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Skin dose and dose–area product values for interventional cardiology procedures

¹ Medical Physics Service
³ Cardiology Service, San Carlos University Hospital
² Radiology Department, Medicine School, Complutense University, 28040 Madrid, Spain

Correspondence: Professor E Vano, Catedra de Fisica Medica, Facultad de Medicina, Universidad Complutense, 28040 Madrid, Spain

	Abstract

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Coronary angiography and percutaneous transluminal coronary angioplasty procedures performed in four different facilities were monitored in the present study by measuring maximum skin dose, dose–area product and other operational parameters. Radiographic slow film, thermoluminescent dosemeters and transmission ion chambers were used to measure dose related quantities. Values of 107–711 mGy for maximum skin dose and 27.3–370.6 Gy cm² for dose–area product were found, together with cumulative skin dose estimates of 110–3706 mGy. A discussion of the relationship of measured dose–area product and skin dose values is made using a field concentration factor defined as a way to interpret the findings. No general correlation was observed between dose–area product and maximum skin dose. Cumulative skin dose estimates throughout a procedure should be discarded as a realistic method for assessing deterministic risk in cardiology procedures. Slow film in addition to thermoluminescent dosemeters for measurement of maximum skin dose is a good alternative, especially for complex interventional procedures. For repeated procedures, combining film and dose–area product monitoring favours optimization of radiation protection for the patient.

	Introduction

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Some X-ray cardiology procedures can produce skin injuries to the patients, among other hazards [1–11]; there are also associated relatively high risks for staff [11–13]. Dose–area product (DAP) is a good quantity for estimating stochastic risk for the patient [14, 15]. Transmission ionization chambers are being installed in some modern X-ray systems for interventional procedures. In addition, DAP values have been recorded in some centres, and local dose reference values for patients have been proposed in recent years [11, 16–19], as recommended by the International Commission on Radiological Protection (ICRP) [20]. Monte Carlo factors for calculating organ and effective doses in cardiology procedures have also been published [14].

As an optimization action to reduce the risk of deterministic effects in patients undergoing long cardiology procedures or procedures with non-optimized X-ray equipment, maximum skin dose (MSD) should also be evaluated. Correctly positioned thermoluminescence dosimetry chips could provide these data, but the location of the most heavily irradiated areas cannot be predicted and large chip numbers would be required, thereby making their routine use impractical. A feasible solution is to use slow X-ray film as a detector [21–23]. Film location is much less critical than for thermoluminescent dosemeters (TLDs), and dose estimation can improve reliability since the different irradiated areas are visualized directly on the film. In addition, it is possible to evaluate the use of collimation, edge filters, etc., which will permit retrospective optimization of the procedure protocol.

Concern about skin injuries in X-ray cardiology procedures is widespread. The Food and Drug Administration (FDA), the World Health Organisation, the ICRP and the International Atomic Energy Agency have published (or are producing) documents [24, 25] to avoid deterministic effects in cardiology procedures. At the same time, different working methods, instrument arrays and designs to improve radiation protection and measurement capabilities are being developed and evaluated [26–35]. Moreover, training of physicians in radiation protection and radiation management as a means of reducing doses in each specific procedure is encouraged [20, 36–38].

The International Electrotechnical Commission is also preparing a set of standards entitled "Particular requirements for the safety of x-ray equipment for interventional procedures"; the document examines dosimetric measurements, and both DAP and skin dose are regarded as possible estimators [39]. However, it is also well known that skin dose is not easy to measure, particularly in cardiology procedures where the X-ray beam enters the patient by several sites and the field size varies widely. Estimations based on the output rate of the X-ray tube, using tube potential (kV) and tube current (mA) settings, usually give unrealistic results in cardiology procedures, since the irradiated area and the focus-to-skin distance are often changed. Therefore, research and development of suitable monitoring systems are required [40].

This paper presents experimental DAP and MSD data from coronary angiography and percutaneous transluminal coronary angioplasty (PTCA) procedures from four cardiology facilities in three hospitals. The data substantiate the influence of both the protocol applied by the cardiologist carrying out the procedure and thepathology of the patient in DAP and MSD values measured. In view of the variability in such data, another purpose of this report is to alert medical specialists to the importance of adopting simple, conservative attitudes with respect to radiation protect. In addition, we wish to warn medical physicists that DAP, or other approximations based on X-ray tube output rate, are notsufficient to estimate MSD in cardiology procedures.

	Methods

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Coronary angiography and PTCA procedures were monitored in three hospitals, with three different teams of cardiologists, on a non-selected subset of patients for whom relevant data were recorded. One of the centres has two laboratories dedicated to cardiology procedures. One laboratory has a Philips Integris HM3000 (Philips Medical Systems, The Netherlands), configured specifically for cardiology with a built-in "spectra beam" system (high filtration in the X-ray beam), identified in this paper as HC-I. The second laboratory has a Philips Optimus M-200 system, identified as HC-O. The other two centres, identified as RI and RJB, are both equipped with ADVANTX systems (GE Medical Systems, Milwaukee, WI) configured for cardiology and vascular studies. Only the Integris system is equipped with a DAP meter. Output constancy in the X-ray systems was checked periodically, with satisfactory results.

Slow film dosimetry was selected as the method for dose monitoring, using Kodak X-Omat V films (Eastman Kodak Co., Rochester, NY), commonly available in hospitals having radiotherapy facilities. Previous sensitometry tests and calibration for dose measurements were carried out for typical beam qualities used in cardiology procedures [23]. Films were processed in a Kodak X-Omat-M6B system (with Kodak chemicals). Optical density was measured using a digital Victoreen 07-424 densitometer (Nuclear Associates Victoreen, Cleveland, OH). The highest readable dose at the linear part of the sensitometric curve was about 700 mGy, a value greater than the doses usually measured in most procedures. Precision of values on the sensitometric curve shoulder was rather poor.

Between four and eight lithium fluoride TLD-100 chips, individually calibrated to the X-ray diagnostic energies, from Harshaw TLD/Bicron/NE-Technology (BICRON-NE, Solon, OH), were also used to measure dose by placing them in contact with the films at locations where the highest irradiation would be expected (based upon results from previous similar procedures and the view of the individual conducting the intervention). Data from both the film and the TLD readings were used together, the latter providing readings from the most irradiated area to reduce dose uncertainties in estimating MSD. Some results from TLDs were rejected on account of improper chip placement if no chip was located in the highest optical density film area.

The TLD reader was a System Model 4400 from Harshaw (Harshaw Filtrol Partnership, Solon, OH). DAP measurements were made with Diamentor transmission ion chambers (PTW-Freiburg, Germany).

Reliability of the transmission ion chambers and the TLD system was checked periodically bycomparing their readings with those from aVictoreen calibrated ion chamber (model Rad-Check) and deriving correction factors. Measurement reliability was confirmed to be within 12% for the transmission chambers, with an overall uncertainty (in measurement accuracy) not greater than 15%. Uncertainty of TLD readings was below 7% for the overall dose range throughout the work. Dose estimate errors due to changes in film speed and contrast in the range of X-ray tube potentials used were less than 10%. MSD determined by film and TLDs were fully compatible, with discrepancies below 15%. Uncertainties quoted include detector response changes with the different X-ray beam qualities used.

To assess the radiation field concentration during a cardiology procedure, a concentration factor has been assessed, calculating the ratio between (i) the MSD and (ii) the average dose obtained as the quotient of DAP and the total irradiated area. If a cardiology procedure is performed with radiation fields often located in given skin regions, its concentration factor will exhibit a higher value than for another procedure carried out using more distributed fields; thus, the concentration factor may help to compare cardiology procedures of similar complexity, performed with a given clinical protocol.

An estimate was made for the typical time and the number of images in lateral projections (not imaged by the film under the patient), based on previous survey and the opinion of the individual conducting the procedure, as well as the total irradiated area. Mean field size was calculated from the darkened areas on the slow film, and the quotient between DAP and the mean field size gave the total incident air kerma at skin level.

	Results

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Table 1 presents the results obtained from 26 coronary angiography and 7 PTCA procedures, from which a comprehensive follow-up with DAP records, TLD measurements and slow film images was completed. There is major uncertainty where doses are shown as >700 mGy, as they were estimated only by film density on the shoulder of the sensitometric curve and were not measured byTLDs because of the unsuitable location of theTLD chips. Experimental values were: MSD,107–711 mGy (including backscatter); fluoroscopy time, 2.2–59.2 min; cine frames, 435–1393; mean radiation field size at the entrance of the patient, 53–230 cm²; total irradiated skin area, 245–1400 cm²; and DAP, 27.3–370.6 Gy cm². Values for concentration factor, calculated as described in the previous section, are also presented.

Constancy checks at the RJB centre (under a special survey because of its comparatively high DAP values) yielded dose rates at the entrance of the image intensifier from 0.5–2.1 µGy s^-1, from low to high fluoroscopy modes, for a field size of 22 cm diameter and measured with a grid. This can be considered fairly normal. This is also true for values of dose per frame (0.2–0.6 µGy frame^-1 for the four cine modes, allowing four levels of image quality).

	Discussion

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All experimental values measured lay in a wide range, suggesting different levels of difficulty in the procedures and that optimization from the patient radiation protection approach was not entirely achieved. Nevertheless, the eventual aim of creating a statistically significant database to derive difficulty levels and related parameters will require a great deal of effort in establishing a realistic variation range and subsequent reference values.

In general, DAP values are comparatively high at the RJB centre (mean 111.02 Gy cm²) owing to the higher mean field size (188 cm²), while the average fluoroscopy time (5.1 min) and number of images (964) were comparable with local reference values [18].

For coronary angiography procedures, staff of the HC-O facility seem to be more conservative regarding radiation protection, giving a mean field size of 94 cm². Other mean values from the 13 procedures monitored in this system are 60.2 Gy cm² DAP, 6.5 min for fluoroscopy time and 885 for mean number of frames. Figure 1 shows images of irradiated areas for coronary angiographies No. 27 and No. 57 performed with this system. Figure 2 presents images from procedures No. 37 and No. 53 to appraise the differences in beam collimation.

View larger version (69K): [in this window] [in a new window]   Figure 1. X-ray field images from coronary angiography procedures performed in facility HC-O. Procedure No. 27 (right) yielded a dose–area product (DAP) of 40.3 Gy cm2 and a maximum skin dose (MSD) of 296 mGy, with a mean field size of 71 cm2 and a total irradiated area of 836 cm2. Data from procedure No. 57 (left) were 44.1 Gy cm2 DAP and 161 mGy MSD with a mean field size 90 cm2 and a total irradiated area of 900 cm2. Note that DAP and mean field size were higher in No. 57 for a similar irradiated area, but that MSD was higher in No. 27 owing to higher field concentration. Accordingly, the concentration factor is 6.2 for No. 27 and only 3.3 for No. 57.

View larger version (61K): [in this window] [in a new window]   Figure 2. X-ray field images from coronary angiography procedure No. 37 performed in facility RI (left) and procedure No. 53 performed in facility RJB (right), illustrating differences in beam collimation between them (larger fields and quite superimposed in No. 53 compared with No. 37) and with respect to Figure 1.

Cardiology procedures with large concentration factors, if repeated, would have a higher risk of deterministic effects than other procedures with a lower concentration factor. Thus, this factor can be used together with MSD and DAP as a complementary risk indicator, particularly in procedural repeats or for audits. It establishes a link between MSD and DAP, which requires a rather cumbersome analysis of results, but there is no other easy way to establish such a relationship.

An equal concentration factor in two different procedures with similar total irradiated area would yield proportional values of DAP and MSD, as in coronary angiographies No. 37 and No. 38, for example. This particular result helps explain the general lack of correlation between both radiological quantities.

The definition of concentration factor means that if the average doses used in its calculation (last column in Table 1) are similar for all procedures, the relationship between concentration factor and deterministic risk becomes closely correlated; that is, MSD becomes almost proportional to concentration factor in each procedure. Thus, the concentration factor may also help to classify the interventions according to their complexity. To what extent similar average dose is usual in interventional procedures is the obvious point to study prospectively, and this reinforces the need for further experimental work in this field. However, one can see in the data from the RJB centre how the situation is approximately fulfilled, albeit that the statistical significance is poor to assess the circumstances where similarity could be expected.

The above considerations may be important in the case of PTCA, as shown in Table 2 for 4718 PTCA clinical histories from the HC centre. As can be seen from these data, more than 18% of patients undergo two or more procedures. Of these, more than 5% undergo three or more procedures.

Coronary angiography No. 34 would be an example of good radiation protection practice. In spite of a longer fluoroscopy time than usual and a significant frame number, DAP and MSD values are low. Collimation, use of an edge filter and absence of significant field overlapping have resulted in low dose values and a low concentration factor. This is further indicated by the discrepancy between MSD and total incident air kerma at the patient skin level (see Table 1). The last quantity would roughly match the data supplied by an online patient exposure meter [13] under the assumption that the X-ray beam had constant incidence throughout the procedure, once corrected for backscatter, mass energy absorption coefficient and table attenuation, if necessary. Note that differences of more than one order of magnitude in the value of MSD for the same incident air kerma have been found. Thus, the total incident air kerma cannot predict risk in all situations, contrary to the assertion of some equipment manufacturers [32] who install such a meter in the X-ray system to determine a "cumulative procedural radiation dose" (Patient Exposure Management NETwork—PEMNET—System from Clinical Microsystems, Inc., Arlington, VA) to assess deterministic risk. Cusma et al [41] have used a PEMNET system to perform real-time radiation exposure monitoring during different interventional procedures, stating that their totals do not represent the total exposure to any single area of skin. Therefore, a real-time display of the cumulative exposure incurred throughout a procedure can lead to a conservative attitude in respect to radiation protection, as a DAP meter could do, but it can hardly be used to perform a follow-up of the exposure in a given skin region. Regarding this point, the European Directive 97/43/Euratom [42] makes compulsory in new radiodiagnostic equipment, where practicable, a device informing the practitioner of the quantity of radiation produced by the equipment during the radiological procedure. Spanish Decree 1976/1999 [43] includes this point of the Directive and reinforces its contents by requiring that equipment used in interventional procedures (in service as well as new facilities) shall include a radiation measurement+recording device. However, none of these measures will guarantee patient doses under deterministic levels, and values measured in a given procedure, even in a sample of a given type of intervention, should be carefully used to establish diagnostic reference levels for such a practice alluded to in Directive 97/43 for the adoption of conservative values. This problem is emphasized in the Radiation Protection 109 document of the European Commission [44].

High concentration factors help to illustrate how difficult it is to predict MSD. In PTCAs No. 28 and No. 30, for example, MSDs are high and irradiated areas are relatively large (>700 cm²), with low DAPs. In either case, the field overlap and the concentration of fluoroscopy in a specific skin region (mainly anteroposterior projection was used) could explain the situation.

Two remarks can be made about the data presented here. First, differences of only 5% in DAP could be associated with skin doses varying by as much as a factor of 2, as in coronary angiographies No. 33 and No. 34. Second, relatively low values of DAP could be associated with high skin doses, as in PTCA No. 30. Therefore, in most cases it is not possible to predict MSD using only DAP values. A complementary procedure for skin dose measurements is necessary. From the available data, monitoring based on TLD matrix arrays such as described by Braunlich [28] and evaluated by Geise et al [29, 30] seems adequate but rather burdensome and expensive on a routine basis. Furthermore, use of slow film also seems a valid alternative, although high doses and risky skin locations become time-delayed information. However, an indication derived from total incident air kerma or exposure at the skin level of the patient [31] is not always a practical option when the incidence of the X-ray beam is variable, as in the case of cardiology procedures.

From the above comments, one could infer that the cardiologist's skill and the will to reduce risks in the procedure would play a major role quite apart from the influence of the X-ray system [35, 45]. Thus, assuming that a certain fluoroscopy time and a certain number of images are justified for the medical result, a pragmatic approach to reducing skin dosage would be to adopt a conservative attitude towards radiation protection in all circumstances. To this end, considerations regarding dose rate outputs for a given system lose a major part of their relevance, provided the system exhibits normal performances, and one should follow instead some simple points already stated in the FDA Public Health Advisory Bulletin of September 1994 [24]. Such points should only take into account the chief factors influencing MSD, such as X-ray equipment performance capabilities, patient size and patient pathology. These factors can be summarized as:

1. keep image quality level at the minimum required for the medical output;
   
2. use magnification only when necessary;
   
3. change beam direction whenever possible; and
   
4. use beam collimation and edge filters to avoid field overlap.
   

	Acknowledgments

 
The authors thank the European Commission, the Inter-Department Commission for Science and Technology, and the Nuclear Safety Council for their financial support; Philips Medical Systems Inc. and General Electric Co. for providing equipment data and characteristics; and Ruber Hospitals for access to their facilities and help with the measurements.

Received for publication April 17, 2000. Revision received June 30, 2000. Accepted for publication August 7, 2000.

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