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1 All authors: Department of Radiology, Saiseikai Shiga Hospital, Ohashi 2-4-1, Ritto, Shiga 520-3046, Japan.
Received March 27, 2003;
accepted after revision May 14, 2003.
Address correspondence to T. Katsumori.
Abstract
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MATERIALS AND METHODS. One hundred fifty-two consecutive women underwent embolization for uterine fibroids. Complications and outcomes were analyzed using questionnaires and serial MRI between women with one or more uterine fibroids of 10 cm or larger diameter (mean, 12.4 cm; range, 10–19 cm) (n = 47, group 1) and women with each uterine fibroid of less than 10 cm diameter (mean, 6.8 cm; range, 2–9.5 cm) (n = 105, group 2).
RESULTS. Thirty complications (19.7%, 30/152), which occurred in 27 women (17.8%, 27/152), were noted. However, 25 of 30 complications were minor, requiring no or nominal therapy. They occurred in 19.1% (9/47) of group 1 and in 15.2% (16/105) of group 2 women (p = 0.637). Major complications requiring major therapy, unplanned increased level of care, or unanticipated prolonged hospitalization (> 48 hr) or including permanent adverse sequelae were noted in 6.4% (3/47) of group 1 and in 1.9% (2/105) of group 2 women (p = 0.172). Of these five women, four underwent surgery because of sloughing fibroids. Permanent adverse sequelae were observed in one woman of group 1, who has had sexual dysfunction after embolization. No deaths occurred in either group. There was no significant difference in most outcomes or in intervals until the complete disappearance of postprocedural pain and full recovery between the two groups.
CONCLUSION. We found no increased risk to patients undergoing uterine artery embolization for fibroids on the basis of tumor size. Successful outcomes can be obtained for such lesions.
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Gynecologists diagnosed the tumors as uterine fibroids in all women. Before the procedure, it was confirmed that the findings of Pap smears were negative in all women and that the findings of endometrial biopsies were negative in women with abnormal uterine bleeding. All women underwent axial and sagittal MRI before uterine artery embolization. Of 152 women, 115 women underwent preprocedural MRI in our hospital, whereas the remaining 37 women underwent the examination in outside hospitals. One hundred eighteen women underwent unenhanced and contrast-enhanced MRI before the procedure. However, the remaining 34 women underwent only unenhanced MRI before the procedure. Axial and sagittal unenhanced and contrast-enhanced MRI was performed at 1 week, 4 months, and 1 year after the procedure in our hospital. One woman with asthma underwent only unenhanced MRI before and after embolization, and one woman underwent only unenhanced MRI 4 months after embolization. Preprocedural MRI showed that the tumors were uterine fibroids in all women. The volume of the largest tumor and the uterus was calculated using the formula of a prolate ellipse (length x depth x width x 0.5233). Two radiologists interpreted all MRIs by consensus.
All uterine artery embolization procedures were performed using a unilateral femoral approach as previously described [6, 10]. The embolic agent used was gelatin sponge particles (Spongel, Yamanouchi, Tokyo, Japan) of approximately 500–1,000 µm mixed in the saline, contrast medium (iopamidol, Iopamiro, Bracco, Milan, Italy), and antibiotics (1 g, cefazolin sodium, Cefamezin, Fujisawa, Osaka, Japan). The end point of embolization was near stasis in the ascending uterine artery.
The management of postprocedural cramping has been described [6, 10]. Briefly, it includes the following: In the first 30 patients, an intramuscular injection of morphine (2 mg, butorphanol tartrate, Stadol, Burisutoru Miyazu Sukuibu, Tokyo, Japan), an IV infusion of pentazocine (15 mg, Sosegon, Yamanouchi) and midazolam (1–2 mg, Dormicum, Yamanouchi), and diclofenac sodium (50 mg, Volmagen, Taisyouyakuhinkougyou, Shiga, Japan) were combined as necessary. In subsequent patients, we changed the protocol to an intramuscular and IV infusion of hydrochloride and diclofenac sodium (50 mg) as necessary. In all except one woman, naproxen was administered orally at a dose of 600–800 mg in three divided portions for 7–14 days. If abdominal pain could not be controlled after the first day, an oral administration of loxoprofen sodium (60 mg) and diclofenac sodium (50 mg) was used. Antibiotics (cefazolin sodium) were dripped IV at a dose of 2 mg in two divided portions for 2 days, and thereafter ofloxacin (Tarivid, Daiichiseiyaku, Tokyo, Japan) was administered orally at a daily dose of 200 mg in divided portions for the following 2 days.
The baseline clinical symptoms were assessed with an oral questionnaire before the procedure in all women. Each patient routinely had a hospital stay of 3–4 days, based on our protocol of postprocedural care. After discharge, each patient came to our hospital approximately 1 week, 4 months, and 1 year after the procedure, and we also contacted her directly and obtained the MRI assessment. After 1 year, if patients had some residual issues related to fibroids and the procedure, we contacted them as necessary. A written questionnaire was obtained at 4 months, 1 year, 2 years, and annually after uterine artery embolization.
In this study, we defined large tumors as being 10 cm or larger in diameter. The following factors were compared between women who had one or more uterine fibroids of 10 cm or larger in diameter (group 1) (Fig. 1A, 1B) and women with each uterine fibroid of less than 10 cm in diameter (group 2) (Fig. 2A, 2B): number of patients, age, body weight, maximal diameter of the largest tumor, location of the largest tumor, volume of the largest tumor and uterus, and number of uterine fibroids of more than 1 cm in diameter per patient, which were measured using baseline MRI.
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The adverse events were analyzed between the two groups. We defined complications in the hospital as patients' requiring unanticipated imaging assessment, increased level of care, unanticipated treatment, persistent disability or injury, all of which were associated with the procedure. We defined complications after discharge as patients' requiring unanticipated hospital visits, unanticipated imaging assessment, unanticipated medical treatment, or repeated hospitalization associated with adverse events. These evaluations were similar to the systematic evaluation of complications after uterine artery embolization for symptomatic fibroids reported by Spies et al. [11]. We classified the grade of complications of uterine artery embolization into six categories as previously reported [11, 12]: grade A, no therapy, no consequence; grade B, nominal therapy, observation, no consequence; grade C, required therapy, unanticipated minor hospitalization (< 48 hr); grade D, major therapy, unplanned increased level of care, unanticipated prolonged hospitalization (> 48 hr); grade E, permanent adverse sequelae; and grade F, death. We defined grade A and B as minor complications and grade C through F as major complications. If a patient had two or more complications, we counted all the complications. In this study, amenorrhea or new menopausal symptoms or both after the procedure were defined as complications under the following conditions: when amenorrhea continued for two or more cycles or new menopausal symptoms, including hot flashes, night sweats, or both, occurred at the time of routine or unanticipated hospital visits or by questionnaire obtained at 4 months and 1 year after embolization or both. When women underwent gynecologic intervention, the information was obtained from their gynecologists. We also analyzed the time of the complete disappearance of postprocedural pain and the time of full recovery between the groups. Full recovery was defined when the women felt back to normal, which was assessed by questionnaires obtained at 4 months after embolization.
Between the two groups, we analyzed procedure and fluoroscopy time; dose of morphine used; hospitalization; change of menorrhagia and bulk-related symptoms at 4 months, 1 year, and 2 years after embolization; the largest tumor and uterine volume reduction rates at 4 months and 1 year after embolization; rates of complete devascularization of the largest tumor; and patient satisfaction with the procedure and the outcomes. Complete devascularization of the tumor was assessed using enhanced MRI 1 week after embolization. The infarction rates of fibroids were calculated on the basis of multiple measurements of the maximal fibroid diameter from the enhanced MRI, which was obtained by taking a sagittal slice at the level of the maximal tumor. We defined complete devascularization when MRI signal intensity of the tumor did not change on the enhanced MRI compared with that on the unenhanced MRI [13]. The total dose of morphine used was assessed in 122 women to whom morphine was administered for the management of postprocedural cramping. Changes in menorrhagia and bulk-related symptoms were assessed by written questionnaires at 4 months, 1 year, and 2 years after embolization. The symptomatic outcomes compared to preprocedural conditions, obtained by questionnaire, were classified by grades: grade 4 corresponded to markedly improved; 3, moderately improved; 2, slightly improved; 1, no change; and 0, worsened condition. Patient satisfaction with the procedure and the outcomes was also classified by grades: grade 2 corresponded to markedly satisfied; 1, slightly satisfied; 0, neither satisfied nor dissatisfied; –1, slightly dissatisfied; and –2, markedly dissatisfied.
Statistical analysis was performed using Student's t test, Fisher's exact test, or the Wilcoxon's signed rank test to compare between the groups. A probability value of less than 5% (p < 0.05) was considered significant.
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Group 1 consisted of 47 women and group 2 included the remaining 105 women. No statistical significance in age, body weight, rate of the largest fibroid located at the submucosal area, and the follow-up period was seen between the groups. However, the maximal diameter and the volume of the largest tumor and uterine volume were significantly larger in group 1 than in group 2. The maximal diameter of the largest tumor of group 1 had a mean (± SD) of 12.4 ± 2.2 cm (range, 10–19 cm) and that of group 2 had a mean of 6.8 ± 2.0 cm (range, 2–9.5 cm) (p < 0.001). The largest tumor volume of group 1 was a mean of 701 ± 336 mL (range, 304–1,972 mL) and that of group 2 was a mean of 154 ± 107 mL (range, 4–412 mL) (p < 0.001). The uterine volume of group 1 was a mean of 1,380 ± 500 mL (range, 624–2,506 mL) and that of group 2 was a mean of 684 ± 337 mL (range, 151–1,864 mL) (p < 0.001).
Table 1 shows the complications associated with the procedure. Of 152 women, 30 complications (19.7%), which occurred in 27 women (17.8%), were noted. However, 25 of the 30 complications were minor, with no statistical difference in the minor complication rates of 19.1% (9/47) in group 1 compared with 15.2% (16/105) in group 2 (p = 0.637). Most minor complications were fibroid passage without any intervention, transient amenorrhea, new menopausal symptoms, persistent vaginal discharge, and pain. Two patients had vascular injury during the procedure, which was managed with an embolization technique. They did not have any clinical symptoms caused by the complication.
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There were five major complications, with no statistical difference in the major complication rates of 6.4% (3/47) in group 1 compared with 1.9% (2/105) in group 2 (p = 0.172).
A 35-year-old woman (in group 1) complained of sexual dysfunction 2 years after embolization. She had significantly decreased intensity of internal orgasm during sexual intercourse, which appeared to continue for about 2 years after embolization. Although her sex partner had changed and she experienced severe depression caused by mental shock unrelated to fibroids and embolization during the period, we judged it as a permanent adverse sequela. Enhanced MRI after embolization showed that the cervix was well enhanced with no infarction.
Of all 152 women, six have undergone surgery after embolization at the time of this writing. One underwent a hysterectomy because of early uterine cervical cancer at 5 months after embolization although the results of the preprocedural Pap smear had been negative, and one woman who was taking antiplatelet drugs because of cerebral disease underwent hysterectomy as a result of recurrent uterine bleeding at 11 months after embolization, as reported previously [14]. We did not count either patient as having complications because the surgery was performed for reasons other than complications associated with the procedure. Of the remaining four women, the one with a single submucosal tumor of 5.5 cm in diameter (in group 2) underwent an abdominal hysterectomy at 2 months after embolization because of fibroid expulsion with intrauterine infection. In one woman with a single submucosal tumor of 12 cm in diameter (in group 1) and one woman with a single submucosal tumor of 7.5 cm in diameter (in group 2), sloughing fibroids that blocked the uterine cervical canal were successfully resected transvaginally. One woman with a huge cervical fibroid of 19 cm in diameter (in group 1) had fibroid passage with intrauterine infection and underwent, transvaginally, partial resection of the tumor and antibiotic administration on admission at 2 months after embolization. Although she has had persistent vaginal discharge, she is being followed up as an outpatient at the time of this writing. Therefore, we judged that grade D major therapy, unplanned increased level of care, or unanticipated prolonged hospitalization (> 48 hr) associated with complications, were noted in 4.3% (2/47) of group 1 and in 1.9% (2/105) of group 2 (p = 0.588).
Table 2 shows the outcomes. No statistical difference was seen in the time of complete disappearance of pain and full recovery rates between both groups. There was no statistical difference in most outcomes, including symptom control, tumor and uterine reduction rates, and patient satisfaction, although the improvement of menorrhagia at 4 months and 1 year after embolization and patient satisfaction at 4 months after embolization in group 1 were significantly inferior to those in group 2. However, in group 1, menorrhagia improved markedly or moderately in 32 (89%) of 36 women at 4 months after embolization and in 24 (100%) of 24 women at 1 year after embolization. Thirty-six (82%) of 44 women were markedly satisfied with the procedure and its outcomes at 4 months after embolization and 23 (82%) of 28 women at 1 year after embolization in group 1. Complete devascularization of the largest tumor assessed by enhanced MRI 1 week after embolization was achieved in 72% (34/47) of women in group 1 and 90% (94/104) of women in group 2 (p = 0.007). No statistical difference in the amount of morphine used or the duration of hospital stay was found between the two groups, although the procedure time and fluoroscopy time were significantly shorter in group 2 than in group 1.
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With regard to other problems related to the procedure, there was no statistical difference in the time until complete disappearance of postprocedural pain and full recovery after embolization. Moreover, there was no statistical difference in most outcomes including symptom control, tumor and uterine reduction rates, and patient satisfaction between the two groups, although with regard to improvement of menorrhagia at 4 months and 1 year after embolization and patient satisfaction at 4 months after embolization, group 1 was significantly inferior to group 2.
Enhanced MRI obtained 1 week after embolization showed that complete devascularization of the largest tumor was achieved in 72% (34/47) of women in group 1 and 90% (94/104) of women in group 2 (p = 0.007). This finding suggests that large tumors have increased possibility of supply, not only from the uterine arteries but also from collateral circulation such as the ovarian and vaginal arteries. Therefore, group 1 has more potential for regrowth of residual viable tumor than group 2.
We encountered a woman with sexual dysfunction after embolization. Although data on this complication after uterine artery embolization have been insufficient so far, a case has been described by Lai et al. [15] in which they found that embolization of the cervicovaginal branches may cause injury to the uterovaginal plexus or the vascular supply to the cervix or both, leading to potential sexual dysfunction. In our study, both uterine arteriographic examinations before and during embolization failed to show thick cervicovaginal branches; however, we think that a similar mechanism might occur as a result of embolization.
Several reports have described the relationship between improvements in menorrhagia and initial tumor volume. Pron et al. [16] reported that improvements in menorrhagia were unrelated to initial uterine size. Spies et al. [17] reported that reduction in bleeding at 3 months was not related to baseline-dominant tumor volume. In our study, the improvements in menorrhagia at 4 months and 1 year after embolization in group 1 were significantly inferior to those in group 2, although statistical difference between the groups was not seen at 2 years after embolization. We do not know the reason for the discrepancy between other reports and ours. However, in our study, menorrhagia improved markedly or moderately in 32 (89%) of 36 women of group 1 at 4 months after embolization and in 24 (100%) of 24 women of group 1 at 1 year after embolization. We believe these findings reveal that uterine artery embolization is effective in improving menorrhagia in women with fibroids of 10 cm or larger diameter.
We used gelatin sponge particles as embolic agents in our study. This is because other embolic agents such as polyvinyl alcohol particles or tris-acryl gelatin microspheres (Embosphere, Biosphere Medical, Rockland, MA) were not available commercially in Japan, although most investigators in other countries reported that they used other embolic agents. If we had used other embolic agents in our study, different results might have been obtained.
Our study has limitations. Patient numbers were limited, and we have not performed uterine artery embolization for uterine fibroids of more than 19 cm in diameter. If much larger tumors were included in our study, different results might have been obtained. In addition, we defined large tumors as being 10 cm or larger in diameter; however, if the definition was different, the results might also have been different. Moreover, because this study was performed at one institution, a multicenter prospective study is required. However, we conclude that there is no increased risk to patients undergoing uterine artery embolization for fibroids on the basis of tumor size. Successful outcomes can be obtained for such lesions.
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