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Radiation-induced Skin

Injuries from Fluoroscopy1


Thomas B. Shope, PhD

Since 1992, the U.S. Food and Drug Administration (FDA) has received reports
of radiation-induced injuries to the skin in patients who had undergone fluoro-
scopically guided interventionab procedures. The reports were investigated to
determine the procedure- or equipment-related factors that may have contrib-
uted to the injury. The injuries ranged in severity from erythema to moist
desquamation to tissue necrosis that required skin grafting. They occurred af-
ter a variety of interventionab procedures that required extended periods of
fluoroscopy compared with those of typical diagnostic procedures. Medical fa-
cilities and physicians should be aware of the magnitude of radiation doses to
the skin that can result from the bong exposure times required by complex
interventional procedures. The FDA recommends several steps for reducing
these injuries, incbuding establishing protocols for each procedure, determin-
ing radiation dose rates for specifIc fluoroscopy systems and operating modes,
and monitoring cumulative absorbed doses to areas of the skin.

U INTRODUCTION
Fluoroscopically guided interventional procedures arc often the only available treat-
ment, or the treatment of choice, for serious, life-threatening conditions. These proce-
dures are being performed with increasing frequency, as shown by the example in Fig-
ure 1 The
. introduction of an array of new devices to facilitate the intervcntional treat-
mcnt of a variety of vascular and other conditions has contributed to the increase in the
frequency of interventional procedures. However, many fluoroscopically guided inter-
ventional procedures require extended periods of radiation exposure compared with
the exposure times typically associated with diagnostic procedures. Serious radiation-
induced skin injuries resulting from fluoroscopicalby guided interventional procedures
have recently been reported (2,3).
In 1992 and 1993, the staff of the Center for Devices and Radiological Health of the
U.S. Food and Drug Administration (FDA) received a number ofanecdotal, unvcrifiable
reports of possible radiation injury to patients that resulted from the use of x-ray sys-
tems. In early 1 994, new information permitted verification of the nature of and cir-
cumstanccs surrounding some of these injuries. This information became available pri-
manly because of the mandatory reporting requirements imposed on manufacturers
and users of medical devices under the Safe Medical Devices Act of 1990 (4,5). As a re-

Abbreviations: I)SA digital subtraction angiography. FI)A = Food and 1)rug Administration. RF = radio frequency

Index terms: Fluoroscopy #{149}


Interventional procedures. complications. 40.458 Radiations,
#{149} injurious effects. 40.47
Skin, effects of irradiation on, 40.47

RadloGraphics 1996; 16: 1 195- 1 199

I From the Office of Science and Technology. Center for 1)eviccs and Radiological Health (HFZ140). Food and 1)rug Ad.
nunistration, I 22() Twinhrook Pkwy. Rockville. MD 2085. Recipient of a Cum 1.aude award for a scientific exhibit at
the 1995 RSNA scientific assembly. Received February 1 i. 1996; revision requested April 4 and received April 26: ac-
cepted May 8. Address reprint requests to the author.

. RSNA, 1996

See also the article by Rabin et al (pp 105S- l02) in this issue.

1195
Table 1
Examples of Skin Injuries from Fluoroscopy

Patient/
Age (y)/ Fluoroscopic
Sex Procedure Injury Exposure Time

1/40/M Coronary angiography and PTCA* Skin necrosis that required Unknown (estimated to cx-
followed by repeat coronary 12 x 10-cm graft ceed 120 mm)
angiography
2/NAt/F RF cardiac catheter ablation 7.5 x 12.5-cm second-degree Unknown
burn
3/25/F RE cardiac catheter ablation Skin breakdown 3 wk after Unknown (procedure time,
procedure 325 mm)
4/34/F 1ff cardiac catheter ablation Draining skin lesion on back Unknown (procedure time,
5 wk after procedure 190 mm)
5/62/F Balloon dilation of bile duct Bumbike injury on back that Unknown
anastomosis required skin graft
6/61/F Renal angioplasty Skin necrosis that required Unknown (procedure time,
graft 165 mm)
* PTCA = percutaneous transluminal coronary angioplasty.
t NA = not available.

suit of these requirements, the FDA began to re-


18 Thousanl
ceive formal reports of radiation-induced inju-
16
ries during fluoroscopy, which we investigated
14 ..

further. 12
The purpose of this article is to alert readers 10 . . :

to this potential complication; describe the re- 8 :


sults of our investigation, including the nature 6
of the injuries and the circumstances surround- 4 .

ing their occurrence; and suggest means of re- 2 0.45


ducing such injuries. 1989 1990 1991 1992 1993
Figure 1. Estimated number of radio-frequency
. INVESTIGATION (RE) cardiac catheter ablation procedures performed
All reports of radiation injury resulting from annually, according to a survey of 1 57 electrophysi-
fluoroscopy that have come to the attention of ology laboratories (1).
the FDA have been investigated. The reports,
usually received through the manufacturer of
the x-ray system, contain minimal information have come to the attention of the FDA repre-
regarding the circumstances of the injury. The sent an unknown fraction of the total number
investigation was conducted by means of tele- of radiation-induced injuries resulting from fluo-
phone calls, betters, and personal visits to the fa- roscopically guided procedures.
cilities or individuals involved. Provision of ad- The types of interventionab procedures that
ditional information to the FDA was voluntary, resulted in reports of skin injuries were as fob-
and most of the facilities contacted declined to bows: RF cardiac catheter ablation, n = 1 2; cath-
provide additional information owing to con- eter placement for chemotherapy, n = 1 ; trans-
cerns about liability or confidentiality. jugular intrahepatic portosystcmic shunt place-
The reports discussed in this article were re- ment, n = 3; coronary angioplasty, n = 4; renal
ceived by the FDA between January 1992 and angioplasty, n = 2; multiple hepatic or biliary
October 1995, although some injuries occurred procedures (eg, angioplasty, stent placement,
before 1992. It is probable that the injuries that biopsy), n = 3; and percutaneous cholangiogra-
phy followed by multiple embobization proce-
dures, n = 1 . The injuries ranged from erythema

1196 U Imaging & Therapeutic Technology Volume 16 Number 5


Table 2
Estimated Total Skin Exposure in 0 ne Patient from a Series of Biliary Procedures

Estimated Skin Total Estimated


Fluoroscopic Exposure from No. of Skin Exposure
Exposure Fluoroscopy DSAt from DSA
Procedure Time(min) (mC/kg R)* Frames (mC/kg R)*

Percutaneous cholangiography 21 47 (184) 16 1 (2)


Mesenteric angiography and multiple
embolization procedures 187 396 (1,536) 325 67 (258)
Hepatic embolization procedures 58 108 (419) 149 23 (90)

Total1 266 551 (2,139) 490 91 (350)

Note-Procedures were performed during a 4-week period. Estimates are ofentrance skin exposure and
do not include backscatter.
* Numbers in parentheses represent values in roentgens.
t DSA = digital subtraction angiography.
t Two different fluoroscopy systems were used owing to equipment failure, and multiple dose rates (magni-
fication modes) were used.
I Total exposure may not have been to a single area of skin owing to movement of the x-ray beam. The loca-
tion of the beam was not monitored during various procedures.

in a few cases to moist desquamation in others exposure times, number of DSA frames, expo-
and to skin necrosis that required skin grafting sure rates during fluoroscopy and exposure per
in the most serious cases. frame during DSA, patient thickness, and sys-
Details of a sample of the cases are pre- tcm geometry; these data were recorded by the
scnted in Table 1 . These cases were selected to facility under a program instituted to monitor
illustrate the range of procedures and the sever- patient exposure.
ity of the injuries reported. In the majority of The total skin exposure given in Table 2 of
cases, the information necessary to estimate the 642 mC/kg (2,489 R) was not localized to a spe-
absorbed dose to the skin could not be oh- cHic area of skin; the location and size of the ir-
tamed, either because no records were main- radiated area varied with the procedure and
tamed of the fluoroscopic exposure time and projection. The x-ray field sizes and entrance
other factors related to technique or because field locations were not monitored during the
the facility was unwilling to share additional in- procedures. However, most of the radiation
formation owing to ongoing legal action or con- would have been delivered to the lower right
cerns about liability or adverse publicity. area of the back, with a significant probability
Table 2 presents an example of the magni- of overlapping of fields. Thus, the total expo-
tude of the skin exposures that can result from sure in Table 2 is an upper limit for the cxpo-
a complex case involving multiple diagnostic sure to any specffic area of skin and provides an
and therapeutic procedures. During a 4-week indication that the potential for skin injury was
period, the patient required multiple hepatic significant in this case. In addition, the effect of
and biliary procedures, including percutaneous dose fractionation (due to the dose being dcliv-
cholangiography, mcsenteric angiography, and ercd over a 4-week period) further complicates
multiple embolization procedures. The patient estimation of the expected severity of the in-
received an unknown amount of exposure from jury. Whether skin injury resulted from this se-
procedures performed before arrival at the ter- ries of procedures is unknown because the pa-
tiary care facility. The estimates of skin expo- tient died 2 days after the last procedure.
sure were made by staff of the facility from data
on system technique factors, total fluoroscopic

September 1996 Shope U RadioGraphics U 1197


Figure 2. (a) Photograph of the
patients back 6-8 weeks after mul-

tiple coronary angiography and


angioplasty procedures. (b) Photo-
graph of the injury approximately
16-21 weeks after the procedures.
A small ulcerated area is present. S
(c) Photograph of the injury ap-
proximately 18-21 months after
the procedures. Tissue necrosis is
evident. (d) Close-up photograph
of the lesion shown in c. (e) Photo-
graph of the patients back after
., ii.
skin grafting.

e.

. EXAMPLE OF INJURY with the appearance of a healed burn, except for


An example of a skin injury attributable to x rays a small ulcerated area near the center. Skin
from fluoroscopy is shown in Figure 2. It oc- breakdown with progressive necrosis continued
curred in a 40-year-old man (patient 1 in Table 1) over the following months (Fig 2c, 2d). The in-
who underwent coronary angiography, coronary jury eventually required a skin graft (Fig 2e). The
angioplasty, a second angiography procedure magnitude of the skin dose received by this pa-
(owing to complications), and placement of a tient is not known. However, from the nature of
coronary artery bypass graft, all on March 29, the injury, it is probable that the dose exceeded
1990. Figure 2a shows the area of injury 6-8 20 Gy (2,000 rad) (6).
weeks after the procedures. The injury was de-
scribed as turning red about one month after . FDA RECOMMENDATIONS TO RE-
the procedure and peeling a week later. In the DUCE RADIATION-INDUCED SKIN IN-
middle of May 1990, it had the appearance of a JURIES
second-degree burn. Figure 2b shows the condi- Review of the circumstances of many of the in-
tion in late summer 1990 (exact date unknown), juries revealed a lack of appreciation by the
physicians performing these procedures, prior
to observing the injury, of the magnitude of the

1198 U Imaging & Therapeutic Technology Volume 16 Number 5


skin doses that can result from the bong expo- patients record or sufficient data to permit esti-
sure times that may be required by complex mation of the absorbed dose to those areas of
interventional procedures. This observation bed skin.
the FDA to issue a public health advisory on
September 30, 1994, to alert the radiologic U CONCLUSIONS
community to this concern and to suggest ac- Serious skin injuries can occur as a result of
tions that should be taken to reduce the poten- interventionab procedures involving extended
tial for radiation-induced skin injuries (2). These fluoroscopic exposure times. Facilities and phy-
actions included establishing standard procc- sicians performing interventional procedures
dures and protocols for each procedure, includ- should monitor patient doses delivered during
ing consideration of fluoroscopic exposure these procedures and implement measures to
time; determining the radiation dose rates for reduce the potential for radiation-induced skin
specific fluoroscopy systems and for all operat- injuries.
ing modes; assessing each protocol for the po-
tentiab for radiation injury to the patient; modi- . REFERENCES
fying protocols, when appropriate, to minimize 1. Scheinman MM. NASPE survey on catheter ab-
cumulative absorbed dose to any specific skin lation. Pacing Clin Electrophysiob 1995; 18:
area and using equipment that aids in minimiz- 1474-1478.
2. Food and Drug Administration. Public health
ing absorbed dose; and recording information
advisory: avoidance of serious x-ray-induced
in the patients record that will permit estima-
skin injuries to patients during fluoroscopically-
tion of the absorbed dose to the skin from
guided procedures. Rockville, Md: Center for
interventional procedures. Devices and Radiological Health, Food and Drug
In a September 15, 1995, follow-up to the Administration, September 30, 1994.
last suggestion, the FDA recommended that the 3. Huda W, Peters KR. Radiation-induced tempo-
facility record in the patients record informa- rary epibation after a neuroradiologically guided
tion about the absorbed dose to the skin for any embolization procedure. Radiology 1994; 193:
procedure with the potential for a skin dose ap- 642-644.
proaching or exceeding some threshold dose 4. The Safe Medical Devices Act of 1990. Pub L No.
for injury (7). This threshold dose for the re- 101-629, 21 USC 360i.
5. Federal Register, November 26, 1991; 56:
cording of data should be established by the fa-
60024-60039.
cility. The FDA suggests a threshold absorbed
6. Wagner LK, Eifel PJ, Geise RA. Potential bio-
dose in skin of 1 Gy (100 rad). The following
logical effects following high x-ray dose
procedures are likely to meet this criterion ow- interventional procedures. JVIR 1994; 5:71-84.
ing to their potential for long exposure times: 7. Food and Drug Administration. Important in-
RF cardiac catheter ablation, vascular emboliza- formation for physicians and other healthcare
tion, transjugular intrahepatic portosystemic professionals: recording information in the
shunt placement, and percutaneous endovas- patients medical record that identifies the po-
cular reconstruction. tential for serious x-ray-induced skin injuries fol-
The FDA suggests recording the following in- lowing fluoroscopically guided procedures.
Rockvibbe, Md: Center for Devices and Radiologi-
formation in the patients record: (a) which ar-
cal Health, Food and Drug Administration, Sep-
cas of the patients skin received an absorbed
tember 15, 1995.
dose that may approach or exceed the selected
threshold and (b) the estimated cumulative ab-
sorbed dose to each irradiated area noted in the

September 1996 Shope U RadioGraphics U 1199