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2. 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

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

4. 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 Clinical radiation management for fluoroscopically guided interventional procedures. Radiology, 257,
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

5. 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 Skin dose mapping for fluoroscopically guided interventions. Medical Physics, 38,
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

6. 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 Patient dosimetry approaches in interventional cardiology and literature dose data review. Radiation Protection Dosimetry, 117,
4. STRUELENS, L., BACHER, K., BOSMANS, H., BLEESER, F., HOORNAERT, M. T., MALCHAIR, F. & BALTER, S Establishment of trigger levels to steer the follow-up of radiation effects in patients undergoing fluoroscopically-guided interventional procedures in Belgium. Physica Medica, 30,
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

7. 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 particular requirements for the safety of x-ray equipment for interventional procedures. Report nd 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 particular requirements for the safety of x-ray equipment for interventional procedures. Report nd ed. Geneva, Switzerland: International Electro technical Commission, 2000
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

8. 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 Fluoroscopically guided interventional procedures: A review of radiation effects on patients' skin and hair. Radiology, 254,
8. NCRP NCRP Report 168. Radiation dose management for fluoroscopically-guided interventional medical procedures.
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

9. 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 Radiation doses in interventional radiology procedures: The RAD-IR study part I: Overall measures of dose. Journal of Vascular and Interventional Radiology, 14,
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

10. 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 Radiation safety program for the cardiac catheterization laboratory.
11. FDA Performance standards for ionizing radiation emitting products. Code of Federal Regulations, Part 1020.
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

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

12. 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, Technical White Paper: Monitoring and Tracking of Fluoroscopic Dose.
13. ACR–AAPM, TECHNICAL STANDARD FOR MANAGEMENT OF THE USE OF
RADIATION IN FLUOROSCOPIC PROCEDURES.
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES

13. 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

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

15. 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

16. 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)

17. 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

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

19. 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

20. 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

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

22. 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

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

24. 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 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

25. 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

26. 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

27. 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

28. 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

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

30. REFERENCES
MILLER, D. L., BALTER, S., SCHUELER, B. A., WAGNER, L. K., STRAUSS, K. J. & VAÑÓ, E Clinical radiation management for fluoroscopically guided interventional procedures. Radiology, 257,
JOHNSON, P. B., BORREGO, D., BALTER, S., JOHNSON, K., SIRAGUSA, D. & BOLCH, W. E Skin dose mapping for fluoroscopically guided interventions. Medical Physics, 38,
PADOVANI, R. & QUAI, E Patient dosimetry approaches in interventional cardiology and literature dose data review. Radiation Protection Dosimetry, 117,
STRUELENS, L., BACHER, K., BOSMANS, H., BLEESER, F., HOORNAERT, M. T., MALCHAIR, F. & BALTER, S Establishment of trigger levels to steer the follow-up of radiation effects in patients undergoing fluoroscopically-guided interventional procedures in Belgium. Physica Medica, 30,
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 particular requirements for the safety of x-ray equipment for interventional procedures. Report nd ed. Geneva, Switzerland: International Electro technical Commission, 2000
BALTER, S., HOPEWELL, J. W., MILLER, D. L., WAGNER, L. K. & ZELEFSKY, M. J Fluoroscopically guided interventional procedures: A review of radiation effects on patients' skin and hair. Radiology, 254,
NCRP 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 Radiation doses in interventional radiology procedures: The RAD-IR study part I: Overall measures of dose. Journal of Vascular and Interventional Radiology, 14,
CHAMBERS, C. E., FETTERLY, K. A., HOLZER, R., LIN, P. J. P., BLANKENSHIP, J. C., BALTER, S. & LASKEY, W. K Radiation safety program for the cardiac catheterization laboratory.
FDA Performance standards for ionizing radiation emitting products. Code of Federal Regulations, Part 1020.
CRCPD, Technical White Paper: Monitoring and Tracking of Fluoroscopic Dose.
ACR–AAPM, TECHNICAL STANDARD FOR MANAGEMENT OF THE USE OF RADIATION IN FLUOROSCOPIC PROCEDURES.
CIRSE 2016 RADIATION DOSE MANAGMENT IN IR SUITES