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1 rts and Sciences PCI Reduction of radiation exposure in patients and cardiologists using a noise reduction technique in cardiac catheterization and percutaneous coronary intervention Key words: radiation dose, noise reduction, percutaneous coronary intervention (PCI), occupational exposure bstract We examined the effect of reducing radiation exposure in 86 patients who underwent coronary angiography and percutaneous coronary intervention before and after the introduction of an angiography system equipped with a noise reduction technique (NRT) based on an algorithm for noise reduction processing. dditionally, we examined the reduction in the occupational exposure dose over the past 5 years for cardiologists. The incident imaging dose per frame (ngy/f) and fluoroscopic dose per pulse (ngy/p) to the flat panel detector were able to reduce from 1 ngy/f and ngy/p to ngy/f and ngy/p using NRT. Dose area product (DP) and air kerma (K) per unit time and unit frame were calculated and compared before and after the introduction of the NRT. Significant effects of reducing the fluoroscopic dose of 26% and the imaging dose of % for the DP were respectively confirmed (P<.1). K also showed a significant decrease of 28% (P<.1). Using the NRT, there were significant decreases in the exposure dose of cardiologists: decreases of 43% in the effective dose (P<.5) and 48% in the equivalent dose to lens of the eye (P<.5). NRT 86 5 Flat Panel Detector FPD1 NRT 1nGy/f ngy/f 1nGy/p ngy/p Dose rea Product DP ir Karma K NRT DP 26% % P<.1 K 28% P<.1 43% 48%P< PCI International Commission on Radio- Masayuki Kumashiro 1 2 Takahiro Kataoka 1 Shinobu Yokota 2 Shinobu Nakagawa 2 Fumiaki Kiyokawa 2 Hideki Mitsui 2 Shinji Osumi 2 Kiyonori Yamaoka 1 1 Graduate School of Health Sciences, Okayama University 2 Department of Radiological Technology, Kurashiki Central Hospital Received October, 17; accepted November 24, 17 logical Protection ICRP Food and Drug dministration FD 9-11 PCI 12 Interventional Radiology IVR Clarity IQ NRT %

2 Flat Panel Detector FPD 1 ngy PCI % 19 Swady 5 PCI Philips llura Xper FD / BiplaneClarity IQ NRT Philips llura Clarity FD / Biplane PCI 86 PCI BMI kg/m PCI 5 5 LC 7ml RC5ml LC8RC4 2 bi-plane system LC RO- LO cranial RO caudal-lo P cranial- LO caudal RO cranial-p caudal RC P cranial-lo RO caudal-lo cranial and LV RO-LO FPD1 1 ID FPDIDE 1nGy/f IDF ngy/p IDE ngy/f IDF ngy/p 19 15p/s 15f/s EC min fdose area product DP DPF Gy cm 2 DPE Gy cm 2 DPF rate mgy cm 2 /min DPE rate mgy cm 2 /f K mgy K rate Gy/min f DP K Pearson Spearman Student s t-test P< vol.65 no.787

3 PCI rts and Sciences DP DP K 21 IVRmGy/min Radcal CCU-GOLD US ngy/p ngy/p 1nGy/f ngy/f nGy/f ngy/p 85nGy/f IVR PCI IVR msvmsv 112 PCI CTO IVR CT CTC MRI MRC PCICTO IVR Student s t-test P<.5 3mSv IVR IVR PCIIVR IVR IVR 12Wilcoxon P<.5 De Df 1 2 De D1e M1e D2e M2e / D1e Df D1f M1f D2f M2f / D1f D1e 12 D2e D1f 12 D2f M1e M2e M1f M2f mGy/min K 27mGy/min mgy/min 19mGy/min mGy/min 173mGy/min mGy/min 91mGy/min % 3.7%

4 Table 1 min f DPK P= f 1,651 f P<.1 DP DPF rate KK ratedpf rate 3.49Gy cm 2 /min2.48gy cm 2 /min P<.1 DPE rate 24.5mGy cm 2 /f15.mgy cm 2 /f P<.1 K rate 2 Gy/min f 73 Gy/ min f P<.1 DP 26.4% 1 ID 25.%.3% 1 19 ID 39.9 Table 1 The average standard deviation of the fluoroscopic time min, the number of captured frames f, the DP and K in the conventional method and the new method are shown. Reference New Decreasing rate % p value Fluoroscopic time min Frame number f 1,7 86 1, <.1 DPF Gy cm <.1 DPF rate Gy cm 2 /min <.1 DPE Gy cm <.1 DPE rate mgy cm 2 /f <.1 K mgy <.1 K rate Gy/min f <.1 Values are given as mean standard deviation or number Fig.1Fig.1B DPF P<.1 Fig.2Fig.2B DPE P<.1 Fig.3Fig.3B K P<.1 Fig.4Fig.4B K P<.1 B 9 y = x r = y = 2.5x r =.829 DP F (Gycm 2 ) DP F (Gycm 2 ) Fluoroscopic Time (min) Fluoroscopic Time (min) Fig.1 Correlation between DPF and fluoroscopic time of conventional method Fig.1B Correlation between DPF and fluoroscopic time of new method vol.65 no.787

5 PCI rts and Sciences DP DP E (Gy cm 2 E (Gy cm 2 ) ) DP E (Gy cm 2 ) 9 9 y = y.295x = r = y r y =.295x =.295x r =.578r =.578 Frame Number Frame Number Frame Number DP E (Gy cm 2 ) 9 9 y = y.176x = y =.176x r = r y.627 = x r =.627r =.627 Frame Number Frame Number Frame Number Fig.2 Correlation between DPE and the number of frames in conventional method Fig.2B Correlation between DPE and the number of frames in new method BB B B DP DP E (Gy cm 2 E (Gy cm 2 ) ) DP E (Gy cm 2 ) DP E (Gy cm 2 ) Fig.2 Fig.2 Fig.2 B K (mgy) K (mgy) 7 y = x r =.642 y = 33.3x r =.629 Fluoroscopic time (min) Fluoroscopic time (min) Fig.3 Correlation between K and fluoroscopic time in conventional method Fig.3B Correlation between K and fluoroscopic time in new method B y =.6543x r =.639 y =.49x r =.561 K (mgy) K (mgy) Frame Number Frame Number Fig.4 Correlation between K and the number of frames in conventional method Fig.4B Correlation between K and the number of frames in new method

3.2 3.2.1IVR Fig.5Table 2 5 PCI CTO IVR CTCMRC PCI CTO PCIIVRCTC 12 4,4 16 3,494 1,2 14 MRC 16 599 3.2.2 Table 3 1 1 12 1.63 Sv 1.44 Sv 16.36 Sv 12 16 43% P<.5 Table 3B 1 112 2.94 Sv 141.71 Sv 15 1.

6 IVR Fig.5Table 2 5 PCI CTO IVR CTCMRC PCI CTO PCIIVRCTC 12 4,4 16 3,494 1,2 14 MRC Table Sv 1.44 Sv Sv % P<.5 Table 3B Sv Sv Sv Sv % P<.5 Fig.6 Fig.7 Number of Cases Coronary ngiography PCI CTO blation Peripheral IVR CTC MRC Fig.5 The number of cases in coronary angiography examination, PCI, CTO, ablation, peripheral artery IVR, CTC and MRC in the past 5 years Table 3 The number of cardiologists continuingly engaged from 12, the total cases, the average standard deviation of effective dose, and the average standard deviation of effective dose per a case in each of the year. Year Effective Number of Number Dose Cardiologists of Cases msv Effective Dose p-value per a Case p-value Sv , , , , ** * , * * * Shows the significant difference P<.5 ** Shows the significant difference P<.1 Values are given as mean standard deviation or number Table 2 Number of cases of catherization and IVR form 12 to 16 Number of Cases Year Coronary 4,4 4,368 4,44 3,665 3,494 ngiography PCI 1,1 1,268 1,217 1,121 1,117 blation Peripheral IVR Total ll IVR 5,118 4,92 4,735 4,346 4,126 1,815 1,2 1,95 1,2 1,749 ll IVR total cases of PCI, blation and Peripheral IVR Table 3B The number of cardiologists continuingly engaged from 12, the total cases, the average standard deviation of equivalent dose of the eye lens, and the average standard deviation of equivalent dose of the eye lens per an per a case in each of the year. Year Mean Equivalent Dose Mean Equivalent Dose of p-value p-value Number of Number Cardiologists of Cases of Eye per a Eye msv Case Sv , , , ** * , ** * , * * * Shows the significant difference P<.5 ** Shows the significant difference P<.1 Values are given as mean standard deviation or number vol.65 no.787

7 PCI rts and Sciences Table 4 Table 4B Sv Sv Sv P< Sv Sv 15.2 Sv SvP<.1 Fig % 29.2% 57.5% 48.2% Table 4 The average standard deviation of effective dose and effective dose per a case in cardiologists who were continuingly engaged form 12 to 16. Year Effective Dose msv Median msv p-value **.4** Effective Dose 3.3 per a Case Sv Median Sv p-value **.4** ** Shows the significant difference P<.1 Values are given as mean standard deviation or number Table 4B The average standard deviation of equivalent dose of the eye lens and equivalent dose of the eye lens per a case in cardiologists who were continuingly engaged form 12 to 16. Year Effective Dose (msv) Equivalent Dose of Eye msv Median msv p-value.846.*.2**.2** Equivalent Dose of Eye Lens per a Case Sv Median Sv p-value.846.6**.2**.2** 7 B C D E F G H I J Operator * Shows the significant difference P<.5 ** Shows the significant difference P<.1 Values are given as mean standard deviation or number Fig.6 The transition of the effective dose in cardiologists of the past 5 years Equivalent Dose of Eye Lens (msv) B C D E F G H I J Opertor Fig.7 The transition in the equivalent dose of the eye lens in cardiologists of the past 5 years Decreasing Rate (%) Fluoroscopic Dose in Total Systems (Df) Imaging Dose in Total Systems (De) Effective Dose per a Case Equivalent Dose of Eye Lens per a Case Fig.8 Decreasing rate of fluoroscopic dose Df and imaging dose De in total system are shown from 13 to 16 compared with 12. s contrast of these, decreasing rate of both effective dose and equivalent dose of the eye lens per a case are also shown from 13 to 16 compared with those of 12 in cardiologists

8 4 27mGy/ min mgy/min 26% IVR 6 DRLs mgy/min J-RIME 24 DRLs % 24.4mGy/min mgy/min DRLs 15 PCI DP K Cate 16 1 DP 39 DPBMI 26.4kg/m mGy cm 2 /f 86 DPBMI 24.4kg/m mGy cm 2 /f 42% DP K DP DRLs 15 % IEDP 25 ICRP DRLs DP K DRLs IVR 28 cm 15% FPD 13 IVR 3Gy DRLs DRLs DRLs vol.65 no.787

9 PCI rts and Sciences 2 IVR ESD 2 3Gy 3 5Gy 5Gy 5Gy PSD 15JCI th Edition DRL MRC CTC 16 MRC 17% 5 msvmsv mSv mSv % IVR 6 1 ICRP Publication 59: The biological basis for dose limitation in the skin. nn. ICRP (1992). 2 Shope TB: Radiation-induced skin injuries from fluoroscopy. Radiographics (1996), 16: ICRP Publication 85: voidance of radiation injuries from medical interventional procedures. nn. ICRP (). 4 Wagner LK, Eifel PJ, and Geise R: Potential biological effects following high X-ray dose interventional procedures. J Vasc Interv Radiol (1994) 5: Koenig TR, Wolff D, Mettler F, and Wagner LK: Skin injuries from fluoroscopically guided procedures: part 1, characteristics of radiation injury. JR m J Roentgenol (1)177: Koenig TR, Mettler F, and Wagner LK: Skin injuries from fluoroscopically guided procedures: part 2, review of 73 cases and recommendations for minimizing dose delivered to patient. JR m J Roentgenol (1) 77: Berlin L: Radiation-induced skin injuries and fluoroscopy. JR m J Roentgenol (1) 177: Suzuki S, Furui S, Kohtake H, Yokoyama N, Kozuma K, Yamamoto Y, and Isshiki N: Radiation exposure to patient s skin during percutaneous coronary intervention for various lesions, including chronic total occlusion. Circ J (6) : ICRP Publication 3: The 7 Recommendations of the International Commission on Radiological Protection. nn. ICRP (7). ICRP Publication 113: Education and Training in Radiological Protection for Diagnostic and Interventional Procedures. nn. ICRP (9). 11 Food and Drug dministration (FD): voidance of serious X-ray-induced skin injuries to patients during fluoroscopically-guided procedures. Food and Drug dministration-important information, September 9 and (1994). 12 Guidelines on radiation exposure in cardiovascular care (11 revised edition) Guideline for Radiation Safety in Interventional Cardiology. JCS 11 (11). (in Japanese) 13 Söderman M, Holmin S, ndersson T, Palmgren C, Babic D, and Hoomaert B: Image noise reduction algorithm for digital subtraction angiography: clinical results. Radiology (13) 269:

10 14 Dekker LR, van der Voort PH, Simmers T, Verbeek X, Bullens RW, Veer MV, Brands PJ, and Meijer : New image processing and noise reduction technology allows reduction of radiation exposure in complex electrophysiologic interventions while maintaining optimal image quality: a randomized clinical trial. Heart Rhythm (13) : Bracken J, Mauti M, Kim MS, Messenger JC, and Carroll JD: radiation dose reduction technology to improve patient safety during cardiac catheterization interventions. J Interv Cardiol (15) 28: Ten Cate T, van Wely M, Gehlmann H, Mauti M, Camaro C, Reifart N, Suryapranata H, and de Boer MJ: Novel X-ray image noise reduction technology reduces patient radiation dose while maintaining image quality in coronary angiography. Neth Heart J (15) 23: Nakamura S, Kobayashi T, Funatsu, Okada T, Mauti M, Waizumi Y, and Yamada S: Patient radiation dose reduction using an X-ray imaging noise reduction technology for cardiac angiography and intervention. Heart Vessels (16) 31: Kastrati M, Langenbrink L, Piatkowski M, Michaelsen J, Reimann D, and Hoffmann R: Reducing Radiation Dose in Coronary ngiography and ngioplasty Using Image Noise Reduction Technology. m J Cardiol (16) 118: Kumashiro M, Kataoka T, Yokota S, Nakagawa S, Otsuki K, Miyake N, and Yamaoka K: Image quality of the coronary angiography with noise reduction technology to decrease the radiation dose. cta Med Okayama (18) 72: Swady JM, Kempton TM, Olshove V, Gocha M, et al.: Use of a Dose-dependent Follow-up Protocol and Mechanisms to Reduce Patients and Staff Radiation Exposure in Congenital and Structural Interventions. Catheter and Cardiovasc Interv (11) 78: Maria Mauti, Jan jans: Dap calculation model, n evolution in Dose Product indication. Interventional X-ray, Philips Healthcare, The Netherlands , Dec DRLs IVR DRLs : International tomic Energy gency: Patient Dose Optimization in Fluoroscopically Guided Interventional Procedures. IE-TECDOC-1641, VIENN, : : : circulation journal : X CT Joint Commission International ccreditation Standards for Hospitals, 6th Edition: The effective date of the 6th Edition is 1 July ICRP Publication 118: ICRP Statement on Tissue Reactions/ Early and Late Effects of Radiation in Normal Tissues and Organs. Threshold Doses for Tissue Reactions in a Radiation Protection Context. nn. ICRP 41(1/2), Haga Y, Chida K, Kaga Y, Sota M, Meguro T, Zuguchi M: Occupational eye dose in interventional cardiology procedures. Sci Rep. 17 pr. 3; 7(1): 569, Published online 17 pr. 3. doi vol.65 no.787

Cone-Beam CT Area Detector CT CBCT JNET journal of Neuroendovascular Therapy

Cone-Beam CT Area Detector CT 1 2 1-6 03-3293-1711 shimada.takashi@nihon-u.ac.jp CBCT JNET journal of Neuroendovascular Therapy Cone-Beam CT Area Detector CT Cone-Beam CT(CBCT) CT CBCT CT Area Detector