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First published online November 26, 2007
British Journal of Radiology (2008) 81, 1-7
© 2008 British Institute of Radiology
doi: 10.1259/bjr/15413265

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British Journal of Radiology 81 (2008),1-7 ©2008 The British Institute of Radiology

Radiation risks in interventional radiology

P P Dendy, PhD

1A Coppice Avenue, Great Shelford, Cambridge CB22 5AQ, UK

Correspondence: P P Dendy, 1A Coppice Avenue, Great Shelford, Cambridge CB22 5AQ, UK. E-mail: dendy{at}waitrose.com


    Abstract
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 
The number, diversity and complexity of interventional radiological examinations have all increased markedly in recent years, and it is widely recognized that some of these procedures carry greater risks than many other radiological procedures. This Commentary uses a meeting on "Radiation Protection in Interventional Radiology" held at the British Institute of Radiology on 28 March 2007 as a template to discuss recent progress in this area, some current problems and plans for the future.


Commentary

Radiation risks in interventional radiology

P P Dendy, PhD

1A Coppice Avenue, Great Shelford, Cambridge CB22 5AQ, UK

Correspondence: P P Dendy, 1A Coppice Avenue, Great Shelford, Cambridge CB22 5AQ, UK. E-mail: dendy{at}waitrose.com

The number, diversity and complexity of interventional radiological examinations have all increased markedly in recent years, and it is widely recognized that some of these procedures carry greater risks than many other radiological procedures. This Commentary uses a meeting on "Radiation Protection in Interventional Radiology" held at the British Institute of Radiology on 28 March 2007 as a template to discuss recent progress in this area, some current problems and plans for the future.


    Introduction
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 
It is widely recognized that some procedures in interventional radiology (IR) carry greater radiation risks than many other radiological examinations. There are increased stochastic risks to the patient from long screening procedures and a greater risk of deterministic effects, generally to the skin, especially when the radiation beam is directed at the same area on the skin surface for most, if not all, of the examination. There are also increased stochastic risks, and possibly deterministic risks, to staff who are close to the patient from scattered radiation. For all of these reasons, the European Council Directive of 30 June 1997 on "Health protection of individuals against the dangers of ionising radiation to medical exposure, and repealing Directive 84/466 Euratom" [1] identified IR as a "Special Practice" requiring special attention to be given to quality assurance programmes, quality control measures and patient dose assessment.

Several publications give information and/or guidance on radiological protection in IR (see [24]). However, in the past 4 years, the number, diversity and complexity of IR examinations have all increased markedly. Therefore, it is timely to review recent progress, current problems and plans for the future. This Commentary is based on a meeting held at the British Institute of Radiology on 28 March 2007 to address these issues. The multidisciplinary nature of many of them was emphasized.


    Current trends in interventional radiology — the radiologists' viewpoint
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 
To put the subject into a clinical context, it is helpful to review the state of the art in IR. The first interventional procedure is generally attributed to Dotter in 1964 [5] who used dilators to relieve arterial stenosis. Since that time, proliferation of IR procedures has proceeded apace, often driven by technical advances. By 2000, the compound annual rate of increase in IR across all service settings in the UK was ~10%.

Some recent trends in IR were identified by Hamish Ireland (Edinburgh):

Ireland also indicated some drivers for change in the use of IR procedures:

Using endovascular techniques as a specific example of IR procedures, Anthony Nicholson (Leeds) expanded on some important issues in radiation protection for the radiologist. IR plays a major role in accident/trauma and is becoming an increasing part of emergency work [6, 7]. In some situations, the technique is far more effective than surgery for stopping massive bleeding. Significant doses of radiation are involved, including top-to-toe CT scanning beforehand, a flush aortogram to find the exact site of bleeding and CT scans to check that all is well subsequently, in addition to the radiation required for the interventional procedure itself. Is all this ionizing radiation necessary? Nicholson said that in some cases it was, and suggested that a simple working definition of optimized dose in IR was "the least amount of radiation to get the job done". However, interventionalists must not get carried away by their enthusiasm to utilize fully this new technology now available to them. For example, it may be feasible to follow up a TIPS using ultrasound, with no further need for CT digital subtraction angiography.

For the radiologist, there is uncertainty and some confusion over the most suitable measure of doses to patients in IR. Two points need to be kept in mind. Firstly, the measure required to assess stochastic risk will normally be different from the measure best-suited to assess deterministic risk. Secondly, the pattern of exposure on the skin surface may be entirely localized to one area, e.g. in neuro work, or spread over a larger area, e.g. cardiology. For comparison of performance, cumulative dose (CD) (discussed in the next section) is often preferable to dose-area-product (DAP), and Nicholson expressed concern at the wide range of CDs reported in the literature. For example, as part of a large multi-centre study, Miller et al [8] recorded CDs from 135 TIPS cases. The range was 0.1–8 Gy, with 26% <1 Gy but 21% >3 Gy. This wide range in recorded doses has been reported many times for several different procedures. Setting aside equipment-related factors, which are discussed later, several contributing factors can be identified: patient factors (including complexity of the procedure), poor or no training of the interventionalist, experience of the interventionalist, high/low volume case load, and poor technique. However, in the final analysis, it is difficult to tease out the dominant causes of variation from this list.


    Doses to patients
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 
Elisio Vañó (Madrid) gave an overview of doses to patients. After reviewing the relevant recommendations (e.g. [24]), he made some important points.

Firstly, DAP, which is a measure of the total energy imparted to the patient as ionising radiation, correlates reasonably well with the stochastic risks of induced cancer probability or hereditary effects. Variations in total energy absorbed with kVp, filtration and tissue weighting factors (wT) have a relatively minor effect. Conversely, for many interventional procedures, DAP is a poor measure of the risk of deterministic effects, especially for cardiology where there tends to be several non-overlapping fields. Therefore, it is important to record the CD or cumulative air KERMA (kinetic energy released per unit mass) at the interventional reference point (IRP). Note that manufacturers' data will normally be given in terms of air KERMA dose rate under specified output conditions in a scatter-free measurement at the IRP, chosen to approximate the skin surface. For a system with an isocentre, the IRP is a point on the reference axis 15 cm from the isocentre in the direction of the focal spot [9].

Secondly, the beneficial uses of diagnostic reference levels in plain film radiology are now well established:

Can the principle of reference levels (RLs) be transferred to interventional procedures and would this be an aid to optimization in IR? The starting point is to collect detailed information on a wide range of procedures from a number of different centres. Some preliminary data, using equipment supplied by only one manufacturer, are shown in Table 1Go for both DAP and CD.


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Table 1. Radiation doses in interventional radiology procedures: the data are abstracted from the RAD-IR study [8]

 
Information on the spread of doses can be used to propose RLs for different interventional procedures. However, the exercise is more difficult than for plain film radiography. Variations in dose will arise because of equipment factors, exposure settings and all of the factors noted by Nicholson. Bernadi et al [10] reported a twofold difference in DAP between simple and complex procedures in percutaneous transluminal coronary angioplasty (PTCA). If RLs are adopted for IR procedures, then they may have to be graded for each type of procedure, according to simple, medium and complex.

Further information on patient skin dose monitoring was given by Rachel Morrell (Nottingham). A review of the advantages and limitations of the various methods available shows that none is ideal:

International Commission on Radiological Protection (ICRP) Report 85 [2] recommends that the magnitude and position of the maximum skin dose should be recorded in the patient's notes if it exceeds 1 Gy for procedures that are likely to be repeated, or 3 Gy for all procedures. Patients receiving more than 1 Gy to the same skin area can be considered to be "at risk" from deterministic effects and should be informed about potential symptoms and appropriate action they should take if any skin changes occur.

Morrell and Rogers [11] have made a detailed study of the use of Kodak EDR 2 film (Eastman Kodak Company, Rochester, NY) for skin dose monitoring. Measurements were made for 20 coronary angiography and 32 PTCA procedures. The film gives good information on the pattern of irradiated fields across the patient's back, with variations in radiation blackening. For coronary angiography, all skin doses were well below 1 Gy. However, 23% of PTCA patients received skin doses of 1 Gy (the dose at which the film saturated) or more. The authors concluded that practical compliance with ICRP recommendations requires a robust method for skin dosimetry that is more accurate than DAP and applicable over a wider range of doses than EDR2 film. Gaf chromic films (International Specialty Products, Wayne, NJ) have higher dose ranges than EDR2 film and do not require processing, but at present they are prohibitively expensive for routine dosimetric use.

There are indications that the problem of comprehensive and relevant dosimetry may be amenable to solution by mathematical modelling. For example, a mathematical model developed by Morrell and Rogers [12] uses exposure and projection data from the acquisition runs stored in the DICOM image files to estimate skin doses. Early work showed that maximum skin doses calculated by this model correlated well with those measured on EDR2 film. Three methods for including the relatively smaller dose contribution from fluoroscopy were investigated and all successfully identified patients receiving skin doses in excess of 1 Gy. Two advantages over film dosimetry are that doses above the saturation point of film can be assessed and there is less staff involvement. Furthermore, in theory, the method can be combined both with data on doses to organs and wT values to give an estimate of effective dose to patients, and with data on room scattering to provide information on staff doses. Some of the technology that would be required for a comprehensive dosimetric system is not yet available, but this might be a fruitful area for discussion with manufacturers.


    Staff doses
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 
Vañó emphasised that "appropriate" staff dosimetry is essential, but what is "appropriate"? There are several possibilities:

There are also practical problems with occupational dosimetry:

Nicholson commented that, in the UK, the Regulations did not make it easy for staff to monitor themselves and cited the problem of "Radiation Passports" for interventionalists who work at more than one location. There is general agreement that the interventionalist will be giving 100% of their attention to the patient with little thought for the radiation dose to themselves. However, this should not prevent the wearing of dosemeters as directed.

Mark Whitby (Glasgow) gave further information on staff dose and monitoring requirements. Many factors will influence the amount of scattered radiation reaching staff, including the size of the patient, the equipment and its set-up, the type of procedure (especially its complexity and length), tube geometry, position of staff (especially their hands) relative to the patient, the skill and experience of the operator and the effective use of radiation protection principles and devices.

Given the uncertainties, it is not surprising that Whitby's data showing indicative doses for IR/cardiology covered wide ranges (Table 2Go). It is clear that, at the upper ends of these ranges, staff will need to be "Classified Radiation Workers" and some form of monitoring is essential. The challenge is to ensure that it is both relevant and proportionate to the risk. For whole body monitoring, there is still uncertainty as to whether two monitors (one below the apron at, for example, chest level and one above the apron at collar/eye level) are necessary. Whitby suggested that one monitor should suffice for a low work load, with two monitors for a higher work load. The boundary between low and high workloads should be set in the region of 1–5 mSv per annum for body doses. The second monitor will also be necessary if eye doses are high, i.e. with a boundary in the range 10–50 mSv per annum. Unfortunately, it is difficult to specify the boundary in terms of readily available machine output data such as DAP, because the precise position of the operator is also a factor. Therefore, a conservative approach to monitoring must be taken initially. This can often be relaxed when real monitoring data become available.


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Table 2. Indicative staff dose summary for radiology/cardiology

 
Doses to the hands are highly dependent on their position relative to the beam and the different hand movements in different procedures. For example, this may be a prodding action (advancing/withdrawing the catheter) used in the percutaneous approach, or a combination of prodding and twisting actions used in, for example, the femoral or internal jugular vein approaches. For a mixed work load, a ring dosemeter worn on the ring or fifth finger is a good compromise. For the percutaneous approach, a finger stall at the top of the middle finger might be preferable, with a ring dosemeter worn on the ring or little finger still providing a good estimate of maximum dose.

Because of the uncertainties involved, the hands should always be monitored when a procedure in which the hands have to be close to the main beam is used for the first time. Subsequently, monitoring might be relaxed to "periodic" if the estimated annual hand dose is less than 50 mSv per annum, or stopped altogether if below 10 mSv per annum. For further information on recommended extremity monitoring at different dose levels, see Martin and Whitby [13].

Proper use of protective measures can have a big impact on staff doses and is essential e.g. see Vañó et al [14]. In the example cited, nine staff radiologists and eight interventional cardiology fellows working in a centre performing 5000 procedures a year were monitored using personal dosemeters — below and outside lead aprons — over a period of 15 years. At the start of the study, maximum doses of 100–300 mSv per month above the apron and 5–11 mSv per month (mean 10.2 mSv per year) below the apron were recorded. In the past 5 years, after a programme of optimization, mean occupational doses under the lead apron have fallen to 1.2 mSv per year (14% of those in 1989 to 1992), whereas doses recorded outside the lead apron have fallen by a factor of 14. The most effective actions for reducing the radiation risk were (i) training in radiation protection, (ii) a programme of patient dose reduction, and (iii) the systematic use of radiation protection facilities, specifically ceiling-suspended protective screens.


    Equipment factors and programme set-up
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 
Taking the title "Designing radiation protection into the system", Nick Marshall (London) gave an excellent review of the importance of well-designed equipment in dose reduction. Features of the equipment that are known to affect dose include:

Marshall also made some important general remarks on radiation protection implications of the interface between radiology staff and manufacturers:

Careful attention to detail in setting parameters and clinical observations can aid in optimization and indicate further areas of study. These principles were well illustrated in two case studies in interventional neuroradiology presented by Halina Szutowicz (Cambridge).

A Siemens Axiom Artis BA was installed in Cambridge in May 2004, and each of the factory settings was challenged with alternative options. For example, 15 pulses s–1 was reduced to 7 pulses s–1 but gave jerky movements and was rejected. Dose rates per pulse were reduced from 23 µGy, 32 µGy and 45 µGy per pulse to 15 µGy, 18 µGy and 23 µGy per pulse, respectively. Arrangements were made to put the dose record file with the stored images, and a total dose record was placed in the patient's radiology record.

The first case was a long procedure, lasting a total of 9 h, to embolise a single large occipital arterio/venous malformation. 2.5 weeks later, the patient reported sudden loss of hair from the back of the head, but no apparent erythema at this stage. Subsequently, marked erythema and almost complete epilation developed.

A number of actions were taken:

3 months later, the patient's hair had regrown. This is consistent with temporary epilation. Perhaps there was early erythema that went unnoticed?

Fewer details were given on the second case, except that it was a spinal embolisation. The lateral plane ESD was off scale (maximum 999 mGy) and had to be estimated from the DAP reading at 11.3 Gy. At 10 months, telangiectasia was visible, with perfect collimation to the irradiated site, but the patient had not noticed any of the early effects he had been told to expect.

The work raises some interesting questions for future study:


    Education and training
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 
Several other matters that deserve mention will be grouped together under this heading.

As Claire Cousins (Cambridge) pointed out, very few radiologists or interventionalists will see a radiation injury during their working lifetime and will never know if their use of radiation has caused cancer. However, the fact that "these things happen to someone else" is not an acceptable reason for ignoring radiation doses.

Long-term follow-up of atomic bomb survivors has shown that an excess risk of cancer is associated with a few tens of mSv [16]. At the much lower doses associated with many diagnostic procedures, e.g. those comparable with annual background radiation, extrapolation is more uncertain, not least because homeostatic mechanisms may reduce the radiation effect [17]. However, at the level of effective dose (E) typical of IR, the analysis of Brenner and Elliston [18] is pertinent. They assumed an E value of 12 mSv for a single full whole-body CT examination (lung organ dose ~15 mGy) and estimated a cancer risk of 8x10–4 for a 45-year-old, which falls slightly with age. Adequate information must be given to all relevant staff on such levels of radiation risk, which are typical of many IR procedures, but it is important to emphasize that there are very large sources of error in using the effective dose concept for risk estimation [19]. The 95% confidence interval on the Brenner and Elliston risk estimation [18] was about a factor of three each way, and so numerical estimates of excess risk of fatal cancer derived from E should not be included in patient reports.

A further important aspect of training is to put the radiation risk into perspective with other everyday risks. For example, the risk of death in a car accident in the US in 1999 was about a quarter that of the hypothetical CT scan discussed above, but clearly a series of whole-body CT scans, or comparable IR studies, will accrue a significant risk.

If risk estimation in IR is difficult, then estimating the benefit is infinitely more difficult. Clearly, there are often massive benefits for the patient but we have not even begun to quantify the level at which benefits and radiation risk might be of a similar magnitude. In the absence of a sound methodology, it is difficult to know what to teach. Because, in general, the radiation is being used as an aide to therapy in IR, there is perhaps something to learn from the approach adopted in radiotherapy.

Vañó discussed the work that has been done in Europe on the theoretical training required [20]. A syllabus has been prepared and a recommended teaching time allocated to each subject for different staff groups, e.g. diagnostic radiology specialists, IR specialists, other medical doctors using X-ray systems, radiographers and maintenance engineers. Total teaching varies from 10 h to 60 h. The International Atomic Energy Agengy (IAEA) has produced specific training material for cardiologists and held regional courses in several continents. An ICRP Working Party is currently preparing definitive recommendations with a tentative title "Radiation protection training for physicians that conduct or order diagnostic and interventional procedures using ionising radiation".

On the practical side, Nicholson expressed concern that too many doctors are becoming involved in IR without proper structured training. Ensuring low doses to patients and staff should be an integral part of good technique, and it is a little surprising that there was no mention of radiation dose or radiation risk in a 2002 publication on IR education in Seminars in Interventional Radiology [21]. The article on "Virtual Reality Training in Interventional Radiology" in that issue would have been a good opportunity to discuss how the technical variables that affect patient and staff doses might be factored into such training.

Another problem is accreditation. It may be feasible for training centres to be accredited by National Professional Bodies but how will the "students" be assessed and how does one decide the level at which they can be considered competent? Multiple choice questions seem entirely inadequate.

There is also much to learn for the radiographer in the IR room. Kevin Walker (Stirling) suggested that because of their background and previous training, the radiographer is best suited to be the Radiation Protection Supervisor (RPS). This could be a good arrangement provided that the radiographer is experienced and has a "hands-on" role in the interventional room on a regular basis. He or she must not only be responsible for their own training, i.e. the equipment, quality assurance, optimization of procedures and importance of interdisciplinary work, but must also supervise the training of others. New staff need to know about stochastic and deterministic effects, scattered radiation, protective devices, how to wear their dosemeters and dose limits. The RPS must also ensure that other staff, who are preoccupied with the procedure and the patient, do not inadvertently and unnecessarily increase their own doses, and must be generally pro-active in radiation protection matters. With the future developments in "skill mix", other individuals may be better equipped to be the RPS in certain situations.


    Conclusions and future work
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 
To sum up briefly:

Received for publication June 11, 2007. Revision received August 30, 2007. Accepted for publication August 31, 2007.


    References
 Top
 Abstract
 Introduction
 Current trends in interventional...
 Doses to patients
 Staff doses
 Equipment factors and programme...
 Education and training
 Conclusions and future work
 References
 

  1. European Union, Council Directive 97/43/EURATOM of 30 June 1997. Health protection of individuals against the dangers of ionising radiation in relation to medical exposure (repealing Directive 84/466/EURATOM, O.J. No L 265/1, 5.10.1984). Luxembourg: Official Journal of the European Communities 1997. L180:22–27.
  2. International Commission on Radiological Protection, Report 85. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP 2000; 30.
  3. IAEA. Radiological protection of patients in diagnostic and interventional radiology, nuclear medicine and radiotherapy. Proceedings of an International Conference; 2001 March; Malaga, Spain. Vienna: IAEA.
  4. IPEM Medical and Dental Guidance Notes. A good practice guide on all aspects of ionising radiation protection in the clinical environment. York, UK: Institute of Physical Sciences in Medicine; 2002.
  5. Dotter CT, Judkins MP Transluminal treatment of arteriosclerotic obstruction. Description of a new techic and a preliminary report of its application. Circulation 1964;30:654–70.[Abstract/Free Full Text]
  6. Surash S, Robertson I, Calvey AJ, Kessel D, Patel J, Kent PJ, et al. An audit of out of hours interventional vascular radiology. Eur J Vasc Endovasc Surg 2003;25:573–7.[CrossRef][Medline]
  7. Funaki B. On call treatment of acute gastrointestinal haemorrhage. In Van Ha TG, editor. Interventional Radiology on Call. Sems in Interven Radiol 2006;23:215–22.[CrossRef]
  8. Miller D L, Balter S, Cole P E, Hollington T L, Schueler B A, Geisinger M, et al. Radiation doses in interventional procedures. The RAD-IR Study Part 1: overall measures of dose. J Vasc Interv Radiol 2003;14:711–28.[Medline]
  9. British Standard: medical electrical equipment. Part 2–43: particular requirements for the safety of X-ray equipment for interventional procedures. BS EN 60601-2-43; 2001.
  10. Bernardi G, Padovani R, Morocutti G, Vañó E, Malisan MR, Rinuncini M, et al. Clinical and technical determinants of the complexity of percutaneous transluminal coronary angioplasty procedures: analysis in relation to radiation exposure parameters. Catheterisation and Cardiovascular Intervention 2000;51:1–9.[CrossRef]
  11. Morrell RE, Rogers AT. Kodak EDR2 film for patient skin dose assessment in cardiac catheterisation procedures. Br J Radiol 2006;79:603–7.[Abstract/Free Full Text]
  12. Morrell RE,Rogers AT. A mathematical model for patient skin dose assessment in cardiac catheterisation procedures. Br J Radiol 2006;79:756–61.[Abstract/Free Full Text]
  13. Martin CJ, Whitby M. Application of ALARP to extremity doses for hospital workers. J Radiol Prot 2003;23:405–21.[CrossRef][Medline]
  14. Vañó E, Gonzales L, Fernandez JM, Alfonso F, Macaya C. Operational radiation doses in interventional cardiology: a 15 year follow up. Br J Radiol 2006;79:383–8.[Abstract/Free Full Text]
  15. Hernanz-Schulman M. Can fluoroscopic radiation dose be substantially reduced? Radiology 2006;238:1–2.[Abstract/Free Full Text]
  16. Preston DL Shimizu Y, Pierce DA, Suyama A, Mabuchi K. Studies of mortality of atomic bomb survivors. Report 13. Solid cancer and non-cancer disease mortality. Rad Res 2003;160:381–407.[CrossRef][Medline]
  17. Dendy P, Brugmans MPJ. Commentary: low dose radiation risk. Br J Radiol 2003;76:674–7.[Free Full Text]
  18. Brenner, Elliston CD. Estimated radiation risks potentially associated with full body CT screening. Radiology 2004;232:735–8.[Abstract/Free Full Text]
  19. Martin CJ. Effective dose: how should it be applied to medical exposures? Br J Radiol 2007;80:639–47.[Abstract/Free Full Text]
  20. Radiation protection 116. Guidelines on education and training in radiation protection for medical exposures, 2000. Available from: http://europa.eu.int/comm/energy/nuclear/radioprotection/publication_en.htm [Accessed 5 November 2007]
  21. Interventional Radiology Education. In Kaufman JA, Rösch J, editors. Seminars in Interventional Radiology; 2002; 19.




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