Beth A. Schueler

Radiation Doses in Interventional Radiology Procedures: The RAD-IR Study Part I: Overall Measures of Dose

PURPOSE To determine patient radiation doses for interventional radiology and neuroradiology procedures, to identify procedures associated with higher radiation doses, and to determine the effects of various parameters on patient doses. MATERIALS AND METHODS A prospective observational study was performed at seven academic medical centers. Each site contributed demographic and radiation dose data for subjects undergoing specific procedures in fluoroscopic suites equipped with built-in cumulative dose (CD) and dose-area-product (DAP) measurement capability compliant with International Electrotechnical Commission standard 60601-2-43. The accuracy of the dosimetry was confirmed by comprehensive measurements and by frequent consistency checks performed over the course of the study. RESULTS Data were collected on 2,142 instances of interventional radiology procedures, 48 comprehensive physics evaluations, and 581 periodic consistency checks from the 12 fluoroscopic units in the study. There were wide variations in dose and statistically significant differences in fluoroscopy time, number of images, DAP, and CD for different instances of the same procedure, depending on the nature of the lesion, its anatomic location, and the complexity of the procedure. For the 2,142 instances, observed CD and DAP correlate well overall (r = 0.83, P <.000001), but correlation in individual instances is poor. The same is true for the correlation between fluoroscopy time and CD (r = 0.79, P <.000001). The correlation between fluoroscopy time and DAP (r = 0.60, P <.000001) is not as good. In 6% of instances (128 of 2,142), which were principally embolization procedures, transjugular intrahepatic portosystemic shunt (TIPS) procedures, and renal/visceral artery stent placements, CD was greater than 5 Gy. CONCLUSIONS Most procedures studied can result in clinically significant radiation dose to the patient, even when performed by trained operators with use of dose-reducing technology and modern fluoroscopic equipment. Embolization procedures, TIPS creation, and renal/visceral artery stent placement are associated with a substantial likelihood of clinically significant patient dose. At minimum, patient dose data should be recorded in the medical record for these three types of procedures. These data should include indicators of the risk of deterministic effects as well as the risk of stochastic effects.

Guidelines for Patient Radiation Dose Management

Michael S. Stecker, MD, Stephen Balter, PhD, Richard B. Towbin, MD, Donald L. Miller, MD, Eliseo Vano, PhD,Gabriel Bartal, MD, J. Fritz Angle, MD, Christine P. Chao, MD, Alan M. Cohen, MD, Robert G. Dixon, MD,Kathleen Gross, MSN, RN-BC, CRN, George G. Hartnell, MD, Beth Schueler, PhD, John D. Statler, MD,Thierry de Baere, MD, and John F. Cardella, MD, for the SIR Safety and Health Committee and the CIRSEStandards of Practice Committee

Radiation Doses in Interventional Radiology Procedures: The RAD-IR Study Part II: Skin Dose

PURPOSE To determine peak skin dose (PSD), a measure of the likelihood of radiation-induced skin effects, for a variety of common interventional radiology and interventional neuroradiology procedures, and to identify procedures associated with a PSD greater than 2 Gy. MATERIALS AND METHODS An observational study was conducted at seven academic medical centers in the United States. Sites prospectively contributed demographic and radiation dose data for subjects undergoing 21 specific procedures in a fluoroscopic suite equipped with built-in dosimetry capability. Comprehensive physics evaluations and periodic consistency checks were performed on each unit to verify the stability and consistency of the dosimeter. Seven of 12 fluoroscopic suites in the study were equipped with skin dose mapping software. RESULTS Over a 3-year period, skin dose data were recorded for 800 instances of 21 interventional radiology procedures. Wide variation in PSD was observed for different instances of the same procedure. Some instances of each procedure we studied resulted in a PSD greater than 2 Gy, except for nephrostomy, pulmonary angiography, and inferior vena cava filter placement. Some instances of transjugular intrahepatic portosystemic shunt (TIPS) creation, renal/visceral angioplasty, and angiographic diagnosis and therapy of gastrointestinal hemorrhage produced PSDs greater than 3 Gy. Some instances of hepatic chemoembolization, other tumor embolization, and neuroembolization procedures in the head and spine produced PSDs greater than 5 Gy. In a subset of 709 instances of higher-dose procedures, there was good overall correlation between PSD and cumulative dose (r = 0.86; P <.000001) and between PSD and dose-area-product (r = 0.85, P <.000001), but there was wide variation in these relationships for individual instances. CONCLUSIONS There are substantial variations in PSD among instances of the same procedure and among different procedure types. Most of the procedures observed may produce a PSD sufficient to cause deterministic effects in skin. It is suggested that dose data be recorded routinely for TIPS creation, angioplasty in the abdomen or pelvis, all embolization procedures, and especially for head and spine embolization procedures. Measurement or estimation of PSD is the best method for determining the likelihood of radiation-induced skin effects. Skin dose mapping is preferable to a single-point measurement of PSD.

Diagnostic ionizing radiation exposure in a population-based cohort of patients with inflammatory bowel disease

OBJECTIVE:For diagnosis, assessing disease activity, complications and extraintestinal manifestations, and monitoring response to therapy, patients with inflammatory bowel disease undergo many radiological studies employing ionizing radiation. However, the extent of radiation exposure in these patients is unknown.METHODS:A population-based inception cohort of 215 patients with inflammatory bowel disease from Olmsted County, Minnesota, diagnosed between 1990 and 2001, was identified. The total effective dose of diagnostic ionizing radiation was estimated for each patient. Linear regression was used to assess the median total effective dose since symptom onset.RESULTS:The number of patients with Crohns disease and ulcerative colitis was 103 and 112, with a mean age at diagnosis of 38.6 and 39.4 yr, respectively. Mean follow-up was 8.9 yr for Crohns disease and 9.0 yr for ulcerative colitis. Median total effective dose for Crohns disease was 26.6 millisieverts (mSv) (range, 0–279) versus 10.5 mSv (range, 0–251) for ulcerative colitis (P < 0.001). Computed tomography accounted for 51% and 40% of total effective dose, respectively. Patients with Crohns disease had 2.46 times higher total effective dose than ulcerative colitis patients (P= 0.001), adjusting for duration of disease.CONCLUSIONS:Annualizing our data, the radiation exposure in the inflammatory bowel disease population was equivalent to the average annual background radiation dose from naturally occurring sources in the U.S. (3.0 mSv). However, a subset of patients had substantially higher doses. The development of imaging management guidelines to minimize radiation dose, dose-reduction techniques in computed tomography, and faster, more robust magnetic resonance techniques are warranted.

Radiation doses in interventional radiology procedures: The RAD-IR study. Part III: Dosimetric performance of the interventional fluoroscopy units

PURPOSE To present the physics data supporting the validity of the clinical dose data from the RAD-IR study and to document the performance of dosimetry-components of these systems over time. MATERIALS AND METHODS Sites at seven academic medical centers in the United States prospectively contributed data for each of 12 fluoroscopic units. All units were compatible with International Electrotechnical Commission (IEC) standard 60601-2-43. Comprehensive evaluations and periodic consistency checks were performed to verify the performance of each units dosimeter. Comprehensive evaluations compared system performance against calibrated ionization chambers under nine combinations of operating conditions. Consistency checks provided more frequent dosimetry data, with use of each units built-in dosimetry equipment and a standard water phantom. RESULTS During the 3-year study, data were collected for 48 comprehensive evaluations and 581 consistency checks. For the comprehensive evaluations, the mean (95% confidence interval range) ratio of system to external measurements was 1.03 (1.00-1.05) for fluoroscopy and 0.93 (0.90-0.96) for acquisition. The expected ratio was 0.93 for both. For consistency checks, the values were 1.00 (0.98-1.02) for fluoroscopy and 1.00 (0.98-1.02) for acquisition. Each system was compared across time to its own mean value. Overall uncertainty was estimated by adding the standard deviations of the comprehensive and consistency measurements in quadrature. The authors estimate that the overall error in clinical cumulative dose measurements reported in RAD-IR is 24%. CONCLUSION Dosimetric accuracy was well within the tolerances established by IEC standard 60601-2-43. The clinical dose data reported in the RAD-IR study are valid.

Clinical radiation management for fluoroscopically guided interventional procedures.

The primary goal of radiation management in interventional radiology is to minimize the unnecessary use of radiation. Clinical radiation management minimizes radiation risk to the patient without increasing other risks, such as procedural risks. A number of factors are considered when estimating the likelihood and severity of patient radiation effects. These include demographic factors, medical history factors, and procedure factors. Important aspects of the patients medical history include coexisting diseases and genetic factors, medication use, radiation history, and pregnancy. As appropriate, these are evaluated as part of the preprocedure patient evaluation; radiation risk to the patient is considered along with other procedural risks. Dose optimization is possible through appropriate use of the basic features of interventional fluoroscopic equipment and intelligent use of dose-reducing technology. For all fluoroscopically guided interventional procedures, it is good practice to monitor radiation dose throughout the procedure and record it in the patients medical record. Patients who have received a clinically significant radiation dose should be followed up after the procedure for possible deterministic effects. The authors recommend including radiation management as part of the departmental quality assurance program.

MRI compatibility and visibility assessment of implantable medical devices

We have developed a protocol to evaluate the magnetic resonance (MR) compatibility of implantable medical devices. The testing protocol consists of the evaluation of magnetic field‐induced movement, electric current, heating, image distortion, and device operation. In addition, current induction is evaluated with a finite element analysis simulation technique that models the effect of radiofrequency fields on each device. The protocol has been applied to several implantable infusion pumps and neurostimulators with associated attachments. Experiments were performed using a 1.5‐T whole‐body MR system with parameters selected to approximate the intended clinical and worst case configuration. The devices exhibited moderate magnetic field‐induced deflection and torque but had significant image artifacts. No heating was detected for any of the devices. Pump operation was halted in the magnetic field, but resumed after removed. Exposure to the magnetic field activated some of the neurostimulators.J. Magn. Reson. Imaging 1999;9:596–603.

Operator shielding: How and why

Staff are exposed to potentially high levels of radiation exposure during interventional radiology procedures. Radiation protection shielding devices should be used to help maintain personnel exposures as low as reasonably achievable. Body protection tools include lead aprons, thyroid shields, radiation protection cabins, and floor- and table-mounted shields. Eye protection tools include leaded glasses, ceiling-mounted shields, and protective patient drapes. Hand protection tools include leaded surgical gloves and protective patient drapes. For the most part, these radiation protection tools provide substantial dose reduction for personnel, with several notable exceptions. Leaded glasses without lateral protection do not provide adequate protection to operators because they are typically exposed to scatter radiation from the side. Leaded surgical gloves are not useful for hand protection when hands are placed in the primary x-ray beam. Although other radiation protection tools are effective, they come with drawbacks, including staff physical discomfort and reduced procedure efficiency. As a result, further development of new protection devices is encouraged.

A survey of clinical factors and patient dose in mammography.

A survey was conducted to estimate the mean glandular dose (MGD) for women undergoing mammography and to report the distribution of doses, compressed breast thickness, glandular tissue content, and mammographic technique factors used. From 24,471 mammograms, of 6,006 women, clinical data were collected. The survey data included mammograms from seven modern units using a molybdenum (Mo) anode and either Mo or rhodium (Rh) filter. Exposure factors for each mammogram were recorded automatically onto a floppy disk on each unit. All mammography units were calibrated individually using breast tissue equivalent attenuation slabs of varying glandular content, so the breast glandular content could be estimated on the basis of exposure factors and compressed breast thickness. The MGD was estimated for each mammogram based on the normalized glandular dose and calculated entrance exposure in air. The survey found a median MGD of 2.6 mGy. The median breast glandular tissue content was 28% and the median compressed breast thickness was 5.1 cm. Also, patient attenuation data were converted to equivalent BR-12 and acrylic thickness to help determine appropriate phantom thicknesses required for mammography unit automatic exposure control performance assessment.

A Novel Automated Mammographic Density Measure and Breast Cancer Risk

BACKGROUND Mammographic breast density is a strong breast cancer risk factor but is not used in the clinical setting, partly because of a lack of standardization and automation. We developed an automated and objective measurement of the grayscale value variation within a mammogram, evaluated its association with breast cancer, and compared its performance with that of percent density (PD). METHODS Three clinic-based studies were included: a case-cohort study of 217 breast cancer case subjects and 2094 non-case subjects and two case-control studies comprising 928 case subjects and 1039 control subjects and 246 case subjects and 516 control subjects, respectively. Percent density was estimated from digitized mammograms using the computer-assisted Cumulus thresholding program, and variation was estimated from an automated algorithm. We estimated hazards ratios (HRs), odds ratios (ORs), the area under the receiver operating characteristic curve (AUC), and 95% confidence intervals (CIs) using Cox proportional hazards models for the cohort and logistic regression for case-control studies, with adjustment for age and body mass index. We performed a meta-analysis using random study effects to obtain pooled estimates of the associations between the two mammographic measures and breast cancer. All statistical tests were two-sided. RESULTS The variation measure was statistically significantly associated with the risk of breast cancer in all three studies (highest vs lowest quartile: HR = 2.0 [95% CI = 1.3 to 3.1]; OR = 2.7 [95% CI = 2.1 to 3.6]; OR = 2.4 [95% CI = 1.4 to 3.9]; [corrected] all P (trend) < .001). [corrected]. The risk estimates and AUCs for the variation measure were similar to [corrected] those for percent density (AUCs for variation = 0.60-0.62 and [corrected] AUCs for percent density = 0.61-0.65). [corrected]. A meta-analysis of the three studies demonstrated similar associations [corrected] between variation and breast cancer (highest vs lowest quartile: RR = 1.8, 95% CI = 1.4 to 2.3) and [corrected] percent density and breast cancer (highest vs lowest quartile: RR = 2.3, 95% CI = 1.9 to 2.9). CONCLUSION The association between the automated variation measure and the risk of breast cancer is at least as strong as that for percent density. Efforts to further evaluate and translate the variation measure to the clinical setting are warranted.