The Di PEP  (Diagnosis of  PE  in Pregnancy) biomarker study: An observational cohort study augmented with additional cases to determine the diagnostic utility of biomarkers for suspected venous thromboembolism during pregnancy and puerperium

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Summary

This study aimed to estimate the diagnostic utility of biomarkers for suspected venous thromboembolism ( VTE) in pregnancy and the puerperium. Research nurses/midwives collected blood samples from 310 pregnant/postpartum women with suspected pulmonary emboli ( PE) and 18 with diagnosed deep vein thrombosis ( DVT). VTE was diagnosed using imaging, treatment and adverse outcome data. Primary analysis was limited to women with conclusive imaging (36 with VTE, 247 without). The area under the curve ( AUC) for each biomarker was: activated partial thromboplastin time 0·669 (95% confidence interval 0·570–0·768), B‐type natriuretic peptide 0·549 (0·453–0·645), C‐reactive protein 0·542 (0·445–0·639), Clauss fibrinogen 0·589 (0·476–0·701), D‐Dimer (by enzyme‐linked immunosorbent assay) 0·668 (0·561–0·776), near‐patient D‐Dimer 0·651 (0·545–0·758), mid‐regional pro‐atrial natriuretic peptide 0·524 (0·418–0·630), prothrombin fragment 1 + 2 0·562 (0·462–0·661), plasmin‐antiplasmin complexes 0·639 (0·536–0·742), prothombin time 0·613 (0·508–0·718), thrombin generation lag time 0·702 (0·598–0·806), thrombin generation endogenous potential 0·559 (0·437–0·681), thrombin generation peak 0·596 (0·478–0·715), thrombin generation time to peak 0·655 (0·541–0·769), soluble tissue factor 0·531 (0·424–0·638) and serum troponin 0·597 (0·499–0·695). No diagnostically useful threshold for diagnosing or ruling out VTE was identified. In pregnancy and the puerperium, conventional and candidate biomarkers have no utility either for their negative or positive predictive value in the diagnosis of VTE.

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An official American Thoracic Society/Society of Thoracic Radiology clinical practice guideline: evaluation of suspected pulmonary embolism in pregnancy.

Megan B McCullough, D. Lockwood, Jannine Cody … (2011)

Pulmonary embolism (PE) is a leading cause of maternal mortality in the developed world. Along with appropriate prophylaxis and therapy, prevention of death from PE in pregnancy requires a high index of clinical suspicion followed by a timely and accurate diagnostic approach. To provide guidance on this important health issue, a multidisciplinary panel of major medical stakeholders was convened to develop evidence-based guidelines for evaluation of suspected pulmonary embolism in pregnancy using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system. In formulation of the recommended diagnostic algorithm, the important outcomes were defined to be diagnostic accuracy and diagnostic yield; the panel placed a high value on minimizing cumulative radiation dose when determining the recommended sequence of tests. Overall, the quality of the underlying evidence for all recommendations was rated as very low or low, with some of the evidence considered for recommendations extrapolated from studies of the general population. Despite the low-quality evidence, strong recommendations were made for three specific scenarios: performance of chest radiography (CXR) as the first radiation-associated procedure; use of lung scintigraphy as the preferred test in the setting of a normal CXR; and performance of computed-tomographic pulmonary angiography (CTPA) rather than digital subtraction angiography (DSA) in a pregnant woman with a nondiagnostic ventilation-perfusion (V/Q) result. The recommendations presented in this guideline are based upon the currently available evidence; availability of new clinical research data and development and dissemination of new technologies will necessitate a revision and update.

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The use of D-dimer with new cutoff can be useful in diagnosis of venous thromboembolism in pregnancy.

Mirjana Kovac, Zeljko Mikovic, Ljiljana Rakicevic … (2010)

D-dimer testing has an important role in the exclusion of acute venous thromboembolism (VTE) in the nonpregnant population. Establishing D-dimers role in the diagnosis of VTE in pregnancy is hampered because of the substantial increase of D-dimer throughout gestational age. In a prospective study we followed 89 healthy pregnant women to establish the reference range of D-dimer for each trimester. D-dimer testing was also performed in 12 women with clinical suspicion of VTE and their results were compared with the established new reference range of D-dimer, and with the recorded ultrasound findings. In the first trimester, 84% women from reference group had normal D-dimer, in the second 33%, and by the third trimester only 1%, which suggests that D-dimer has no practical diagnostic use in ruling out VTE if the threshold of 230 ng/mL for abnormal is used. All pregnant women with thrombosis who had positive ultrasound findings also had statistically significant elevation of the D-dimer level, considering the established reference range of the corresponding trimester. We found 100% sensitivity of D-dimer test. A women developed thrombosis in the first trimester had 6.7-7.6 time higher level of D-dimer than the mean value in the reference group, and in the third trimester thrombotic women had 2.0-3.8 time higher level of D-dimer, p<0.0001. D-dimer test with the new threshold for: the first of 286, the second of 457 and the third trimester of 644 ng/mL can be useful in diagnosis of pregnancy related VTE.

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Large D-Dimer Fluctuation in Normal Pregnancy: A Longitudinal Cohort Study of 4,117 Samples from 714 Healthy Danish Women

Katrine K. Hedengran, Malene Andersen, Steen Stender … (2016)

Introduction. D-dimer levels increase throughout pregnancy, hampering the usefulness of the conventional threshold for dismissing thromboembolism. This study investigates the biological fluctuation of D-dimer in normal pregnancy. Methods. A total of 801 healthy women with expected normal pregnancies were recruited. D-dimer was repeatedly measured during pregnancy, at active labor, and on the first and second postpartum days. Percentiles for each gestational week were calculated. Each individual D-dimer was normalized by transformation into percentiles for the relevant gestational age or delivery group. The range in percentage points during the pregnancy and the delivery was calculated, and reference intervals were calculated for each pregnancy trimester, during vaginal delivery and scheduled and emergency cesarean section, and for the first and second day postpartum. Results. D-dimer increased during pregnancy; the maximal fluctuation was approximately 20 percentile points in approximately half of the women. In one out of ten women, the D-dimer values fluctuated by more than 50 percentile points. Conclusions. Due to the biological variation in D-dimer within each individual woman during normal pregnancy, repeated D-dimer measurements are of no clinical use in the evaluation of thromboembolic events during pregnancy.

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Author and article information

Contributors

Beverley J Hunt:

ORCID: http://orcid.org/0000-0002-4709-0774

beverley.hunt@gstt.nhs.uk

Journal

Journal ID (nlm-ta): Br J Haematol

Journal ID (iso-abbrev): Br. J. Haematol

Journal ID (doi): 10.1111/(ISSN)1365-2141

Journal ID (publisher-id): BJH

Title: British Journal of Haematology

Publisher: John Wiley and Sons Inc. (Hoboken )

ISSN (Print): 0007-1048

ISSN (Electronic): 1365-2141

Publication date (Electronic): 23 January 2018

Publication date (Print): March 2018

Volume: 180

Issue: 5 ( doiID: 10.1111/bjh.2018.180.issue-5 )

Pages: 694-704

Affiliations

[ ¹ ] Guy's & St Thomas's NHS Foundation Trust London UK

[ ² ] School of Health and Related Research University of Sheffield Sheffield UK

Author notes

[*] [* ] Correspondence: Beverley Hunt, Guy's & St Thomas's NHS Foundation Trust, Great Maze Pond, London, SE1 9RT, UK.

E‐mail: beverley.hunt@ 123456gstt.nhs.uk

Author information

Beverley J Hunt http://orcid.org/0000-0002-4709-0774

Article

Publisher ID: BJH15102

DOI: 10.1111/bjh.15102

PMC ID: 5887890

PubMed ID: 29359796

SO-VID: 0c2da575-5577-4f1a-ba3c-7ee1f7e25460

License:

This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

History

Date received : 31 August 2017

Date accepted : 07 November 2017

Page count

Figures: 3, Tables: 5, Pages: 11, Words: 7434

Funding

Funded by: United Kingdom National Institute for Health Research Health Technology Assessment programme

Funded by: NHS

Funded by: NIHR

Funded by: Department of Health

Custom metadata

source-schema-version-number 2.0

component-id bjh15102

cover-date March 2018

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.3.3 mode:remove_FC converted:28.03.2018

ScienceOpen disciplines: Hematology

Keywords: pulmonary embolism,pregnancy,postpartum,biomarkers,d‐dimer,diagnosis

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ScienceOpen disciplines: Hematology

Keywords: pulmonary embolism, pregnancy, postpartum, biomarkers, d‐dimer, diagnosis

The DiPEP (Diagnosis of PE in Pregnancy) biomarker study: An observational cohort study augmented with additional cases to determine the diagnostic utility of biomarkers for suspected venous thromboembolism during pregnancy and puerperium

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Most cited references 14

An official American Thoracic Society/Society of Thoracic Radiology clinical practice guideline: evaluation of suspected pulmonary embolism in pregnancy.

The use of D-dimer with new cutoff can be useful in diagnosis of venous thromboembolism in pregnancy.

Large D-Dimer Fluctuation in Normal Pregnancy: A Longitudinal Cohort Study of 4,117 Samples from 714 Healthy Danish Women

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