Validating the safety of low-dose CTPA in pregnancy: results from the OPTICA (Optimised CT Pulmonary Angiography in Pregnancy) Study

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 undefin...

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Veröffentlicht in:European radiology 2024-08, Vol.34 (8), p.4864-4873
Hauptverfasser: Gillespie, Ciara D., Yates, Andrew, Hughes, Mark, Ewins, Karl, McMahon, Gabriella, Hynes, John, Murphy, Mark C., Galligan, Marie, Vencken, Sebastian, Alih, Ekele, Varden, John, Donnelly, Jennifer, Bolster, Ferdia, Rowan, Michael, Foley, Shane, NíAinle, Fionnuala, MacMahon, Peter J.
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container_end_page 4873
container_issue 8
container_start_page 4864
container_title European radiology
container_volume 34
creator Gillespie, Ciara D.
Yates, Andrew
Hughes, Mark
Ewins, Karl
McMahon, Gabriella
Hynes, John
Murphy, Mark C.
Galligan, Marie
Vencken, Sebastian
Alih, Ekele
Varden, John
Donnelly, Jennifer
Bolster, Ferdia
Rowan, Michael
Foley, Shane
NíAinle, Fionnuala
MacMahon, Peter J.
description 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 ( Opti mised C T Pulmonary A ngiography in Pregnancy) study prospectively defines th
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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 ( Opti mised C T Pulmonary A ngiography 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.</description><identifier>ISSN: 1432-1084</identifier><identifier>ISSN: 0938-7994</identifier><identifier>EISSN: 1432-1084</identifier><identifier>DOI: 10.1007/s00330-024-10593-y</identifier><identifier>PMID: 38296849</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adult ; Angiography ; Benchmarks ; Breast ; Chest ; Computed tomography ; Computed Tomography Angiography - methods ; Diagnostic Radiology ; Embolism ; Female ; Fetuses ; Humans ; Image contrast ; Image enhancement ; Image quality ; Imaging ; Internal Medicine ; Interventional Radiology ; Medical imaging ; Medicine ; Medicine &amp; Public Health ; Monte Carlo simulation ; Neuroradiology ; Observational studies ; Pregnancy ; Pregnancy Complications, Cardiovascular - diagnostic imaging ; Prospective Studies ; Pulmonary Embolism - diagnostic imaging ; Pulmonary embolisms ; Radiation ; Radiation Dosage ; Radiology ; Safety ; Signal quality ; Signal to noise ratio ; Thromboembolism ; Ultrasound</subject><ispartof>European radiology, 2024-08, Vol.34 (8), p.4864-4873</ispartof><rights>The Author(s), under exclusive licence to European Society of Radiology 2024. 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The Author(s), under exclusive licence to European Society of Radiology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-656def1f40392d9dc23bdb706d39e570b8e7e2ac5e07b44f207f320ff39cb7413</cites><orcidid>0000-0002-3006-1467</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00330-024-10593-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00330-024-10593-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38296849$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gillespie, Ciara D.</creatorcontrib><creatorcontrib>Yates, Andrew</creatorcontrib><creatorcontrib>Hughes, Mark</creatorcontrib><creatorcontrib>Ewins, Karl</creatorcontrib><creatorcontrib>McMahon, Gabriella</creatorcontrib><creatorcontrib>Hynes, John</creatorcontrib><creatorcontrib>Murphy, Mark C.</creatorcontrib><creatorcontrib>Galligan, Marie</creatorcontrib><creatorcontrib>Vencken, Sebastian</creatorcontrib><creatorcontrib>Alih, Ekele</creatorcontrib><creatorcontrib>Varden, John</creatorcontrib><creatorcontrib>Donnelly, Jennifer</creatorcontrib><creatorcontrib>Bolster, Ferdia</creatorcontrib><creatorcontrib>Rowan, Michael</creatorcontrib><creatorcontrib>Foley, Shane</creatorcontrib><creatorcontrib>NíAinle, Fionnuala</creatorcontrib><creatorcontrib>MacMahon, Peter J.</creatorcontrib><title>Validating the safety of low-dose CTPA in pregnancy: results from the OPTICA (Optimised CT Pulmonary Angiography in Pregnancy) Study</title><title>European radiology</title><addtitle>Eur Radiol</addtitle><addtitle>Eur Radiol</addtitle><description>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 ( Opti mised C T Pulmonary A ngiography 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.</description><subject>Adult</subject><subject>Angiography</subject><subject>Benchmarks</subject><subject>Breast</subject><subject>Chest</subject><subject>Computed tomography</subject><subject>Computed Tomography Angiography - methods</subject><subject>Diagnostic Radiology</subject><subject>Embolism</subject><subject>Female</subject><subject>Fetuses</subject><subject>Humans</subject><subject>Image contrast</subject><subject>Image enhancement</subject><subject>Image quality</subject><subject>Imaging</subject><subject>Internal Medicine</subject><subject>Interventional Radiology</subject><subject>Medical imaging</subject><subject>Medicine</subject><subject>Medicine &amp; 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Yates, Andrew ; Hughes, Mark ; Ewins, Karl ; McMahon, Gabriella ; Hynes, John ; Murphy, Mark C. ; Galligan, Marie ; Vencken, Sebastian ; Alih, Ekele ; Varden, John ; Donnelly, Jennifer ; Bolster, Ferdia ; Rowan, Michael ; Foley, Shane ; NíAinle, Fionnuala ; MacMahon, Peter J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-656def1f40392d9dc23bdb706d39e570b8e7e2ac5e07b44f207f320ff39cb7413</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Angiography</topic><topic>Benchmarks</topic><topic>Breast</topic><topic>Chest</topic><topic>Computed tomography</topic><topic>Computed Tomography Angiography - methods</topic><topic>Diagnostic Radiology</topic><topic>Embolism</topic><topic>Female</topic><topic>Fetuses</topic><topic>Humans</topic><topic>Image contrast</topic><topic>Image enhancement</topic><topic>Image quality</topic><topic>Imaging</topic><topic>Internal Medicine</topic><topic>Interventional Radiology</topic><topic>Medical imaging</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Monte Carlo simulation</topic><topic>Neuroradiology</topic><topic>Observational studies</topic><topic>Pregnancy</topic><topic>Pregnancy Complications, Cardiovascular - diagnostic imaging</topic><topic>Prospective Studies</topic><topic>Pulmonary Embolism - diagnostic imaging</topic><topic>Pulmonary embolisms</topic><topic>Radiation</topic><topic>Radiation Dosage</topic><topic>Radiology</topic><topic>Safety</topic><topic>Signal quality</topic><topic>Signal to noise ratio</topic><topic>Thromboembolism</topic><topic>Ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gillespie, Ciara D.</creatorcontrib><creatorcontrib>Yates, Andrew</creatorcontrib><creatorcontrib>Hughes, Mark</creatorcontrib><creatorcontrib>Ewins, Karl</creatorcontrib><creatorcontrib>McMahon, Gabriella</creatorcontrib><creatorcontrib>Hynes, John</creatorcontrib><creatorcontrib>Murphy, Mark C.</creatorcontrib><creatorcontrib>Galligan, Marie</creatorcontrib><creatorcontrib>Vencken, Sebastian</creatorcontrib><creatorcontrib>Alih, Ekele</creatorcontrib><creatorcontrib>Varden, John</creatorcontrib><creatorcontrib>Donnelly, Jennifer</creatorcontrib><creatorcontrib>Bolster, Ferdia</creatorcontrib><creatorcontrib>Rowan, Michael</creatorcontrib><creatorcontrib>Foley, Shane</creatorcontrib><creatorcontrib>NíAinle, Fionnuala</creatorcontrib><creatorcontrib>MacMahon, Peter J.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>European radiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gillespie, Ciara D.</au><au>Yates, Andrew</au><au>Hughes, Mark</au><au>Ewins, Karl</au><au>McMahon, Gabriella</au><au>Hynes, John</au><au>Murphy, Mark C.</au><au>Galligan, Marie</au><au>Vencken, Sebastian</au><au>Alih, Ekele</au><au>Varden, John</au><au>Donnelly, Jennifer</au><au>Bolster, Ferdia</au><au>Rowan, Michael</au><au>Foley, Shane</au><au>NíAinle, Fionnuala</au><au>MacMahon, Peter J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validating the safety of low-dose CTPA in pregnancy: results from the OPTICA (Optimised CT Pulmonary Angiography in Pregnancy) Study</atitle><jtitle>European radiology</jtitle><stitle>Eur Radiol</stitle><addtitle>Eur Radiol</addtitle><date>2024-08</date><risdate>2024</risdate><volume>34</volume><issue>8</issue><spage>4864</spage><epage>4873</epage><pages>4864-4873</pages><issn>1432-1084</issn><issn>0938-7994</issn><eissn>1432-1084</eissn><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 ( Opti mised C T Pulmonary A ngiography 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.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>38296849</pmid><doi>10.1007/s00330-024-10593-y</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-3006-1467</orcidid></addata></record>
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source MEDLINE; SpringerNature Journals
subjects Adult
Angiography
Benchmarks
Breast
Chest
Computed tomography
Computed Tomography Angiography - methods
Diagnostic Radiology
Embolism
Female
Fetuses
Humans
Image contrast
Image enhancement
Image quality
Imaging
Internal Medicine
Interventional Radiology
Medical imaging
Medicine
Medicine & Public Health
Monte Carlo simulation
Neuroradiology
Observational studies
Pregnancy
Pregnancy Complications, Cardiovascular - diagnostic imaging
Prospective Studies
Pulmonary Embolism - diagnostic imaging
Pulmonary embolisms
Radiation
Radiation Dosage
Radiology
Safety
Signal quality
Signal to noise ratio
Thromboembolism
Ultrasound
title Validating the safety of low-dose CTPA in pregnancy: results from the OPTICA (Optimised CT Pulmonary Angiography in Pregnancy) Study
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