Estimating Radiation Doses to the Skin from Interventional Radiology Procedures for a Patient Population with Cancer

Article Outline

• Abstract
• Materials and Methods
  • Case and Subject Selection
  • Fluoroscopic Equipment
  • Dose Measurement
  • Clinical Data Collection
  • Estimating Peak Skin Dose from PKA
  • Statistical Analysis
• Results
• Discussion
• Acknowledgments
• References
• Copyright

Purpose

To estimate the peak radiation skin doses for interventional radiology cases performed at a cancer center, identify procedure types likely to result in skin doses exceeding the American College of Radiology's 3 Gy follow-up level, and determine a kerma area product (P_KA) for use in monitoring.

Materials and Methods

A single-center retrospective study was performed to estimate doses from consecutive procedures performed during 2006. Of 6,598 procedures, 3,925 (60%) had P_KA recorded and were included. Forty-three procedure types are represented.

Results

The median estimated peak skin dose was 39 mGy (third quartile, 205 mGy). In 2.6% of the cases, the estimated skin dose exceeded 3 Gy. No procedures resulted in skin doses greater than 15 Gy, and 94% of the cases resulted in skin doses less than 1 Gy. Procedure types with instances of skin doses greater than 1 Gy included hepatic, portal, and other arterial embolizations; diagnostic arteriography; biliary drainages; stent placements and catheter exchanges; nephrostomy/nephroureterostomy; urinary catheter exchanges; inferior vena cava filters; foreign body retrieval; abscess drainage; catheter exchange; and fistulography. Hepatic embolizations, nonhepatic arterial embolizations, and biliary drain/stent procedures were most likely to result in skin doses greater than 1 Gy. Significant variations in skin dose were noted within the same procedure type. No patients were noted to have developed any sequelae from radiation.

Conclusions

It is unlikely that typical cases in an oncologic interventional radiology practice would exceed the Joint Commission's “reviewable sentinel event” skin dose level of 15 Gy. A P_KA trigger of 300 Gycm² could be used in the authors' clinic to identify follow-up requirements.

Abbreviations: ACR, American College of Radiology, FDA, Food and Drug Administration, P_KA, kerma area product, PSD, peak skin dose

A wide variety of medical specialists employ fluoroscopy to perform image-guided medical interventions. Patient radiation dose carries risks of stochastic or deterministic injury, and the highest dose is to the skin at the entrance site of the radiation beam (1). As public awareness of medical radiation exposure has increased, there has been heightened awareness among physicians and regulatory agencies regarding the monitoring of administered radiation dosages. Instances of skin injury reported in the literature or to the United States Food and Drug Administration (FDA) have primarily resulted from prolonged interventional cardiology procedures such as cardiac radiofrequency ablations or coronary angioplasty (1, 2, 3, 4). Other reported injuries include those resulting from interventional radiology procedures such as transjugular intrahepatic portosystemic shunt creation, renal angioplasty, hepatic/biliary procedures, or embolizations (1, 2, 5, 6, 7, 8).

Deterministic radiation-induced skin injuries range from transient erythema at low doses to dermal necrosis or chronic ulceration at very high doses (5, 9, 10, 11). Threshold doses in sensitive patients for various effects are approximately 3 Gy (300 rad) for temporary epilation, approximately 6 Gy (600 rad) for main erythema, and 15–20 Gy (1,500–2,000 rad) for moist desquamation, dermal necrosis, and secondary ulceration (12). The manifestation of radiation injury to the skin is not immediate, but usually appears days to weeks after irradiation (13). At high doses, such injuries may have permanent sequelae.

A number of studies have been performed to determine skin dose ranges for various interventional radiology procedures (14, 15, 16, 17, 18). In practice, most fluoroscopic equipment provides only surrogate measures of skin dose. Our purpose was to estimate peak radiation skin doses for the entire range of interventional radiology procedures performed at a high-volume cancer center. We sought to identify the procedures most likely to result in skin doses that could exceed the American College of Radiology (ACR) trigger level of 3 Gy for follow-up (19), and to determine an associated kerma area product (P_KA) for use in monitoring such a skin dose.

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Materials and Methods 

Case and Subject Selection 

A retrospective study was carried out on all consecutive interventional radiology procedures performed on oncology patients at our institution, a National Cancer Institute–designated Comprehensive Cancer Center, during 2006. For each of these procedures, radiologic technologists recorded surrogate measures of skin dose that included fluoroscopy time or P_KA, as measured by a dose–area product (DAP) meter. P_KA is defined as the integral of air kerma for a cross section of the x-ray beam (20). This study included all cases in which P_KA was recorded.

Of the 6,598 consecutive cases, 3,925 (60%) had P_KA recorded and formed the study group. The first column of Table 1 lists each of the 43 types of interventional radiology procedures included in the study. Subjects ranged in age from 5 to 92 years (median, 62 y). Of the 3,925 cases, 2,045 (52%) were performed on male patients and 1,880 (48%) were performed on female patients. Subjects' weight ranged from 18.5 to 177 kg (median, 73 kg).

Table 1. Data for Interventional Radiology Procedures Performed in 2006

Note.—IVC = inferior vena cava.

There was no attempt to influence or control how any instance of any procedure was conducted with regard to fluoroscopic technique, image acquisition, criteria for success, choice of subject, choice of operator, choice of fluoroscopic unit, or any other factor. An institutional review board waiver for retrospective review of data was obtained.

Fluoroscopic Equipment 

Procedures were performed on three different angiographic equipment models, including Advantx/LCA (GE Healthcare, Milwaukee, Wisconsin), Integris Allura (Philips Medical Systems, Best, The Netherlands), and Innova 4100 (GE Healthcare) models. These machines incorporate typical state-of-the-art dose reduction features, including modern image intensifier video systems or flat panels, pulsed fluoroscopy, lose-dose continuous fluoroscopy, recursive filtration, digital subtraction angiography, variable-frame-rate digital subtraction angiography, visualization of collimator without radiation, and availability of filters to modify beam quality. Recorded dosimetry information included fluoroscopy time and/or P_KA. This study used procedures with recorded P_KA values.

Each fluoroscopic unit in this study is capable of operation in various modes of operation. The fluoroscopic mode for each instance of each procedure was chosen by the operator to best suit the intervention and operator preferences. No attempt was made to standardize the use of any fluoroscopic mode. Therefore, the results of this study represent the current typical methodologies for oncologic interventional radiology procedures at the authors' institution. Fluoroscopic beams were automatically filtered with built-in aluminium and/or copper depending on fluoroscopic modes and automatic dose controls to preferentially remove lower-energy x-rays and hence reduce the absorbed dose from these softer radiation beams.

The units are routinely tested for exposure, time, and kVp reproducibility. Fluoroscopic output rates are measured for different patient thicknesses such as those of pediatric patients and small, average, large, and heavyset adults. Imaging tests such as high-contrast and low-contrast resolution are performed as per local Department of Health guidelines. Beam quality tests are also performed for various kVp settings. The estimated average equivalent half-value layer under clinical operation was typically approximately 9 mm of aluminum. The P_KA meter outputs were verified accurate to within approximately 10%.

Dose Measurement 

A wide variety of dose surrogates have been used to evaluate patient “doses,” and a set of useful dose metrics has emerged in the last twenty years (21). Key definitions and elements of their use are found in International Commission on Radiation Units and Measurements Report 74 (22), International Electrotechnical Commission standard 6601-2-43 (23), and current FDA regulations (24). This publication conforms to the notation of International Commission on Radiation Units and Measurements Report 74 as far as possible based on these conventions.

Air kerma is a measure of the energy delivered to air by an x-ray beam. The typical unit of measurement is the gray (Gy). The fluoroscopes used in this study have “dose” meters that actually measure air kerma or calculate P_KA from machine settings. Kerma area product is the air kerma measured at a given distance from the x-ray tube multiplied by the area of the x-ray beam, or F_s at that distance. P_KA may be used in radiation management programs, provided the beam sizes used for typical clinical procedures can be estimated (13).

Clinical Data Collection 

We retrospectively collected demographic and radiation dose data for all instances of interventional radiology procedures during the period from January 2006 through December 2006. Data were collected for each fluoroscopic unit. For each instance, an electronic data form was completed that included fluoroscopic equipment designation, patient data (weight and age), operator, procedure type, and fluoroscopy time and/or P_KA. Procedures were divided into subgroup types defined by the institutional radiology data protocols. Any procedures that had only fluoroscopy time recorded or for which data were incomplete after review were discarded. In addition, data were discarded if only one case was recorded for a given procedure type. All data were collected in a computerized database (Excel 2000; Microsoft, Redmond, Washington).

Estimating Peak Skin Dose from P_KA 

Dose estimates were made according to standard dosimetric protocols as outlined by the American Association of Physicists in Medicine for 40–300-kV x-ray beam dosimetry (25). In this study, the P_KA was considered to be reasonably estimated by incident air kerma (K_a,i) multiplied by the x-ray field size at the patient's skin (F_s). When an estimate of K_a,i is available, the peak skin dose (PSD) is estimated by applying a kerma-based backscatter factor for water, the ratio of mass energy-absorption coefficients for water to air averaged over the primary photon spectrum free in air, and a conversion factor for dose to water to dose to skin. These factors were applied to a typical beam F_s of 150 cm² and were interpolated from standard dosimetric tables available in the literature (25). These dose estimates were used to evaluate the number of cases that would have exceeded the ACR trigger level of 3 Gy for follow-up (19).

Statistical Analysis 

Descriptive and summary statistics were performed with a spreadsheet application (Excel 2000; Microsoft). Quartile and 95% CI values were calculated with the spreadsheet and standard techniques for determining CIs with the Student t distribution (26).

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Results 

For each of the 43 procedure types represented, Table 1 presents data on the number of cases recorded, as well as quartile values for P_KA, and estimated PSDs. Certain procedures were represented by fewer than 10 instances each. Even though these data may not be representative of all populations because of the small sample size, they were included for completeness. The overall mean estimated PSD for all procedures was 39 mGy (third quartile, 205 mGy). No procedures resulted in skin doses greater than 15 Gy, and 94% of the procedures resulted in skin doses less than 1 Gy. The histogram for estimated PSDs is skewed or characterized by an asymmetric shape with a main peak in the lower dose region, a tail, and a few extreme values (Fig 1). This shape is representative of what is expected for examinations involving fluoroscopy (27).

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• Figure 1. 

  Histogram of estimated PSD for 3,945 instances of various interventional radiology procedures for oncology patients during 2006.

In 2.6% of the cases, the estimated skin dose exceeded 3 Gy. Procedure types with specific cases in which the skin dose was greater than 1 Gy included hepatic embolization, portal venous embolization, nonhepatic embolization, diagnostic arteriography, nephrostomy, nephroureterostomy, genitourinary catheter exchange, biliary drainage, biliary stent placement, biliary catheter exchange, inferior vena cava filter, abscess catheter, abscess drainage, fistulography, and foreign body retrieval. Hepatic embolizations, other arterial embolizations, and biliary drain/stent procedures were most likely to result in skin doses greater than 1 Gy. The histogram for estimated PSDs for all embolization procedures is also skewed or characterized by an asymmetric shape with a main peak in the lower dose region, a tail, and a few extreme values (Fig 2).

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• Figure 2. 

  Histogram of estimated PSD for 190 instances of embolization-related interventional radiology procedures for oncology patients during 2006.

Significant variations in skin dose were noted for various instances of the same procedure. For example, estimated PSDs ranged from 220 mGy to 9.5 Gy for hepatic embolizations (Fig 3). In this study, no patients were noted to have developed any sequelae from radiation.

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• Figure 3. 

  Range of estimated PSDs compared with the RAD-IR study (14).

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Discussion 

This study was intended to provide dose estimates for a variety of interventional procedures performed at a major oncologic medical center, with no attempt to standardize the technical factors for each fluoroscopic unit (including the type of dosimetry system) or the way in which each procedure was performed. Although the fluoroscopy units in this study were not equipped to record the International Electrotechnical Commission standard cumulative dose or onboard PSD and were limited to estimating PSDs from P_KA, the results reported are based on our best estimates for the fluoroscopy units available and the types of procedures performed at our institution.

It is difficult to provide actual real-time monitoring of PSDs or to routinely perform skin dose mapping during fluoroscopic procedures. It was decided to use recorded P_KA because this measure represented the best dose surrogate information collected. Institutional protocols in 2006 required that total fluoroscopy time or P_KA be reported in the patient record. A comparison of procedure types indicates that all procedure types are represented by recorded P_KA values and that the selection is random, minimizing the potential for selection bias. The relative ease of use of recorded P_KA allowed for large numbers of patient doses to be evaluated. P_KA is a good estimator for stochastic risk for patients and staff (28). P_KA values can also be used with imaging geometry and anatomic patient information to estimate organ dose as well as stochastic risk (29, 30, 31). Although the RAD-IR project (14) demonstrated a good concordance between maximum reference point dose and peak skin air kerma, the accumulated dose at a reference point is perhaps a more appropriate estimator of the risk of deterministic injuries (29). The potential for errors introduced in the estimation of the PSD from P_KA has been evaluated in the literature and found to be bounded by a potential error of approximately 30%–40%, a level of uncertainty that can be regarded as acceptable and comparable with those in other methods of estimating PSDs (20, 31, 32).

The oncology patient population evaluated in this study and the types of procedures performed in an oncology practice may differ from those performed in a more general interventional radiology practice. For example, this institution does not perform cardiac catheterizations or large numbers of transjugular intrahepatic portosystemic shunt procedures.

Recorded P_KA values for the present study are comparable with those found in the literature. Efstathopoulos et al (17) recorded mean a P_KA for hepatic chemoembolizations of 150.5 Gycm² ± 76 for six patients. Vano et al (18) recorded a mean P_KA for hepatic embolization of 121 Gycm² in 149 patients. Aroua et al (33) estimated a third-quartile value of 620 Gycm² for hepatic embolizations. Our study recorded a mean P_KA for hepatic embolizations of 255 ± 187 Gycm² in 148 patients. In addition, the PSD estimates obtained in this study have been compared with the results of the RAD-IR study (9, 14), a prospective study that measured PSDs for a variety of interventional radiology procedures. As shown in Table 2, and Figure 3, although similar procedure types show comparable ranges of values for PSD, for most procedure types, the maximum PSD estimates obtained in this study are slightly higher than those reported in the RAD-IR study (9, 14). This is most likely a result of the differing patient populations evaluated. Our study is based on a population of oncology patients, increasing the probability for more complex interventional procedures. Increasing procedure complexity has been shown to be directly correlated with increased skin doses (34, 35). These overall comparisons serve to corroborate the appropriateness of the methodology for estimating PSDs used in this study. We believe our estimates represent the range of best estimates based on the available information for our oncology patient population.

Table 2. Estimated PSDs Compared with the RAD-IR Study (14)

Note.—IVC = inferior vena cava.

The variability of radiation dose for different instances of the same procedure is believed to be a result of operator, patient, and data categorization factors. For example, the category “hepatic embolization” includes patients undergoing an initial embolization procedure (characterized by diagnostic arteriography of the celiac axis and superior mesenteric artery followed by liver embolization), patients undergoing a repeat embolization (in which only limited arteriography precedes embolization), and patients with variant or complex anatomy (eg, in which access to the hepatic artery might require a sometimes lengthy retrograde catheterization of collateral branches). Operator factors might include extent of experience and imaging preferences. An important patient factor is weight. The complex interplay of these factors contributes to the variability of administered dose for different instances of the same procedure.

The FDA published a public health advisory in 1994 (12) that provided detailed advice and information on avoidance of serious x-ray–induced skin injuries during fluoroscopically guided procedures. Minimization of skin dose is best accomplished by taking steps to reduce radiation dose in general while maintaining adequate image quality for diagnosis and intervention (36). There are many proven methodologies and suggestions given in the literature for optimizing radiation dose and ultimately reducing patient PSD and room scatter (2, 13, 36, 37).

The FDA published additional guidance in 1995 (38) suggesting that the potential for injury be recorded in the patient's record for any procedure a facility determines could result in a cumulative absorbed dose in a specific area of skin equal to or greater than 1 Gy (100 rad). The FDA now requires all new fluoroscopic assemblies sold in the United States to have the capability to record reference point air kerma (K_a,r) or the air kerma, measured free in air, accumulated at a defined reference point during a single fluoroscopic procedure (13). The dosimetry portion of the International Electrotechnical Commission standard 60601-2-43 (23) now codifies the new dosimetry monitoring concept.

Although the use of K_a,r is a useful development in equipment capabilities, a real-time skin dose mapping and display process would prove extremely helpful to physicians. There have also been several attempts to provide such information to the physician (39, 40). There is one system that will dynamically record and display an estimate of total skin entrance dose (37) with use of an add-on device that is called the PEMNET system (Clincal Microsystems, Arlington, Virginia) that measures peak kilovoltage, tube current (ie, milliamperage), and exposure time signals from the x-ray generator to dynamically compute and display an estimate of the skin entrance dose based on calibration of radiation output as a function of these parameters. Another system, previously marketed as the CareGraph System (Siemens Medical Solutions, Malvern, Pennsylvania), used a mathematical model to combine data from the x-ray system's internal K_a,r meter with geometric information on patient size and beam location to provide a display of dose rate and cumulative dose and a real-time graphical display of the estimated dose distribution on the skin of the patient (20).

The continuing occurrence of fluoroscopic injuries is of concern to many organizations (13). The Joint Commission (previously known as the Joint Commission on Accreditation of Healthcare Organizations) added prolonged fluoroscopy with skin dose greater than 15 Gy (1,500 rads) to its list of reviewable sentinel events in 2006 (41, 42). They indicated that one of the main reasons for adding this event to the list of reviewable sentinel events was to raise awareness of the severity of the associated outcomes that, according to the Joint Commission, are often overlooked or unrecognized because of the delay in their appearance (43). The Joint Commission's standard indicates the necessity to have a system in place to detect any occurrences of such reviewable sentinel events. A methodology for evaluating patient skin doses is therefore essential to the field of interventional radiology.

The ACR, in collaboration with the Society of Interventional Radiology (SIR), has published a practice guideline for the reporting and archiving of interventional radiology procedures (44), which suggests that the permanent medical record for all cases include measures of ionizing radiation exposure. In addition, a system for developing guidance levels has been recommended (18, 29). In a recent technical standard (19), the ACR now notes that if the cumulative air kerma at the reference point exceeds 3 Gy, provisions should be made for follow-up of those areas for determination of radiation effects. In such circumstances, the ACR suggests that there should be documentation in the medical record that the patient was advised of the potential for radiation injury to the skin and was given instructions for proper follow-up.

Based on the calculations used in this evaluation, a threshold level for clinical follow-up could be presented. For example, if P_KA is less than 1600 Gycm² for a 150-cm2 field size, then it is unlikely that the PSD will be greater than the 15 Gy reviewable sentinel event level. Similarly, if P_KA is less than 320 Gycm², it is unlikely that the PSD will be greater than the 3 Gy threshold that would warrant clinical follow-up. The ACR notes that there should be documentation in the medical record that the patient was advised of the potential for radiation injury to the skin and was given instructions for proper follow-up (19). Wagner (35) also suggests to advise the patient of the potential for radiation skin reactions, and that the patient should be asked to examine him- or herself approximately 2–3 weeks after the procedure for any skin changes in the imaging entrance skin areas (34).

At our institution, we are creating a system to identify patients with cumulative skin exposures of greater than 300 Gycm² to provide information about possible skin signs of radiation effects, including a follow-up clinical evaluation.

Estimated PSD results reported here represent the current practice at a high-volume cancer center interventional radiology service. No procedures resulted in estimated PSDs greater than 15 Gy. Trigger levels for clinical follow-up can be developed based on available dosimetric measurements.

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Acknowledgments 

The authors acknowledge the assistance and support of staff members and administrators in the Departments of Radiology and Medical Physics at Memorial Sloan-Kettering Cancer Center.

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