D-Dimer Test and Diagnosis of Deep Vein Thrombosis: A Comparative Study of 7 Assays

1996 ◽  
Vol 76 (04) ◽  
pp. 518-522 ◽  
Author(s):  
A Elias ◽  
I Aptel ◽  
B Huc ◽  
J J Chale ◽  
F Nguyen ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Latex Agglutination ◽  
Lower Limbs ◽  
First Episode ◽  
Lower Sensitivity ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
D Dimer

SummaryThe current D-Dimer ELISA methods provide high sensitivity and negative predictive value for the diagnosis of deep vein thrombosis but these methods are not suitable for emergency or for individual determination. We have evaluated the performance of 3 newly available fast D-Dimer assays (Vidas D-Di, BioMerieux; Instant IA D-Di, Stago; Nycocard D-Dimer, Nycomed) in comparison with 3 classic ELISA methods (Stago, Organon, Behring) and a Latex agglutination technique (Stago). One-hundred-and-seventy-one patients suspected of presenting a first episode of deep vein thrombosis were investigated. A deep vein thrombosis was detected in 75 patients (43.8%) by ultrasonic duplex scanning of the lower limbs; in 11 of them the thrombi were distal and very limited in size (<2 cm). We compared the performance of the tests by calculating their sensitivity, specificity, positive and negative predictive value for different cut-off levels and by calculating the area under ROC curves. The concordance of the different methods was evaluated by calculating the kappa coefficient. The performances of the 3 classic ELISA and of the Vidas D-Di were comparable and kappa coefficients indicated a good concordance between the results provided by these assays. Their sensitivity slightly declined for detection of the very small thrombi. Instant IA D-Di had a non-significantly lower sensitivity and negative predictive value than the 4 previous assays; however its performance was excellent for out-patients. As expected, the Latex assay had too low a sensitivity and negative predictive value to be recommended. In our hands, Nycocard D-Dimer also exhibited low sensitivity and negative predictive value, which were significantly improved when the plasma samples were tested by the manufacturer. Thus significant progress has been made, allowing clinical studies to be planned to compare the safety and cost-effectiveness of D-Dimer strategy to those of the conventional methods for the diagnosis of venous thrombosis.

Evaluation of a New Rapid Quantitative D-dimer Assay in Patients with Clinically Suspected Deep Vein Thrombosis

1996 ◽  
Vol 75 (03) ◽  
pp. 412-416 ◽  
Author(s):  
Armando D’Angelo ◽  
Gabriella D’Alessandro ◽  
Loredana Tomassini ◽  
Jean Louis Pittet ◽  
G Dupuy ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Predictive Value ◽  
Cost Savings ◽  
Pretest Probability ◽  
First Episode ◽  
Consecutive Series ◽  
Vein Thrombosis ◽  
Baseline Testing ◽  
Deep Vein ◽  
D Dimer

SummaryThe sensitivity and specificity for deep vein thrombosis (DVT) of a new rapid, quantitative and precise (total imprecision < 10%) D-dimer assay suitable for individual measurements (VIDAS D-DIMER, bio-Merieux, France) were evaluated in a consecutive series of 103 in- and out-patients submitted to serial compression ultrasonography (C-US) for the clinical suspicion of DVT (n = 66) or of DVT recurrence (n = 37) and symptoms lasting from 1 to 15 days. DVT was found in 22 patients at baseline testing and no patient with an initially negative C-US developed vein incompressibility at follow up. The time elapsed from the onset of symptoms was negatively associated with D-dimer levels both in patients with and in those without DVT. In the entire series of patients, the sensitivity of a positive D-dimer test (≥1.0 Μg/ml) for the presence of DVT was 96% (21/22 patients, 95% confidence interval 75-100%) with a specificity of 75% (64-84%), a negative predictive value of 98% (90-100%), a positive predictive value of 51% (35-67%), and an overall accuracy of 80% (70-87%). A normal D-dimer value (0.22 Μg/ml) was observed in one patient with DVT and symptoms lasting from 15 days. The approach of withholding C-US testing in patients with symptoms lasting from less than 11 days and D-dimer levels below the cut-off value was compared to serial C-US testing alone in a cost-effectiveness analysis subdividing the 66 patients with a first episode according to their clinical pretest probability of DVT. Thrombosis was detected in 6.7% of the patients in the low probability group (n = 15), 16.7% of the patients in the moderate probability group (n = 24), 51.9% of the patients in the high probability group (n = 27) and 8.1% of patients with suspected DVT recurrence. Calculated cost-savings for each DVT diagnosed ranged from 5% in the high pretest probability group to 55% in the low pretest probability group and to 77% in patients with suspected DVT recurrence.The safety of avoiding C-US testing in symptomatic patients with a negative D-dimer test should be evaluated in clinical management studies.

Diagnosis of Deep Vein Thrombosis by Combination of Doppler Ultrasound Flow Examination and Strain Gauge Plethysmography

1982 ◽  
Vol 47 (02) ◽  
pp. 141-144 ◽  
Author(s):  
H Bounameaux ◽  
B Krähenbühl ◽  
S Vukanovic
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Doppler Ultrasound ◽  
Strain Gauge ◽  
Predictive Value ◽  
Lower Limbs ◽  
Vein Thrombosis ◽  
Non Invasive ◽  
Strain Gauge Plethysmography ◽  
Deep Vein

SummaryDoppler ultrasound flow examination, strain gauge plethysmography and contrast venography were performed in 160 lower limbs of 80 in-patients. Deep vein thrombosis (DVT) was suspected in 87 limbs. Using measurement of venous stop-flow pressure, the Doppler method had an overall sensitivity of 83%. By combined use of Doppler and Plethysmography, sensitivity was increased to 96%. Specificity was 62% and 51%, respectively. With a positive and a negative predictive value of 80% and 73%, respectively, the combination of both non-invasive methods cannot reliably replace venography in the diagnosis of DTV, although all (40/40) thromboses proximal to or involving the popliteal segment were detected by either Doppler and Plethysmography or both.After exclusion of 14 patients (18%) suffering from conditions known to alter the results of these non-invasive methods, the positive predictive value of abnormal findings in both Doppler and Plethysmography was increased to 94% for suspected limbs, whilst negative predictive value of both negative Doppler and Plethysmography was 90%, allowing the avoidance of venography in these patients.

Risk of Venous Thromboembolism Recurrence: High Negative Predictive Value of D-dimer Performed after Oral Anticoagulation Is Stopped

2002 ◽  
Vol 87 (01) ◽  
pp. 7-12 ◽  
Author(s):  
Cristina Legnani ◽  
Benilde Cosmi ◽  
Giuliana Guazzaloca ◽  
Claudia Pancani ◽  
Sergio Coccheri ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Recurrent Events ◽  
Oral Anticoagulant Therapy ◽  
Lower Limbs ◽  
First Episode ◽  
Vein Thrombosis ◽  
D Dimer

SummaryIn some patients with previous venous thromboembolism (VTE) D-dimer levels (D-Dimer) tend to increase after oral anticoagulant therapy (OAT) is stopped. The aim of our study was to evaluate the predictive value of D-Dimer for the risk of VTE recurrence after OAT withdrawal. After a first episode of deep vein thrombosis (DVT) of the lower limbs and/or pulmonary embolism (PE), 396 patients (median age 67 years, 198 males) were followed from the day of OAT discontinuation for 21 months. D-dimer was measured on the day of OAT withdrawal (T1), 3-4 weeks (T2) and 3 months (+/− 10 days, T3) thereafter. The main outcome events of the study were: objectively documented recurrent DVT and/or PE. D-dimer was found to be increased in 15.5%, 40.3% and 46.2% of the patients at T1, T2 and T3, respectively. In 199 (50.2%) patients, D-dimer levels were elevated in at least one measurement. During a follow-up of 628.4 years, 40 recurrences were recorded (10.1% of patients; 6.4% patient-years of follow-up). D-dimer was increased in at least one measurement in 28 of these cases, but remained normal in 11 subjects (three of whom had recurrent events triggered by circumstantial factors, three with malignancyassociated factors) (in one subject D-dimer was not measured). The negative predictive value (NPV) of D-dimer was 95.6% (95% CI 91.6-98.1) at T3 and was even higher (96.7%; 95% CI 92.9-98.8) after exclusion of the six recurrences due to circumstantial factors. Only five idiopathic recurrences occurred in the 186 patients with consistently normal D-dimer. In conclusion, D-dimer has a high NPV for VTE recurrence when performed after OAT discontinuation.

Evidence for Safe Exclusion of Deep Vein Thrombosis (DVT) by a Rapid ELISA D-Dimeer Test at Cut-Off Levels of 500 and 1000 Ng/Ml in 1046 Consecutive Outpatients with Suspected DVT.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1059-1059
Author(s):  
Jan Jacques Michels ◽  
Jan Hermssen ◽  
Paul H. Trienekens
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Clinical Score ◽  
Large Prospective Study ◽  
Vein Thrombosis ◽  
Persistent Symptoms ◽  
Deep Vein ◽  
D Dimer ◽  
Compression Ultrasonography

Abstract Introduction.A normal compression ultrasonography (CUS) safely excludes proximal deep vein thrombosis (DVT) with a negative predictive value of 97% indicating the need to repeat CUS testing within one week. In 3 studies, the rapid ELISA D-dimer assay at a cut-off of 500 ng/ml did have a sensitivity of 100% for the exclusion of venographically documented distal and proximal DVT irrespective of clinical score. To test this hypothesis we performed a large prospective study in outpatients with suspected DVT. Methods. CUS and a rapid ELISA D-Dimer test (VIDAS, BioMérieux L’Etoile, France) were performed in patients with suspected DVT. A negative CUS with a D-Dimer result of <500 ng/ml exclude DVT, and with a D-Dimer result of >500 ng/ml was followed by a second CUS within one week. Results. The prevalence of DVT 1046 consecutive out patients with suspected DVT was 23,4%. The first CUS was positive in 228 with a rapid ELISA D-Dimer of >500 ng/ml in 227 and of <500 ng/ml in one case, indicating a sensitivity of 99,6% irrespective of clinical score. The first CUS was negative in 818. The rapid ELISA D-dimer test Was <500 ng/ml in 297 of which 296 had a negative first CUS indicating a negative predictive value of 99.7% at a specificity of 37% irrespective of the clinicl score. The negative predictive value of a negative CUS plus a rapid ELISA D-Dimer result of less than 1000 ng/ml is 99.5% at a specificity of 67,9% irrespective of clinical score. The prevalence of DVT in patients with negative first CUS and a ELISA D-Dimer of >1000 ng/ml was 5.6% as documented by CUS repeat within on week. Conclusion.A normal rapid ELISA D-dimer test, <500 ng/ml, in outpatients with suspected DVT safely excludes DVT irrespective of clinical score. After a negative rapid ELISA result (<500 ng/ml), CUS is still indicated for safety reasons in patients with suspected DVT and persistent symptoms in search for an alternative diagnosis, or for a rare case of DVT. A negative CUS plus and ELISA D-Dimer result of <1000 ng/ml safely exclude DVT without the need to repeat CUS in 2/3 of patients with a negative first CUS.

scholarly journals Residual Vein Thrombosis Echogenicity Is Associated to the Risk of DVT Recurrence: A Cohort Study

2017 ◽  
Vol 24 (3) ◽  
pp. 477-482 ◽  
Author(s):  
Bruna M. Mazetto ◽  
Fernanda L. A. Orsi ◽  
Sandra A. F. Silveira ◽  
Luis F. Bittar ◽  
Mariane M. C. Flores-Nascimento ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Late Complication ◽  
Predictive Marker ◽  
Predictive Markers ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
D Dimer

Although deep vein thrombosis (DVT) recurrence is a common late complication of the disease, there are few predictive markers to risk-stratify patients long-term after the thrombotic event. The accuracy of residual vein thrombosis (RVT) in this context is controversial, possibly due to a lack of a standardized methodology. The objective of the study was to evaluate the accuracy of RVT echogenicity as a predictive marker of late DVT recurrence. To evaluate the accuracy of RVT echogenicity as a predictive marker of late DVT recurrence. This prospective study included patients with history of DVT in the past 33 months. Ultrasound examination was performed to detect the presence of RVT, and its echogenicity was determined by calculating the grayscale median (GSM) of the images. Blood samplings were taken for plasma D-dimer levels. Patients were followed-up for 28 months and the primary end point was DVT recurrence. Deep vein thrombosis recurrence was confirmed or excluded by ultrasound during the follow-up. Fifty-six patients were included, of which 10 presented DVT recurrence during the follow-up. D-dimer levels above 630 ng/mL conferred higher risk for recurrence with a negative predictive value of 94%. The absence of RVT was a protective marker for recurrence with a negative predictive value of 100%. Also, the presence of hypoechoic RVT, determined by GSM values below 24, positively predicted 75% of DVT recurrences. Our results suggest that the persistence of RVT and, particularly, the presence of hypoechoic thrombi (GSM < 24) are predictive markers of the risk of DVT recurrence. Residual vein thrombosis echogenicity, by GSM analysis, could represent a new strategy for the evaluation of recurrence risk in patients with DVT.

scholarly journals Performance of a New Fibrin Monomer Assay to Exclude Deep Vein Thrombosis in Symptomatic Outpatients

1999 ◽  
Vol 81 (01) ◽  
pp. 50-53 ◽  
Author(s):  
Christoph Caliezi ◽  
Nadja Fünfsinn ◽  
Thomas Mauron ◽  
Iris Baumgartner ◽  
Irmela Sulzer ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Vein Thrombosis ◽  
Fibrin Monomer ◽  
Objective Tests ◽  
Sensitivity Specificity ◽  
Deep Vein ◽  
Accuracy Indices ◽  
D Dimer

SummaryIn this study we prospectively assessed the reliability of a new fibrin monomer assay in 106 outpatients with clinically suspected deep venous thrombosis of the lower limb. According to the results of the objective tests and using different cut-off points we calculated the sensitivity, specificity and negative predictive value of the fibrin monomer assay. The prevalence of deep vein thrombosis was 44.3% (31.1% proximal, 13.2% distal). Using a cut-off level of plasma fibrin monomer of 3.5 μg/ml, a sensitivity, specificity and negative predictive value of 100% (95% CI: 94-100%), 35.6% (95% CI: 23-48%) and 100% (95% CI: 86-100%), respectively, were obtained. The exclusion rate was 19.8% (95% CI: 12-27%) of all referred patients. These accuracy indices compared favourably with the respective results of a routine D-dimer ELISA used for comparison. Conclusion: This new fibrin monomer assay appears to be a reliable method for the exclusion of deep vein thrombosis in symptomatic outpatients.

D-dimer levels in combination with residual venous obstruction and the risk of recurrence after anticoagulation withdrawal for a first idiopathic deep vein thrombosis

2005 ◽  
Vol 94 (11) ◽  
pp. 969-974 ◽  
Author(s):  
Cristina Legnani ◽  
Michela Cini ◽  
Giuliana Guazzaloca ◽  
Gualtiero Palareti ◽  
Benilde Cosmi
Keyword(s):  
Deep Vein Thrombosis ◽  
Recurrence Rate ◽  
Oral Anticoagulant Therapy ◽  
Lower Limbs ◽  
First Episode ◽  
Venous Obstruction ◽  
Risk Of Recurrence ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
D Dimer

SummaryWe assessed the predictive value of D-dimer levels in combination with residual venous obstruction (RVO) for recurrent venous thromboembolism (VTE) in a prospective cohort of outpatients after oral anticoagulant therapy (OAT) suspension for a first episode of idiopathic proximal deep vein thrombosis of the lower limbs during a 2-year follow-up. Patients (n=400) were enrolled on the day of OAT suspension when RVO was determined by compression ultrasonography (present in 48.6% of patients). D-dimer (cut-off value: 500 ng/mL) was measured 30±10 days afterwards (abnormal in 56.4% of patients). The overall recurrence rate was 16.7% (67/400; 95% confidence intervals - CI -:13–21%). The multivariate hazard ratio (HR) for recurrence was 3.32 (95% CI:1.78–6.75; p > 0.0001) for abnormal D-dimer compared to normal D-dimer and 1.2 (95% CI:0.72–2.07; p>0.05) for RVO compared to absent RVO. The recurrence rate was 5.7% (95% CI:2–13%) and 10.4% (95% CI:6–18%), respectively, for normal D-dimer either without or with RVO, 22.9% (95% CI:14–33%) and 25.9% (95% CI: 18–35%), respectively, for abnormal D-dimer, either without or with RVO. When compared with normal D-dimer without RVO, the multivariate HR for recurrence was similar for abnormal D-dimer either with RVO (4.76 – 95% CI:1.78–12.8) or without RVO (4.3–95%:1.56–11.88). Abnormal D-dimer at one month after OAT withdrawal is an independent risk factor for recurrent VTE, while RVO at the time of OAT withdrawal, either with normal or abnormal D-dimer after one month, does not influence the risk of recurrence.

D-dimer and residual vein obstruction as risk factors for recurrence during and after anticoagulation withdrawal in patients with a first episode of provoked deep-vein thrombosis

2011 ◽  
Vol 105 (05) ◽  
pp. 837-845 ◽  
Author(s):  
Cristina Legnani ◽  
Michela Cini ◽  
Giuliana Guazzaloca ◽  
Gualtiero Palareti ◽  
Benilde Cosmi
Keyword(s):  
Risk Factors ◽  
Deep Vein Thrombosis ◽  
Recurrence Risk ◽  
Lower Limbs ◽  
University Hospital ◽  
First Episode ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
Residual Vein Obstruction ◽  
D Dimer

SummaryD-dimer and residual venous obstruction (RVO) have been separately shown to be risk factors for recurrent venous thromboembolism (VTE) after a first episode of unprovoked proximal deep-vein thrombosis (DVT). It was the objective of this study to assess the predictive value of D-dimer and residual vein obstruction (RVO), alone and in combination, for recurrence after provoked DVT of the lower limbs. A total of 296 consecutive patients with a first episode of symptomatic provoked proximal DVT were evaluated at a university hospital in Bologna, Italy. On the day of anticoagulation withdrawal (T0), RVO was determined by compression ultrasonography. D-dimer levels (cut-off: 500 ng/ml) were measured at T0 and after 30 ±10 days (T1). The main outcome was recurrent VTE during a two-year follow-up. D-dimer was abnormal in 11.6% (32/276) and 31% (85/276) of subjects at T0 and at T1, respectively. RVO was present in 44.8% (132/294) of patients. Recurrence rate was 5.1% (15/296; 95% confidence interval [CI]: 3–8%; 3% patient-years; 95% CI: 2–5 %). An abnormal D-dimer either at T0 or at T1 was associated with an adjusted hazard ratio (HR) for recurrence of 4.2 (95% CI:1.2–14.2; p=0.02) and 3.8 (95%CI: 1.2–12.1; p=0.02), respectively, when compared with normal D-dimer. The HR for recurrence associated with RVO was not significant, and RVO did not increase the recurrence risk associated with an abnormal D-dimer either at T0 or T1. In conclusion, an abnormal D-dimer during vitamin K antagonist (VKA) treatment or at one month after VKA withdrawal is a risk factor for recurrence in patients with provoked DVT, while RVO at the time of anticoagulation withdrawal is not.

Risk of Deep Vein Thrombosis Recurrence: High Negative Predictive Value of D-dimer Performed during Oral Anticoagulation

2002 ◽  
Vol 88 (07) ◽  
pp. 162-163 ◽  
Author(s):  
Annalisa Fattorini ◽  
Luciano Crippa ◽  
Silvana D’Angelo ◽  
Elisabetta Pattarini ◽  
Armando D’Angelo
Keyword(s):  
Deep Vein Thrombosis ◽  
Negative Predictive Value ◽  
Oral Anticoagulation ◽  
Predictive Value ◽  
Vein Thrombosis ◽  
High Negative Predictive Value ◽  
Deep Vein ◽  
D Dimer

scholarly journals Predictive value of preoperative erythrocyte electrophoresis exponent for acute deep vein thrombosis after total knee arthroplasty in patients with knee osteoarthritis

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Dai Xiaoyu ◽  
Chen Kai ◽  
Huang Zhihui ◽  
Li Huan ◽  
Zhang Naidong ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Deep Vein Thrombosis ◽  
Knee Osteoarthritis ◽  
Knee Arthroplasty ◽  
Predictive Value ◽  
Lower Limbs ◽  
Vein Thrombosis ◽  
Post Surgery ◽  
Total Knee ◽  
Deep Vein

Abstract Background Hemorheological parameters have been confirmed to be related with deep vein thrombosis (DVT). This study is aimed to verify whether preoperative erythrocyte electrophoresis exponent was associated with postoperative deep vein thrombosis (DVT) risk after total knee arthroplasty (TKA) in patients with primary knee osteoarthritis (KOA). Methods From March 2010 to May 2020, a total of 750 consecutive KOA patients who accepted unilateral TKA were enrolled. They were divided into DVT (176 patients) and non-DVT groups (574 patients) according to the examination results of the Doppler ultrasound of deep veins in both lower limbs on postoperative day 3. The Chi-square test, Student’s t test, and multivariate logistic regression analysis were performed to analyze the correlation of erythrocyte electrophoresis exponent and DVT risk in 2 groups. Receiver operating characteristic (ROC) analysis was used to assess predictive value of erythrocyte electrophoresis exponent for DVT. Results A low erythrocyte electrophoresis exponent was a significant risk factor for DVT in patients with primary KOA (p < 0.05), especially in females when stratified by gender (p < 0.05). Conclusions The findings suggest that lower erythrocyte electrophoresis before surgery may be independently associated with a higher post-surgery DVT risk in primary KOA patients. It is necessary to optimize prophylaxis strategies for DVT in these patients.

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