging techniques (ultrasonography, computed tomography or ventilation/perfusion lung scintigraphy, as appropriate) and classified into segmental or subsegmental PE and proximal or distal DVT. Non-VTE was identified by imaging techniques or absence of VTE in a three month follow up of medical records. Age adjusted cutoff values were calculated if age was ≥50 years according to Douma et al.2, as age x 0.01 for assays measured in mg/L FEU (Siemens INNOVANCE® D-dimer and STA®-Liatest® D-Di) and as age x 0.005 for Roche Tina-quant D-dimer and as age x 0.004 for MediRox D-dimer. Results: VTE was found in 125 patients (13.3%), PE in 35 (3.7%; 3.0% segmental and 0.7% subsegmental) and DVT in 90 (9.6%; 6.3% proximal and 3.4% distal). The diagnostic performances of the assays are displayed below, see table 1. All assays had excellent areas under the ROC-curve (AUC) and all except MediRox D-dimer fulfilled the FDA requirements of sensitivity > 95% and a NPV > 97%, at the cutoff recommended by the manufacturer. When age adjusted cutoffs were applied, all assays maintained their sensitivities, whereas specificities increased by 6-7%. The rate of false positive results decreased by 6% overall, but 10-20% for patients older than 70, see table 2. Conclusion: D-dimer is still the only biomarker used for suspected VTE, even though low specificity with false positive results presents a significant problem due to an elderly patient population burdened with co-morbidity. The examined age-adjusteddecision thresholds increase specificity for VTE without decreasing sensitivity and can thus be used to improve diagnosis of VTE. With fewer false positives, diagnosis will be faster, cheaper and will result in decreased health risks from intravenous contrast, radiation and unnecessary hospital admissions. References 1. Haase C, et al. Age- and sex-dependent reference intervals for D-dimer: evidence for a marked increase by age. Thromb Res. 2013;132(6):676-80. 2. Douma RA, et al. Potential of an age adjusted D-dimer cut-off value to improve the exclusion of pulmonary embolism in older patients: a retrospective analysis of three large cohorts. BMJ. 2010;340:c1475. Disclosures Farm: Leo Pharma: Research Funding; Triolab: Honoraria; Siemens: Honoraria. Chaireti:Baxalta: Research Funding. Antovic:Siemens: Honoraria; Roche: Honoraria; Baxter Healthcare Corporation: Honoraria, Research Funding; Novo Nordisk: Honoraria; Sysmex: Honoraria; Stago: Honoraria.

Can a State-of-the-Art d-Dimer Test Be Used to Determine the Need for CT Imaging in Patients Suspected of Having Pulmonary Embolism?

2002 ◽  
Vol 9 (9) ◽  
pp. 1013-1017 ◽  
Author(s):  
Gerald A.L Irwin ◽  
Jonathan S Luchs ◽  
Virginia Donovan ◽  
Douglas S Katz
Keyword(s):  
Pulmonary Embolism ◽  
State Of The Art ◽  
Ct Imaging ◽  
D Dimer

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

Tissue plasminogen activator as a novel diagnostic aid in acute pulmonary embolism

VASA ◽  
2014 ◽  
Vol 43 (6) ◽  
pp. 450-458 ◽  
Author(s):  
Julio Flores ◽  
Ángel García-Avello ◽  
Esther Alonso ◽  
Antonio Ruíz ◽  
Olga Navarrete ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Negative Predictive Value ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Predictive Value ◽  
Acute Pulmonary Embolism ◽  
Enzyme Linked Immunosorbent Assay ◽  
Diagnostic Utility ◽  
Tissue Plasminogen ◽  
D Dimer

Background: We evaluated the diagnostic efficacy of tissue plasminogen activator (tPA), using an enzyme-linked immunosorbent assay (ELISA) and compared it with an ELISA D-dimer (VIDAS D-dimer) in acute pulmonary embolism (PE). Patients and methods: We studied 127 consecutive outpatients with clinically suspected PE. The diagnosis of PE was based on a clinical probability pretest for PE and a strict protocol of imaging studies. A plasma sample to measure the levels of tPA and D-dimer was obtained at enrollment. Diagnostic accuracy for tPA and D-dimer was determined by the area under the receiver operating characteristic (ROC) curve. Sensitivity, specificity, predictive values, and the diagnostic utility of tPA with a cutoff of 8.5 ng/mL and D-dimer with a cutoff of 500 ng/mL, were calculated for PE diagnosis. Results: PE was confirmed in 41 patients (32 %). Areas under ROC curves were 0.86 for D-dimer and 0.71 for tPA. The sensitivity/negative predictive value for D-dimer using a cutoff of 500 ng/mL, and tPA using a cutoff of 8.5 ng/mL, were 95 % (95 % CI, 88–100 %)/95 % (95 % CI, 88–100 %) and 95 % (95 % CI, 88–100 %)/94 %), respectively. The diagnostic utility to exclude PE was 28.3 % (95 % CI, 21–37 %) for D-dimer and 24.4 % (95 % CI, 17–33 %) for tPA. Conclusions: The tPA with a cutoff of 8.5 ng/mL has a high sensitivity and negative predictive value for exclusion of PE, similar to those observed for the VIDAS D-dimer with a cutoff of 500 ng/mL, although the diagnostic utility was slightly higher for the D-dimer.

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