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Review |
1
Department of Radiology, The University of Texas-Houston Medical School, 6431
Fannin St., Houston, TX 77030.
2
Department of Radiology, University of New Mexico School of Medicine, 915
Camino de Salud, Albuquerque, NM 87131-5336.
Received September 21, 2000;
accepted after revision December 13, 2000.
Address correspondence to L. K. Wagner.
Introduction
 Top Introduction Case ReportsTechnical Factors for...ConclusionsReferences |
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TopIntroductionCase ReportsTechnical Factors for...ConclusionsReferences |
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Radiation Skin Dose Monitoring
Real-time measurement of the absorbed skin dose was not performed in any of
the patients. A retrospective dose estimate was made in 21 patients, using
available data on fluoroscopy time, cineradiography, and so forth. The dose
was frequently calculated as the total dose that accumulated over several
procedures separated by various intervals. The dose for a single procedure
(eight patients) ranged from 8 to 58 Gy. Although the accuracy of some
estimates can be questioned, the results show that dangerous radiation levels
are possible.
Equipment Malfunction and Deficiencies
Rosenthal et al. [18]
report a woman who underwent radiofrequency catheter ablation that required 65
min of fluoroscopy. The machine failed in its pulsed mode, which resulted in a
continuous output at a high tube current. The subsequent skin dose was
estimated as between 15 and 26 Gy. At 3 weeks the patient developed pruritus
and her skin blistered and necrosed. It subsequently healed slowly over the
next 4-5 months.
In 1976, Iyer [3] published a report of two cases of severe radiation injury. One was related to a single coronary angiogram with an estimated skin dose of 22 Gy. The second case involved placement of a cardiac pace-maker and resulted in an estimated dose of 58 Gy. Severe equipment deficiencies were cited as the causes of these high doses.
Breast Lesions
Two female patients developed skin lesions at the lateral aspect of the
right breast. One was a 17-year-old girl who underwent two radiofrequency
ablation procedures [20]
(Fig. 1). The other was a
52-year-old woman who had several coronary procedures
[11]. The patients developed
early and late skin changes including early erythema, moist desquamation, and
ulceration. Female breast tissue, especially in young patients, is among the
most radiosensitive for induced cancer. Between 1920 and 1955,
radiation-induced breast cancer was a known late complication resulting from
direct exposure of the breast during the treatment of pulmonary tuberculosis
using fluoroscopically guided, artificially induced pneumothoraces
[30]. In the two injuries that
we reviewed, the location shows that the entrance beam was directed onto the
right breast in a lateral or a shallow oblique direction. Dose to the breast
tissue is likely to be quite high under these circumstances and will increase
the risk of breast cancer.
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Coronary Angiography and Intervention—47 Patients
The high proportion of coronary procedures (47 cases) in our database
reflects the high number of annually performed cardiologic interventions
compared with other procedures
[1] (
700,000 coronary
procedures vs. 30,000 other procedures). Three patients underwent only
diagnostic coronary angiography. The remaining 44 had additional percutaneous
transluminal angioplasty, 11 had stent placements, and two had mechanical
thrombolysis. Some patients had several procedures performed on separate days.
Thirty-six patients showed signs of early skin reactions that include an
erythematous reaction, dry and moist skin desquamation, and ulceration. Even
more reports mentioned late skin changes, including chronic ulcers. Twelve
patients required a skin graft (Table
2).
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The mean age of injured patients undergoing coronary procedures was 60.1 years, and 89% were men. Radiation use in two large series of patients—1503 and 992 patients—who underwent coronary angiography and interventions was studied by Pattee et al. [31] and Cusma et al. [32], respectively (Table 2). The mean ages in their groups were 56.0 and 64.6 years, with a male distribution of 77.5% and 64.3%, respectively. The male predominance reflects the sex distribution of coronary artery disease. The reason for the higher number of male patients in our group is unknown; there is no known male predilection for radiation injuries [33]. Potential explanations include a larger body habitus or more advanced disease in men.
Pattee et al. [31] and Cusma et al. [32] found mean fluoroscopic times of 5.4 and 4.5 min, respectively (Table 2), and mean cine times of approximately 1 min for diagnostic coronary angiographic procedures. The fluoroscopy time for angioplasty is much longer and reportedly averages about 20 min. We found significantly longer fluoroscopic times in injured patients, up to 172 min for a single procedure. The average time was about 1 hr (12 patients). These procedures sometimes involved more than one lesion. One patient had a single angiogram that lasted 34 min. All patients had late skin damage. For the case requiring the longest time (172 min), two stenotic areas of the same artery were treated by atherectomy, percutaneous transluminal coronary angioplasty, and stent placement. The number of cine frames in this patient is unknown but is thought to be between 4000 and 6000. After a prolonged erythema, a nonhealing skin ulceration developed in the region of the right scapula, possibly as a result of biopsy. The lesion required skin grafting (Fig. 2A,2B; and Table 1, patient 8). Long fluoroscopic times were also noted by Shope [6] (>120 min) and Poletti [9] (101 min) in patients who had skin damage after several procedures on the same day.
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Reasons for the prolonged interventions included three-vessel disease [16], dissection during coronary balloon dilatation [11, 13] (Table 1, patient 4), cardiac event [17], and a tortuous iliac artery and anomalous origin of the right coronary artery [14].
The absorbed dose rate to the skin for conventional fluoroscopy is typically 0.02-0.05 Gy/min. Cineradiography involves a dose rate that is roughly 10 times greater per imaging frame. For 30 frames per second, the typical rate is about 0.3-0.6 Gy/min [21]. However, quoting such data is hazardous because wide variations in these values occur, depending on patient size, imaging geometry (including angulation), frame rate, peak kilovoltage, and other factors. These variations are a major source of uncertainty in any retrospective dose assessment. Using a chest phantom, Cusma et al. [32] showed that the dose increases by 50% when the mean anteroposterior chest diameter is increased from 23 to 28 cm. Coronary angiography uses various projections, usually right or left anterior oblique, with different degrees of craniocaudal angulation to visualize the entire coronary system. Increasing angulation increases the length of the X-ray path through tissue and puts the skin closer to the X-ray source. Angulation of the beam from 40° left anterior oblique to 40° left anterior oblique with 30° of cranial angulation multiplies the dose rate by a factor of 4 [32]. The actual increase depends on how the equipment maintains image brightness and will vary for different fluoroscopes. About 83% of injuries occurred with the beam in a steeply angled orientation (Table 3 and Fig. 2A,2B).
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Pattee et al. [31] and Cusma et al [32] estimated the mean skin dose from a percutaneous transluminal coronary angioplasty at 1.24 and 3.7 Gy, respectively (Table 2). Neither estimate is corrected for changes in irradiated skin site caused by different beam angles during the procedure, and both may overestimate the real dose. A recent study by Hwang et al. [34] determined a mean skin dose of 1.02 Gy for a percutaneous transluminal coronary angioplasty (Table 2). The dose was measured with a skin dosimeter, the position of which could be verified on the fluoroscopic image. The radiation dose for a single stent placement ranged between 1.53 [34] and 3.76 Gy [32]. In our review of injured patients, skin dose was retrospectively estimated in 11 of the 47 patients. The cumulative dose ranged from 10.0 to 38.4 Gy in these patients (Table 2), 10 of whom had two or more procedures. Four of these patients required a skin graft. The estimated doses in these patients are much higher than the mean doses reported for average procedures.
Cardiac Radiofrequency Catheter Ablation—12 Patients
Approximately 22,000 cardiac radiofrequency catheter ablation procedures
were performed in 1996 for the treatment of supraventricular and selected
ventricular tachyarrhythmia
[1]. The high success rate and
low incidence of significant complications has made this a widely used and
safe procedure [18,
35]. Fluoroscopy is used to
localize the position of the intracardiac catheter.
Twelve cases of radiation-induced skin injury after radiofrequency ablation were reviewed. Patients' ages ranged between 7 and 50 years; three were younger than 18 years (7, 12, and 17 years). Only one patient needed a second procedure after an interval of 11 months.
Fluoroscopic times varied between 45 and 190 min, the latter resulting from a technically difficult case [19]. These times are at the longer end of the range of 46.5 ± 31 min found by Park et al. [35] in a series of 500 patients undergoing cardiac ablation procedures.
Early skin changes included erythema, blister formation, skin desquamation, and acute ulceration. Late changes consisted of hypo- and hyperpigmentation, telangiectasia, skin induration, recurrent erosions, severe ulceration, and scarring. The affected skin areas were on the back or the right arm. Radiation doses were estimated in three patients to range from 11 to 20 Gy, which is more than 10 times the mean radiation exposure of 0.93 ± 0.62 Gy in the series of Park et al. [35]. Reasons for the high doses and long fluoroscopy times were a difficult procedure [19, 20], unfavorable positioning of the patient's arm [20, 21], and faulty equipment [18].
Wagner and Archer [21] describe a severe radiation injury to a patient's arm. The dose delivered to the arm was probably more than 25 Gy during only 20-25 min of fluoroscopy to that specific skin area. The arm was positioned in the primary X-ray beam close to the X-ray port. The patient subsequently developed deep skin ulceration above the elbow joint [21, 29]. The humerus was exposed after about 5 months. Vañó et al. [20] described a similar, but less severe, injury to the arm of a 7-year-old girl from similar circumstances.
TIPS Placement—Seven Patients
We reviewed seven cases of radiation skin injury after TIPS placement. The
patients were all men between 42 and 61 years old. Because of incomplete or
unsuccessful initial attempts, four patients had two or more procedures.
Procedure times were given in five patients and varied between 4 hr 20 min and
6 hr 30 min for a single procedure. Two patients who underwent three TIPS
procedures had total procedure times between 12 hr 15 min and 16 hr.
Total fluoroscopic times are uncertain. Saxon and Lakin [36] mention that an uncomplicated procedure usually can be completed in approximately 90 min of procedure time, which suggests that the procedures resulting in injury were difficult and prolonged, requiring more fluoroscopy than usual.
Patients had skin reactions ranging from acute erythema with discoloration immediately after hospital discharge to skin ulceration after several months. Four patients needed a skin graft. Three patients needed repeated skin grafts [24, 25] (Table 1, patient 12). Deep tissue ulceration was present for more than 4 years in one patient with a suspected hypersensitivity to radiation [25] and for about 1 year or longer in three others (Table 1, patients 8, 9, and 12). The lesions were located in the mid back or in right subscapular location, which corresponds to the use of the posteroanterior projection.
Neuroradiologic Embolization—Three Patients
Three cases of skin damage in patients ranging between 32 and 38 years old
have been reported after embolization procedures for arteriovenous
malformations. The arteriovenous malformations were located in the paraorbital
[26] and cerebral
[28] areas and at the level of
the lumbar vertebrae L3-L4
[27].
The interventions to treat the paraorbital and cerebral arteriovenous malformations resulted in temporary epilation of scalp hair in the occipital and temporal regions. The hair regrew after 2-3 months. Skin dose in one case was estimated to be 6.6 Gy [26]. The dose to the patient with the embolization of the lumbar arteriovenous malformation was about 25 Gy over the course of 4 months. The epidermis sloughed about 4 weeks after the last procedure. The wound healed with conservative treatment during the following weeks, but a residual dyspigmented scar remained [27].
Norbash et al. [37] reported that in a series of 87 patients who underwent interventional neuroradiologic procedures, nine (10%) experienced temporary or long-term epilation. Epilation after neuroradiologic procedures is probably not an uncommon finding, but it should initiate a review of radiation management practices.
Other Interventions
Skin injuries related to other interventional procedures in the abdomen and
chest were reported to the Food and Drug Administration between January 1992
and October 1995 [6]. These
injuries include three cases of multiple hepatic and biliary interventions
(e.g., angioplasty, stent placement, and biopsy), percutaneous cholangiography
followed by multiple embolization procedures (one case), renal angioplasty
(two cases), and catheter placement for chemotherapy (one case). A case of
renal and biliary angioplasty resulted in skin damage severe enough to
necessitate skin grafting. Details regarding the other cases were not
published. A case of skin necrosis after two renal angioplasties was recently
described by Dandurand et al.
[13].
Technical Factors for Controlling Dose and Skin Damage
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TopIntroductionCase ReportsTechnical Factors for...ConclusionsReferences |
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Use of dose-saving variable pulsed fluoroscopy is of significant benefit in reducing the dose rate to the skin [40,41,42,43]. This technology reduces effective beam on-time by pulsing the beam many times a second at a frequency suitable for the study. For example, by using pulses that are on only half the time, dose rate on some units decreases by a factor of two. Varying the frequency to lower pulse rates results in lower dose rates to the skin. Actual dose abatement depends on the equipment, and some machines do not reduce the dose at all or may even increase it. A medical physicist can verify the actual behavior.
Irradiation Through Thick Masses of Tissue
Fluoroscopically guided interventional procedures use low-energy X-ray
radiation that is rapidly attenuated as the beam penetrates tissue, resulting
in absorption that is most intense at the surface where the beam enters the
patient. The dose decreases by a factor of about 2 for every 45-50 mm of
soft-tissue depth [44]. For
this reason, the radiation absorbed dose is greatest in the dermal and
epidermal tissues of the skin at the entrance beam site. Because of the low
penetrability of these X-rays, much greater entrance skin dose rates are
required in large patients or for steeply angled beam orientations. As a
result, many injuries are associated with large patients and steep beam angles
through thick body parts (Figs.
1,2A,2B,3).
A quantitative assessment of the relationship of patient weight to cases of
injury was not possible because of lack of data. In one particularly severe
injury, the patient weighed 160 kg (Fig.
3 and Table 1, patient 11). The photographs in our review suggest that overweight or heavyset
individuals are common among injured patients. In addition to the
recommendations in the previous paragraphs, standard procedures, such as
assuring that the image intensifier is kept close to the patient and the X-ray
source as far away as possible, become much more important for minimizing dose
rate [21].
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The separator cone is a mechanical safety device that prevents skin from approaching too close to the X-ray source by forcing a minimum distance between the source and the surface of the exit-beam port. This separator device can be removed, and often is, because it interferes with the mechanical rotation of the X-ray unit. For some units the devices are not easily removed and replaced. Some other X-ray units have nonremovable separator devices. The separator cone, when used properly, plays an important role in assisting with skin dose management.
Skin dose rate is usually reduced when the beam energy is increased. Some machines use a heavy beam filter (e.g., 0.2 mm of copper) to harden the beam and to reduce the entrance skin dose rate [37, 45, 46]. Such a filter typically has a minimal effect on image quality, often even improving quality. Such filtration is highly recommended if patients are large or steep beam angles are frequently used. Alternatively, increasing the fluoroscopic peak kilovoltage in some procedures will decrease the dose to the patient but may result in a loss in image contrast that may or may not be acceptable for the proper completion of the procedure [40, 46, 47].
Scatter-Removing Grid
The scatter-removing grid improves image quality by removing scattered
X-rays from the image. The reduced scatter causes a loss in image brightness.
To compensate, X-ray output is increased, which increases dose. During
procedures in which a large air gap exists between the patient and the image
intensifier, the grid is unnecessary because the air gap permits a good
portion of the scattered X-rays to escape before interacting in the image
receptor. Soderman et al. [46]
showed that removing the grid during neuroradiologic interventional procedures
can reduce dose to the patient by about 34%. Removing the grid for other
procedures, such as pain management, that use large air gaps between the
patient and the image intensifier might also be possible to reduce the dose to
the skin.
Field of View
Another factor contributing to the severity of a radiation wound is the
size of the radiation field. Large lesions are clinically less well tolerated
[48]. If the dose is
sufficiently great to totally deplete basal cells in the irradiated area,
healing of a skin defect (e.g., moist desquamation) occurs mainly from the
edges of the lesion. Regeneration will then be relatively ineffective and
prolonged, exposing tissues to the risk of secondary ulceration
[49].
Collimators are devices that can be manually adjusted to reduce the field of view of the X-ray exposure. Collimation is recommended for the following reasons: it reduces the patient's stochastic risk of induced cancer by reducing the volume of tissue exposed; it reduces scatter radiation in the room; the smaller field allows better recovery of injured tissue; and it can reduce the accumulated dose to the skin by eliminating the overlap of fields when different beam angles are used. An example of how overlapping fields contribute to skin injury is shown in Figure 4A,4B, in which secondary ulceration is present at the overlap of the fields from two angioplasty procedures. However, the more narrow the collimated field is, the higher is the dose to the remaining irradiated skin [21, 40]. The higher dose occurs because narrow collimation also reduces scatter to the image, which results in reduced image brightness. To compensate, the machine typically increases dose rate. If the field is collimated to block part of the area that is used to control image brightness, the system will think that image brightness is decreasing and will also increase dose rate.
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Field of view can also be adjusted using electronic or geometric magnification [21]. With geometric magnification, an air gap exists between the patient and the image intensifier, which increases the entrance dose to the skin according to the inverse-square law. How dose rate changes under electronic magnification depends on machine design and operation, but typically it increases as magnification increases.
Several authors identified the extensive use of a high-magnification mode as an important factor leading to high radiation doses [5, 7, 9, 15, 18, 23]. Under these circumstances, many fluoroscopes operate at very high output. Patient 9 in Table 1 is an example of an injury in which the highest magnification mode (4.5-inch [11.43-cm] field size) was used during the procedure (Fig. 5). Fluoroscopy on-time was 100 min, with probably 2000-3000 cine frames. The radiation dose was estimated as 13-22 Gy.
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High-Skin-Dose Modes of Operation
Several reports (e.g., see
[5,
7,
15] and
Fig. 5) have cited the
extensive use of imaging modes that produce high dose rates or high
resolution. Dose rates to the skin are typically much greater when high
magnification is used. Cineangiocardiography, digital fluorography,
high-dose-rate fluoroscopy, and high-magnification modes must be used
sparingly and judiciously
[21].
Extraneous Body Parts in the Beam
Injuries to the arms and breasts occurred in several cases. Keeping the
patient's arms out of the field of view is essential because doses are
increased by the machine to penetrate the extra tissue. Dose accumulation can
be rapid in these tissues if they are located on the port side of the X-ray
system. Appropriate arm rests and a conscientious effort to avoid direct
irradiation of a woman's breasts are also important elements of good patient
care.
Real-Time Dose Monitoring
No dose monitoring was reported for any of the reviewed cases. Real-time
dose monitoring is not available on many fluoroscopic machines. Installing
real-time dose monitoring equipment has many advantages. Dose is a far more
relevant indicator of risk than fluoroscopy on-time, and monitoring it
eliminates the need to monitor fluoroscopy time. Furthermore, a dose monitor
keeps track of doses from fluorography and cine as well as from fluoroscopy,
whereas fluoroscopy on-time ignores these other factors. Knowing the skin
dose, or at least an approximation of it, will assist physicians in the
benefit-risk decisions concerning potential alternative actions when dose
accumulation becomes a concern. Knowing the rate of dose accumulation can be a
warning to take action to lessen the dose rate early in the procedure. Dose
rate monitors will also catch the X-ray output malfunctions that occasionally
occur and result in injury to patients
[3,
18]. Although this capability
will be available on future equipment, retrospectively fitting such devices on
established equipment is recommended
[38].
Dosimeters that allow real-time dose measurement are preferred over postprocedure readout dosimeters. Various dosimeter systems are reviewed in articles by Geise and O'Dea [50], Hwang et al. [34], Cusma et al. [32], and Wagner and Pollock [51]. Protocols for each procedure should be developed that define a certain dose (e.g., 1-3 Gy) as a threshold dose at which some action is taken. For example, beam angulation could be changed to avoid irradiation of the same skin area for a prolonged time [38, 39].
Quality Control
The value of a good quality control program in managing radiation use has
been discussed by many authors
[39,
52,53,54].
Such programs not only assure that dose rates are appropriate, they also help
the physician to minimize procedure time by assuring high standards of image
quality.
Training in Fluoroscopic Technique
Many physicians from a wide variety of specialities are becoming involved
in interventional work. Most specialties provide little or no training in the
biologic effects and appropriate and inappropriate applications of radiation
[38,
39,
55]. Wagner et al.
[40] have shown how easy it is
to increase the skin dose to patients by deviating slightly from standard
methods of skin dose management. In their example of a 90-min beam-on time, a
difference of 8 Gy between standard and nonstandard techniques was shown. Even
greater differences can be achieved. Training of physicians in the proper use
of fluoroscopic technique should be required
[38,
39,
55].
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TopIntroductionCase ReportsTechnical Factors for...ConclusionsReferences |
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This second part of our series indicates that multiple technical factors contribute to circumstances that result in radiation injury to patients from fluoroscopy and accompanying fluorography. Foremost on the list are long fluoroscopy times through thick body parts and no radiation dose monitoring. Appropriate training in the safe and efficient completion of a procedure is essential. Physicians should seek the assistance of more experienced interventionalists before attempting a difficult procedure beyond their own experience.
Other contributing factors include unnecessary direct irradiation of certain body parts such as arms and breasts and the overuse of high-dose-rate modes of operation. We reviewed recommendations to improve patient care that include avoiding long durations of fluoroscopy over the same skin area, especially through thick body masses; appropriately using dose-reducing pulsed fluoroscopy or other low-dose-rate modes of operation; using heavy beam filtration; removing the grid when appropriate; establishing action thresholds for long procedures; removing breasts and arms from the entrance beam; measuring doses delivered to patients; and training personnel in the low-dose technical application of radiation. A good quality control program and proper use of the separator device, collimation, and field of view will also contribute to an appropriately low skin dose.
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TopIntroductionCase ReportsTechnical Factors for...ConclusionsReferences |
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