Marc Righini1, Helia Robert-Ebadi1, Antoine Elias2, Olivier Sanchez3, Emmanuelle Le Moigne4, Jeannot Schmidt5, Catherine Le Gall6, Jacques Cornuz7, Drahomir Aujesky8, Pierre-Marie Roy9, Céline Chauleur10, Olivier T Rutschmann1, Pierre-Alexandre Poletti1, Grégoire Le Gal11. 1. Geneva University Hospitals, Geneva, Switzerland (M.R., H.R., O.T.R., P.P.). 2. Centre Hospitalier de Toulon, Toulon, France (A.E.). 3. Université Paris Descartes, Sorbonne Paris Cité, and Hôpital Européen Georges Pompidou, Paris, France (O.S.). 4. INSERM UMR S 1140, Paris, France, F-CRIN INNOVTE, Saint-Etienne, France, and Université de Brest, Brest, France (E.L.). 5. Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France (J.S.). 6. Centre Hospitalier d'Argenteuil, Argenteuil, France (C.L.). 7. Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (J.C.). 8. Bern University Hospital, University of Bern, Bern, Switzerland (D.A.). 9. University Hospital of Angers, Angers, France (P.R.). 10. INSERM U1059, University of Lyon, and University Hospital, Saint-Etienne, France (C.C.). 11. Université de Brest, Brest, France, and Ottawa Health Research Institute, Ottawa, Ontario, Canada (G.L.).
Abstract
Background: Data on the optimal diagnostic management of pregnant women with suspected pulmonary embolism (PE) are limited, and guidelines provide inconsistent recommendations on use of diagnostic tests. Objective: To prospectively validate a diagnostic strategy in pregnant women with suspected PE. Design: Multicenter, multinational, prospective diagnostic management outcome study involving pretest clinical probability assessment, high-sensitivity D-dimer testing, bilateral lower limb compression ultrasonography (CUS), and computed tomography pulmonary angiography (CTPA). (ClinicalTrials.gov: NCT00740454). Setting: 11 centers in France and Switzerland between August 2008 and July 2016. Patients: Pregnant women with clinically suspected PE in emergency departments. Intervention: Pulmonary embolism was excluded in patients with a low or intermediate pretest clinical probability and a negative D-dimer result. All others underwent lower limb CUS and, if results were negative, CTPA. A ventilation-perfusion (V/Q) scan was done if CTPA results were inconclusive. Pulmonary embolism was excluded if results of the diagnostic work-up were negative, and untreated pregnant women had clinical follow-up at 3 months. Measurements: The primary outcome was the rate of adjudicated venous thromboembolic events during the 3-month follow-up. Results: 441 women were assessed for eligibility, and 395 were included in the study. Among these, PE was diagnosed in 28 (7.1%) (proximal deep venous thrombosis found on ultrasonography [n = 7], positive CTPA result [n = 19], and high-probability V/Q scan [n = 2]) and excluded in 367 (clinical probability and negative D-dimer result [n = 46], negative CTPA result [n = 290], normal or low-probability V/Q scan [n = 17], and other reason [n = 14]). Twenty-two women received extended anticoagulation during follow-up, mainly for previous venous thromboembolic disease. The rate of symptomatic venous thromboembolic events was 0.0% (95% CI, 0.0% to 1.0%) among untreated women after exclusion of PE on the basis of negative results on the diagnostic work-up. Limitation: There were several protocol deviations, reflecting the difficulty of performing studies in pregnant women with suspected PE. Conclusion: A diagnostic strategy based on assessment of clinical probability, D-dimer measurement, CUS, and CTPA can safely rule out PE in pregnant women. Primary Funding Source: Swiss National Foundation for Scientific Research, Groupe d'Etude de la Thrombose de Bretagne Occidentale, and International Society on Thrombosis and Haemostasis.
Background: Data on the optimal diagnostic management of pregnant women with suspected pulmonary embolism (PE) are limited, and guidelines provide inconsistent recommendations on use of diagnostic tests. Objective: To prospectively validate a diagnostic strategy in pregnant women with suspected PE. Design: Multicenter, multinational, prospective diagnostic management outcome study involving pretest clinical probability assessment, high-sensitivity D-dimer testing, bilateral lower limb compression ultrasonography (CUS), and computed tomography pulmonary angiography (CTPA). (ClinicalTrials.gov: NCT00740454). Setting: 11 centers in France and Switzerland between August 2008 and July 2016. Patients: Pregnant women with clinically suspected PE in emergency departments. Intervention: Pulmonary embolism was excluded in patients with a low or intermediate pretest clinical probability and a negative D-dimer result. All others underwent lower limb CUS and, if results were negative, CTPA. A ventilation-perfusion (V/Q) scan was done if CTPA results were inconclusive. Pulmonary embolism was excluded if results of the diagnostic work-up were negative, and untreated pregnant women had clinical follow-up at 3 months. Measurements: The primary outcome was the rate of adjudicated venous thromboembolic events during the 3-month follow-up. Results: 441 women were assessed for eligibility, and 395 were included in the study. Among these, PE was diagnosed in 28 (7.1%) (proximal deep venous thrombosis found on ultrasonography [n = 7], positive CTPA result [n = 19], and high-probability V/Q scan [n = 2]) and excluded in 367 (clinical probability and negative D-dimer result [n = 46], negative CTPA result [n = 290], normal or low-probability V/Q scan [n = 17], and other reason [n = 14]). Twenty-two women received extended anticoagulation during follow-up, mainly for previous venous thromboembolic disease. The rate of symptomatic venous thromboembolic events was 0.0% (95% CI, 0.0% to 1.0%) among untreated women after exclusion of PE on the basis of negative results on the diagnostic work-up. Limitation: There were several protocol deviations, reflecting the difficulty of performing studies in pregnant women with suspected PE. Conclusion: A diagnostic strategy based on assessment of clinical probability, D-dimer measurement, CUS, and CTPA can safely rule out PE in pregnant women. Primary Funding Source: Swiss National Foundation for Scientific Research, Groupe d'Etude de la Thrombose de Bretagne Occidentale, and International Society on Thrombosis and Haemostasis.
Authors: Robert A Ariëns; Beverley J Hunt; Ejaife O Agbani; Josefin Ahnström; Robert Ahrends; Raza Alikhan; Alice Assinger; Zsuzsa Bagoly; Alessandra Balduini; Elena Barbon; Christopher D Barrett; Paul Batty; Jorge David Aivazoglou Carneiro; Wee Shian Chan; Moniek de Maat; Kerstin de Wit; Cécile Denis; Martin H Ellis; Renee Eslick; Hongxia Fu; Catherine P M Hayward; Benoit Ho-Tin-Noé; Frederikus A Klok; Riten Kumar; Karin Leiderman; Rustem I Litvinov; Nigel Mackman; Zoe McQuilten; Matthew D Neal; William A E Parker; Roger J S Preston; Julie Rayes; Alireza R Rezaie; Lara N Roberts; Bianca Rocca; Susan Shapiro; Deborah M Siegal; Lirlândia P Sousa; Katsue Suzuki-Inoue; Tahira Zafar; Jiaxi Zhou Journal: Res Pract Thromb Haemost Date: 2022-07-06
Authors: Marilyn L Kwan; Diana L Miglioretti; Emily C Marlow; E J Aiello Bowles; Sheila Weinmann; Stephanie Y Cheng; Kamala A Deosaransingh; Prachi Chavan; Lisa M Moy; Wesley E Bolch; James R Duncan; Robert T Greenlee; Lawrence H Kushi; Jason D Pole; Alanna K Rahm; Natasha K Stout; R Smith-Bindman Journal: JAMA Netw Open Date: 2019-07-03
Authors: David C Rotzinger; Vincent Dunet; Vesna Ilic; Olivier W Hugli; Reto A Meuli; Sabine Schmidt Journal: Eur Radiol Date: 2019-11-14 Impact factor: 5.315