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Patient Radiation Dose Associated with Uterine Artery Embolization¹

¹ From the Departments of Radiology (B.N., J.B.S., S.A.) and Radiation Oncology and Radiotherapy (M.J.L.), Georgetown University Hospital, 3800 Reservoir Rd, NW, Washington, DC 20007. From the 1998 RSNA scientific assembly. Received October 16, 1998; revision requested December 29; final revision received April 15, 1999; accepted July 27. Address reprint requests to B.N. (e-mail: Nikolic@medlib.georgetown.edu).

	Abstract

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
PURPOSE: To evaluate the estimated absorbed radiation doses to the ovaries and skin entrance during uterine artery embolization (UAE) for leiomyomas.

MATERIALS AND METHODS: Radiation dose was measured in 20 patients who underwent UAE for leiomyomas. Measurements were obtained by placing lithium fluoride dosimeters both into the posterior fornix of the vagina and on the skin at the beam entrance site. Patient doses were obtained with thermoluminescent dosimeters.

RESULTS: The mean fluoroscopic time was 21.89 minutes, and the mean number of angiographic exposures was 44. The mean estimated absorbed ovarian dose was 22.34 cGy, and the mean absorbed skin dose was 162.32 cGy. These values compare to published values for the assessed absorbed ovarian dose during hysterosalpingography (0.04–0.55 cGy), fallopian tube recanalization (0.2–2.75 cGy), computed tomography of the trunk (0.1–1.9 cGy), and pelvic irradiation for Hodgkin disease (263–3,500 cGy).

CONCLUSION: The estimated absorbed ovarian dose during UAE is greater than that during common fluoroscopic procedures. On the basis of the known risks of pelvic irradiation for Hodgkin disease, the dose associated with UAE is unlikely to result in acute or long-term radiation injury to the patient or to a measurable increase in the genetic risk to the patient's future children.

Index terms: Interventional procedures, technology, 854.1264, 989.1264 • Ovary, 852.47 • Radiations, exposure to patients and personnel, 852.47, 854.47 • Radiations, injurious effects, 852.47, 854.47 • Uterine neoplasms, therapy, 854.1264

	Introduction

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
A new minimally invasive procedure, uterine artery embolization (UAE), has been reported on recently (1–4) as a therapy for uterine fibroids (leiomyomata). The preliminary reports have been promising. With this new technique, menorrhagia has been controlled in approximately 85% of symptomatic patients and bulk-related symptoms of pelvic pressure and bladder compression have been controlled in approximately 90% (1,2).

Although there have been few complications associated with UAE to date, there is as yet limited experience with the procedure, and, to our knowledge, no study has assessed the radiation exposure to the patient that occurs during the procedure.

Radiation injuries are typically divided into two types of effects, deterministic and stochastic (5). Deterministic effects are those associated with a minimum threshold dose below which the effect is not seen. Examples of deterministic effects are early transient erythema, temporary epilation (hair loss), and cataracts. Stochastic effects are those for which, in theory, there is no threshold dose, and these include cancer and genetic damage. Because UAE is performed in women of childbearing age, the potential for genetic injury is of particular interest.

We measured the average radiation dose to the skin and estimated the absorbed dose to the ovaries (hereafter referred to as "ovarian dose") in a group of patients who underwent UAE for fibroids. To determine the importance of these findings, we compared them with those from common diagnostic radiographic procedures in which the ovaries might be directly exposed. In addition, we compared our findings with the radiation dose associated with radiation therapy for pelvic Hodgkin disease. Finally, we calculated the potential effect of UAE on the genetically significant dose, which is an assessment of the genetic risk of a particular source of exposure on the population as a whole.

	MATERIALS AND METHODS

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
UAE for symptomatic uterine fibroids was begun at our institution in July 1997. To date, all patients have been treated under an institutional review board–approved protocol and have given informed consent for the UAE procedure and use of radiation detectors. As of July 1998, 33 patients have been treated. After the fifth patient, we modified our protocol to include the measurement of the radiation dose; thus, we began this study with our sixth patient. Five additional patients have been treated, but we were unable to measure the radiation dose in them because detectors were not available at the time of the procedure. These were the 11th, 18th, 21st, 22nd, and 26th patients (counted from the first patient treated). Thus, we have measured the radiation dose in 23 patients (mean age, 43.7 years; age range, 30–53 years). Three patients in whom vaginal and skin dose measurements were obtained were excluded from analysis because their mean vaginal radiation dose measurements were substantially lower than those in the average patient despite long fluoroscopic times and large exposure numbers. This was probably due to the temporary exclusion of the vaginal detectors from the x-ray beam field. In addition, large SDs were calculated with both the vaginal and skin detectors. We therefore analyzed the measurements obtained in a total of 20 patients. Body weight as a parameter influencing absorbed skin dose was not evaluated in any of the patients in whom the radiation dose was measured.

Thermoluminescent dosimeters (TLDs) were used to measure the absorbed radiation dose. These dosimeters were made of lithium fluoride (Harshaw, Solon, Ohio). Each dosimeter was calibrated for an 80-kVp beam, and a corresponding calibration factor was applied after absorbed ovarian and skin doses were measured. Fifteen TLDs were placed into the vagina, and 10 were placed on the skin. The TLDs were placed into plastic tubing carriers, with five TLDs placed into each carrier. The vaginal detectors were placed into the posterior fornix of the vagina. The skin detectors were placed under the middle region of the buttocks at approximately the lower tip of the sacrum. The relative position of the TLDs is illustrated in the Figure. The TLDs were positioned within the fluoroscopic and imaging fields at all times.

View larger version (173K): [in this window] [in a new window] [Download PPT slide]   Figure 1. Fluoroscopic image shows the position of vaginal (curved arrow) and skin (straight arrow) TLDs during a UAE procedure.

The dosimeters were read with a TLD reader (Harshaw). All procedures were performed with the same angiographic imaging system (Siemens, Erlangen, Germany) and a conventional (nonpulsed) fluoroscopic unit (Polydoros 100; Siemens) equipped with a Digitron 2 (Siemens) digital imaging system. At 81 kVp with fixed filtration, a half value layer of 3.1 mm of aluminum was measured. The use of fluoroscopy was minimized where possible, and the field was collimated to the central pelvis. Oblique projections and magnification were used only when necessary. Digital road mapping was frequently used to guide the placement of the catheters selectively into the uterine arteries. Digital subtraction angiography was the primary means of permanently recording the angiographic studies. Imaging was usually performed at a rate of one image per second. On occasion, a 100-mm camera was used to supplement the imaging.

The embolization procedures were performed by using standard techniques. In the first two patients in whom the radiation dose was measured, a unilateral puncture was used for embolization of first the left and then the right uterine artery with the same catheter. Access to the ipsilateral side was achieved by using a Waltman loop technique. All subsequent patients were treated by using bilateral femoral access and crossover catheters. Early in our experience—that is, in treating the first two patients—we performed angiography of each vessel separately before and after the embolization. In the remaining 18 patients, a final angiogram was obtained with simultaneous injection of contrast material into both femoral catheters. This effectively reduced the number of angiographic series by one. On occasion, repeat embolization was necessary, and an additional final angiogram was obtained on that side. An initial aortogram was not obtained in any of the patients in whom we measured the radiation dose.

All embolizations were performed by placing the catheter in the distal third of the uterine artery. Spasm occurred frequently, and when it limited blood flow, a coaxial microcatheter was used. The selective catheter used in most cases was a 5-F Glidecath (Boston Scientific/Medi-tech, Boston, Mass). If a microcatheter was necessary, a Tracker 0.325 Fast Track (Target Therapeutics/Boston Scientific, Boston, Mass) was used most commonly. Polyvinyl alcohol particles (500–700 µm) (Ivalon; Cook, Bloomington, Ind, Trufill; Cordis, Miami Lakes, Fla, or Contour; Target Therapeutics/Boston Scientific) were used in all cases. Embolization was terminated when all flow to the fibroids had ceased and slight antegrade flow was still present in the uterine artery.

The fluoroscopic times, number of exposures, and skin and vaginal radiation doses were recorded, and the mean values and SDs were computed for each. The genetically significant dose GSD was calculated with the following formula (6): GSD = (N_xy x P_xy x D_xy)/(N_x x P_x), where N_xy is the potential population for this procedure; P_xy, the number of expected children for each patient; D_xy, the mean ovarian dose; N_x, the number of women of childbearing age in the United States; and P_x, the average number of children of all women of childbearing age.

The following assumptions were used in the calculation. We estimated the potential population for this procedure N_xy to be one (10%) in 10 of all patients who undergo hysterectomy for fibroids in the United States in a year (17,500 patients assessed [7]). The number of expected children P_xy for each patient treated with UAE was 0.1. The number of women of childbearing age in the country N_x, according to official data from the 1990 consensus counts, was approximately 58,540 million, and the average number of children of all women of childbearing age P_x was estimated to be 1.22. The mean ovarian dose D_xy was calculated from the measurements we obtained from the 20 subsequent patients.

	RESULTS

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
The fluoroscopic time for the UAE procedures ranged from 8.9 to 52.5 minutes (mean, 21.89 minutes) and generally decreased with increasing number of treated patients (Table). The radiation dose rates for fluoroscopy ranged from 2.9 R/min (0.75 mC/kg/min) to 4.4 R/min (1.13 mC/kg/min), and the number of exposures ranged from 21 to 62 (mean, 44) (Table). Individual absorbed ovarian and skin doses were assessed by calculating the mean value of all vaginal and skin detector measurements for each patient (Table). The intraindividual consistency of measurements was evaluated by calculating the SD of the vaginal and skin dose measurements for each patient (Table). In three patients in whom vaginal and skin doses were measured, these measurements were inconsistent and the SD of the mean vaginal and skin measurements was exceptionally high. In addition, the vaginal dose measurements were substantially lower than those of the average patient, despite long fluoroscopic times and high exposure numbers. This was probably caused by the temporary exclusion of the vaginal detectors from the primary x-ray beam. These patients were therefore eliminated from analysis.

A dose equivalent of 0.23 mSv (23 mrem) was previously estimated for the genetically significant dose from medical diagnostic procedures, and the genetically significant dose from all sources—primarily cosmic radiation—was estimated to be 1.2 mSv (120 mrem) (6). The contribution from UAE procedures to the genetically significant dose from medical applications is therefore approximately 2.2%, and the contribution to the total genetically significant dose is close to 0.4%.

	DISCUSSION

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 
Before UAE can be accepted as an alternative to surgery in general practice, the radiation effects from this procedure should be carefully assessed. To date, we have noted no radiation effects in any of our patients. Given the doses to both the skin and the ovaries that we measured, however, it is possible that effects will occur in some patients who undergo particularly long or complicated procedures.

The absorbed ovarian dose was assessed by obtaining measurements from radiation detectors placed into the posterior vaginal fornix; this is an established approximation that has been performed previously (8). This location is as proximal to the ovaries as practically accessible in a patient undergoing a radiologic procedure, and the accuracy of the obtained measurements as a surrogate for the absorbed ovarian dose is as high as practically achievable. Nevertheless, three patients had to be excluded from the study. In these patients, the vaginal and skin dose measurements were inconsistent, and the vaginal doses were substantially lower than those in the average patient, despite relatively high exposure numbers and long fluoroscopic times. This can probably be explained by the temporary exclusion of the intravaginal dosimeters from the x-ray beam owing to collimation. We believe that for the remaining patients in whom radiation measurements were obtained, the vaginal detectors were permanently within the x-ray beam field and that one or both ovaries were always within the primary beam field during the entire UAE procedure. Partial exclusion of the detectors from the field might have occurred to a much lesser extent, however, even in these remaining patients, with the result being an underestimation of the absorbed ovarian dose. Although we believe that this potential underestimation is probably nonsubstantial, the validity of the measurements obtained from the vaginal detectors as a reflection of the absorbed ovarian dose is uncertain.

The best protocol for adequately evaluating the uterine arteries and monitoring the progress of embolization has yet to be established. Our study was performed early in our experience, and as our experience has grown, we have reduced the fluoroscopic time needed for this procedure. We have reduced our imaging rate to one image per second and further reduced the number of exposures by obtaining a completion angiogram in both uterine arteries simultaneously in most patients with bilateral femoral access. A further decrease would be possible by imaging the uterine arteries simultaneously at the initial study, with digital road map images for completion studies and, possibly, digital spot radiography or road mapping as the sole means of angiographic recording.

We recognize that our current angiographic equipment does not offer radiation reduction tools such as pulsed fluoroscopy and advanced imaging systems. In previous studies (9,10), the use of pulsed instead of nonpulsed fluoroscopy during diagnostic and interventional procedures reduced the radiation exposure in pediatric patients by 40%–50%. We also hope to refine imaging sequences to reduce the number of exposures. With the sum of these changes, we anticipate a substantial reduction in radiation dose. It should be noted, however, that the absorbed ovarian dose is not determined purely by using the fluoroscopic time and exposure numbers. It is also substantially influenced by each patient's individual ovarian location and body habitus. In one of our study patients (patient 16), for instance, the estimated absorbed ovarian dose was substantially higher than the average value despite below-average fluoroscopic time and exposure numbers.

We think that it is unlikely that any of our study patients had any skin changes as a result of this treatment. Deterministic skin effects have a threshold between 200 and 2,000 cGy, depending on the severity (5). Many authors (11,12) believe that transient erythema, the earliest radiation effect, is unlikely to occur with radiation doses of less than 400–500 cGy. Although our mean skin entrance dose was 162.32 cGy, the highest mean skin dose that we recorded was 303.89 cGy (in patient 16). Therefore, it is not difficult to envision a circumstance in which prolonged fluoroscopic and/or extensive angiographic imaging might result in an entrance dose in the 400–500 cGy range. Transient erythema is, by itself, a self-limited change, and more severe and chronic changes such as skin ulceration and permanent epilation are very unlikely.

The dose level that might cause alteration of ovarian function is not known, and there does not appear to be a clear dose threshold for ovarian failure. Ovarian failure is manifested by amenorrhea and premature menopausal symptoms and has been reported after pelvic irradiation for Hodgkin disease (13–17) and obstetric embolotherapy (18). It has been found that the same dose of radiation is more likely to cause ovarian failure in older (late 40s) patients than in younger (late 20s) patients (19). Temporary or permanent ovarian dysfunction has been observed in 53%–94% of patients who received an ovarian dose of 263–3,500 cGy during pelvic irradiation for Hodgkin disease (13,16,17). Niroomand-Rad and Cumberlin (6) used a phantom to simulate pelvic irradiation for Hodgkin disease and found the estimated gonadal dose to range from 80 to 100.2 cGy, depending on the beam energy. Ray et al (16), conversely, assumed a minimal ovarian dose of 263–660 cGy from the actual pelvic irradiation for Hodgkin disease in their patients. These latter numbers exceeded our approximated mean absorbed ovarian organ dose during UAE by a factor of at least 12–30. In our study, we encountered one patient (patient 5), aged 51 years, who had temporary cessation of menstruation for 3 months. The cause of her temporary amenorrhea is unknown, and she spontaneously resumed having normal menstrual periods, with resolution of her preprocedural menorrhagia.

The average dose estimated in our study (22.34 cGy) is substantially higher than that which has been assessed during hysterosalpingography and fallopian tube recanalization, procedures that are also performed in women of childbearing age (8,20–23). Hedgpeth et al (8) reported an average approximated absorbed ovarian dose of 0.85 cGy (range, 0.20–2.75 cGy) during fluoroscopically guided fallopian tube recanalization. Absorbed ovarian radiation doses of 0.04–0.55 cGy were estimated in various studies during hysterosalpingography (20–22). An average entrance skin dose of 1.33 cGy also has been reported with hysterosalpingography (20).

Lavoie and Don (24) reported an average ovarian dose of 0.65 cGy during a double-contrast barium enema study. In their series of 43 patients, measurements were obtained by fixing TLDs on top of the rectal tube. Other authors (25) have estimated the average ovarian dose during a barium enema study to be 0.79 cGy. Mini et al (26) estimated the absorbed radiation dose with computed tomography of the trunk by using an anthropomorphic phantom that contained TLDs. The dose to the ovaries was estimated to be less than 0.1–1.9 cGy, and the estimated dose to the skin was 2.2–3.6 cGy.

It thus appears that UAE results in ovarian and skin doses that are at least 30–100 times higher than those during conventional diagnostic radiographic examinations and 12–30 times lower than those during radiation therapy for Hodgkin disease of the pelvis. Although radiation therapy causes temporary ovarian dysfunction in many patients with Hodgkin disease, it does not appear to affect long-term fertility. Patients have had successful pregnancies without substantial increases in genetic defects compared with those that occur in the general population (13).

One way to evaluate the potential effect from a particular source of radiation exposure is to calculate the genetically significant dose, "the dose equivalent to the gonads weighted for the age and sex distribution in those members of the exposed population expected to have offspring" (27). In calculating the genetically significant dose, we used the number of hysterectomies performed annually in the United States due to fibroids as a reference. This is the only reliable reference value for the treatment of uterine fibroids in the United States that is currently available. We also believe that the indication for UAE will be mostly limited to those patients in whom less invasive surgical procedures (eg, myomectomy, myolysis, cryoablation and laser ablation, and medical and hormonal treatments) either have failed or cannot be performed and in whom hysterectomy would be the only treatment option. In this study, we assumed that 10% of the patients who were being treated for fibroids with hysterectomy would undergo UAE instead and that 10% of those patients would have a child in the future.

Currently, there are probably not more than 1,000 UAE procedures performed annually in the United States. On the basis of these numbers, the additional contribution to the genetically significant dose from UAE would be approximately 2.2% to diagnostic medical applications, and that to the total genetically significant dose would be close to 0.4%. By comparison, Niroomand-Rad and Cumberlin (6) reported a genetically significant dose of less than 0.01 mSv (1 mrem) with pelvic irradiation in patients with Hodgkin disease, which represents a contribution of approximately 4% to the genetically significant dose from medical procedures and of less than 1% to the genetically significant dose from all sources. In making this comparison, it is important to consider that pelvic irradiation for Hodgkin lymphoma is a frequently curative treatment for a malignancy, whereas UAE is a new optional therapy for a benign disease. Because UAE is at an investigative stage, it is especially important to limit radiation exposure during this procedure and to take all measures to minimize the radiation dose. These measures include minimizing the fluoroscopic time, magnification views, tube angulation, and angiographic imaging.

In conclusion, with proper technique, the radiation dose with UAE is not likely to result in radiation-induced skin effects or a substantial increase in the risk of genetic injury to the patient's future children. The temporary radiation effects on ovarian function, however, cannot be fully assessed at this point, and further investigation is necessary.

	Footnotes

 
Abbreviations: TLD = thermoluminescent dosimeter UAE = uterine artery embolization

Author contributions: Guarantors of integrity of entire study, B.N., J.B.S., M.J.L.; study concepts and design, J.B.S., B.N.; definition of intellectual content, J.B.S., B.N.; literature research, S.A., B.N., J.B.S.; clinical studies, J.B.S., B.N.; data acquisition, J.B.S., M.J.L., B.N.; data analysis, M.J.L., B.N.; manuscript preparation, B.N., S.A.; manuscript editing and review, B.N., J.B.S., S.A.

	References

TOP Abstract Introduction MATERIALS AND METHODS RESULTS DISCUSSION References

 

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This Article Abstract Figures Only Full Text (PDF) Erratum (v218,p920) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Nikolic, B. Articles by Abbara, S. Search for Related Content PubMed PubMed Citation Articles by Nikolic, B. Articles by Abbara, S.