Strategies for the Safe and Effective Exclusion and Diagnosis of Deep Vein Thrombosis by the Sequential Use of Clinical Score, D-Dimer Testing, and Compression Ultrasonography

Jan Jacques Michiels; Geneviéve Freyburger; Fedde Van Der Graaf; Mirian Janssen; Wija Oortwijn; Edwin J. R Van Beek

doi:10.1055/s-2000-13222

Seminars in Thrombosis and Hemostasis, Inhaltsverzeichnis

Semin Thromb Hemost 2000; 26(6): 657-668
DOI: 10.1055/s-2000-13222

Strategies for the Safe and Effective Exclusion and Diagnosis of Deep Vein Thrombosis by the Sequential Use of Clinical Score, D-Dimer Testing, and Compression Ultrasonography

Jan Jacques Michiels¹ , Geneviéve Freyburger² , Fedde Van Der Graaf³ , Mirian Janssen⁴ , Wija Oortwijn⁵ , Edwin J. R. Van Beek⁶

¹Clinical Hemostasis and Thrombosis, Department of Hematology, University Hospital Antwerp and the Goodheart Institute Center for Hemostasis, Thrombosis, and Vascular Pathology, Rotterdam, The Netherlands
²Laboratoire d'Hématologie, Hôpital Pellegrin, Bordeaux, France
³Clinical Laboratories, Sint Joseph Hospital Veldhoven, The Netherlands
⁴Department of Internal Medicine, Canisius-Wilhelmina Hospital Nijmegen, The Netherlands
⁵TNO, Prevention and Health, Leiden, The Netherlands
⁶Division of Clinical Sciences, Academic Radiology, Royal Hallamshire Hospital Sheffield, United Kingdom

Abstract

ABSTRACT

Patients with suspected deep vein thrombosis (DVT) are subjected to leg vein compression ultrasonography (CUS) that confirms DVT in only 20 to 30% of patients. A positive CUS is consistent with DVT irrespective of clinical score. The sequential use of a simple clinical score assessment, a rapid sensitive enzyme-linked immunosorbent assay (ELISA) D-dimer test and CUS to safely exclude DVT is promising. The clinical score is a validated clinical model of complaints, signs, and symptoms, on the basis of which a pretest clinical probability for DVT can be estimated as low, moderate, and high. The safe exclusion of DVT by a rapid sensitive D-dimer test in combination with clinical score or CUS necessitates a negative predictive value of more than 99%. The negative predictive value for DVT is determined by the sensitivity of the rapid ELISA D-dimer test and the prevalence of DVT in subgroups of outpatients with suspected DVT. The prevalence of DVT in outpatients with a low, moderate, and high clinical score varies widely from 3 to 10%, 15 to 30% and more than 70%, respectively. A negative rapid ELISA D-dimer and a low clinical score (prevalence DVT 3 to 5%) will have a very high negative predictive value of more than 99.5% to exclude DVT without the need of CUS testing. A negative ELISA D-dimer test and a first-negative CUS safely exclude DVT in patients with a moderate clinical score with a negative predictive value of more than 99.5%, therefore obviating the need to repeat CUS. The use of a rapid ELISA D-dimer testing in patients with a high clinical score is not recommended. A negative CUS, a low clinical score, and a positive ELISA D-dimer, even less than 1000 ng/mL exclude DVT with a negative predictive value of more than 99%. Patients with a negative CUS, but a positive ELISA D-dimer, and a moderate or high clinical score have a probability of DVT of 3 to 5% and 20 to 30%, respectively, and are thus candidates for repeated CUS testing. The proposed sequential use of the clinical score assessment, a rapid ELISA D-dimer test, and CUS will be the most cost-effective diagnostic strategy for DVT because of a significant reduction of CUS examinations and gain of time for the patient and physician in charge.

KEYWORD

Deep vein thrombosis - ELISA D-dimer assay - compression ultrasonography - clinical score - diagnostic management - cost-effectiveness

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Referenzen

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