Liselotte M van der Pol1, Cecile Tromeur1, Ingrid M Bistervels1, Fionnuala Ni Ainle1, Thomas van Bemmel1, Laurent Bertoletti1, Francis Couturaud1, Yordi P A van Dooren1, Antoine Elias1, Laura M Faber1, Herman M A Hofstee1, Tom van der Hulle1, Marieke J H A Kruip1, Maxime Maignan1, Albert T A Mairuhu1, Saskia Middeldorp1, Mathilde Nijkeuter1, Pierre-Marie Roy1, Olivier Sanchez1, Jeannot Schmidt1, Marije Ten Wolde1, Frederikus A Klok1, Menno V Huisman1. 1. From the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden (L.M.P., T.H., F.A.K., M.V.H.), the Department of Internal Medicine, Haga Teaching Hospital (L.M.P., A.T.A.M.), and the Department of Internal Medicine, Haaglanden Medical Center (H.M.A.H.), the Department of Vascular Medicine, Amsterdam University Medical Center, University of Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam (I.M.B., S.M.), the Department of Internal Medicine, Flevo Hospital, Almere (I.M.B., M.W.), the Department of Internal Medicine, Gelre Hospital, Apeldoorn (T.B.), the Department of Pulmonology, Groene Hart Hospital, Gouda (Y.P.A.D.), the Department of Internal Medicine, Red Cross Hospital, Beverwijk (L.M.F.), the Department of Hematology, Erasmus University Medical Center, Rotterdam (M.J.H.A.K.), and the Department of Internal Medicine, University Medical Center Utrecht, Utrecht (M.N.), all of which are part of the Dutch Thrombosis Network (DTN) - all in the Netherlands; the Department of Internal Medicine and Chest Diseases, Brest Hospital Center, Groupe d'Etude de Thrombose de Bretagne Occidentale, University of Brest, EA 3878, CIC-INSERM 1412, University of Brest, Brest (C.T., F.C.), Service de médecine vasculaire et thérapeutique, Centre Hospitalier Universitaire (CHU) Saint Etienne, INSERM CIC-1408, INSERM Unité 1059, Equipe Dysfonction Vasculaire et Hémostase, Université Jean-Monnet, Saint Etienne (L.B.), the Department of Vascular Medicine, Sainte Musse Hospital, Toulon (A.E.), the Emergency Department, CHU Grenoble-Alpes, Hypoxy-Physiopathology laboratory HP2 INSERM 1042, Grenoble (M.M.), the Emergency Department, CHU d'Angers, UFR Santé, Université d'Angers, Institut Mitovasc, UMR CNRS 6015 UMR INSERM 1083, Angers (P.-M.R.), the Department of Pulmonary Disease and Intensive Care Unit, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Faculté de Médecine, Université Sorbonne Paris Cité, INSERM UMR S 1140, Paris (O.S.), and the Emergency Department, CHU de Clermont-Ferrand, Clermont-Ferrand (J.S.), all of which are part of the French Clinical Research Infrastructure Network-Investigation Network on Venous Thrombo-Embolism (F-CRIN INNOVTE Network, Saint Etienne) - all in France; and the School of Medicine, University College Dublin, and the Department of Haematology, Rotunda Hospital Dublin, INViTE Network, Dublin (F.N.A.).
Abstract
BACKGROUND: Pulmonary embolism is one of the leading causes of maternal death in the Western world. Because of the low specificity and sensitivity of the d-dimer test, all pregnant women with suspected pulmonary embolism undergo computed tomographic (CT) pulmonary angiography or ventilation-perfusion scanning, both of which involve radiation exposure to the mother and fetus. Whether a pregnancy-adapted algorithm could be used to safely avoid diagnostic imaging in pregnant women with suspected pulmonary embolism is unknown. METHODS: In a prospective study involving pregnant women with suspected pulmonary embolism, we assessed three criteria from the YEARS algorithm (clinical signs of deep-vein thrombosis, hemoptysis, and pulmonary embolism as the most likely diagnosis) and measured the d-dimer level. Pulmonary embolism was ruled out if none of the three criteria were met and the d-dimer level was less than 1000 ng per milliliter or if one or more of the three criteria were met and the d-dimer level was less than 500 ng per milliliter. Adaptation of the YEARS algorithm for pregnant women involved compression ultrasonography for women with symptoms of deep-vein thrombosis; if the results were positive (i.e., a clot was present), CT pulmonary angiography was not performed. All patients in whom pulmonary embolism had not been ruled out underwent CT pulmonary angiography. The primary outcome was the incidence of venous thromboembolism at 3 months. The secondary outcome was the proportion of patients in whom CT pulmonary angiography was not indicated to safely rule out pulmonary embolism. RESULTS: A total of 510 women were screened, of whom 12 (2.4%) were excluded. Pulmonary embolism was diagnosed in 20 patients (4.0%) at baseline. During follow-up, popliteal deep-vein thrombosis was diagnosed in 1 patient (0.21%; 95% confidence interval [CI], 0.04 to 1.2); no patient had pulmonary embolism. CT pulmonary angiography was not indicated, and thus was avoided, in 195 patients (39%; 95% CI, 35 to 44). The efficiency of the algorithm was highest during the first trimester of pregnancy and lowest during the third trimester; CT pulmonary angiography was avoided in 65% of patients who began the study in the first trimester and in 32% who began the study in the third trimester. CONCLUSIONS: Pulmonary embolism was safely ruled out by the pregnancy-adapted YEARS diagnostic algorithm across all trimesters of pregnancy. CT pulmonary angiography was avoided in 32 to 65% of patients. (Funded by Leiden University Medical Center and 17 other participating hospitals; Artemis Netherlands Trial Register number, NL5726.).
BACKGROUND:Pulmonary embolism is one of the leading causes of maternal death in the Western world. Because of the low specificity and sensitivity of the d-dimer test, all pregnant women with suspected pulmonary embolism undergo computed tomographic (CT) pulmonary angiography or ventilation-perfusion scanning, both of which involve radiation exposure to the mother and fetus. Whether a pregnancy-adapted algorithm could be used to safely avoid diagnostic imaging in pregnant women with suspected pulmonary embolism is unknown. METHODS: In a prospective study involving pregnant women with suspected pulmonary embolism, we assessed three criteria from the YEARS algorithm (clinical signs of deep-vein thrombosis, hemoptysis, and pulmonary embolism as the most likely diagnosis) and measured the d-dimer level. Pulmonary embolism was ruled out if none of the three criteria were met and the d-dimer level was less than 1000 ng per milliliter or if one or more of the three criteria were met and the d-dimer level was less than 500 ng per milliliter. Adaptation of the YEARS algorithm for pregnant women involved compression ultrasonography for women with symptoms of deep-vein thrombosis; if the results were positive (i.e., a clot was present), CT pulmonary angiography was not performed. All patients in whom pulmonary embolism had not been ruled out underwent CT pulmonary angiography. The primary outcome was the incidence of venous thromboembolism at 3 months. The secondary outcome was the proportion of patients in whom CT pulmonary angiography was not indicated to safely rule out pulmonary embolism. RESULTS: A total of 510 women were screened, of whom 12 (2.4%) were excluded. Pulmonary embolism was diagnosed in 20 patients (4.0%) at baseline. During follow-up, popliteal deep-vein thrombosis was diagnosed in 1 patient (0.21%; 95% confidence interval [CI], 0.04 to 1.2); no patient had pulmonary embolism. CT pulmonary angiography was not indicated, and thus was avoided, in 195 patients (39%; 95% CI, 35 to 44). The efficiency of the algorithm was highest during the first trimester of pregnancy and lowest during the third trimester; CT pulmonary angiography was avoided in 65% of patients who began the study in the first trimester and in 32% who began the study in the third trimester. CONCLUSIONS:Pulmonary embolism was safely ruled out by the pregnancy-adapted YEARS diagnostic algorithm across all trimesters of pregnancy. CT pulmonary angiography was avoided in 32 to 65% of patients. (Funded by Leiden University Medical Center and 17 other participating hospitals; Artemis Netherlands Trial Register number, NL5726.).
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