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Medical Physics |
1 From the Departments of Medical Physics (K.P., J.D., N.T.), Orthopaedics and Traumatology (G.P., A.H.), and Radiology (N.G.), University Hospital of Iraklion, University of Crete, Faculty of Medicine, PO Box 2208, 71003 Iraklion, Crete, Greece. Received September 2, 2003; revision requested November 20; revision received December 10; accepted January 13, 2004. Address correspondence to K.P. (e-mail: perisina@med.uoc.gr).
| ABSTRACT |
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MATERIALS AND METHODS: Dose values normalized over dose-area product were determined for all radiosensitive organs and tissues by using a humanoid phantom and thermoluminescence dosimetry separately for anteroposterior and lateral projections. Measurements were obtained for treatments of the fifth, eighth, and 11th thoracic vertebrae and the first, third, and fifth lumbar vertebrae. Total fluoroscopy time and resultant dose-area product from each fluoroscopic exposure were monitored in 11 consecutive patients (seven women and four men) undergoing kyphoplasty. The age range of these patients was 4178 years, and the mean age was 58 years.
RESULTS: Mean total fluoroscopy time for kyphoplasty was 10.1 minutes ± 2.2 (standard deviation). Mean effective dose to patients from kyphoplasty was 8.512.7 mSv, and mean gonadal dose was 0.0416.4 mGy, depending on the level of the treated vertebra. Skin injuries after kyphoplasty are improbable if source-to-skin distance is 35 cm or more; however, such injuries may occur if the total fluoroscopy time per projection is extended and/or the source-to-skin distance is less than 35 cm during the procedure.
CONCLUSION: Patient radiation exposure and associated risks from vertebroplasty or kyphoplasty may be considerable. Data obtained in the current study may be used to establish patient effective dose, gonadal dose, and entrance skin exposure, as well as associated risks, from these fluoroscopically guided surgical treatments of spinal disorders.
© RSNA, 2004
Index terms: Dosimetry Experimental study Fluoroscopy, 32.1267 Radiations, injurious effects Phantoms Spine, surgery
| INTRODUCTION |
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Patient radiation doses that result from exposures during routine medical imaging are generally insufficient for induction of the lowest-threshold deterministic effect (ie, skin erythema). Nevertheless, radiation-induced patient skin injuries have been reported to result from extended fluoroscopic exposures (1114). Given that the onset of such injuries is usually delayed up to 2 weeks, the operating physician cannot be alerted to prevent the damage by observing the patient during treatment. Therefore, the Food and Drug Administration Center for Devices and Radiological Health (15,16) and the International Commission on Radiological Protection (17) have proposed several measures for the avoidance of radiation-induced skin injuries in patients undergoing fluoroscopically guided medical procedures. In addition, very large patient doses associated with high-exposure interventional procedures can lead to an increased risk of delayed effects such as cancer induction, as well as to hereditary effects. The potential for radiation-related cancer induction increases with patient effective dose, whereas the potential for hereditary effects depends on the radiation dose absorbed by the gonads (18). In addition, the risk for stochastic effects depends on the age of the irradiated patient; younger patients have much higher risks (19,20). Although vertebroplasty and kyphoplasty are usually performed in elderly patients, individuals of childbearing age may well be candidates for these treatments (1). Therefore, apart from the radiation-related risk for skin injury, the risk for stochastic effects resulting from the fluoroscopic exposure in such procedures also should be investigated. To our knowledge, no data have been published previously about patient exposure and radiation risks associated with fluoroscopically guided vertebroplasty and kyphoplasty.
The purpose of our study was to derive normalized data for the estimation of effective, gonadal, and peak skin doses to patients undergoing vertebroplasty or kyphoplasty and to investigate the potential for cancer induction, genetic effects, and radiation-induced skin injury after such procedures.
| MATERIALS AND METHODS |
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Phantom Exposures and Measurements
The dose absorbed by each radiosensitive organ from fluoroscopic exposures during vertebroplasty and kyphoplasty was measured by using a humanoid phantom (RANDO; Alderson Research, Stanford, Calif) and thermoluminescence dosimetry. The phantom mimics the trunk of an individual 1.75 m in height and 73.5 kg in weight. The internal structure of the phantom comprises synthetic human skeleton, lung and soft tissue, and air cavities appropriately sculptured to simulate the esophagus, trachea, and stem bronchi. The thorax is constructed to represent neutral respiratory volume, with the left lung smaller than the right to allow for the heart. Five hundred twenty thermoluminescent dosimeter (TLD) chips with dimensions of 3.0 x 3.0 x 0.9 mm were appropriately placed by one of the authors (N.T.) in special TLD holders introduced into holes in each phantom section, to determine the dose to each radiosensitive organ. Entrance skin dose was estimated for each projection by using an array of five rows of TLD chips, with five chips in each row, separated by 2 cm. The phantom was positioned prone on the radiolucent table. Anteroposterior projections were obtained with the x-ray tube positioned under the table, and lateral projections were obtained with the x-ray tube on the right side of the phantom. Dosimetric data were obtained separately for the anteroposterior and lateral fluoroscopic projections. Separate data were obtained for the fluoroscopic projections centered on phantom sections 12, 15, 18, 21, 24, and 27, which correspond to the fifth thoracic (T5), eighth thoracic (T8), 11th thoracic (T11), first lumbar (L1), third lumbar (L3), and fifth lumbar (L5) vertebrae, respectively. The equivalence of the phantom sections to the levels of the patient body trunk defined by the vertebrae was based on previously published data and an atlas of sectional anatomy (22,23). Dosimetric data were obtained for a 10° angled anteroposterior projection centered on L1 to investigate the influence of angulation on the measured effective and gonadal doses. Similarly, dosimetric data were obtained also for a lateral projection centered on L1 with the x-ray tube positioned on the left side of the phantom to evaluate the difference in effective and gonadal doses between right and left lateral projections. The fluoroscopy time for each phantom exposure was 30 minutes to achieve sufficient TLD readout. The experimental error related to the uncertainty introduced by the use of TLD chips to determine organ doses has been estimated to be less than 15% (22). The operating tube voltage, tube current, x-ray source-to-skin distance (SSD), and resultant dose-area product (DAP) for each phantom exposure were recorded by one of three authors (K.P., J.D., N.T.).
Phantom exposures were performed by using a mobile C-arm fluoroscopy unit (Siremobil; Siemens, Erlangen, Germany) with last-image-hold capability. Image intensifier magnification mode was not used. The focustoimage intensifier distance was 90 cm and the minimum SSD allowed was 20 cm. Automatic brightness control was used, and DAP was monitored with a dose-area meter permanently fixed on the x-ray unit. The half-value layer of the x-ray beam was measured to be 4.0 mm aluminum at 80 kV, corresponding to a total filtration of 4.6 mm aluminum. The x-ray tube output of the fluoroscopic unit at 58 cm from the tube, with the operating table positioned between the x-ray focus and the output meter, was measured at 70 kVp and 1.1 mA, 80 kVp and 1.6 mA, and 90 kVp and 2.1 mA to be 3.9, 7.8, and 13.6 mGy/min, respectively. The x-ray tube output also was measured without the interposition of the operating table between the x-ray focus and the output meter at 70 kVp and 1.1 mA, 80 kVp and 1.5 mA, and 90 kVp and 2.0 mA to be 6.3, 11.5, and 19.3 mGy/min, respectively.
Patient Study
The total DAP, duration of fluoroscopy, and parameters for anteroposterior and lateral fluoroscopic projections were recorded in 11 consecutive patients (seven women and four men) who underwent kyphoplasty from January 2003 to April 2003. The study was approved by the local ethics committee, and all patients gave informed consent. The age range of these patients was 4178 years, and the mean age was 58 years. Treated vertebrae ranged from T10 to L5. An inflatable bone tamp (KyphX Xpander; Kyphon, Zaventem, Belgium) was percutaneously introduced into the vertebral body during fluoroscopic guidance (Fig 1). The bone tamp was inflated to improve vertebral height and correct kyphotic deformity. After inflation, the tamp was deflated and removed, and the cavity thus created was filled with polymethylmethacrylate cement, which was introduced with low pressure.
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The total effective dose (Etot) to a patient undergoing fluoroscopically guided surgical treatment of a spinal disorder may be determined from:
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AP and
L are the factors for conversion from DAP to effective dose for anteroposterior and lateral fluoroscopic projections, respectively; and DAPAP and DAPL are the total DAP values for anteroposterior and lateral projections, respectively.
Similarly, patient gonadal dose (GDtot) may be estimated by using the following equation:
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The entrance skin doses normalized to fluoroscopy time for anteroposterior and lateral projections (esdp) were estimated from phantom exposures. For patients undergoing fluoroscopically guided kyphoplasty or vertebroplasty, the entrance skin dose for the anteroposterior or lateral projection (ESDp) may be estimated by using the following equation:
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Risks for Radiation-induced Effects
The skin dose threshold for the induction of skin erythema (ie, the lowest-threshold deterministic effect) has been reported to be 2 Gy (24). For each fluoroscopic projection, the minimum exposure duration required for the induction of erythema was estimated by dividing the threshold value by the skin dose rate measured during the phantom study.
The risk for hereditary effects associated with fluoroscopy was estimated by multiplying the procedure-related dose to gonads (in milligrays) by the hereditary effect risk factor of 0.01 Sv1, as recommended by the International Commission on Radiological Protection. The risk for fatal cancer induction associated with a typical procedure was estimated by multiplying the effective dose resulting from the procedure by previously published age- and sex-related risk coefficients (19,20).
| RESULTS |
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| DISCUSSION |
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The mean total fluoroscopy time for kyphoplasty procedures performed at our institution was 10.1 minutes (4.7 minutes for the anteroposterior projection and 5.4 minutes for the lateral projection). Depending on the treated region, the patient effective dose from an average kyphoplasty procedure was 8.512.7 mSv, and the entrance skin exposure was 173233 mGy. These values are much higher than the patient effective doses from common radiologic examinations such as abdominal (0.16 mSv), chest (0.03 mSv), and skull (0.008 mSv) radiography (25), but they are comparable with the effective doses from other common high-exposure interventional fluoroscopic procedures, such as radiofrequency catheter cardiac ablation (5.7 mSv) (10), endoscopic retrograde cholangiopancreatography (12.4 mSv) (26), and enteroclysis (14.0 mSv) (27).
Reporting of patient effective dose or entrance skin exposure from an average kyphoplasty procedure at a certain institution is of limited value, given the great variability of equipment used and techniques followed at different institutions. Normalized dosimetric data should be available that take into account the different fluoroscopy times, characteristics of equipment, and other fluoroscopic parameters involved. In the present study, dosimetric data normalized to DAP were obtained separately for the anteroposterior and lateral projections commonly obtained during vertebroplasty and kyphoplasty, and for six different spinal regions treated, by using a phantom. The degree of uncertainty introduced into the normalized data as a result of the standard phantom dimensions may be considered minor compared with that introduced by the use of TLD chips. The DAP depends on fluoroscopy time and equipment characteristics such as output, filtration, and image-intensifier diameter, as well as operating parameters such as kilovoltage and milliamperage. Thus, our data may be used for the estimation of effective dose to patients undergoing vertebroplasty or kyphoplasty at other institutions and with different techniques and equipment.
The age- and sex-averaged risks for fatal cancer induction and for detrimental hereditary disorders associated with fluoroscopically guided kyphoplasty are 410 x 106 and 10 x 106, respectively, whereas the spontaneous cancer risk is 200 000 x 106, or 20%, and the incidence of serious birth defects is 60 000 x 106, or 6% (28). In other words, among 1 million patients undergoing kyphoplasty requiring a 10-minute fluoroscopic exposure, 410 fatal cancers might be induced in addition to the naturally occurring 200 000. Likewise, among 1 million infants with a parent who underwent a typical kyphoplasty procedure, the expected number of infants with a defect is 60 010, in 10 of whom the defect may be attributed to radiation received by the gonads of the irradiated parent. These theoretical radiation-related risks for stochastic effects associated with a typical kyphoplasty procedure may be considered tolerable. However, stochastic risks should not be disregarded, especially when treated patients are young individuals with many years of expected life remaining and with complex spinal disorders requiring extended fluoroscopic screening.
Entrance skin dose was normalized over fluoroscopy time and not over DAP because DAP does not depend on SSD, whereas entrance skin dose strongly depends on SSD. Our data show that skin injuries might occur after kyphoplasty in large patients, in whom lengthy fluoroscopic observation with lateral projections is required. SSD of 20 cm is the minimum value allowed by our equipment or by any fluoroscope intended for specific surgical applications that meets the requirements of the Food and Drug Administration. Apart from the fluoroscopic exposure duration and patient size, the main factors that affect patient entrance skin dose are the SSD and the output of the x-ray system. SSD may be easily measured during the procedure, and the output of the x-ray unit is generally available, since it is routinely measured at various kilovoltage values during the standard periodic quality-control check. Thus, the operating physician and/or technologist may use the data from our study to establish fluoroscopy time thresholds for the induction of deleterious skin effects for the specific equipment and technique used at a particular institution.
Radiation risks associated with fluoroscopically guided kyphoplasty are not trivial. Therefore, efforts should be made toward optimization of fluoroscopic parameters during treatment, especially when the treated patients are young individuals with many decades of expected life remaining. The most effective approach for decreasing patient radiation exposure is to minimize the exposure time. Minimum patient exposure may be accomplished if vertebroplasty and kyphoplasty are performed only by physicians and assisting personnel who have been trained in radiation protection. With an awareness of the major factors that affect patient radiation dose, operating physicians can deliver a low patient dose without compromising the efficacy of the procedure. Collimation should be adjusted so that the radiation field includes only the anatomic region of interest. Last image hold, automatic brightness control, and pulsed fluoroscopy mode are features of modern fluoroscopic systems that should be preferably used if available. The SSD should always be the maximum possible, and never less than 30 cm. Use of the low-dose mode, available with some dedicated fluoroscopic suites, is strongly recommended. The x-ray system should be subjected to periodic inspection for quality assurance by a qualified medical physicist. Physicians who perform fluoroscopically guided procedures should always keep in mind that minimization of patient exposure results also in minimization of the dose received by operating personnel.
In conclusion, the patient radiation burden and associated radiation risks from fluoroscopically guided vertebroplasty or kyphoplasty may be considerable. We believe that our data are useful for establishing patient effective dose, gonadal dose, and entrance skin exposure, as well as the associated risks from fluoroscopically guided surgical treatments of spinal disorders, not only at our institution but also at other institutions.
| FOOTNOTES |
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See also the editorial by Seibert in this issue.
Abbreviations: DAP = dose-area product, SSD = source-to-skin distance, TLD = thermoluminescent dosimeter
Author contributions: Guarantor of integrity of entire study, K.P.; study concepts, K.P.; study design, K.P., J.D., N.T., G.P.; literature research, K.P., J.D., N.T.; clinical studies, G.P., A.H.; experimental studies, K.P., J.D., N.T.; data acquisition, K.P., J.D., N.T., G.P.; data analysis/interpretation, K.P., N.T.; manuscript preparation, K.P., J.D., N.T., A.H., N.G.; manuscript definition of intellectual content, K.P., A.H., N.G.; manuscript editing, K.P.; manuscript revision/review, K.P., J.D., N.T.; manuscript final version approval, K.P., J.D., A.H., N.G.
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