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British Journal of Radiology (2003) 76, 726-730
© 2003 British Institute of Radiology
doi: 10.1259/bjr/73325000
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Full Paper

Patient dose values in a dedicated Greek cardiac centre

V Tsapaki, MSc, PhD 1 S Kottou, MSc, PhD 2 E Vano, MSc, PhD 3 K Faulkner, MSc, PhD 4 J Giannouleas, MD 5 R Padovani, PhD 6 E Kyrozi, MSc 1 M Koutelou, MD 1 E Vardalaki, MSc 1 and V Neofotistou, MSc, PhD 5

1 Department of Bioengineering, Onassis Cardiac Surgery Centre, Athens, 2 Medical Physics Department, Athens University, Medical School, Athens, Greece, 3 Medical Physics Service and Radiology Department, San Carlos University Hospital and Complutense University, Madrid, Spain, 4 Quality Assurance Reference Centre, Newcastle General Hospital, Newcastle upon Tyne, UK, 5 Medical Physics Department, Regional Athens General Hospital "G.Gennimatas", Athens, Greece, and 6 Servizio di Fisica, Ospedale S. Maria della Misericardia, 33100 Udine, Italy


   Abstract
Top
 Abstract
Introduction
 Materials and methods
 Results
 Discussion
 Conclusions
 References
 
The purpose of this study was to collect information on the practice and patient doses in a major Greek cardiac centre, investigate differences between senior cardiologists of various levels of experience and compare results with the literature, in order to optimize angiographic and interventional cardiology procedures. Radiation doses from 292 patients have been studied, 195 of which had undergone coronary angiography and 97 percutaneous transluminal coronary angioplasty. All procedures were undertaken on a Siemens Angioscop X-ray equipment. The system performed under automatic exposure control using pulsed fluoroscopy of 12.5 pulses s-1 and cine frame rate of 25 frames s-1. Dose–area product values, fluoroscopy times, total number of cine frames as well as operator's name were collected for each patient. Only senior cardiologists have participated in the study. Median values for dose–area product were 39.1 Gy cm2 for coronary angiography and 58.3 Gy cm2 for percutaneous transluminal coronary angioplasty. Median fluoroscopy time was 5.0 min and 9.7 min and median number of frames was 1588 and 1823 for coronary angiography and percutaneous transluminal coronary angioplasty, respectively. Comparison showed that patient dose–area product values were lower than other studies and fluoroscopy time values were comparable. However, the total number of frames used was much higher than other published results. Differences between cardiologists with increased experience have been found. Analysis of the patient dose values obtained initiated a program of radiation protection optimization. The need for continuous training in radiation protection for interventionalists has been verified.


   Introduction
Top
 Abstract
 Introduction
Materials and methods
 Results
 Discussion
 Conclusions
 References
 
The number of interventional cardiology (IC) procedures has increased rapidly in recent years [1–3]. Once performed only in teaching hospitals, coronary angiography (CA) and percutaneous transluminal coronary angioplasty (PTCA) are now widely performed as a matter of routine in many general hospitals and are considered safe procedures in the hands of experienced cardiologists. However, it is also known that these procedures are associated with high radiation doses due to long fluoroscopy time (T) and large numbers of cine frames (F). These levels of radiation may even lead to radiation skin injuries under certain conditions. The United States Food and Drug Administration (FDA) [4] has published recommendations on how to avoid these injuries.

A number of studies [5–11] have investigated patient radiation doses in IC procedures, revealing variability not only in the methods of radiation measurement, but also in the level of radiation dose received by the patient. The complexity of the procedure, experience of the operator, level of training in radiation protection and type of X-ray equipment available in the catheterization laboratory are some of the factors that are responsible for the differences in results. Recognizing the need for continuously monitoring the radiation dose and optimizing and harmonizing IC procedures, the European DIMOND (measures for optimizing radiological information and dose in digital imaging and interventional radiology) research cardiology group [12] has measured radiation doses on patients undergoing CA and PTCA. The objectives of this study were to optimize practice so that radiation doses would be the lowest practically achievable, consistent with the clinical needs. Subsidiary objectives of these measurements were to obtain preliminary European reference levels and investigate the knowledge of cardiologists about radiation protection on patient exposures.


   Materials and methods
Top
 Abstract
 Introduction
 Materials and methods
Results
 Discussion
 Conclusions
 References
 
This study formed part of a local evaluation performed using a common protocol for patient dose collection agreed between the DIMOND partners (www.dimond3.org). Information on routine practice in a major Greek cardiac centre was collected; differences between cardiologists with various levels of experience were investigated. Between May 2001 and November 2001, 292 patients, randomly selected, have been studied. Of those 195 had undergone CA and 97 a PTCA procedure.

The X-ray system used was a Siemens Angioscop (Siemens, Erlangen, Germany) with an undercouch tube and an overcouch image intensifier (II) with three field sizes of 33 cm, 23 cm and 17 cm. The system performs under automatic control and utilizes three fluoroscopy modes, i.e. continuous, 12.5 pulses s-1 and 25 pulses s-1. The fluoroscopy mode routinely used is 12.5 pulses s-1. There are two cine modes available: 25 frames s-1, routinely used for adult patients, and 50 frames s-1 used exclusively for paediatric patients.

Measured dose rates and dose per frame are given in Table 1Go. Dose measurements were performed using a digital dosimeter (Solidose 400, RTI Electronics, Mölndal, Sweden) with a solid state detector (R100) that was calibrated with a calibration traceable to a standard laboratory. The accuracy of dose and dose rate measurements of the instrument, as quoted by the manufacturer, is ±5%. Patient radiation doses were measured with a calibrated dose–area product (DAP) meter (Gammex-RMI, Nottingham, UK) attached to the X-ray tube. For DAP calibration, the National Protocol for Patient Dose Measurements in Diagnostic Radiology [13] was followed. The uncertainty in the reading of the instrument quoted by the manufacturer is ±4%.


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  		Table 1. Dose rates and dose per frame values are presented for the Siemens Angioscop X-ray system in all Image Intensifier (II) fields (source to image distance: 95 cm) using a 20 cm polymethyl methacrylate (PMMA) phantom placed on the examination table (source to phantom distance: 70 cm)

 
Data collected included patient's sex, age, height, weight, total DAP reading, fluoroscopy time (T), total number of frames (F), as well as name of the cardiologist performing the IC procedure. Only cardiologists with more than 1 year of experience have been included in the study, since it has been demonstrated that radiation dose is higher in their initial year [14]. The X-ray system used undergoes regular quality control checks to ensure acceptable performance in terms of imaging and radiation dose.


   Results
Top
 Abstract
 Introduction
 Materials and methods
 Results
Discussion
 Conclusions
 References
 
During the study, 13 cardiologists performed 292 interventional cardiology procedures, of which 195 patients (66.8%) underwent CA and 97 patients (33.2%) PTCA. For CA procedures, 72.8% were male and 27.2% were female, whereas for PTCA, 85.6% were male and 14.4% were female. As may be deduced from Figure 1Go, the highest percentage of IC procedures was performed in patients in the age group 50 years to 60 years.



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  		Figure 1. Age distribution in coronary angiography and percutaneous transluminal coronary angioplasty (292 patients).

 
Radiation dose measurements in terms of DAP, fluoroscopy time (T) and total number of cine images (F) are given in Table 2Go. Since the DAP values measured do not exhibit a normal distribution, as well as the mean and standard deviation, median and third quartile values have also been calculated. As expected, PTCA presents higher mean, median and third quartile values of DAP, T and F.


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  		Table 2. Dose–area product (DAP) results in Gy cm2, fluoroscopy time (T) in min and total number of cine frames (F) for coronary angiography (CA) and percutaneous transluminal coronary angioplasty (PTCA)

 
Tables 3 and 4GoGo summarize the results according to operator, for CA and PTCA, respectively. The operators were divided into three groups dependent upon their experience. Level I being defined as a cardiologist having more than 10 years of experience; level II, 5 to 10 years experience and level III 1 to 5 years experience. For statistical reasons, all operators had performed at least 10 procedures of either type (CA or PTCA) during our investigation. From Tables 3 and 4GoGo, one may deduce that DAP, T and F values decreased from Level III to Level I and the implication is that the experience of the cardiologist will affect patient dose. Figure 2Go reveals the differences between different years of experience for all technical parameters of this study for CA. It is shown that for 10 years or more of practice, the decrease in radiation dose and total number of images is substantial. For PTCA procedures (see Figure 3Go), the reduction of dose is also evident.


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  		Table 3. Median and range of measurements in coronary angiography (CA) are presented according to cardiologist's years of experience. Level I indicates more than 10 years of experience, level II 5–10 years of experience and level III 1–5 years of experience. N is the number of patients involved in the study for each level of experience

 

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  		Table 4. Median and range of measurements in percutaneous transluminal coronary angioplasty (PTCA) are presented according to cardiologist's years of experience

 


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  		Figure 2. Combined results for the three levels of experience among cardiologists are presented for coronary angiography. DAP, dose–area product; T, fluoroscopy time.

 


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  		Figure 3. Combined results for the three levels of experience among cardiologists are presented for percutaneous transluminal coronary angioplasty. DAP dose–area product; T, fluoroscopy time.

 
For CA procedures, the correlation of DAP with T or F was weak (r=0.56 and 0.46, respectively), whereas for PTCA, the correlation of DAP with F (r=0.55) was weak and correlation of DAP with T (r=0.7) was moderate.


   Discussion
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
Conclusions
 References
 
Comparison of our results with results found in the literature (Tables 5 and 6GoGo) showed that during CA, Vano et al [5] had higher DAP values but Padovani et al [6] had slightly lower DAP values owing to lower fluoroscopy times and number of frames (45% and 51% lower, respectively). During PTCA, although Padovani et al reported an F value 25% lower, DAP and T values were 50% and 52% higher, respectively. Comparison with the results presented by Broadhead et al [7] showed that although fluoroscopy times are comparable for PTCA, the DAP values are higher than ours. However, her values on total number of cine frames are substantially lower than ours, 62% lower in CA and 74% in PTCA. Zorzetto et al [8] found higher DAP values, comparable values for T, but again lower values for F. However, these comparisons may have limited value, as in recent years a considerable effort has been made in Europe to improve radiation protection of the patient in interventional procedures through optimization programmes and technical improvement of the X-ray systems.


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  		Table 5. Comparison of this study with recent literature, in coronary angiography

 

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  		Table 6. Comparison of this study with recent literature, in percutaneous transluminal coronary angioplasty

 
In 2001, Neofotistou [15] published proposed reference dose levels (RDL) for IC procedures in terms of DAP, T and F which were derived from measurements taken by three European countries participating in a European concerted action concerning dose and image quality in digital imaging and interventional radiology. Her values were 67 Gy cm2, 6 min and 1600 frames for CA and 110 Gy cm2, 20 min and 1700 frames for PTCA. Comparison of our results with the proposed RDL showed that median radiation doses of this study are lower (DAP is 39.1 Gy cm2 for CA and 58.3 Gy cm2 for PTCA), whilst fluoroscopy time is comparable in CA (5.0 min) and much lower for PTCA (9.7 min). The total number of frames is also comparable in CA (1588), but higher in PTCA (1823). Widmark et al [9] published the results of a Nordic cooperation on radiation protection concerning three interventional procedures, one of which was PTCA, from measurements in 22 hospitals in the Nordic countries. This study proposed preliminary guidance levels in terms of mean DAP and T and their values for PTCA were 89.3 Gy cm2 and 15.1 min, respectively. Nordic guidance levels are higher than median values found in this study, showing acceptable performance of our hospital in these terms.

The variability in dose found in PTCA can be explained by the fact that it is a therapeutic procedure that depends on the pathology of the patient. Bernardi [16] found an increase of T and F in complex PTCA procedures. Padovani et al [17] found an increase of about 50% in radiation dose for medium complex procedures and an increase of 100% for complex procedures. Comparison of our results with previous studies has shown that patient radiation doses are lower. These observations are consistent with our dose-rates/dose values being lower than International Recommendations under automatic control [18]. However, the total number of frames observed in this study is the highest found in the literature. Unfortunately, it was not possible to determine the contribution of fluoroscopy and cine dose in the total value. The literature states that cine DAP accounts for 60–70% of the total dose in CA and 20–55% for PTCA [19, 20]. Despite the low levels of correlation between DAP and F that indicate that there is weak linear relationship between dose and total number of frames, the high dose rate in the cine mode justifies any attempt at cine frame reduction.

As far as national training requirements in radiation protection for IC are concerned, there is no agreement at the moment on either accreditation in radiation protection following a relevant training programme, nor a relevant qualification. The Council Directive 97/43/Euratom [21] states in Article 7, "Member States should ensure practitioners have adequate theoretical and practical training for the purpose of radiological practices". The importance of training in radiation protection as well as quality assurance programs is clear from the study by Vano et al [22] where it is concluded that under these conditions and regular patient dose measurements, IC procedures are not the main cause of possible radiation skin injuries. Furthermore, the International Commission on Radiological Protection (ICRP) [23] have emphasized the importance of education and training, as far as interventional procedures are concerned. ICRP have stated, "It is particularly important that individuals performing these procedures are adequately trained in both the clinical technique and in knowledge of radiation protection. A special training in radiation protection, additional to that undertaken for diagnostic radiology, is desirable" [23]. In Spain, a Royal Decree on Quality Criteria for Diagnostic Radiology was activated in 1999 [24] and one of its requirements was an accreditation programme in Radiation Protection for interventional practices supervised by the Spanish Health Authority. This approach is consistent with that advocated in a World Health Organization (WHO) document [3] concerning radiation safety in interventional radiology (IR). In this document, WHO [3] states "the specific training and educational guidelines should be instituted at a national level, to guarantee a high quality of medical service in IR. To practice IR or IC, physicians must have certification in the specialty concerned’’. Within the DIMOND group a document on radiation protection training in IR was produced [25]. This could be a starting point for developing a training programme.

As far as operator experience is concerned, the following observations may be made. Level I cardiologists tend to deal with the most complex situations and in addition, often teach other operators with lesser experience during IC procedures. Therefore, a simple comparison of DAP, T and F values for an operator may be misleading. It is also important to study the degree of complexity of the procedures the cardiologist undertakes. The American Association of Physicists in Medicine (AAPM) has recently produced a report [26] associated with performance and radiation safety in catheterization laboratories. In this document it is stated that more complicated procedures, such as PTCA, lead to more cineangiography runs compared with CA and that going from single-vessel to double-vessel PTCA procedure fluoroscopy time is increased by 3 min and cine time by 20 s, which results in 500 frames more for a 25 frames s-1 cine frame rate X-ray equipment. It is also reported that an angioplasty of a totally occluded artery results in a 50% increase in fluoroscopy time compared with an angioplasty of a subtotal stenosis. As reported in the study of Cusma et al [10], one of the determinants of radiation dose is also the size of the patient. Variation in patient size can increase exposure rates by a factor of 10. According to their study, the clinical protocol that each operator utilizes so as to perform an IC procedure concerning mainly the type of projection, also plays a great role in radiation dose, since the exposure rate varies with projection from 1.9 and 20.3 R min-1 (RAO 30°) to 9.9 and 123.6 R min-1 (LAO 40° Cran 40°) for fluoroscopy and cine exposure, respectively.


   Conclusions
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Conclusions
References
 
The increasing number of IC procedures, as well as the increasing complexity of cases which may be treated by interventional cardiologists has resulted in the potential for deterministic injuries during IC procedures. This implies continuous monitoring of patient radiation dose, not only for patient safety, but also for the staff involved. This study indicated that although patient radiation doses and fluoroscopy times were low, the number of cine frames was the highest of all. This is consistent with reduced technique factors during automatic control. Doses decreased with increasing cardiologist's experience. Operators who consistently exceeded median values of DAP, T or F were informed, to optimize their technique in the catheterization laboratory in the future. Reducing the cine frame rate used was stressed. The need for training in radiation protection in IC as an integral part of education for interventional cardiologists is supported by this study findings.


   Acknowledgments
 
The authors are grateful to all the staff of the Onassis Cardiac Centre for their cooperation and assistance during this study.


   Footnotes
 
This work has been undertaken with the support of the European Commission (DIMOND project, contract FIGM-CT-2000-00061) as part of the Fifth Framework Programme. Back

Received for publication December 11, 2002. Revision received March 22, 2003. Accepted for publication June 6, 2003.


   References
Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Conclusions
 References
 

  1. Sources and Effects of Ionizing Radiation. United Nations Scientific Committee on the Effects of Atomic Radiation. UNSCEAR 2000 Report to the General Assembly with Scientific Annexes. New York: United Nations, 2000.
  2. Balter S, Shope TB. Syllabus: A categorical course in physics: physical and technical aspects of angiography and interventional radiology. 81st Scientific Assembly, Dec 1995. RSNA’95 Scientific Program 1995:1–258.
  3. World Health Organization. Efficacy and radiation safety in interventional radiology. Geneva: World Health Organization, 2000.
  4. United States Food and Drug Administration (FDA). Avoidance of serious X-ray induced skin injuries to patients during fluoroscopically guided procedures. Medical Bulletin 1994;24:7–17.
  5. Vano E, Gonzalez L, Fernandez JM, Guibelalde E. Patient dose values in interventional radiology. Br J Radiol 1995;68:1215–20.[Abstract/Free Full Text]
  6. Padovani R, Novario R, Bernardi G. Optimization in coronary angiography and percutaneous transluminal coronary angioplasty. Radiat Prot Dosim 1998;80:303–6.[Abstract]
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  8. Zorzetto M, Bernardi G, Morocutti G, Fontanelli A. Radiation exposure to patients and operators during diagnostic catheterization and coronary angioplasty. Cathet Cardiovasc Diagn 1997;40:348–51.[CrossRef][Medline]
  9. Widmark A, Fosmark H, Einarsson G, et al. Guidance levels in the Nordic Countries: A preliminary report for selected interventional procedures. Radiat Prot Dosim 2001;94:133–5.[Abstract]
  10. Cusma JT, Bell MR, Wondrow MA, Taubel JP, Holmes DR. Real-time measurement of radiation exposure to patients during diagnostic coronary angiography and percutaneous interventional procedures. J Am Coll Cardiol 1999;33:427–35.[Abstract/Free Full Text]
  11. Clark AL, Brennan AG, Robertson LJ, McArthur JD. Factors affecting patient radiation exposure during routine coronary angiography in the tertiary referral centre. Br J Radiol 2000;73:184–9.[Abstract]
  12. Measures for optimizing radiological information and dose in digital imaging and interventional radiology. European Commission. Fifth Framework Program, 1998–2002. Program Acronym: FP5-EAECTP C. Project Reference: FIGM-CT-2000–00061.Project Acronym: DIMOND III. http://dbs.cordis.lu/fep/FP5/FP5_PROJl_search.html.
  13. Dosimetry Working Party of the Institute of Physical Sciences in Medicine. National protocol for patient dose measurements in diagnostic radiology. Chilton: NRPB, 1992.
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