PMP Progress in Medical Physics 30(4), December 2019 https://doi.org/10.14316/pmp.2019.30.4.75 eISSN 2508-4453 Review Article Review of National Diagnostic Reference Levels for Interventional Procedures Min Young Lee , Jae Kwon , Gang Woo Ryu , Ki Hoon Kim , Hyung Woo Nam , Kwang Pyo Kim Department of Nuclear Engineering, Kyung Hee University, Yongin, Korea Received 6 December 2019 Revised 19 December 2019 Accepted 23 December 2019 Corresponding author Kwang Pyo Kim (kpkim@khu.ac.kr) Tel: 82-31-201-2560 Fax: 82-31-202-8106 Diagnostic reference level (DRL) is employed to optimize the radiation doses of patients. The objective of this study is to review the DRLs for interventional procedures in Korea and abroad. Literature review was performed to investigate radiation dose index and measurement methodology commonly used in DRL determination. Dose area product (DAP) and fluoroscopy time within each major procedure category were systematically abstracted and analyzed. A wide variation was found in the radiation dose. The DAP values and fluoroscopy times ranged 0.01一3,081 Gyㆍcm2 and 2一16,878 seconds for all the interventional procedures, 8.5一1,679 Gyㆍcm2 and 32一5,775 seconds for the transcatheter arterial chemoembolization (TACE), and 0.1一686 Gyㆍcm2 and 16一6,636 seconds for the transfemoral cerebral angiography (TFCA), respectively. The DRL values of the DAP and fluoroscopy time were 238 Gyㆍcm2 and 1,224 seconds for the TACE and 189 Gyㆍcm2 and 686 seconds for the TFCA, respectively. Generally, the DRLs of Korea were lower than those of other developed countries, except for the percutaneous transluminal angioplasty with stent in arteries of the lower extremity (LE PTA and stent), aneurysm coil embolization, and Hickman insertion procedures. The wide variation in the radiation doses of the different procedures suggests that more attention must be paid to reduce unnecessary radiation exposure from medical imaging. Furthermore, periodic nationwide survey of medical radiation exposures is necessary to optimize the patient dose for radiation protection, which will ultimately contribute to patient dose reduction and radiological safety. Keywords: Interventional radiology, Radiation protection, Diagnostic reference level, Patient dose, Radiation exposure Introduction the use of interventional radiology is rapidly increasing with the increase in average life expectancy and techno- Interventional radiology is a medical specialization that logical development.1) involves performing a range of imaging procedures to Fig. 1 shows the number of interventional radiology pro- obtain images of the inside of the body of a patient. Inter- cedures performed during the period of 2007–2011, as re- ventional radiologists conduct various procedures, such as ported in a 2013 domestic study. The use of interventional treating tumors, taking organ biopsies, or placing stents, by radiology increased by approximately 12% per year, from inserting miniature instruments and thin catheters into the 22,000 in 2007 to approximately 35,000 in 2011. These re- body via an artery or a vein. Interventional radiology has sults included only the procedures involving imaging tests the advantage of reducing medical expenses as well as the performed during interventional radiology in that period. pain from invasive procedures (e.g., surgery). Currently, Therefore, the actual number of procedures is expected to Copyright © 2019 Korean Society of Medical Physics This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/bync/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. CC Min Young Lee, et al:DRL of Interventional Procedures 76 Therefore, the necessity of setting a reference radiation 40,000 Number of examinations dose for a patient has emerged. As interventional radiology is a procedure that is directly related to the life of the pa- 30,000 tient, it is inappropriate to apply extremely strict controls. Therefore, the equipment or institutions that administer 20,000 extremely high or extremely low radiation doses need to be identified, and the doses should be optimized. 10,000 A reference level was introduced to implement radiation dose reduction and establish a reference standard. This 0 2007 2008 2009 2010 2011 concept was first introduced in ICRP Publication 60.3) Subsequently, the ICRP recommended the use of diagnostic Years Fig. 1. Number of interventional procedures per year in Korea. reference levels (DRLs) for medical purposes in ICRP Publication 73, 8 and ICRP Supporting Guidance 2.4,7) be larger than the above value.2) In addition, interventional The International Atomic Energy Agency (IAEA) also radiology requires a longer time and relatively higher radi- endorses establishing DRLs, the recommended radiation ation doses than other diagnostic radiology examinations. dose levels for patients in accordance with the medical Considering its increased usage and high radiation dose, conditions, in each country.8) According to these guide- currently, radiation protection and patient dose manage- lines, various countries, such as the United Kingdom, the ment are important in interventional radiology. Further, United States, and European countries, are conducting because interventional radiology is an important proce- radiation exposure status surveys and DRL studies on vari- dure directly related to the survival of a patient, it is inap- ous diagnostic procedures, to optimize patient dose man- propriate to apply extremely strict measures on the radia- agement. tion exposure received by the patient. However, efforts to In Korea, the Ministry of Food and Drug Safety (MFDS) optimize the procedure and measures for patient radiation and the Center for Disease Control and Prevention have protection are needed. conducted DRL determination studies on various diagnos- Guidance or recommendations for radiation protection tic procedures by measurements or surveys.9,10) The scope in diagnostic radiology are provided by the International of the investigation for DRL determination ranges from Commission on Radiological Protection (ICRP). The ICRP hospital units to regional and national levels. Considering uses the following approach for radiation protection of the increased usage of interventional radiology and high patients. Generally, radiation exposure of a patient dur- radiation doses, it is necessary to investigate and analyze ing radiology, such as interventional radiology, is higher studies on DRL determination for domestic and interna- than that in daily life; however, the patient also receives tional interventional radiology in terms of patient radiation the medical benefits from the procedure. The ICRP states protection and patient dose management. that radiation in these areas of medical care must be used The purpose of this study was to review the DRLs for for the benefit of the patient and the dose should be opti- interventional radiology in Korea and abroad. To this end, mized.3) Summarizing, the basic principle of patient pro- we first examined the methodology of DRL determination. tection in medical exposure is to maximize the medical The radiation dose index and measurement or irradiation benefits of radiation use while keeping the dose as low as methodology commonly used in DRL determination for reasonably achievable considering economic and social interventional radiology were investigated. In addition, factors.4-6) studies on the DRL determination for domestic and inter- The measured or irradiated radiation dose at a radiological examination facility differs according to the radiologist, national interventional procedures were examined, and the results were compared and analyzed. patient, and hospital, even if the same procedure is used. www.ksmp.or.kr 77 Progress in Medical Physics Vol. 30, No. 4, December 2019 Diagnostic Reference Level and Radiation Dose for a Diagnostic Reference Level 2. Radiation dose for interventional procedure diagnostic reference level The measurement or survey methodology for the radia- 1. Diagnostic reference level tion dose indicator was investigated. The ICRP, InternaIn this study, we investigated the DRL determination tional Commission on Radiation Units and Measurements methodology and the radiation dose indicator used to (ICRU), and IAEA have proposed radiation dose units for determine a DRL. A DRL may be used as an indicator for DRLs.6,12,13) The ICRP proposes as conditions of the patient evaluating how much radiation dose is used for a patient. radiation dose indicator that the assessment of the amount DRL determination can be conducted by large-scale ra- of ionizing radiation used in a procedure and easy mea- diation dose surveys or measurements across hospitals, surement or determination of the indicator.6) The ICRU and regions, or a country. A DRL is generally determined as the IAEA recommend using a physical quantity that can be 75th percentile level of the measured or surveyed radiation represented by air kerma as the unit of the radiation dose dose distribution. It can be applied in various diagnostic of a DRL.12,13) In general, the dose area product (DAP) and procedures, such as computed tomography (CT), nuclear reference air kerma (RAK) are used for the measurement of medicine, and interventional radiology. Fig. 2 presents an the radiation dose of a patient in an interventional proce- example of the radiation dose distribution and DRL. From dure, because they are easy to be calculated and measured. Fig. 2, it can be seen that although most radiation doses are Further, the fluoroscopy time is employed as an additional low, some are extremely high. The identification and cor- indicator. rective actions of facilities or equipment that administer The concept of DAP is displayed in Fig. 3. The DAP is abnormally high radiation doses can significantly reduce defined as the product of the absorbed dose that does not the radiation dose of a patient. DRL determination should include the backscattering effects in air measured at the not end as a one-time event; the DRL needs to be mea- same distance from the focal point and the area of the X-ray sured and examined periodically and updated. In the UK, irradiation field. The DAP can provide information about where early studies of DRL determination have been con- the irradiation area in which a patient is actually exposed. ducted, it has been found that the radiation dose decreases The intensity of the radiation decreases in inverse propor- 11) tion to the square of the distance on going further from the over time. focal point. In contrast, the irradiation area of the radiation increases in proportion to the square of the distance; thus, the above two effects cancel each other. Therefore, the DAP 40 DRL 35 Focus Counts 30 25 20 15 10 DAP1=A1xDose1 Area1 DAP1=DAP2 5 DAP2=A2xDose2 0 0 5 10 15 Area2 Dose (mGy) Fig. 2. Dose distributions of diagnostic radiology and diagnostic reference level (DRL). Fig. 3. Concept of the dose area product (DAP) measurement. www.ksmp.or.kr Min Young Lee, et al:DRL of Interventional Procedures 78 can be defined at any position on the beam axis between easily collecting information because it does not require a the X-ray focal point and the patient. It can be derived from separate measuring equipment. However, the fluoroscopy direct measurements or calculations. Direct measurement time can be used only as a reference because it does not re- of the DAP employs an area dosimeter at the outlet of the flect the intensity of the injected X-ray, performance of the X-ray tube. Recently used interventional procedure equip- device, or irradiation area. Other studies suggest that the ment utilize the area dosimeter at their outlets or use a fluoroscopy time alone is not a useful indicator of the dose calculation formula to display the DAP value employed for of a patient during a procedure and that we should not ex- the patient during the procedure on a screen. amine it separately for patient dose investigation.15-19) The conceptual diagram of the RAK measurement is shown in Fig. 4. The RAK is a value indicating the radiation Nationwide Diagnostic Reference Level for Interventional Procedures dose incident on the skin surface of a patient during an interventional procedure or fluoroscopy. It is measured at a point in space located at a certain distance from the fo- 1. UK cal point. In general, in the case of a C-arm, it is measured at a patient incident reference point 15 cm away from the In the UK, DRL determination studies on diagnostic center of rotation on the X-ray beam axis in the focal point radiology are actively conducted by the Health Protection direction.14) This incident reference point is similar to the Agency (HPA). The UK Department of Health and Social point where the skin of the patient is located, assuming a Security periodically collects exposure dose information standard sized patient is lying on the bed. Therefore, the regarding diagnostic radiology and determines the DRL RAK can be used to indirectly determine the skin dose based on the collected data. A DRL determination and received by a patient. Various terms are used in different exposure studies for interventional procedures in the UK organizations to indicate the RAK, such as reference air were conducted in 2005 and 2010.11,20) In a 2012 study, data kerma, cumulative air kerma, reference point air kerma, on various diagnostic procedures, including interventional and cumulative dose. procedures and diagnostic radiation, were collected from The fluoroscopy time is the total time the fluoroscopy January 2006 to December 2010 at a total of 320 medical was performed during the interventional procedure. Be- institutions nationwide for patient dose investigation. This cause the radiation dose is directly proportional to the time number represents approximately 25% of the hospitals of use, the fluoroscopy time is a significant contributor with diagnostic radiography equipment in the UK. In the to the exposure dose. In addition, it has the advantage of UK, data on six major procedures, such as biliary intervention and facet joint injection, were collected. Data were collected not only on the DAP and the fluoroscopy time, but also on patient information, such as age and weight. The information collection for the DAP was based on approximately 15,000 and 14,000 cases of patients, respectively. Each exposure dose information was collected by Isocenter of C-arm Patient reference point (RAK) filling out questionnaires, and the data verification was Patient 15 cm DAP meter Source to image-receptor distance Source to object distance performed by a statistical analysis program. Table 1 summarizes the DRL and survey results for the DAP and the fluoroscopy time during the interventional procedures in the UK as of 2010.11) X-ray tube Fig. 4. Concept of the reference air kerma (RAK) measurement. DAP, dose area product. www.ksmp.or.kr 79 Progress in Medical Physics Vol. 30, No. 4, December 2019 (SIR).21) From 2003 to 2009, these organizations performed 2. USA a study of the patient dose measurement and evaluation In the US, medical radiation exposure status surveys of 21 interventional procedures called “Radiation Doses in were conducted driven by the Food and Drug Administra- Interventional Radiology Procedures (RAD-IR) Study”. To tion (FDA) and the Society of Interventional Radiology this end, the radiation dose data were collected from a total Table 1. Dose area products (DAPs) and fluoroscopy times for interventional procedures in the UK (2012) Radiation dose unit DAP (Gy·cm2) Fluoroscopy time (s) Procedure Biliary intervention Facet joint injection Hickman line insertion Nephrostomy Oesophageal stent Pacemaker (permanent) PTCA 1 stent Biliary intervention Facet joint injection Hickman line insertion Nephrostomy Oesophageal stent Pacemaker (permanent) PTCA 1 stent Measurement (n) Hospital Room Patient 10 20 21 24 15 31 14 9 17 18 20 12 24 10 22 30 37 31 24 78 39 21 28 34 25 21 63 35 279 2,720 829 464 199 5,062 5,805 276 2,641 696 332 165 4,475 5,444 Mean 33 4 2 8 13 7 34 687 61 75 399 249 307 516 Minimum Maximum 6 0.2 0.1 0.5 3 0.2 12 147 4 4 57 51 103 84 111 16 10 24 76 34 81 1,116 118 510 1,630 696 670 882 DRL 43 6 3 13 13 7 40 849 84 87 404 298 358 675 DRL, diagnostic reference level; PTCA, percutaneous transluminal coronary angioplasty. Table 2. Diagnostic reference levels for interventional procedures in the US (2012) Procedure Transjugular intrahepatic portosystemic shunt creation Biliary drainage Nephrostomy for obstruction Nephrostomy for stone access Pulmonary angiography Inferior vena cava filter placement Renal or visceral angioplasty without stent Renal or visceral angioplasty with stent Iliac angioplasty without stent Iliac angioplasty with stent Bronchial artery embolization Hepatic chemoembolization Uterine fibroid embolization Other tumor embolization Gastrointestinal hemorrhage localization and treatment Embolization in the head for AVM Embolization in the head for aneurysm Embolization in the head for tumor Vertebroplasty Pelvic artery embolization for trauma or tumor Embolization in the spine for AVM or tumor Number Dose (Gy) 300 20 12 14 215 40 210 200 300 350 450 300 450 325 425 1,500 1,350 1,700 120 550 1,500 3 1.4 0.4 0.7 0.5 0.25 2 2.3 1.25 1.9 2 1.9 3.6 2.6 3.8 6 4.75 6.2 2 2.5 8 DAP, dose area products; AVM, arteriovenous malformation. www.ksmp.or.kr DAP (Gy·cm2) Fluoroscopy time (s) 525 100 40 60 110 60 200 250 250 300 240 400 450 390 520 550 360 550 120 550 950 3,600 1,800 900 1,500 600 240 1,200 1,800 1,200 1,500 3,000 1,500 2,160 2,100 2,100 8,100 5,400 12,000 1,260 2,100 7,800 Min Young Lee, et al:DRL of Interventional Procedures 80 of approximately 2,100 procedures of the medical institu- approximately 1,400 cases of the procedures were investi- tions participating in the study. The radiation dose data gated. Information was collected on the DAP, fluoroscopy were examined for the DAP, RAK, fluoroscopy time, and time, patient gender, age, size, and weight. In addition, the number of images. The age, height, and weight of a patient information on the level of Complexity of the procedures were recorded for each procedure performed, and test cas- (CI) to determine its difficulty was also classified into three es for each procedure were selected to reduce the devia- levels (low, medium, and high). However, the study deter- tion caused by the size of the patient. Thus, approximately, mined that the number of samples collected was not suf- 1,960 out of the 2,100 cases of procedures were used for the ficient, and thus, the complexity level was not used. In the statistical analysis of the data. Table 2 lists the third quartile investigation, the overall DAP distribution of interventional DRL values of the DAP and fluoroscopy time for each inter- procedures was 0.6–1136 Gy·cm2. The fluoroscopy time ventional procedure analyzed in the study in the US. These distribution ranged from 0.3 to 80 minutes. The number of third quartile values are determined as the national patient digital subtraction angiography (DSA) image distributions 22) DRLs for US interventional procedures. ranged from 0 to 893 images. The DRL was set as the third quartile of the DAP, fluoroscopy time, and number of DSA images. Table 3 summarizes the results of determining the 3. Spain interventional procedure DRL in Spain in 2008. DRL studies in Spain are conducted by the National Soci- In 2016, the SNSC conducted a study to reestablish the ety of Interventional Radiology (NSIR) and the Spanish Nu- DRL.25) In this study, senior interventionists and medi- clear Safety Council (SNSC). In Spain, patient dose surveys cal physicists at eight university hospitals were surveyed. and DRL determination studies for interventional radiol- Seven procedures, including biliary drainage and hepatic ogy are conducted under the European Medical Exposures chemoembolization, were performed, and approximately 23) Directive, which recommends DRL determination. 1,600 cases were surveyed over three years from 2010 to In a 2008 study by the NSIR, a survey was conducted with 2013. The DRL was reset to the third quartile of the sur- interventional radiologists and medical physicists of ten veyed DAP, fluoroscopy time, and DSA image number public hospitals nationwide. 24) The survey was performed by seven procedures with the highest frequency, including distribution. Table 4 lists the results of determining the interventional radiology DRL in Spain in 2016. the biliary drainage and hepatic chemoembolization. Thus, Table 3. Dose area products (DAPs) and fluoroscopy times for interventional procedures in Spain (2008) Dose Index 2 DAP (Gy·cm ) Fluoroscopy time (s) Procedure Fistulography Lower limb arteriography Renal arteriography Biliary drainage Hepatic chemoembolization Iliac stent Uterine embolization Fistulography Lower limb arteriography Renal arteriography Biliary drainage Hepatic chemoembolization Iliac stent Uterine embolization Number Maximum Minimum Mean DRL 180 685 55 205 151 70 45 180 685 55 205 151 70 45 83 608 397 428 830 1,136 677 3,120 3,408 1,650 4,764 4,800 4,026 2,670 0.6 2.4 7.7 0.6 27.4 14.1 26.6 18 30 18 36 168 78 18 9 58 75 61 216 91 170 150 180 336 870 1,188 552 1,428 12 73 89 80 289 94 236 150 198 516 1,188 1,458 654 1,818 DRL, diagnostic reference level. www.ksmp.or.kr 81 Progress in Medical Physics Vol. 30, No. 4, December 2019 Table 4. Dose area products (DAPs) and fluoroscopy times for interventional procedures in Spain (2016) Procedure Number Mean DAP (Gy·cm2) 3th Q DAP (Gy·cm2) 3th Q fluoroscopy time (s) 784 37 30 314 56 31 269 62 66 30.8 30.8 189.6 120.2 216.1 83.9 105.7 45 30 214 169 303 119 170 240 336 792 1,038 1,860 2,790 1,578 1,800 1,284 Lower extremity arteriography Renal arteriography Transjugular hepatic biopsies Biliary drainage Uterine fibroid embolization Colon endoprostheses Hepatic chemoembolization Femoropopliteal revascularization Iliac stent Table 5. Dose area products (DAPs) for interventional procedures in Germany (2019) Procedure Thrombus aspiration after stroke (recanalization of cerebral arteries) Coiling of a cerebral aneurysm (EVAR of the cerebral artery) PCI Combined CA and PCI TAVI EVAR For thoracic aorta For infrarenal abdominal aorta For suprarenal abdominal aorta TACE PTA For pelvis For thigh and knee For lower leg and food DAP (Gy·cm2) Deff (mSv) 25th 50th 75th DRL 51 91 158 180 11 74 121 192 250 16 20 28 25 34 40 49 49 55 82 48 55 80 9 10 15 47 55 47 62 114 108 95 121 203 203 218 224 230 230 28 32 36 392 22 8 6 44 15 10 87 35 20 90 40 25 23 10 6 DRL, diagnostic reference level; Deff, effective dose; EVAR, endovascular treatment of abdominal aortic aneurysms; PCI, percutaneous coronary intervention; CA, coronary angiography; TAVI, transcatheter aortic valve implantation; TACE, transcatheter arterial chemoembolization; PTA, percutaneous transluminal angioplasty. man Institute of Interventional Radiology (DeGIR), and 4. Germany AQUA Institute. In Germany, the DRLs were determined In Germany, research on medical exposure status and for interventional radiology in 2003, 2016, and 2019 based DRL determination has been conducted, with focus on on the collected data.26-28) In 2003, two procedures of the the Federal Office for Radiation Protection (BfS). The BfS percutaneous transluminal angioplasty (PTA) and percuta- revised the radiation-related regulations in 2003 to recom- neous transluminal coronary angioplasty were set. In 2016 mend the establishment of DRLs in diagnostic radiographs. and 2019, 12 and 11 procedures were announced, includ- Since then, periodic investigations and DRL determina- ing the percutaneous coronary intervention, transcatheter tion of various medical radiation have been performed. aortic valve implantation, transcatheter arterial chemo- The DRL for interventional radiology was set based on embolization, endovascular treatment of abdominal aortic numerous databases collected nationally from the “ärz- aneurysms, and PTA. Table 5 and 6 summarize Germany’s tliche Stellen” (the Quality Assurance Commission), Ger- interventional radiology DRL as of 2019.28) www.ksmp.or.kr Min Young Lee, et al:DRL of Interventional Procedures 82 by the Radiation and Nuclear Safety Authority (STUK). The 5. Switzerland STUK measures or evaluates the patient doses every three Swiss medical radiation survey research is conducted years to establish the interventional radiology DRL. Fin- by the Swiss Federal Office of Public Health. In the early land has presented a DRL for interventional radiology in 2000s, the Federal Office of Public Health, in collaboration 2016.30) In Finland, in interventional radiology and cardiol- with two university radiation physics laboratories formed ogy procedures, the difficulty of the procedure may have a a working group for the radiation protection optimiza- larger impact on the radiation dose than on the procedure tion of X-ray examination. The purpose of this group was steps or procedure equipment. Thus, it is recommended to generate awareness of the radiation risks to physicians to use the radiation doses of numerous patients to set the and radiologists to optimize dose-intensive radiographs. In DRL and consider the difficulties in the procedure, if nec- 2007, DRL determination was performed for interventional essary. Table 8 presents the DRL for interventional radiol- radiology and diagnostic fluoroscopy.29) In this study, ap- ogy in Finland conducted in 2016. proximately 1,000 procedures were investigated in the radiology and cardiac disease departments of nine national and private hospitals for two years. Twelve procedures 7. United Nations Scientific Committee on the Effects of Atomic Radiation were investigated in total, and among these, six types of interventional radiology were examined, including hepatic The United Nations Scientific Committee on the Effects embolization, biliary drainage, and stent insertion. The ra- of Atomic Radiation (UNSCEAR) is an international organi- diation dose information was examined for the DAP, fluo- zation established by the United Nations (UN) for the anal- roscopy time, and number of images. Table 7 presents the ysis of the effects and risks of radiation on the human body. 29) UNSCEAR collects information on the medical radiation DRL for Switzerland in 2007. exposure doses in all the countries to understand the current status of medical radiation safety management. The 6. Finland information is gathered by collecting questionnaires from Research on medical radiation in Finland is conducted representatives of each country or by researching national Table 6. Fluoroscopy times for interventional procedures in Germany (2019) Fluoroscopy time (s) Procedure Thrombus aspiration after stroke (recanalization of cerebral arteries) Coiling of a cerebral aneurysm (EVAR of the cerebral artery) PCI Combined CA and PCI TAVI EVAR For thoracic aorta For infrarenal abdominal aorta For suprarenal abdominal aorta TACE PTA For pelvis For thigh and knee For lower leg and food 25th 50th 75th 720 1,260 312 354 474 1,260 2,040 558 570 720 2,100 3,240 780 780 1,080 420 840 840 660 720 1,260 1,560 1,020 1,140 1,980 3,120 1,500 420 420 540 600 660 1,020 1,020 1,080 1,860 EVAR, endovascular treatment of abdominal aortic aneurysms; PCI, percutaneous coronary intervention; CA, coronary angiography; TAVI, trans­ca­theter aortic valve implantation; TACE, transcatheter ar­terial chemo­embolization; PTA, percutaneous transluminal angio­ plasty. www.ksmp.or.kr 83 Progress in Medical Physics Vol. 30, No. 4, December 2019 Table 7. Dose area products (DAPs) and fluoroscopy times for interventional procedures in Switzerland (2007) Category Diagnostic Interventional Combined Procedure Fluoroscopy time (min) Frame (n) DAP (Gy·cm2) 7 8 15 10 7 1 30 25 50 25 20 20 20 40 150 480 25 1,400 480 160 30 800 200 1,500 800 2,800 60 210 1,215 150 80 10 620 240 440 460 110 140 260 30 0 280 Barium meal Lower limb and iliac angiography Cerebral angiography Barium enema Coronary angiography Electrophysiology Hepatic embolization Biliary drainage and stent insertion Cerebral embolization Iliac dilatation and stent insertion Percutaneous coronary intervention Cardiac thermo-ablation Coronary angiography+ percutaneous coronary intervention Electrophysiology+cardiac thermo-ablation Table 8. Diagnostic reference levels (DRLs) for interventional proce­dures in Finland (2016) Procedure Coronary artery examination using a contrast medium Percutaneous coronary intervention* Pacemaker installation (excluding CRT pacemaker installation) Transcatheter aortic valve implantation Electrophysiological treatment of atrial fibrillation CRT pacemaker installation Electrophysiological treatment of atrial flutter Electrophysiological treatment of atrioventricular nodal reentrant tachycardia DAP (Gy·cm2) Fluoroscopy time (min) 30 75 3.5 90 25 22 16 6 4 15 5 19 12 - DAP, dose area products; CRT, cardiac resynchronization therapy. *Including potential angiography (ad hoc percutaneous coronary intervention). research reports and literatures. The UNSCEAR recently 8. Korea published a report on the results of worldwide medical radiation exposure surveys obtained from countries and 1) Survey research on the actual conditions of patient dose institutions during 1997–2007. In this study, although the in the interventional radiation procedures in Korea is interventional radiology DRL was not set, the distributions actively conducted with the MFDS. The MFDS set a DRL and differences in the DAPs for different countries at a based on the collected information of the radiation dose of particular procedure were analyzed by the UNSCEAR. The the interventional radiology performed in 2007 and 2012. UNSCEAR collected the results of the DAP and effective In the 2012 study, 11 procedures were selected from among dose evaluation for 30 procedures regarding interventional the interventional radiology procedures performed in Ko- radiology according to five major categories of biopsy, bili- rea, which were relatively numerous procedures or were ary tract, and urinary system. In the 2010 report, the DAP of high importance in relation to the radiation protection, collected from each country was presented in each litera- including the TACE, arteriovenous fistula (AVF), percuta- ture. Table 9 lists the distribution of the DAP according to neous transluminal angioplasty with stent in arteries of the the interventional radiology reported by the UNSCEAR. lower extremity (LE PTA and stent). The study collected patient radiation dose data from the eleven interventional www.ksmp.or.kr Min Young Lee, et al:DRL of Interventional Procedures 84 Table 9. Dose distributions for interventional procedures in the United Nations Scientific Committee on the Effects of Atomic Radiation (2010) Category Procedure Biopsy Pathological specimen Biopsy Small bowel biopsy Venous sampling Bile duct drainage Bile duct dilation/Stenting Biliary intervention Biliary duct stone extraction Lithotripsy Nephtostomy Ureteric stenting Kidney stent insertion Emboliztion Management of caricocele Neuroembolization Thrombolysis TIPS Valvuloplasty Vascular stenting Pelvic vein embolization Insertion of caval filters Removal of foreings bodies Coronary angiography PTCA Stent procedures Pacemaker insertion Uterine fibroid embolization Feeding tube Gastrostomy Diliation/stenting oesophagus Dilation pyloric stenosis Colonic stent Nerve injection Biliary and urinary systems Cardiovascular Uterine fibroid embolization Gastroinstinal DAP (Gy·cm2) Effective dose (mSv) 6 1 38–150 43–54 54 27 5 8–56 18 49 75–114 50.8–131 81–320 13.5 77–524 162 40–42 48 12.7–147 11.8–205 41–166 8.46–19 30.6–298 13 13 15 27 1.7 1.6 1.6 0.26 0.4 9.9–38 11–14 14 7 1.3 2.1–15 4.7 12.7 20–30 6.4–38 2.3–11 3.5 20–87 29 5.8–10 60 13 7 3.1–16 5.4–41 7–13 8–78 3.4 3.4 1.5 7 7 0.2 DAP, dose area products; TIPS, transjugular intrahepatic portosystemic shunt; PTCA, percutaneous transluminal coronary angioplasty. radiology procedures selected from 24 major hospitals na- each procedure is found to be 0.01–3081 Gy·cm2 overall, tionwide. The data surveys were performed according to with 8.5–1679 Gy·cm2 for the TACE and 0.1–686 Gy·cm2 for the DAP and fluoroscopy time. In addition, 8,415 domestic the transfemoral cerebral angiography (TFCA) procedure data were obtained for each procedure, and the DRL was reprehensively. The fluoroscopy time distribution is overall presented as the third quartile of the survey results. 10) In 2–16,878 seconds, with 32–5,775 seconds for the TACE and addition, the accuracy of the built-in DAP meter of the IR 16–6,636 seconds for the TFCA procedure reprehensively. equipment installed in Korea was evaluated, and the actual Even for the same procedure, the difference is more than effects of the dose reduction parameters were evaluated by several hundred times for the performer, patient, and hos- phantom measurement experiments. pital. The DRL is set to the third quartile of the DAP and Table 10 lists the results of the 2012 Korean interven- fluoroscopy time distributions for each procedure. Repre- 10) sentatively, the DRLs for the TACE and TFCA are 238 and tional radiology DRL study. The DAP distribution for www.ksmp.or.kr 85 Progress in Medical Physics Vol. 30, No. 4, December 2019 Table 10. Dose area products (DAPs) and fluoroscopy times for interventional procedures in Korea (2012) Radiation dose units DAP (Gy·cm2) Fluoroscopy time (s) Measurement (n) Procedure Hospital Room Patient 22 9 13 18 15 15 21 13 15 20 17 22 9 13 18 15 15 21 13 15 20 17 35 14 16 29 18 25 36 15 20 24 17 35 14 16 29 18 25 36 15 20 24 17 3,139 234 278 2,083 320 566 118 219 519 479 460 3,139 234 278 2,083 320 566 118 219 519 479 460 TACE AVF LE PTA & Stent TFCA Aneurysm coil PTBD Biliary Stent PCN Hickman Chemoport Perm-cath TACE AVF LE PTA & Stent TFCA Aneurysm Coil PTBD Biliary Stent PCN Hickman Chemoport Perm-cath Mean Minimum Maximum DRL 191.1 14.1 85.4 149.6 316.9 36.1 47.4 19 4 2.1 3.7 935.6 649.8 1,090.8 599.9 2,325.5 379.3 606.5 222.9 51.3 34.1 56.3 8.5 0.2 1.3 0.1 35.8 0.3 0.7 0.5 0.03 0.01 0.02 32.0 30.0 42.0 16.0 250.0 16.0 30.0 8.0 5.0 5.0 2.0 1,678.8 113.1 571.0 685.5 3,080.5 1,290.8 289.4 189.1 75.3 31.7 37.4 5,775.0 3,715.0 5,897.0 6,636.0 16,878.0 6,777.0 2,493.0 1,643.0 987.0 428.4 507.0 237.7 17.3 114.1 188.5 383.5 37.5 64.6 22.4 4.3 2.8 4.4 1,224.0 786.1 1,460.4 686.0 2,975.8 427.5 759.8 236.0 54.0 43.0 67.8 DRL, diagnostic reference level; TACE, transcatheter arterial chemoembolization; AVF, arteriovenous fistula; TFCA, transfemoral cerebral angiography; PTBD, percutaneous transhepatic biliary drainage; PCN, percutaneous nephrostomy. 700 TACE LE PTA & stent PTBD Biliary stent PCN Hickman insertion 250 500 DAP (Gy cm2) DAP (Gy cm2) 600 300 Aneurysm coil embolization Average 400 300 200 200 150 Average 100 50 100 0 0 KR USA SP 1 SP 2 GE SW KR SP 1 GE KR USA GE SW 2012 2009 2008 2016 2019 2007 2012 2008 2019 2012 2009 2019 2007 KR USA SP 1 SP 2 KR UK SW KR UK USA KR UK 2012 2009 2008 2016 2012 2012 2007 2012 2012 2009 2012 2012 Countries Countries Fig. 5. Dose area products (DAPs) for interventional procedures by country. TACE, transcatheter arterial chemoembolization; PTBD, percutaneous transhepatic biliary drainage; PCN, percutaneous nephrostomy. 189 Gy·cm2 for the DAP and 1,224 and 686 seconds for the ventional procedures. The domestic DRL is generally low fluoroscopy time, respectively. compared to the DRLs in other countries. Comparing the Fig. 5 and 6 display the comparison of the DAPs and DRL for the domestic DAP with the average of that in other fluoroscopy times in domestic and international inter- countries, the domestic DRL is found to be about two times www.ksmp.or.kr Min Young Lee, et al:DRL of Interventional Procedures 86 6,000 TACE LE PTA & stent 2,000 Aneurysm coil embolization Fluoroscopy time (s) Fluoroscopy time (s) 5,000 4,000 3,000 2,000 Average PTBD Biliary stent 1,800 PCN Hickman insertion 1,600 1,400 Average 1,200 1,000 800 600 400 1,000 200 0 0 KR USA SP 1 SP 2 KR UK SW KR UK USA KR UK 2012 2009 2008 2016 2012 2012 2007 2012 2012 2009 2012 2012 KR USA SP 1 SP 2 GE SW KR SP 1 GE KR USA GE SW 2012 2009 2008 2016 2019 2007 2012 2008 2019 2012 2009 2019 2007 Countries Countries Fig. 6. Fluoroscopy times for interventional procedures by country. TACE, transcatheter arterial chemoembolization; PTBD, percutaneous transhepatic biliary drainage; PCN, percutaneous nephrostomy. lower for the percutaneous transhepatic biliary drainage DRL setting in domestic and foreign interventional radiol- (PTBD) and biliary stent procedures. Further, for the TACE ogy procedures. Further, they were compared and analyzed and percutaneous nephrostomy (PCN) procedures, it is to understand the radiation dose exposure status and pa- approximately 55% and 18% lower, respectively. For the tient dose management in interventional radiology for the LE PTA and stent, aneurysm coil embolization, and Hick- Korean population. man insertion procedures, it is approximately 30%, 8%, In Korea, a study on setting the interventional radiology and 30% higher, respectively. Further, when comparing DRL was conducted in 2012 by the Ministry of Food and the DRL for the fluoroscopy time with the average of the Drug Safety. In this study, DRLs were set for the DAPs and other countries, the domestic DRL is lower, except for the fluoroscopy times of eleven procedures, which relatively LE PTA and stent procedure, which is at a similar level. It have numerous procedures or are of high importance in is about approximately thrice lower for the PTBD and PCN relation to radiation protection. They included the TACE, procedures and approximately 50% lower for the biliary AVF, and LE PTA and stent, among interventional radiol- stent and Hickman insertion procedures. Moreover, it is ogy performed in Korea. Representatively, the DRLs for the approximately 30% lower for the TACE and aneurysm coil TACE and TFCA were 237.7 and 188.5 Gy·cm2, respectively, embolization procedures, and is similar to that of the other and for the fluoroscopy time, 1,224 and 686 seconds, re- countries for the LE PTA and stent procedures. spectively. When comparing the domestic interventional radiology DRL with those of other countries, the domestic DRL was found to be low, in general. When comparing the Conclusions DRL for the domestic DAP with the average values of the The use of interventional radiology is rapidly increas- other countries, for the PTBD, biliary stent, TACE, and PCN ing owing to the increase in its demand arising from the procedures, it was found to be as low as 20% to as high as average lifespan increase and technology development. It nearly twice the average values of the other countries. Fur- is known that interventional radiology takes longer than ther, for the LE PTA and stent, aneurysm coil embolization, other radiographies and uses relatively high radiation and Hickman insertion procedures, it was approximately doses. Considering the increased usage and high radia- 30%, 8%, and 30% higher, respectively. In addition, when tion dose of these interventional procedures, the radiation comparing the DRL for the fluoroscopy time with the aver- protection of a patient and patient dose management are age of the other countries, the domestic DRL was lower, important during interventional procedures. Under these except for the LE PTA and stent procedures, which were at circumstances, we investigated the current status of the similar levels. www.ksmp.or.kr Progress in Medical Physics Vol. 30, No. 4, December 2019 Interventional radiology, as medical radiation exposure, 87 1991. benefits a patient and is an important procedure that is di- 4. ICRP Publication 73: Radiological protection and safety in rectly related to the life of a patient; thus, it is not appropri- medicine. Ottawa: International Commission on Radio- ate to perform extremely strict management of the radia- logical Protection; 1991. tion exposure that a patient receives without considering 5. ICRP Publication 105: Radiological protection in medi- the overall circumstances. However, to optimize the proce- cine. Ottawa: International Commission on Radiological dure and reduce patient dose, it is necessary to understand Protection; 2007. the current status of domestic patient dose management 6. ICRP Publication 135: Diagnostic reference levels in medi- by investigating the patient exposure level and DRL setting cal imaging. Ottawa: International Commission on Radio- during the interventional procedure. In the future, if the logical Protection; 2017. nationwide survey is continuously conducted for medical 7. ICRP Supporting Guidance 2: Radiation and your patient: radiation safety management and patient protection, it will a guide for medical practitioners. Ottawa: International ultimately contribute to maximizing the benefit to patients Commission on Radiological Protection; 2002. from interventional radiology while minimizing the radiation dose of the patient. 8. 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