Clinical study
Withholding treatment in patients with acute pulmonary embolism who have a high risk of bleeding and negative serial noninvasive leg tests

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Abstract

PURPOSE: Patients who have nonmassive acute pulmonary embolism and a high risk of bleeding or contraindication to anticoagulants, such recent surgery or gastrointestinal bleeding, present a clinical dilemma. We sought to estimate whether such patients could be safely left untreated if serial compression ultrasound or serial impedance plethysmography were negative and cardiorespiratory reserve was adequate.

SUBJECTS AND METHODS: The frequency of recurrent pulmonary embolism among patients with nonmassive acute pulmonary embolism and negative serial noninvasive leg tests who were not treated was estimated from two prospective studies of the noninvasive management of patients with suspected pulmonary embolism. One of the studies used serial impedance plethysmography of the lower extremities; the other used serial compression ultrasound. The prevalence of pulmonary embolism in patients with nondiagnostic ventilation/perfusion lung scans was determined from the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED).

RESULTS: The estimated frequency of fatal recurrent pulmonary embolism was 1% [95% confidence interval (CI), 0% to 5%) among untreated patients with nonmassive pulmonary embolism who had negative serial impedance plethysmograms and 0% (95% CI, 0% to 4%) among those with negative serial compression ultrasonograms. The frequency of nonfatal recurrent pulmonary embolism among untreated patients was 3%, regardless of whether they had negative serial impedance plethysmograms or negative serial compression ultrasonograms. These results were comparable with the frequency of recurrent pulmonary embolism among patients treated with anticoagulants or with inferior vena cava filters.

CONCLUSION: Withholding treatment of nonmassive acute pulmonary embolism, if serial impedance plethysmograms or serial venous ultrasonograms are negative and cardiopulmonary reserve is adequate, is a possible strategy for the management of patients with a high risk of bleeding or other contraindication to anticoagulants. This strategy may be associated with fewer adverse events than treatment with anticoagulants or an inferior vena cava filter. Prospective trials comparing alternative treatments are needed.

Section snippets

Material and methods

The risk of fatal or nonfatal recurrent pulmonary embolism among untreated patients with nonmassive acute pulmonary embolism who have negative serial impedance plethysmography or negative serial compression ultrasonography of the lower extremities was estimated from prior level-I studies. The essential features of level-I studies are that patients must be studied consecutively; all patients must undergo both the test under consideration and a reference test; a broad spectrum of patients should

Calculations based on serial impedance plethysmography in patients with suspected pulmonary embolism, nondiagnostic lung scans, and adequate cardiorespiratory reserve

Nondiagnostic ventilation/perfusion lung scans were observed in 711 patients with suspected pulmonary embolism and adequate cardiopulmonary reserve (1). Among these, 185 (26%) are presumed to have had pulmonary embolism initially, based on the results of PIOPED (4). Serial impedance plethysmography showed proximal deep venous thrombosis in 84 of these patients. They were treated with anticoagulants and considered to have pulmonary embolism. The remaining 101 patients who were presumed to have

Discussion

These projections suggest that treatment with anticoagulants may be withheld safely in patients with a high risk of bleeding or contraindication to anticoagulants, providing that serial noninvasive leg tests are negative and cardiorespiratory reserve is adequate. In the context of established pulmonary embolism, this is a new and untested approach. Previous strategies that used serial noninvasive leg tests were applicable to patients with suspected pulmonary embolism 1, 2, 17. Management of

Acknowledgements

We thank Matthew S. Butcher, BS, and Andrew F. Mah, BS, for their assistance in the preparation of the manuscript.

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