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Skin radiation injuries in patients following repeated coronary angioplasty procedures

¹Medical Physics Service, ²Interventional Cardiology Service and ³Radiotherapy Service, San Carlos University Hospital, 28040 Madrid, Spain

Correspondence: Prof. E Vano, Medical Physics Group, Radiology Department, Medicine School, Complutense University, 28040 Madrid, Spain

	Abstract

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This study investigates the incidence of skin injuries and retrospectively estimates skin doses in a sample of patients who had multiple coronary angiographies and who underwent more than four percutaneous transluminal coronary angioplasties (PTCAs), performed primarily by the same team of cardiologists in a university hospital. A database of 7824 PTCAs performed during the last 14 years was analysed. Patients were selected and reviewed by a cardiologist and two radiotherapists with experience in radiation-induced skin injuries. A retrospective analysis of skin doses was performed using data from the patients' files and from the quality assurance (QA) programme of the hospital, which includes periodic patient dose measurements. 14 patients were included in the study. Each patient had undergone between 4 and 14 coronary angiographies and between 5 and 10 PTCAs, performed over a period of 2–10 years. The estimated mean dose–area product per procedure was 46 Gy cm² for coronary angiography and 82 Gy cm² for PTCA. Mean values of maximum skin dose per procedure were 217 mGy for the diagnostic studies and 391 mGy for the PTCAs. Only a slight radiation skin injury was clinically demonstrated in one patient with a history of 10 coronary angiographies and 10 PTCAs (estimated maximum skin dose 9.5 Gy). Another patient who underwent 14 coronary angiographies and 10 PTCAs (estimated maximum skin dose 7.3 Gy) showed a slight telangiectasia and discrete pigmentation. Another patient with a cutaneous lupus erythematosus showed pigmentation in the area of the radiation field following seven coronary angiographies and six PTCAs (estimated maximum skin dose 5.6 Gy), as expected bearing in mind that skin tolerance to high doses may be altered for patients with this pathology. Each of the remaining 11 patients with no skin injuries had undergone between 5 and 7 PTCAs and between 5 and 14 additional angiographies. None of the 14 patients reported acute skin injuries and no necrosis or radiodermatitis was observed.

	Introduction

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The frequency and complexity of fluoroscopically guided interventional procedures have increased substantially in recent years. This is in part due to the benefits of interventional cardiology (IC), since patients can often be treated as outpatients for clinical conditions that would otherwise require surgery and admittance to hospital for a significant period of time. Frequently, a procedure is repeated owing to restenosis, maybe several times in a short period. Measures to control doses and to optimize radiation protection (RP) during procedures should ensure that doses in a single procedure are only a fraction of the threshold for severe deterministic effects [1].

IC procedures are known to require radiation exposures that may substantially exceed those of diagnostic procedures. In some instances, such procedures have resulted in deterministic skin injuries to the patient [1–6]. Because of the increased use of radiation, staff are also at greater risk of radiation exposure [7]. Concern about radiation risks and injuries is considerable. The United States Food and Drug Administration, the World Health Organisation [8–10], the International Commission on Radiological Protection (ICRP) [11] and the International Atomic Energy Agency have published (or are producing) recommendations on how to avoid radiation injuries. In addition, the International Electrotechnical Commission has published a standard entitled "Particular requirements for the safety of X-ray equipment for interventional procedures" [12], which includes general safety and RP aspects.

At present, different techniques have been proposed and are being developed to improve RP and measurement capabilities of doses to patients and staff [13–16]. Skin dose distributions are not easy to measure in IC procedures, since the X-ray beam can enter the patient at many different sites, and field size and focus-to-skin distance may change during the procedure. Different magnification and fluoroscopy modes (sometimes with different X-ray beam filtration) contribute to the difficulty of estimating skin dose. Accordingly, dose estimates based on the X-ray tube output rate, calculated using the tube potential (kV), filtration and tube current (mA) settings, are usually inaccurate owing to the difficulty in accurately recording the data together with the complexity of the calculations. However, computerized systems employing this technique are more reliable. In addition, differences in the highest dose to the skin received by the patient throughout the procedure, known as maximum skin dose (MSD), can exceed one order of magnitude for similar procedures, depending on the X-ray system used, the skill of the specialist and the status of the disease. Entrance dose rates for standard sized patients in the range of 15–20 mGy min^-1 are usual in a well optimized system, while values up to 60–80 mGy min^-1 or higher are not unusual in non-optimized systems for standard fluoroscopy modes. A similar or greater difference can be found in the entrance dose per frame in cine or digital acquisition where the absolute rates are typically ten times higher.

The above considerations result in a wide range of risks among patients who vary markedly in size and health status. This range increases even more owing to different working protocols and equipment. Under the assumption that such equipment operates in correct conditions with regard to RP, the critical points to achieve a reasonable minimum skin dose per procedure are: (1) to keep dose-related parameters (fluoroscopy time, number of images and dose–area product (DAP)) below certain reference levels; and (2) to ensure that the radiation field is not maintained over the same skin area for a prolonged period of time. This calls for strict collimation and the use of different beam orientations, together with conservative use of X-ray beam imaging (avoiding fluoroscopy or image acquisition in high dose modes).

The extent to which repeated percutaneous transluminal coronary angioplasties (PTCAs) in a patient might contribute to skin radiation injuries is a critical question in the justification and optimization of procedures. To the best of our knowledge there are no published studies relating the number of repeated procedures to patient doses and deterministic effects. In most cases, published papers on skin radiation injuries have always been associated with lack of quality control in the X-ray systems or a lack of training in RP of the specialists performing the procedures. This conclusion can be drawn out of the ICRP report [11], which refers to several cases of skin injuries in which there was no awareness about radiation protection and/or substandard equipment was used. Wagner et al [16] discuss a case report and review the literature. From this review, it can be concluded that no quality control on the equipment that imparted high doses was documented. This work is a systematic retrospective study based on procedures carried out by the same medical team on controlled X-ray facilities. Present data show that multiple PTCAs over a 15-year period, performed by skilled cardiologists aware of RP, using properly operating X-ray systems, did not cause severe skin injuries.

	Material and methods

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The IC Service of the San Carlos University Hospital (SCUH) in Madrid, Spain, has two interventional laboratories presently performing more than 4500 diagnostic and interventional procedures per year. The laboratories are equipped with C-arm angiographic X-ray units designed for interventional work (Integris HM3000 and Optimus M-200 models; Philips Medical Systems, Best, The Netherlands). Each unit has an image intensifier of 23 cm and conventional cine camera and digital cine acquisition. The Integris system also has a built-in "spectra beam" tool (high filtration in the X-ray beam) and a DAP meter.

Some procedures carried out before 1992 were performed with angiographic equipment that has since been replaced (Compagnie Generale de Radiologie, GE-CGR). During this period prior to 1992, cardiologists were not specifically trained in RP and there was no quality control relating to patient dose measurements. Frame rates for cine acquisition at that time were set at 25 frames s^-1 (in the new systems, the filming rate is usually 12.5 frames s^-1 and the fluoroscopy is pulsed). The conditions of the old X-ray system were incorporated into our dose estimates when applicable. Since 1992, the two laboratories have been subject to a strict quality assurance (QA) programme including regular patient dose evaluations (DAP and skin dose evaluations using slow films and thermoluminiscent dosemeters) [17]. The cardiology team had specific training in RP during 1992 and 1995, as required by national legislation, and since then continuing training activities in radiation protection have been organized.

From 1985 until April 1999 a total of 7824 PTCAs in 6640 patients were carried out in this service. During 1998, the IC Service of the SCHU carried out 3311 diagnostic and 1118 therapeutic catheterization procedures [18]. Thus, 75% of the procedures were diagnostic procedures.

All patients with more than four PTCAs were checked to detect possible skin injuries following these repeated procedures (usually complemented with an important number of diagnostic catheterizations). Table 1 presents data regarding the cases undergoing more than one PTCA. Nearly 20% of the patients treated in the IC Service of the SCHU underwent more than one PTCA in this hospital. In all cases, the need for repeat procedures was dictated by symptoms or by the detection of ischaemia in non-invasive testing.

View larger version (125K): [in this window] [in a new window]   Figure 1. Image of a slow film to evaluate the skin dose distribution and maximum skin dose (MSD) in a coronary angiography. Dose–area product 36 Gy cm2, 1031 frames and 2.1 min of fluoroscopy. The MSD was 144 mGy.

View larger version (125K): [in this window] [in a new window]   Figure 2. Image of a slow film to evaluate the skin dose distribution and maximum skin dose (MSD) in a percutaneous transluminal coronary angioplasty. The high concentration of radiation fields was unusual. Dose–area product 64 Gy cm2, 660 frames and 10.0 min. The MSD was 750 mGy.

Because fluoroscopy time and the total number of frames (or metres of cine) were not included in the clinical history of the patients, all the films corresponding to these patients were reviewed and analysed by an expert cardiologist to help in the retrospective dose evaluation and to determine the number of frames registered. Fluoroscopy time has been assumed to be proportional to the number of frames acquired and the level of difficulty of the procedure [19], according to the mean value recorded in the database of cardiology patients created by the Medical Physics Service (which includes number of images, fluoroscopy time, DAP values and, in some cases, skin dose distribution and MSDs). The proportionality factors to correlate fluoroscopy time and number of frames were 1.5 s of fluoroscopy per cine frame in PTCA and 0.55 s of fluoroscopy per cine frame in coronary angiography. It is normal that during PTCAs the ratio between fluoroscopy time and frame number is three times greater than during coronary angiography.

When above average, the weight of the patient was included in the analysis, since overweight patients (i.e. >75 kg) require more dose per frame and a higher dose rate at the skin. For the present angiographic equipment, the entrance dose increase was a factor of 1.5–1.8 for an increase of 4 cm in chest thickness (from 18 cm to 22 cm), depending on the operational parameters (i.e. tube potential, filtration, field size, etc).

A level of difficulty was assigned to PTCAs and coronary angiographies by the cardiologist (JG), scoring them as high, medium or low according to the degree of technical difficulty. The number of vessels approached and the specific characteristics of each of the lesions were considered. Single vessel dilation of type A or B1 lesions [20] was considered as low difficulty; multivessel type A or B1 dilations and single vessel dilations of type B2 lesions were considered as medium difficulty; all type C lesions and type B2 in the case of multivessel dilations were considered high difficulty. Lesion classification was assessed based on the modified American Heart Association/American College of Cardiology Grading System classification [21].

The relationship between the complexity of the procedure and the fluoroscopy time has already been analysed [19], giving an increase factor in the ratio of fluoroscopy time (in s) vs the number of cine frames of 1.5 from medium to low difficulty and 1.9 from high to medium difficulty. Thus, the different levels of complexity defined by the expert cardiologist were taken into account by increasing the assigned fluoroscopy time for the different procedures according to the registered number of frames.

Given that the two X-ray systems supply different mean values of patient dose (see Table 2), the assigned dose for a procedure was corrected according to the X-ray room where the procedure was performed when known. When this detail was not reported in the clinical history of the patient, the mean dose value of the full databank during the period 1995–96 was considered representative for this retrospective evaluation.

(2) For procedures performed with the old GE-CGR system, a dose increase of 30% (assuming that filming was at 25 frames s^-1) has been assumed. The cine dose contribution in the database is approximately 20% for PTCA and 33% for coronary angiography. A duplication in the cine dose contribution could mean a 25% increase in the total patient dose. Also, the image intensifier probably at that time required a greater entrance dose than in the present systems, but no record of this system is currently available. In addition, during this period prior to 1992 the cardiologists were not specifically trained in RP and there was a lack of quality control regarding patient dose measurements.

(3) Mean values of DAP and MSD reported in Table 2 have been corrected considering the actual number of frames for the patients checked. Typical DAP per frame is a well known value for the current Philips systems, thus it has been possible to estimate DAP for individual patients, when the real number of frames (the only related dosimetric parameter that has been evaluated in this retrospective study) was above or below the mean value of frames in the database.

(4) Mean values of the database have been assumed to match procedures of medium difficulty. Values of 75% for fluoroscopy contribution and 25% for cine contribution are adopted as mean percentages of the total DAP for PTCA and coronary angiography (the fluoroscopy percentage in the database is in fact 80% for PTCA and 67% for coronary angiography). The number of frames is known for all the patients and the fluoroscopy time contribution is modified according to the level of difficulty. The degree of difficulty increases values by a factor of 1.5 for low to medium difficulty and 1.9 for medium to high difficulty [19]. Thus, the global factors for total DAP are a 25% decrease from medium to low difficulty and a 68% increase from medium to high difficulty. The mean values in the database, according to the specific number of frames per procedure, are also modified. For example, values of 1300 frames for PTCA involve an increase of 30% of the mean value of DAP presented in Table 2.

(5) Since some procedures have been carried out in other hospitals, and no specific data are available, the mean value of the remaining procedures performed for a given patient in this hospital has been assigned to all procedures. However, this may be one of the main causes of inaccuracy in the present estimation. In these cases, skin doses may be higher if a QA programme was absent in the other centres [2].

Thus, the approach used to estimate total MSD (mGy) was the following: MSD=[(46 Gy cm² ABC)+(83 Gy cm²A'BC)]DEF where the values 46 Gy cm² and 83 Gy cm² are the adopted mean values of DAP for coronary angiography and PTCA, respectively, assessed from data for the two X-ray systems (see Table 2); A and A' are the number of procedures; B accounts for the procedure difficulty, according to [20]; C is a correction factor to allow for the old X-ray system, when used; D takes into account the number of frames per procedure; E accounts for the patient size; and F is the estimate of MSD per DAP unit. Table 3 displays and justifies the values adopted for all these factors.

	Results

Top Abstract Introduction Material and methods Results Discussion Conclusions References

View larger version (90K): [in this window] [in a new window]   Figure 3. Patient with pigmentation and subcutaneous fibrosis. Patient ID MEG-8, 73 years of age, 10 coronary angiographies and 10 percutaneous transluminal coronary angioplasties (PTCAs) carried out between 1992 and 1998. Two PTCAs were performed in another hospital. Total estimated dose–area product 2019 Gy cm2; total estimated maximum skin dose 9.5 Gy.

The 11 patients without skin injuries underwent between 5 and 7 PTCAs and between 5 and 14 additional angiographies. None of the 14 patients reported acute skin injuries and no necrosis or radiodermatitis was observed.

	Discussion

Top Abstract Introduction Material and methods Results Discussion Conclusions References

 
It should be noted that any retrospective evaluation of patient doses is intrinsically inaccurate owing to various factors:

1. A long interval between procedures, representing variations in the cardiology team, clinical protocols and specific settings of the X-ray systems.
   
2. A few procedures have been carried out in hospitals other than the SCHU (see Table 4) and in these cases patient doses could be different.
   
3. The present X-ray systems installed at the SCUH have been operating since 1994 and 1992, and some improvements in the image chain have occurred during this period. Some of the interventions were performed with an old GE-CGR system.
   
4. Only since 1995 have patient dose data (and quality controls) from the IC rooms at the SCHU been reliably maintained.
   
5. Adopted mean values are not always representative of specific procedures. To treat a specific lesion it is sometime necessary to "concentrate" the radiation fields in a specific skin area, and in these cases the applied relationship between MSD and DAP could underestimate skin dose. This is illustrated in Figure 1, which corresponds to a typical coronary angiography with a MSD of 144 mGy, and in Figure 2, showing a complex PTCA with an unusual concentration of the radiation fields and a MSD of 750 mGy.
   

	Conclusions

Top Abstract Introduction Material and methods Results Discussion Conclusions References

 
It is possible to conclude that, in our experience, for IC procedures performed on modern X-ray systems under QA programmes and by cardiologists trained in RP, repetition of procedures is not the main cause of possible skin radiation injuries. A regular QA programme in interventional rooms, with patient dose measurements, helps to avoid the complication of severe deterministic effects. Moreover, some individual patients, such as those affected by cutaneous lupus erythematosus, may exhibit alterations in skin tolerance to high doses, thus necessitating further radiation protection measures.

	Acknowledgments

 
The authors are grateful for the help received from Dr L Azcona and E Amador (San Carlos University Hospital) in the process of reviewing patient records. The authors also thank Prof. L Wagner (University of Texas, Houston) and Prof. S Balter (Cornell University, New York) for their comments on improving the contents of the paper.

	Footnotes

 
Current address for J Goicolea: Meixoeiro Hospital, Vigo, Spain. Current address for J I Ten: Radiodiagnostics Service, San Carlos University Hospital, 28040 Madrid, Spain.

Received for publication October 26, 2000. Revision received April 17, 2001. Accepted for publication June 4, 2001.

	References

Top Abstract Introduction Material and methods Results Discussion Conclusions References

 

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This Article Abstract Figures Only Full Text (PDF) Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Vano, E Articles by Macaya, C Search for Related Content PubMed PubMed Citation Articles by Vano, E Articles by Macaya, C