Simple and safe exclusion of pulmonary embolism in outpatients using quantitative D-dimer and Wells’ simplified decision rule

Summary

A safe and effective management strategy is pivotal in excluding pulmonary embolism (PE). The combination of Wells’ simplified dichotomous clinical decision rule and D-dimer test is non-invasive and could be highly efficient, though its safety has not been widely studied. We evaluated safety and efficiency of this combination in excluding PE. Wells clinical decision rule was performed in 941 consecutive patients with suspected PE and, if patients had a score ≤ 4.0 points, a VIDAS D-dimer test followed. Patients with a normal D-dimer concentration had no further tests, PE was considered excluded, and patients did not receive anticoagulant treatment. Patients, in whom PE was excluded, were followed up for three months. Four hundred fifty patients (51.2%) had a clinical decision score ≤ 4.0 points and a normal D-dimer concentration. In 45 of these patients, during the initial diagnostic period additional objective testing, although not indicated, was performed, and PE was established in two patients. During three months of follow up no venous thromboembolic events (VTE) occurred. Therefore, the overall VTE failure rate was two of 450 (0.4% [95%CI 0–1.1]); the overall prevalence of PE was 12.3%. The diagnostic protocol could be completed and allowed a decision to be made in 90% of the study patients. This study has prospectively established the safety of a combination of a dichotomized clinical decision rule and D-dimer test in ruling out PE. The strategy proved highly efficient, since more than 50% of patients could be managed without the need for more invasive and expensive tests.

Keywords

Clinical studies - pulmonary embolism - diagnosis management - D-dimer - clinical decision rule

• References

• 1 Value of the ventilation/perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). The PIOPED Investigators. J Am Med Assoc 1990; 263: 2753-9.
• 2 Wells PS, Ginsberg JS, Anderson DR. et al Use of a clinical model for safe management of patients with suspected pulmonary embolism. Ann Intern Med 1998; 129: 997-1005.
• 3 Hull RD, Hirsh J, Carter CJ. et al Pulmonary angiography, ventilation lung scanning, and venography for clinically suspected pulmonary embolism with abnormal perfusion lung scan. Ann Intern Med 1983; 98: 891-9.
• 4 de Groot MR, Van Marwijk KM, Pouwels JG. et al The use of a rapid D-dimer blood test in the diagnostic work-up for pulmonary embolism: a management study. Thromb Haemost 1999; 83: 1588-92.
• 5 Ginsberg JS, Wells PS, Kearon C. et al Sensitivity and specificity of a rapid whole-blood assay for D-dimer in the diagnosis of pulmonary embolism. Ann Intern Med 1998; 129: 1006-11.
• 6 Wells PS, Anderson DR, Rodger M. et al Excluding pulmonary embolism at the bedside without diagnostic imaging: management of patients with suspected pulmonary embolism presenting to the emergency department by using a simple clinical model and d-dimer. Ann Intern Med 2001; 135: 98-107.
• 7 Wicki J, Perneger TV, Junod AF. et al Assessing clinical probability of pulmonary embolism in the emergency ward: a simple score. Arch Intern Med 2001; 161: 92-7.
• 8 Le Gal G, Righini M, Roy PM. et al Prediction of pulmonary embolism in the emergency department: the revised Geneva score. Ann Intern Med 2006; 144: 165-71.
• 9 Leclercq MG, Kruip MJ, Mac Gillavry MR. et al Observer variability in the assessment of clinical probability in patients with suspected pulmonary embolism. J Thromb Haemost 2004; 2: 1204-6.
• 10 Elias A, Cazanave A, Elias M. et al Diagnostic management of pulmonary embolism using clinical assessment, plasma D-dimer assay, complete lower limb venous ultrasound and helical computed tomography of pulmonary arteries. A multicentre clinical outcome study. Thromb Haemost 2005; 93: 982-8.
• 11 Wells PS, Anderson DR, Rodger M. et al Derivation of a simple clinical model to categorize patients probability of pulmonary embolism: increasing the models utility with the SimpliRED D-dimer. Thromb Haemost 2000; 83: 416-20.
• 12 van BA, Buller HR, Huisman MV. et al Effectiveness of managing suspected pulmonary embolism using an algorithm combining clinical probability, D-dimer testing, and computed tomography. J Am Med Assoc 2006; 295: 172-9.
• 13 Perrier A, Howarth N, Didier D. et al Performance of helical computed tomography in unselected outpatients with suspected pulmonary embolism. Ann Intern Med 2001; 135: 88-97.
• 14 Ghanima W, Almaas V, Aballi S. et al Management of suspected pulmonary embolism (PE) by D-dimer and multi-slice computed tomography in outpatients: an outcome study. J Thromb Haemost 2005; 3: 1926-32.
• 15 Perrier A, Roy PM, Sanchez O. et al Multidetectorrow computed tomography in suspected pulmonary embolism. N Engl J Med 2005; 352: 1760-8.