Elsevier

The Lancet

Volume 353, Issue 9148, 16 January 1999, Pages 190-195
The Lancet

Articles
Non-invasive diagnosis of venous thromboembolism in outpatients

https://doi.org/10.1016/S0140-6736(98)05248-9Get rights and content

Summary

Background

We designed a simple and integrated diagnostic algorithm for acute venous thromboembolism based on clinical probability assessment of deep-vein thrombosis (DVT) or pulmonary embolism (PE), plasma D-dimer measurement, lower-limb venous compression ultrasonography, and lung scan to reduce the need for phlebography and pulmonary angiography.

Methods

918 consecutive patients presenting at the emergency ward of the Geneva University Hospital, Geneva, Switzerland, and Hôpital Saint-Luc, Montreal, Canada, with clinically suspected venous thromboembolism were entered into a sequential diagnostic protocol. Patients in whom venous thromboembolism was deemed absent were not given anticoagulants and were followed up for 3 months.

Findings

A normal D-dimer concentration (<500 μg/L by a rapid ELISA) ruled out venous thromboembolism in 286 (31%) members of the study cohort, whereas DVT by ultrasonography established the diagnosis in 157 (17%). Lung scan was diagnostic in 80 (9%) of the remaining patients. Venous thromboembolism was also deemed absent in patients with low to intermediate clinical probability of DVT and a normal venous ultrasonography (236 [26%] patients), and in patients with a low clinical probability of PE and a non-diagnostic result on lung scan (107 [12%] patients). Pulmonary angiography and phlebography were done in only 50 (5%) and 2 (<1%) of the patients, respectively. Hence, a non-invasive diagnosis was possible in 866 (94%) members of the entire cohort. The 3-month thromboembolic risk in patients not given anticoagulants, based on the results of the diagnostic protocol, was 1·8% (95% CI 0·9–3·1).

Interpretation

A diagnostic strategy combining clinical assessment, D-dimer, ultrasonography, and lung scan gave a non-invasive diagnosis in the vast majority of outpatients with suspected venous thromboembolism, and appeared to be safe.

Introduction

Venous thromboembolism is a common and potentially fatal disease.1 Novel diagnostic instruments are useful for both suspected pulmonary embolism (PE) and suspected deep-vein thrombosis (DVT). The plasma concentration of D-dimer, a degradation product of cross-linked fibrin, is almost always raised in the event of an acute DVT or PE; therefore, a normal D-dimer concentration measured by ELISA almost rules out acute venous thromboembolism.2, 3, 4, 5 Moreover, new rapid ELISAs are now available,6, 7, 8, 9 better suited for use in an emergency situation than the classic and more labour-intensive ELISA. Lower-limb venous compression ultrasonography is widely used to detect symptomatic proximal DVT (sensitivity and specificity higher than 97%10, 11). However, the sensitivity of ultrasonography for diagnosis of distal DVT is substantially lower. Hence, various strategies based on serial plethysmography or ultrasonography have been assessed, all requiring the repetition of the examination from two to five times over a period of 7–14 days12, 13, 14, 15, 16, 17, 18, 19 to detect the eventual proximal extension of a distal DVT.20, 21 Lower-limb ultrasonography has also proved useful in patients with suspected PE, since a residual DVT can be shown by ultrasonography in 30–50% of patients with PE.5, 22 Finally, the clinical likelihood of DVT or PE can be estimated either empirically (suspected PE23) or by a score (suspected DVT19, 24). The value of clinical assessment of patients with suspected venous thromboembolism19, 23, 24, 25 has also been recognised. PE may be satisfactorily ruled out by the combination of a low clinical probability of PE and a low-probability lung scan on the grounds of both theoretical25 and clinical23 evidence. The clinical probability of DVT can also be combined with ultrasonography to reduce the need for phlebography.19

We designed a prospective outcome study to validate a simple diagnostic algorithm for suspected venous thromboembolism combining clinical probability assessment, a rapid D-dimer ELISA, a single lower-limb venous ultrasonography, and lung scan, to reduce the need for phlebography and angiography. Since untreated PE or DVT will result in a high frequency of recurrences,26, 27 all patients were followed up for 3 months to assess the safety of the management strategy.

Section snippets

Patients

We studied prospectively 1102 consecutive patients presenting with clinically suspected PE or DVT at the emergency centre or the outpatient clinics of the University Hospital of Geneva, Geneva, Switzerland, and the Hôpital Saint-Luc, Montreal, Canada, between Nov 1, 1996, and Oct 31, 1997. Inclusion criteria were clinical suspicion of DVT or PE and age older than 16 years. Exclusion criteria were refusal or inability to consent to the study (n=24); continuing anticoagulation at onset of

Results

The series included 918 patients (745 from Geneva; 173 from Montreal). The median age was 61 years (range 19–97) for the entire group and did not differ between patients with suspected PE and those with suspected DVT (table 1). The prevalence of venous thromboembolism was 23%, and was similar in patients with suspected DVT (111 [23%] of 474) and PE (104 [23%] of 444).

Discussion

In this series, a diagnosis could be established non-invasively in 863 (94%) of 918 patients with clinically suspected venous thromboembolism referred to an emergency centre. In the strategy studied, two potentially widely available instruments (D-dimer measurement and ultrasonography) were used at the beginning of the diagnostic work-up, and clinical assessment was combined with ultrasonography and lung scan. The strategy proved safe, with a low thromboembolic risk during the 3-month

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