The American Journal of Medicine
Volume 123, Issue 2 , Pages 158-165, February 2010

Outcomes for Inpatients with Normal Findings on Whole-leg Ultrasonography: A Prospective Study

  • Marie-Antoinette Sevestre, MD, MSc

      Affiliations

    • Techniques de l'Ingénierie Médicale et de la Complexité, Unité Mixte de Recherche 5525, Centre National de la Recherche Scientifique, Université Joseph Fourier, Grenoble, France
    • Vascular Medicine Unit, Amiens University Hospital, Amiens, France
    • ,
  • José Labarère, MD

      Affiliations

    • Quality of Care Unit, Grenoble University Hospital, France
    • Corresponding Author InformationReprint requests should be addressed to José Labarère, MD, Quality of Care Unit, Pavillon Taillefer, CHU BP 217, 38043 Grenoble Cedex 9, France
    • ,
  • Pierre Casez, MSc

      Affiliations

    • Techniques de l'Ingénierie Médicale et de la Complexité, Unité Mixte de Recherche 5525, Centre National de la Recherche Scientifique, Université Joseph Fourier, Grenoble, France
    • ,
  • Luc Bressollette, MD

      Affiliations

    • Department of Vascular Medicine, Brest University Hospital, Brest, France
    • ,
  • Myriam Haddouche, RN

      Affiliations

    • Techniques de l'Ingénierie Médicale et de la Complexité, Unité Mixte de Recherche 5525, Centre National de la Recherche Scientifique, Université Joseph Fourier, Grenoble, France
    • ,
  • Gilles Pernod, MD, PhD

      Affiliations

    • Techniques de l'Ingénierie Médicale et de la Complexité, Unité Mixte de Recherche 5525, Centre National de la Recherche Scientifique, Université Joseph Fourier, Grenoble, France
    • ,
  • Isabelle Quéré, MD, PhD

      Affiliations

    • Department of Vascular Medicine, Montpellier University Hospital, Montpellier, France
    • ,
  • Jean-Luc Bosson, MD, PhD

      Affiliations

    • Techniques de l'Ingénierie Médicale et de la Complexité, Unité Mixte de Recherche 5525, Centre National de la Recherche Scientifique, Université Joseph Fourier, Grenoble, France
    • Center for Clinical Research, Grenoble University Hospital, Grenoble, France

Abstract 

Background

Ultrasonography is used routinely for ruling out suspected deep vein thrombosis in hospitalized patients, although most evidence supporting this strategy is derived from the outpatient setting. This study aimed to estimate the rate of venous thromboembolism when anticoagulant therapy was withheld from inpatients with normal findings on whole-leg ultrasonography.

Methods

As part of a prospective multicenter cohort study, 1926 medical and surgical inpatients with clinically suspected deep vein thrombosis during their stay were enrolled. Ultrasonography of all lower extremities was performed by board-certified vascular medicine physicians using a standardized examination protocol. Deep vein thrombosis was detected in 395 patients (20%). Anticoagulant therapy was withheld from patients with normal findings, and 523 of them were randomly selected for follow-up. The main outcome measure was 3-month incidence of symptomatic venous thromboembolism.

Results

A total of 513 patients with normal findings on ultrasonography successfully completed 3 months of follow-up, 9 patients were lost to follow-up, and 1 patient received anticoagulant therapy during follow-up. Three patients (0.6%) experienced nonfatal symptomatic venous thromboembolic events confirmed by objective testing. The cause of death was judged to be possibly related to pulmonary embolism for 7 other patients (1.3%). Overall, the 3-month rate of venous thromboembolism was 1.9% (10/513; 95% confidence interval, 0.9-3.5).

Conclusion

Although withholding anticoagulant therapy after a single negative whole-leg ultrasonography seems to be safe, up to 3.5% of inpatients may nevertheless develop venous thromboembolism in the next 3 months. Further study is warranted to determine whether this strategy is equivalent to serial compression ultrasonography limited to proximal veins.

Keywords: Cohort studies, Inpatients, Veins/ultrasonography, Venous thrombosis

 

 Funding: This study was supported by a grant from the French Ministry of Health (Programme Hospitalier de Recherche Clinique), by Grenoble University Hospital (Programme de Recherche Clinique), and by Sanofi-Aventis, Paris, France. The funding sources had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation, review, and approval of the manuscript.

 Conflicts of Interest: Drs Sevestre, Bosson, and Quéré served as consultants for Sanofi-Aventis.

 Authorship: M.A. Sevestre and J. Labarere had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All the authors have made substantive contributions to the study, have participated in the concept and design, analysis and interpretation of data, drafting or revising the manuscript, and have approved the manuscript as submitted.

PII: S0002-9343(09)00870-5

doi:10.1016/j.amjmed.2009.05.034

The American Journal of Medicine
Volume 123, Issue 2 , Pages 158-165, February 2010

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