Abstract
Background
Pulmonary embolism (PE) is a leading cause of pregnancy-related mortality. CT pulmonary angiogram (CTPA) is the first-line advanced imaging modality for suspected PE in pregnancy at institutes offering low-dose techniques; however, a protocol balancing safety with low dose remains undefined. The wide range of CTPA doses reported in pregnancy suggests a lack of confidence in implementing low-dose techniques in this group.
Purpose
To define and validate the safety, radiation dose and image quality of a low-dose CTPA protocol optimised for pregnancy.
Materials and methods
The OPTICA study is a prospective observational study. Pregnant study participants with suspected PE underwent the same CTPA protocol between May 2018 and February 2022. The primary outcome, CTPA safety, was judged by the reference standard; the 3-month incidence of venous thromboembolism (VTE) in study participants with a negative index CTPA. Secondary outcomes defined radiation dose and image quality. Absorbed breast, maternal effective and fetal doses were estimated by Monte-Carlo simulation on gestation-matched phantoms. Image quality was assessed by signal-to-noise and contrast-to-noise ratios and a Likert score for pulmonary arterial enhancement.
Results
A total of 116 CTPAs were performed in 113 pregnant women of which 16 CTPAs were excluded. PE was diagnosed on 1 CTPA and out-ruled in 99. The incidence of recurrent symptomatic VTE was 0.0% (one-sided 95% CI, 2.66%) at follow-up. The mean absorbed breast dose was 2.9 ± 2.1mGy, uterine/fetal dose was 0.1 ± 0.2mGy and maternal effective dose was 1.4 ± 0.9mSv. Signal-to-noise ratio (SNR) was 11.9 ± 3.7. Contrast-to-noise ratio (CNR) was 10.4 ± 3.5.
Conclusion
The OPTICA CTPA protocol safely excluded PE in pregnant women across all trimesters, with low fetal and maternal radiation.
Clinical relevance
OPTICA (Optimised CT Pulmonary Angiography in Pregnancy) is the first prospective study to define the achievable radiation dose, image-quality and safety of a low-dose CT pulmonary angiogram protocol optimised for pregnancy (NCT04179487). It provides the current benchmark for safe and achievable CT pulmonary angiogram doses in the pregnant population.
Key Points
• Despite the increased use of CT pulmonary angiogram in pregnancy, an optimised low-dose protocol has not been defined and reported doses in pregnancy continue to vary widely.
• The OPTICA (Optimised CT Pulmonary Angiography in Pregnancy) study prospectively defines the achievable dose, image quality and safety of a low-dose CT pulmonary angiogram protocol using widely available technology.
• OPTICA provides a benchmark for safe and achievable CT pulmonary angiogram doses in the pregnant population.
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Abbreviations
- AEC:
-
Automatic exposure control
- ATPM:
-
Automatic tube potential modulation
- CIAC:
-
Central independent adjudication committee
- CNR:
-
Contrast-to-noise ratio
- CTDIvol:
-
Volume CT dose index
- DLP:
-
Dose length product
- ICC:
-
Intra-class correlation coefficient
- IQR:
-
Interquartile range
- PE:
-
Pulmonary embolism
- SNR:
-
Signal-to-noise ratio
- VTE:
-
Venous thromboembolism
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Acknowledgements
The authors acknowledge Ms Brenda Molloy and the UCD Clinical Research Committee’s assistance with trial set-up and statistical analysis, the Mater Misericordiae University Hospital Data Protection Officer, Mr Ronan O’Halloran for advising on data-access considerations and Dr. Lee and the National Cancer Institute for access to the NCICT software for Monte-Carlo analysis. Furthermore, the authors acknowledge that a small subset of OPTICA’s dataset (20 of 100 CTPAs) was previously analysed with regard to the impact of shielding on breast dose, as per protocol.
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The authors state that this work has not received any funding.
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The scientific guarantor of this publication is the principal investigator Professor Peter MacMahon.
Conflict of interest
The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.
Statistics and biometry
The UCD Clinical Research Committee kindly provided statistical advice for this manuscript and the authors include a biostatistician.
Informed consent
Written informed consent was obtained from all subjects (patients) in this study.
Ethical approval
Institutional Review Board approval was obtained at Mater Misericordiae University Hospital, Dublin, Ireland.
Study subjects or cohorts overlap
A small subset of OPTICA’s dataset (20 of 100 CTPAs) was previously analysed and reported with regard to the impact of shielding on breast dose [1]. This was planned as part of the study and laid out in our published protocol [2]. Breast shielding was not implemented in the remaining 80 CTPAs in part due to concerns regarding cross-contamination in the context of the pandemic.
1. Gillespie CD, Yates A, Murphy MC, Hughes M, Ewins K, NíAinle F, Bolster F, Rowan M, Foley S, MacMahon PJ. Breast shielding combined with an optimized computed tomography pulmonary angiography pregnancy protocol: a special use-case for shielding? J Thorac Imaging 2023;38(1):36–43. https://doi.org/10.1097/rti.0000000000000677.
2. Gillespie C, Foley S, Rowan M, Ewins K, NiAinle F, MacMahon P. The OPTICA study (Optimised Computed Tomography Pulmonary Angiography in Pregnancy Quality and Safety study): rationale and design of a prospective trial assessing the quality and safety of an optimised CTPA protocol in pregnancy. Thrombosis research 2019;177:172–179. https://doi.org/10.1016/j.thromres.2019.03.007.
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Gillespie, C.D., Yates, A., Hughes, M. et al. Validating the safety of low-dose CTPA in pregnancy: results from the OPTICA (Optimised CT Pulmonary Angiography in Pregnancy) Study. Eur Radiol (2024). https://doi.org/10.1007/s00330-024-10593-y
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DOI: https://doi.org/10.1007/s00330-024-10593-y