title: Diagnosis of deep vein thrombosis: how many tests do we need?
abstract: The requirement for a safe diagnostic strategy should be based on an overall post-test incidence of venous thromboembolism (VTE) of less than 1% during 3 month follow-up. Compression ultrasonography (CUS) has a negative predictive value (NPV) of 97 to 98% indicating a post-CUS incidence of deep vein thrombosis (DVT) of 2 to 3%. A post-CUS DVT incidence of 3% implicates that 90 to 120 DVTs per 1 million inhabitants will be overlooked each year indicating the need to improve the diagnostic work-up of DVT as much as possible. The qualitative D-dimer test (SimpliRed) has a sensitivity of 82 to 89% and a negative predictive value of 94 to 95% indicating a 5 to 6% post-test incidence of DVT, which is not sensitive enough for venous thrombosis exclusion. The post-test DVT incidence could be reduced from 3.2% to 0.6% in one study and from 11% to 2% in another study by the combination of a normal CUS and low clinical score and from 4.5% to 1.6% by the combination of low clinical score and a negative SimpliRed test in one study. The combination of a negative CUS and a negative SimpliRed test reduced the post-test incidence of DVT from 2.6% to < 1% or even < 1% in two management studies without the need of a repeated CUS on the basis of which anticoagulant therapy can safely be withheld. The rapid quantitative turbidimetric D-dimer assay (Tinaquant) has a sensitivity and a negative predictive value (NPV) of 97.7% with a 2.3% post-test incidence of DVT. The combination of a normal Tinaquant D-Dimer test result plus a low to moderate clinical score reduces the post-test incidence of DVT from 2.3 to 0.6% without the need of CUS testing in 29% of patients with suspected DVT. The rapid ELISA VIDAS D-dimer assay has a sensitivity and NPV of 98.6 and 99.5% in two management studies for the exclusion of DVT irrespective of clinical score. The combination of a normal ELISA VIDAS D-Dimer test with clinical score assessment will reduce the post-test DVT incidence of less than 0.5% and the need for CUS testing by 40 to 50%. It is concluded that the sequential use of a rapid quantitative D-dimer test, clinical score and CUS appears to be safe and the most cost-effective diagnostic work-up of DVT.
authors.affiliation: Hemostasis and Thrombosis Research, Department of Hematology, University Hospital Antwerp, Edegem. jan.michiels@uza.be
authors.forename: J J
authors.initials: JJ
authors.lastname: Michiels
authors.forename: A
authors.initials: A
authors.lastname: Gadisseur
authors.forename: M
authors.initials: M
authors.lastname: van der Planken
authors.forename: W
authors.initials: W
authors.lastname: Schroyens
authors.forename: Z
authors.initials: Z
authors.lastname: Berneman
authors.forename: M
authors.initials: M
authors.lastname: De Maeseneer
authors.forename: J T
authors.initials: JT
authors.lastname: Hermsen
authors.forename: P H
authors.initials: PH
authors.lastname: Trienekens
mesh_terms: D003663:Decision Trees; D006801:Humans; D014463:Ultrasonography; D020246:Venous Thrombosis / Q000175:diagnosis* / Q000000981:diagnostic imaging