Abstract
Objectives
To assess information reflecting radiation dose and define diagnostic reference levels (DRL) on a European basis for four interventional radiology (IR) procedures considering clinical indication, anatomical region, and procedure.
Methods
A prospective European study was performed to provide data on the IR procedures percutaneous recanalization of iliac arteries, percutaneous recanalization of femoropopliteal arteries, transarterial chemoembolization of hepatocellular carcinoma, and percutaneous transhepatic biliary drainage. Hospitals were asked to complete a questionnaire giving information on procedure, equipment, and protocol. Patient size and weight, experience of the operator graded in number of procedures performed, and complexity level of each procedure were reported. Sixteen hospitals from 13 countries could be surveyed. The percentiles of the kerma-area product, fluoroscopy time, cumulative air kerma at the interventional reference point, and number of images were determined. The impact of equipment, year of installation, and complexity level of the procedure on dose were analyzed.
Results
DRLs based on clinical indication were defined. Dose values varied considerably within hospitals, between them, and within each subgroup of complexity level. The use of state-of-the-art equipment reduced dose significantly by 52%. Although dose also varied within each subgroup of complexity level, for transarterial chemoembolization of hepatocellular carcinoma and percutaneous transhepatic biliary drainage, dose significantly correlated with complexity.
Conclusions
This was the first study reporting exposure practice and defining DRLs based on clinical indication for four IR procedures on a European basis. These DRLs can serve as a baseline for comparison with local practice, the study as a guideline for future surveys.
Key Points
• The use of state-of-the-art angiographic equipment reduces dose significantly.
• A significant correlation between radiation dose and complexity level is found.
• Dose values vary considerably, both within and between individual hospitals, and within each complexity level of interventional radiology procedure.
This is a preview of subscription content, access via your institution.









Abbreviations
- AEC:
-
Automatic exposure control
- CI:
-
Clinical indication
- DRL:
-
Diagnostic reference level
- ESR:
-
European Society of Radiology
- EUCLID:
-
European Study on Clinical DRLs
- fps:
-
Frames per second
- ICRP:
-
International Commission on Radiological Protection
- IR:
-
Interventional radiology
- K a,r :
-
Cumulative air kerma at the patient entrance reference
- NI :
-
Number of frames in cine mode
- pct:
-
Percentile
- P KA :
-
Kerma-area product
- PTA:
-
Percutaneous transluminal angioplasty
- PTBD:
-
Percutaneous transhepatic cholangiography and biliary drainage
- T :
-
Fluoroscopy time
- TACE:
-
Transarterial chemoembolization of hepatocellular carcinoma
References
European Commission (2014) Medical radiation exposure of the European population. Radiation Protection 180. European Commission, Brussels. Available via https://ec.europa.eu/energy/topics/nuclear-energy/radiation-protection/scientific-seminars-and-publications/radiation-protection-publications_en. Accessed 8 Jan 2021
United Nations Scientific Committee on the Effects of Atomic Radiation (2008) Sources and effects of ionizing radiation UNSCEAR Report to the General Assembly I:1-24. United Nations, New York. Available via https://www.unscear.org/unscear/en/publications/2008_1.html. Accessed 8 Jan 2021
Miller DL, Vañó E, Bartal G et al (2010) Occupational radiation protection in interventional radiology: a joint guideline of the cardiovascular and interventional radiology society of Europe and the society of interventional radiology. Cardiovasc Intervent Radiol 33:230–239
Council of the European Union (2014) 2013/59/Euratom on basic safety standards for protection against the dangers arising from exposure to ionising radiation and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom. Official Journal of the EU L 13:1-73. European Council, Brussels. Available via https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32013L0059&qid=1614947445366. Accessed 8 Jan 2021
International Commission on Radiological Protection (2017) Diagnostic reference levels in medical imaging. ICRP Publication 135. Ann ICRP 46
Miller DL, Hilohi CM, Spelic DC (2012) Patient radiation doses in interventional cardiology in the U.S.: advisory data sets and possible initial values for U.S. reference levels. Med Phys 39:6276–6286
Miller DL, Kwon D, Bonavia GH (2009) Reference levels for patient radiation doses in interventional radiology: proposed initial values for U.S. practice. Radiology 253:753–764
Vañó E, Gonzalez L (2001) Approaches to establishing reference levels in interventional radiology. Radiat Prot Dosimetry 94:109–112
European Society of Radiology (2020) EUCLID – European study on clinical diagnostic reference levels for X-ray medical imaging. European Society of Radiology, Vienna. Available via http://www.eurosafeimaging.org/euclid/. Accessed 8 Jan 2021
International Electrotechnical Commission (2017) Medical electrical equipment - Part 2-43: particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures IEC 60601-2-43+AMD1
Ruiz-Cruces R, Vañó E, Carrera-Magariño F et al (2016) Diagnostic reference levels and complexity indices in interventional radiology: a national programme. Eur Radiol 26:4268–4276
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG (2009) Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377–381
Fetterly KA, Lennon RJ, Bell MR, Holmes DR, Rihal CS (2011) Clinical determinants of radiation dose in percutaneous coronary interventional procedures. JACC Cardiovasc Interv 4:336–343
European Commission (2012) Criteria for acceptability of medical radiological equipment used in diagnostic radiology, nuclear medicine and radiotherapy. Radiation Protection 162. European Commission, Brussels. Available via https://ec.europa.eu/energy/topics/nuclear-energy/radiation-protection/scientific-seminars-and-publications/radiation-protection-publications_en. Accessed 8 Jan 2021
International Atomic Energy Agency (2014) Radiation protection and safety of radiation sources: international basic safety standards. General safety requirements part 3. International Atomic Energy Agency, Vienna. Available via https://www.iaea.org/publications/8930/radiation-protection-and-safety-of-radiation-sources-international-basic-safety-standards. Accessed 8 Jan 2021
Vañó E, Gonzalez L, Fernandez JM, Prieto C, Guibelalde E (2006) Influence of patient thickness and operation modes on occupational and patient radiation doses in interventional cardiology. Radiat Prot Dosimetry 118:325–330
Pitton MB, Kloeckner R, Schneider J, Ruckes C, Bersch A, Düber C (2012) Radiation exposure in vascular angiographic procedures. J Vasc Interv Radiol 23:1487–1495
Balter S, Miller DL, Bushberg JT et al (2014) Outline of administrative policies for quality assurance and peer review of tissue reactions associated with fluoroscopically-guided interventions. National Council on Radiation Protection and Measurements (NCRP) Statement No. 11
Federal Republic of Germany (2018) Radiation protection ordinance. Federal law gazette Part 1 No. 41. Federal Republic of Germany, Bonn. Available at: https://www.bmu.de/en/law/radiation-protection-ordinance-1/. Accessed 8 Jan 2021
Etard C, Bigand E, Salvat C et al (2017) Patient dose in interventional radiology: a multicentre study of the most frequent procedures in France. Eur Radiol. https://doi.org/10.1007/s00330-017-4780-5
Schegerer A, Loose R, Heuser LJ, Brix G (2019) Diagnostic reference levels for diagnostic and interventional X-Ray procedures in Germany: update and handling. Rofo 191:739–751
Schmitz D, Vogl T, Nour-Eldin NA et al (2019) Patient radiation dose in percutaneous biliary interventions: recommendations for DRLs on the basis of a multicentre study. Eur Radiol 29:3390–3400
Acknowledgements
The authors are grateful to the participating hospitals for their contribution to this study. Furthermore, the support of the representatives of national authorities and professional societies is gratefully acknowledged. In particular, the authors thank Jonathan Clark, Ulrike Mayerhofer-Sebera, and Monika Hierath, ESR, for their untiring commitment in organizing and administrating this project. The EUCLID project was financially supported by the grant ENER/2017/NUCL/SI2.759174 of the European Commission.
Funding
This study has received funding from the European Commission, grant no. ENER/2017/NUCL/SI2.759174.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Guarantor
The scientific guarantor of this publication is Prof. Guy Frija.
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
One of the authors has significant statistical expertise.
Informed consent
Written informed consent was waived by the Institutional Review Boards.
Ethical approval
Institutional Review Board approval was obtained.
Methodology
• prospective
• cross-sectional study
• multicenter study
Additional information
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Supplementary Information
ESM 1
(DOCX 17 kb)
Rights and permissions
About this article
Cite this article
Schegerer, A.A., Frija, G., Paulo, G. et al. Radiation dose and diagnostic reference levels for four interventional radiology procedures: results of the prospective European multicenter survey EUCLID. Eur Radiol 31, 9346–9360 (2021). https://doi.org/10.1007/s00330-021-08029-y
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00330-021-08029-y