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Patient Skin Dose IN IR THEORY VERSUS PRACTISE Leeo’hora BSC, MSc Radiation protection officer mAter Misericordiae University Hospital DUBLIN IE CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

OVERVIEW QUANTIFICATION OF SKIN DOSE SUBSTANTIAL RADIATION DOSE LEVELS INTERNATIONAL PRACTISE CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

QUANTIFICATION OF SKIN DOSE The best quantity to assess the risk to skin is Peak Skin Dose Peak Skin Dose (PSD)¹ Peak Skin Dose has been described as the highest dose at any portion of a patient’s skin during a procedure. Peak skin dose includes contributions from both the primary x-ray beam and from scatter. Peak skin dose is measured in Grays (to soft tissue) 1. MILLER, D. L., BALTER, S., SCHUELER, B. A., WAGNER, L. K., STRAUSS, K. J. & VAÑÓ, E. 2010. Clinical radiation management for fluoroscopically guided interventional procedures. Radiology, 257, 321-332. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Direct measurement of PSD QUANTIFICATION OF SKIN DOSE Direct measurement of PSD PSD can be directly measured using radio chromic films or a matrix of thermo luminescent dosimeters (TLDs). ‘Skin dose mapping’ can be used as a direct, real time indicator of PSD when exposure and geometric factors are available for pairing with an anatomical patient models². 2. JOHNSON, P. B., BORREGO, D., BALTER, S., JOHNSON, K., SIRAGUSA, D. & BOLCH, W. E. 2011. Skin dose mapping for fluoroscopically guided interventions. Medical Physics, 38, 5490-5499. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

DIRECT PSD – PROBLEMS! FILMS/TLDs - labour intensive and do not give real time dose readings. More suitable for research purposes on a small sample of patients³ . Skin dose mapping facilities - not widely available and, therefore ‘absent in routine practice’. 3. PADOVANI, R. & QUAI, E. 2006. Patient dosimetry approaches in interventional cardiology and literature dose data review. Radiation Protection Dosimetry, 117, 217-221. 4. STRUELENS, L., BACHER, K., BOSMANS, H., BLEESER, F., HOORNAERT, M. T., MALCHAIR, F. & BALTER, S. 2014. Establishment of trigger levels to steer the follow-up of radiation effects in patients undergoing fluoroscopically-guided interventional procedures in Belgium. Physica Medica, 30, 934-940. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

QUANTIFICATION OF SKIN DOSE Indirect measurement of PSD PSD can be indirectly measured using other dose metrics; Fluoroscopic Time (FT) DAP⁵’⁶ (Dose/Kerma Area Product) Kar (Air Kerma at a Reference point) The official notation for kerma area product recommended in ICRU report 74 is PKA. ICRU, International Commission on Radiation Units and Measurements, Patient Dosimetry for X Rays used in Medical Imaging, ICRU Report 74, Oxford University Press, Oxford, UK, Vol. 5, N° 2, 2005. International Electrotechnical Commission. Medical electrical equipment: part 2-43- particular requirements for the safety of x-ray equipment for interventional procedures. Report 60601. 2nd ed. Geneva, Switzerland: International Electrotechnical Commission, 2010 5. ICRU, International Commission on Radiation Units and Measurements, Patient Dosimetry for X Rays used in Medical Imaging, ICRU Report 74, Oxford University Press, Oxford, UK, Vol. 5, N° 2, 2005. 6. International Electro technical Commission. Medical electrical equipment: part 2-43- particular requirements for the safety of x-ray equipment for interventional procedures. Report 60601. 2nd ed. Geneva, Switzerland: International Electro technical Commission, 2000 CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

indIRECT PSD – PROBLEMS! FT - Non-dosimetric quantity BUT readily available . Should not be relied on as the sole dose metric for complex IR procedures as it is an extremely poor indicator of the risk of skin injury⁷. DAP – DAP (Pka) is a good surrogate for the amount of energy delivered to the patient and is generally used as a predictor of the risk of stochastic effects in IR⁸. 7. BALTER, S., HOPEWELL, J. W., MILLER, D. L., WAGNER, L. K. & ZELEFSKY, M. J. 2010. Fluoroscopically guided interventional procedures: A review of radiation effects on patients' skin and hair. Radiology, 254, 326-341. 8. NCRP 2010. NCRP Report 168. Radiation dose management for fluoroscopically-guided interventional medical procedures. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

indirect PSD –kAR “This is the cumulative kerma at a point along the central ray of the x ray beam, 15cm from the isocenter, towards the x ray tube”⁹ 9. MILLER, D. L., BALTER, S., COLE, P. E., LU, H. T., SCHUELER, B. A., GEISINGER, M., BERENSTEIN, A., ALBERT, R., GEORGIA, J. D., NOONAN, P. T., CARDELLA, J. F., ST. GEORGE, J., RUSSELL, E. J., MALISCH, T. W., VOGELZANG, R. L., MILLER III, G. L. & ANDERSON, J. 2003. Radiation doses in interventional radiology procedures: The RAD-IR study part I: Overall measures of dose. Journal of Vascular and Interventional Radiology, 14, 711-727. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

inDIRECT PSD –kAR Kar has been shown as a good surrogate for PSD¹’¹⁰ IEC and the FDA require this metric to be displayed on fluoroscopic equipment⁶’¹¹ Kar is generally used as a predictor of tissue reactions in IR⁸ . 10. CHAMBERS, C. E., FETTERLY, K. A., HOLZER, R., LIN, P. J. P., BLANKENSHIP, J. C., BALTER, S. & LASKEY, W. K. 2011. Radiation safety program for the cardiac catheterization laboratory. 11. FDA 2002. Performance standards for ionizing radiation emitting products. Code of Federal Regulations, Part 1020. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

OVERVIEW QUANTIFICATION OF SKIN DOSE SUBSTANTIAL RADIATION DOSE LEVELS INTERNATIONAL PRACTISE CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

SUBSTANTIAL RADIATION DOSE LEVELS As seen, direct estimation of this is not widely clinically available and it is for this reason that the NCRP⁸, CRCPD¹² and ACR and AAPM¹³ have suggested identical, unambiguous indirect dose parameter ‘trigger values’ or ‘substantial radiation dose levels (SRDLs)’ for the routine identification of and follow up of potential tissue reactions post interventional radiological procedures. 12. CRCPD, 2010. Technical White Paper: Monitoring and Tracking of Fluoroscopic Dose. http://www.crcpd.org/Pubs/WhitePaper-MonitoringAndTrackingFluoroDose-PubE-10-7.pdf. 13. ACR–AAPM, 2013. TECHNICAL STANDARD FOR MANAGEMENT OF THE USE OF RADIATION IN FLUOROSCOPIC PROCEDURES. http://www.acr.org/~/media/f22c9d1ff46f43aab001f9ed0466b7e9.pdf CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Parameter Threshold PSD Kar Pka FT 3000 mGy Kar 5000 mGy Pka 500 Gy.cm2 FT 60 min CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

OVERVIEW QUANTIFICATION OF SKIN DOSE SUBSTANTIAL RADIATION DOSE LEVELS INTERNATIONAL PRACTISE CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

91 18 Dr. Louise Rainford Dr. Marie Louise Butler 6 11 4 3 3 STAFF AND TRAINING IR SPECIALITY/PROCEDURE NUMBERS EQUIPMENT AND DOSE METRICS IR CONSENT TISSUE REACTION IDENTIFICATION PATIENT FOLLOW-UP TISSUE REACTION MANAGMENT 18 11 4 3 3 91 Dr. Louise Rainford Dr. Marie Louise Butler A total of 136 questionnaires were completed from 7 countries. Country Respondent Numbers Italy 91 England 18 Ireland 11 Singapore 6 The Netherlands 4 Belgium 3 Portugal 3 6 CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Section1 – Staff and training Q.2 (n=135). In procedure radiation safety operations were carried out predominantly by; • Radiographers, 70.4% of the time (n=95) • Radiographer and interventional physician, 15.6% of the time (n=21) • Interventional physicians, 9.6% of the time (n=13) • Physicists 2.96% (n=4)

QUESTION In procedure radiation safety operations are carried out predominantly by; a) Radiographers b) Radiographer and interventional physician c) Interventional physicians d) Physicists CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Section 2 – IR specialities and procedure numbers Q.5 (n=102). 254054 annual IR procedures were reported across 7 countries, with a mean annual IR procedure number of 2502.51 ± 298.537 (SEM) per respondent/facility. 45.2 % were cardiology procedures, 24.5% general, 24.28% vascular, 5.45% neurological 0.57% were classified as ‘other’.

Section 3 – Equipment and dose metrics Missing Kar 45 Missing Kar, PSD supplied 9 Missing DAP 1 Missing DAP and Kar 2 Missing FT and Kar Missing FT and DAP Q7. 53 respondents (98 pieces of equipment) also gave sufficient equipment make and model details to allow dose metric comparison Quoted dose metrics were compared to manufacturer specifications and categorized as correct or incorrect. Overall 60.2% (n=59) of dose metric information supplied (n=98) was incorrect. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Section 4 – Patient consent Q10 (n=125). Only 35.2% (n=44) of respondents routinely included any radiation effects in IR procedure consent, 64.8% (n=81) do not include radiation effects. Q.12 Further analysis of the ‘NO’ responses(n=81), asked if this was considered where patient dose may be high, 74 respondents answered – 20 yes, 54 no Increasing consent numbers to 51.2 % , n=64 CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

QUESTION Are radiation effects included routinely ± in certain circumstances in IR patient consent YES NO CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Section 5, Tissue reaction identification 108 RESPONSES 25 USE SRDL -23% 5 BPG – 4.6% Q15 (n=108). Only 23.1% (n=25) of respondents use a trigger value or SRDL to identify patients who may have a potential tissue reaction. Q16. Of the 29 dose metric trigger values supplied by respondents, 24 were meaningful (Value and unit for SRDL supplied for correct metric). 5 of which were in line with international best practice guidance, representing a worrying CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

QUESTION Do you use SRDLs? YES NO CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Section 5, Tissue reaction identification Annual procedures SRDL reached % of total procedures IR 62143 938 1.51 Cardiology 40221 920 2.29 Vascular 5027 5 0.1 General 14245 12 0.08 Neuro 1650 1 0.06 Q 17. 14 facilities from 4 countries supplied information on annual procedure numbers and potential trigger reaction procedure numbers. Of 62,143 IR procedures, 1.51% (n=938) reached (or exceeded) a pre-determined trigger level/SRDL. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Section 5, Tissue reaction identification Type of IR procedure for which trigger values were reached Number Percutaneous coronary intervention 869 Chronic total occlusion 34 Coronary angiogram 8 Trans catheter arterial chemoembolization 7 Endovascular aneurysm repair 5 Trans catheter aortic valve implantation 4 Trans jugular intrahepatic Porto systemic shunt 2 Mesenteric angiogram Uterine fibroid embolization Green filter stent removal 1 Neurological arteriovenous malformation 13 respondents gave sufficient information on specific type of procedure for 935 IR procedures which reached or exceeded trigger values. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Section 6, Tissue reaction management Q20 (n=22). Of respondents who profess to use trigger values, 50% do not inform the patient of potential tissue reactions. Large variation between countries surveyed, With Singapore (n=3) giving information to 0% of patients to England (n=6) giving informing to 100% of patients. CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

In Summary Radiographers predominantly responsible for optimization of procedure dose (70% and involved 85%) Cardiology procedures account for 45% of IR procedures. Cardiology has the highest incidence of SRDL procedures at 2.29% (Predominantly PCI procedures) Knowledge of patient dose metrics is poor (60% incorrect) Radiation effects included in IR consent only 51% of cases Only 23% use SRDLs (And only half of these inform the patient once a SRDL is reached) Only 5% use internationally recognized best practice SRDL CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

Session summary Patient dose monitoring is essential in ensuring dose optimization Inter professional communication and teamwork is key in patient dose quantification and appropriate utilization of this information Dose quantification in IR is multi factorial and must consider both stochastic effects and tissue reactions DRLs identify unusually high doses and increase knowledge locally of patient dose Skin dose indicators can be used to identify and follow up potential tissue reactions but clinical implementation is limited CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

THANK YOU…. lohora@mater.ie CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

REFERENCES MILLER, D. L., BALTER, S., SCHUELER, B. A., WAGNER, L. K., STRAUSS, K. J. & VAÑÓ, E. 2010. Clinical radiation management for fluoroscopically guided interventional procedures. Radiology, 257, 321-332 JOHNSON, P. B., BORREGO, D., BALTER, S., JOHNSON, K., SIRAGUSA, D. & BOLCH, W. E. 2011. Skin dose mapping for fluoroscopically guided interventions. Medical Physics, 38, 5490-5499. PADOVANI, R. & QUAI, E. 2006. Patient dosimetry approaches in interventional cardiology and literature dose data review. Radiation Protection Dosimetry, 117, 217-221. STRUELENS, L., BACHER, K., BOSMANS, H., BLEESER, F., HOORNAERT, M. T., MALCHAIR, F. & BALTER, S. 2014. Establishment of trigger levels to steer the follow-up of radiation effects in patients undergoing fluoroscopically-guided interventional procedures in Belgium. Physica Medica, 30, 934-940 ICRU, International Commission on Radiation Units and Measurements, Patient Dosimetry for X Rays used in Medical Imaging, ICRU Report 74, Oxford University Press, Oxford, UK, Vol. 5, N° 2, 2005. International Electro technical Commission. Medical electrical equipment: part 2-43- particular requirements for the safety of x-ray equipment for interventional procedures. Report 60601. 2nd ed. Geneva, Switzerland: International Electro technical Commission, 2000 BALTER, S., HOPEWELL, J. W., MILLER, D. L., WAGNER, L. K. & ZELEFSKY, M. J. 2010. Fluoroscopically guided interventional procedures: A review of radiation effects on patients' skin and hair. Radiology, 254, 326-341. NCRP 2010. NCRP Report 168. Radiation dose management for fluoroscopically-guided interventional medical procedures. MILLER, D. L., BALTER, S., COLE, P. E., LU, H. T., SCHUELER, B. A., GEISINGER, M., BERENSTEIN, A., ALBERT, R., GEORGIA, J. D., NOONAN, P. T., CARDELLA, J. F., ST. GEORGE, J., RUSSELL, E. J., MALISCH, T. W., VOGELZANG, R. L., MILLER III, G. L. & ANDERSON, J. 2003. Radiation doses in interventional radiology procedures: The RAD-IR study part I: Overall measures of dose. Journal of Vascular and Interventional Radiology, 14, 711-727. CHAMBERS, C. E., FETTERLY, K. A., HOLZER, R., LIN, P. J. P., BLANKENSHIP, J. C., BALTER, S. & LASKEY, W. K. 2011. Radiation safety program for the cardiac catheterization laboratory. FDA 2002. Performance standards for ionizing radiation emitting products. Code of Federal Regulations, Part 1020. CRCPD, 2010. Technical White Paper: Monitoring and Tracking of Fluoroscopic Dose. http://www.crcpd.org/Pubs/WhitePaper-MonitoringAndTrackingFluoroDose-PubE-10-7.pdf. ACR–AAPM, 2013. TECHNICAL STANDARD FOR MANAGEMENT OF THE USE OF RADIATION IN FLUOROSCOPIC PROCEDURES. http://www.acr.org/~/media/f22c9d1ff46f43aab001f9ed0466b7e9.pdf CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES