Accuracy of complete compression ultrasound in ruling out suspected deep venous thrombosis in the ambulatory setting

Summary

Evidence on the safety of complete compression ultrasound for ruling out deep venous thrombosis (DVT) is derived from studies conducted in tertiary care centers, although most patients with suspected DVT are managed in the ambulatory office setting. It was the objective of this study to estimate the rate of venous thromboembolism when anticoagulant therapy is withheld from ambulatory patients with normal findings on a single complete compression ultrasound. As part of a prospective cohort study, 3,871 ambulatory patients with clinically suspected DVT were enrolled by 255 board-certified vascular medicine physicians practicing in private offices in France. Compression ultrasound of the entire lower extremities was performed using a standardised examination protocol. Anticoagulant therapy was withheld from patients with negative findings on compression ultrasound, and 1,254 of them were randomly selected for follow-up. The main outcome measure was the three-month incidence of symptomatic venous thromboembolic events confirmed by objective testing. DVT was detected in 1,023 patients (26.4%),including 454 (11.7%) and 569 (14.7%) cases of proximal and isolated distal DVT, respectively. Of the 1,254 patients with negative results sampled for follow-up, six received anticoagulant therapy during follow-up and five were lost to follow-up. Five of 1,243 patients (0.4%, 95% confidence interval [CI], 0.1–0.9) experienced non-fatal symptomatic venous thromboembolic events (pulmonary embolism in two patients and DVT in three patients) and eight of 1,254 patients (0.6%, 95% CI, 0.3–1.2) died during the three-month follow-up. In conclusion, anticoagulant therapy can be safely withheld after negative complete compression ultrasound without further testing in the ambulatory office setting.

Keywords

Venous thrombosis - veins/ ultrasonography - cohort studies

• References

• 1 Wells PS, Owen C, Doucette S. et al. Does this patient have deep vein thrombosis?. J Am Med Assoc 2006; 295: 199-207.
• 2 Kearon C. Natural history of venous thromboembolism. Circulation 2003; 107: I22-30.
• 3 Schellong SM. Venous ultrasonography in symptomatic and asymptomatic patients: an updated review. Curr Opin Pulm Med 2008; 14: 374-380.
• 4 Goodacre S, Sampson F, Stevenson M. et al. Measurement of the clinical and cost-effectiveness of non-invasive diagnostic testing strategies for deep vein thrombosis. Health Technol Assess 2006; 10: 1-168.
• 5 El Kheir D, Buller H. One-time comprehensive ultrasonography to diagnose deep venous thrombosis: is that the solution?. Ann Intern Med 2004; 140: 1052-1053.
• 6 McIlrath ST, Blaivas M, Lyon M. Patient follow-up after negative lower extremity bedside ultrasound for deep venous thrombosis in the ED. Am J Emerg Med 2006; 24: 325-328.
• 7 Palareti G, Agnelli G, Imberti D. et al. A commentary: to screen for calf DVT or not to screen? The highly variable practice among Italian centers highlights this important and still unresolved clinical option. Results from the Italian MASTER registry. Thromb Haemost 2008; 99: 241-244.
• 8 Righini M, Paris S, Le Gal G. et al. Clinical relevance of distal deep vein thrombosis. Review of literature data. Thromb Haemost 2006; 95: 56-64.
• 9 Schellong SM. Distal DVT: worth diagnosing? Yes. J Thromb Haemost 2007; 05: 51-54.
• 10 Bernardi E, Camporese G, Buller HR. et al. Serial 2-point ultrasonography plus D-dimer vs whole-leg color-coded Doppler ultrasonography for diagnosing suspected symptomatic deep vein thrombosis: a randomized controlled trial. J Am Med Assoc 2008; 300: 1653-1659.
• 11 Elias A, Mallard L, Elias M. et al. A single complete ultrasound investigation of the venous network for the diagnostic management of patients with a clinically suspected first episode of deep venous thrombosis of the lower limbs. Thromb Haemost 2003; 89: 221-227.
• 12 Schellong SM, Schwarz T, Halbritter K. et al. Complete compression ultrasonography of the leg veins as a single test for the diagnosis of deep vein thrombosis. Thromb Haemost 2003; 89: 228-234.
• 13 Stevens SM, Elliott CG, Chan KJ. et al. Withholding anticoagulation after a negative result on duplex ultrasonography for suspected symptomatic deep venous thrombosis. Ann Intern Med 2004; 140: 985-991.
• 14 Subramaniam RM, Heath R, Chou T. et al. Deep venous thrombosis: withholding anticoagulation therapy after negative complete lower limb US findings. Radiology 2005; 237: 348-352.
• 15 Qaseem A, Snow V, Barry P. et al. Current diagnosis of venous thromboembolism in primary care: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. Ann Intern Med 2007; 146: 454-458.
• 16 Squizzato A, Ageno W. The 8(th) American College of Chest Physicians Guidelines - a perspective on venous thromboembolism guidelines. Thromb Haemost 2009; 101: 31-35.
• 17 Constans J, Salmi LR, Sevestre-Pietri MA. et al. A clinical prediction score for upper extremity deep venous thrombosis. Thromb Haemost 2008; 99: 202-207.
• 18 Boulay F, Berthier F, Schoukroun G. et al. Seasonal variations in hospital admission for deep vein thrombosis and pulmonary embolism: analysis of discharge data. Br Med J 2001; 323: 601-602.
• 19 Wells PS, Anderson DR, Rodger M. et al. Evaluation of D-dimer in the diagnosis of suspected deepvein thrombosis. N Engl J Med 2003; 349: 1227-1235.
• 20 Buller HR, Agnelli G, Hull RD. et al. Antithrombotic therapy for venous thromboembolic disease: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 401S-428S.
• 21 Kearon C, Kahn SR, Agnelli G. et al. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 454S-545S.
• 22 Hull R, Hirsh J, Sackett DL. et al. Clinical validity of a negative venogram in patients with clinically suspected venous thrombosis. Circulation 1981; 64: 622-625.
• 23 Zierler BK. Ultrasonography and diagnosis of venous thromboembolism. Circulation 2004; 109: I9-14.
• 24 Birdwell BG, Raskob GE, Whitsett TL. et al. The clinical validity of normal compression ultrasonography in outpatients suspected of having deep venous thrombosis. Ann Intern Med 1998; 128: 1-7.
• 25 Cogo A, Lensing AW, Koopman MM. et al. Compression ultrasonography for diagnostic management of patients with clinically suspected deep vein thrombosis: prospective cohort study. Br Med J 1998; 316: 17-20.
• 26 Bernardi E, Prandoni P, Lensing AW. et al. D-dimer testing as an adjunct to ultrasonography in patients with clinically suspected deep vein thrombosis: prospective cohort study. The Multicentre Italian D-dimer Ultrasound Study Investigators Group. Br Med J 1998; 317: 1037-1040.
• 27 Kraaijenhagen RA, Piovella F, Bernardi E. et al. Simplification of the diagnostic management of suspected deep vein thrombosis. Arch Intern Med 2002; 162: 907-911.
• 28 Lagerstedt C, Olsson CG, Fagher B. et al. Oral anticoagulants in calf-vein thrombosis. Lancet 1985; 02: 1311-1312.
• 29 Schwarz T, Schmidt B, Schmidt B. et al. Interobserver agreement of complete compression ultrasound for clinically suspected deep vein thrombosis. Clin Appl Thromb Hemost 2002; 08: 45-49.
• 30 Chunilal SD, Bates SM. Venous thromboembolism in pregnancy: diagnosis, management and prevention. Thromb Haemost 2009; 101: 428-438.
• 31 Pineda LA, Hathwar VS, Grant BJ. Clinical suspicion of fatal pulmonary embolism. Chest 2001; 120: 791-795.