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.).
N Engl J Med. 2019 Mar 21;380(12):1139-1149. doi: 10.1056/NEJMoa1813865.
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.
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.
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.
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.).
肺栓塞是西方世界导致孕产妇死亡的主要原因之一。由于 D-二聚体检测的特异性和敏感性较低，所有疑似肺栓塞的孕妇均行计算机断层扫描（CT）肺动脉造影或通气-灌注扫描，这两种方法均会使母亲和胎儿受到辐射。是否可以使用妊娠适应算法来安全避免疑似肺栓塞孕妇的诊断性影像学检查尚不清楚。
在一项涉及疑似肺栓塞孕妇的前瞻性研究中，我们评估了 YEARS 算法的三个标准（深静脉血栓形成的临床体征、咯血和肺栓塞最可能的诊断）和 D-二聚体水平。如果三个标准均不满足且 D-二聚体水平低于 1000 纳克/毫升，或者如果一个或多个标准满足且 D-二聚体水平低于 500 纳克/毫升，则排除肺栓塞。YEARS 算法对孕妇的适应性涉及对有深静脉血栓形成症状的妇女进行超声压缩检查；如果结果阳性（即存在血栓），则不进行 CT 肺动脉造影。所有未排除肺栓塞的患者均行 CT 肺动脉造影。主要结局是 3 个月时静脉血栓栓塞的发生率。次要结局是未行 CT 肺动脉造影即可安全排除肺栓塞的患者比例。
共筛选了 510 名妇女，其中 12 名（2.4%）被排除。基线时有 20 名患者（4.0%）被诊断为肺栓塞。在随访期间，1 名患者（0.21%；95%置信区间 [CI]，0.04 至 1.2）被诊断为腘窝深静脉血栓形成；无患者发生肺栓塞。195 名患者（39%；95%CI，35 至 44）不需要进行 CT 肺动脉造影，因此避免了进行 CT 肺动脉造影。该算法的效率在妊娠早期最高，在妊娠晚期最低；在妊娠早期开始研究的 65%的患者和妊娠晚期开始研究的 32%的患者中避免了 CT 肺动脉造影。
妊娠适应的 YEARS 诊断算法可在整个妊娠期间安全排除肺栓塞。32%至 65%的患者避免了 CT 肺动脉造影。（由莱顿大学医学中心和其他 17 家参与医院资助；Artemis 荷兰试验登记号，NL5726。）
