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1 All authors: Department of Radiology, Saiseikai Shiga Hospital, Ohashi 2-4-1, Ritto-cho, Kurita-gun, Shiga, 520-3046, Japan.
Received April 23, 2001;
accepted after revision July 18, 2001.
Address correspondence to T. Katsumori.
Abstract
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SUBJECTS AND METHODS. During 38 months, 60 patients (age range, 32-52 years; mean age, 42.5 years) with symptomatic uterine fibroids underwent uterine artery embolization. Only gelatin sponge particles, approximately 500-1000 µm in diameter, were used in all patients. The improvement of clinical symptoms was assessed by questionnaire. Reduction of the largest tumor and uterine volume reductions were assessed using MR imaging. The follow-up period ranged from 1 to 38 months (mean, 10.6 months).
RESULTS. Menorrhagia improved markedly or moderately in 41 (98%) of 42 of patients 4 months after embolization and in 20 (100%) of 20 patients 1 year after embolization. Bulk-related symptoms improved markedly or moderately in 31 (97%) of 32 of patients 4 months after embolization and in 19 (100%) of 19 of patients 1 year after embolization. MR imaging revealed that the mean largest tumor volume reduction rates were 55% at 4 months and 70% at 1 year after embolization, and the mean uterine volume reduction rates were 40% at 4 months and 56% at 1 year after embolization. Follow-up MR imaging showed no new fibroids and no regrowth of existing fibroids. No major complications were observed in any women.
CONCLUSION. We suggest that uterine artery embolization with gelatin sponge particles alone is a safe and effective treatment for symptomatic fibroids. The outcomes bear comparison with those of uterine artery embolization using polyvinyl alcohol particles, which have been reported in the literature.
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In most reports of uterine artery embolization for uterine fibroids in the literature, polyvinyl alcohol particles have been used as the embolic agent [1,2,3,4,5,6,7,8,9]. However, to our knowledge, few reports have been published on the use of gelatin sponge as the primary embolic agent [10, 11]. We previously reported on the gadolinium-enhanced MR imaging findings of uterine fibroids after uterine artery embolization with gelatin sponge particles alone. Our study revealed that most embolized fibroids were completely infarcted and had a decreased volume without recurrence [11]. Here we report the midterm results of uterine artery embolization with gelatin sponge particles alone for symptomatic uterine fibroids, with particular focus on the control of clinical symptoms, complications and side effects, patient satisfaction, and tumor and uterine volume reduction. To the best of our knowledge, this is the largest series of patients treated with uterine artery embolization with gelatin sponge particles alone for symptomatic uterine fibroids.
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The maximum diameter of the largest fibroid, the number of fibroids per patient, the location of the dominant fibroid, and the uterine volume were obtained on baseline MR imaging. We defined the largest fibroid as the dominant fibroid.
We informed all patients of the potential benefits and risks of uterine artery embolization for uterine fibroids and obtained oral and written informed consent from all women. We also informed all women that although the data have not always been sufficient, several publications have reported pregnancy after uterine artery embolization for uterine fibroids. The procedure was approved by the institutional ethics committee.
The follow-up period ranged from 1 to 38 months (mean, 10.6 months). Twelve women were followed from 1 to 4 months, 25 women from 4 to 12 months, and 23 women for more than 12 months.
Angiography and Embolization
All women underwent angiographies with a unilateral femoral approach under
local anesthesia. We have previously described the procedure
[11]; here follows a brief
overview. After purcutaneous insertion of a 5-French sheath introducer
(Supersheath; Medikit, Tokyo, Japan) via the unilateral common femoral artery,
a pelvic arteriogram was acquired using a 5-French catheter (OFTKR; Clinical
Supply, Gifu, Japan) placed above the aortic bifurcation. Next, a 5-French
loop catheter (KSF7; Clinical Supply) was inserted into the left uterine
artery and a microcatheter (Sniper, Clinical Supply; or Mass Transit, Cordis,
Miami, FL) was advanced coaxially into the arch segment. The diameters of the
inner lumen of the microcatheters were 0.022-0.027 inches. Gelatin sponge
particles mixed with saline, contrast medium (Isovue [iopamidol]; Schering,
Berlin, Germany), and antibiotics (cefazolin sodium, 1g; Fujisawa, Osaka,
Japan) were infused very slowly under fluoroscopy, using 3 mL syringes. In
most patients, the solution was made of 40 mL of saline solution, 20 mL of
contrast medium, and gelatin sponge particles made from 2-4 gelatin sponge
sheets. The procedure was continued until the proximal ascending uterine
artery was completely occluded under fluoroscopy. Uterine arteriography was
performed immediately after embolization to ensure that the ascending uterine
artery was occluded and that the arch segment and the main descending uterine
arteries were patent at the end of the procedure. Then the contralateral
uterine artery was embolized using the same procedure (Fig.
1A,1B,1C,1D).
We used low-frequency pulsed fluoroscopy during the procedure to reduce
radiation exposure to the patients as much as possible.
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The gelatin sponge particles used in uterine artery embolization were made by the operators from gelatin sponge sheets (Spongel; Yamanouchi, Tokyo, Japan). The sheets were cut into thin slices using a scalpel and compressed until paperlike, then cut into very small fragments using small scissors (Fig. 2A,2B,2C,2D). The size of most gelatin sponge particles when compressed was approximately 500-1000 µm, which was measured with a ruler.
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Cramping that occurred after the procedure was treated with medication. In the first 30 patients, an intramuscular injection of morphine (butorphanol tartrate, 2 mg; Burisutoru Miyazu Sukuizu, Tokyo, Japan), an IV infusion of 15 mg of pentazocine (Yamanouchi) and 1-2 mg of midazolam (Yamanouchi), and 50 mg of diclofenac sodium (Taisyouyakuhinkougyou, Shiga, Japan) were administered in combination as necessary. We changed the protocol in subsequent patients, because we concluded that the medication regimens used for the first 30 women were not sufficient to control cramping. The second 30 patients were given an intramuscular and IV infusion of hydrochloride (Takeda, Tokyo, Japan) and 50 mg of diclofenac sodium. The dose of hydrochloride ranged from 13.5 to 26 mg (mean, 19.5 mg). In all but one woman, naproxen (Tanabe, Osaka, Japan) was administered orally in a dose of 600-800 mg in three divided portions for 7-10 days. If abdominal pain could not be controlled after the first day, the administration of 60 mg of loxoprofen sodium (Sankyo; Tokyo, Japan) and 50 mg of diclofenac sodium was used. Antibiotics (cefazolin sodium) were dripped IV in the dose of 2 g in two divided portions for 2 days, and thereafter ofloxacin (Daiichiseiyaku, Tokyo, Japan) was administered orally in a daily dose of 200 mg in divided portions for the next 2 days.
Neither repeated angiography nor repeated embolization was performed in any patient during the follow-up period.
MR Imaging
MR imaging was performed before and after uterine artery embolization in
all women. Axial and sagittal MR images were obtained before the procedure and
at 1 week, 4 months, and 1 year after the procedure. As previously described
[11], T1-weighted images were
obtained by breath-hold two-dimensional fast low-angle shot (FLASH), and
T2-weighted images were obtained by fast spin echo. T1-weighted images were
obtained using the following parameters: TR/TE, 165/5; field of view, 30 cm;
matrix, 256 x 154; thickness, 10 mm; gap, 2 mm. Breath-hold T2-weighted
images were obtained using the following parameters: 3685/128; echo train, 23;
field of view, 30 cm; matrix, 256 x 138; thickness, 10 mm; gap, 2 mm.
Eighteen of the 60 patients underwent MR imaging before the procedure at other
hospitals using different MR units and sequences.
Analysis of Outcomes
Baseline clinical symptoms were assessed using an oral questionnaire before
the procedure in all patients. We then informed each woman that we would
follow up at 1 week, 4 months, and 1 year after the procedure. A written
questionnaire was obtained at 4 months and 1 year after uterine artery
embolization. The questionnaire asked about changes in clinical symptoms,
complications and side effects, the time elapsed before full recovery, the
time elapsed before complete disappearance of abdominal pain, and patient
satisfaction with the procedure and its outcomes. It also asked whether a
patient would recommend uterine artery embolization to other women with
symptomatic fibroids.
For our purposes, full recovery was defined as feeling "back to normal." We classified the symptomatic outcomes as markedly improved, moderately improved, slightly improved, no change, or worsened, compared with the patient's condition before the procedure. When a patient answered that her symptoms had improved markedly or moderately, we considered this to be successful symptom control. The complications and side effects related to the procedure were assessed by direct contact, a written questionnaire, or both. Patient satisfaction with the procedure and outcomes were classified as markedly satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, or markedly dissatisfied.
The reduction rates of the dominant tumor and of uterine volume were calculated on MR imaging at 4 months and 1 year after uterine artery embolization. The uterine volume was measured with the formula (length x width x depth x 0.5233) as a prolate ellipse. The same two radiologists assessed all MR imaging and consensus was reached.
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Procedure
All patients underwent angiography and embolization via a single femoral
approach. All but one patient successfully underwent embolization of the
bilateral uterine arteries. One uterine artery was absent in one woman; the
unilateral uterine artery was successfully embolized in that patient. No
ovarian artery embolization was performed.
The time of the procedure ranged from 25 to 110 min (mean, 53 min 30 sec). The mean fluoroscopy time ranged from 7 to 32 min (mean, 16 min).
In one woman with severe arteriosclerosis, minor extravasation of contrast material from the left vesicle artery occurred during catheterization of the left uterine artery. After successful left uterine artery embolization, arteriography of the left internal iliac showed no further extravasation of contrast material. Additional embolization of the left proximal anterior division was performed using larger gelatin sponge particles, followed by right uterine artery embolization. In this patient, no symptoms associated with this technical complication developed.
Outcomes
Menorrhagia improved markedly or moderately in 41 (98%) of 42 of patients
at 4 months after uterine artery embolization and in 20 (100%) of 20 patients
at 1 year after the procedure. Bulk-related symptoms improved markedly or
moderately in 31 (97%) of 32 of patients 4 months after uterine artery
embolization and in 19 (100%) of 19 of patients 1 year after the procedure. In
no patients did clinical symptoms worsen after the procedure.
MR imaging after uterine artery embolization revealed that the dominant fibroid volume reduction rates ranged from 22% to 100% (mean reduction, 55%) at 4 months and from 27% to 100% (mean reduction, 70%) at 1 year. The uterine volume reduction rates ranged from 14% to 66% (mean reduction, 40%) at 4 months and from 21% to 87% (mean reduction, 56%) at 1 year. No fibroids regrew during the follow-up period.
No major complications requiring hysterectomy or laparotomy were observed in any patients. In two patients, large sloughing submucosal fibroids blocked the cervical canal at 4 and 7 months after uterine artery embolization, respectively; successful transvaginal resection of the sloughing fibroids immediately relieved the symptoms. Findings on uterine culture were negative in both women. In a 48-year-old woman who had previously undergone right ovariectomy, menopausal symptoms and continued amenorrhea developed 6 months after uterine artery embolization. In 6 women, pieces of broken submucosal fibroids were passed transvaginally during the follow-up period, but no additional intervention was required. The other side effects associated with the procedure were all managed with medication, and no permanent sequela developed in any patients. No patients required additional major surgery as a result of unsuccessful uterine artery embolization.
The period of hospitalization ranged from 4 to 14 days (mean, 4.3 days). Two women were readmitted for treatment of large sloughing submucosal fibroids. The time taken to reach full recovery ranged from 3 to 50 days (mean, 12 days); complete disappearance of abdominal pain was achieved in 2-50 days (mean, 6.1 days).
With regard to patient satisfaction with the procedure and its outcomes, 44 (92%) of 48 of patients were markedly satisfied at 4 months after uterine artery embolization, and 21 (91%) of 23 of patients were markedly satisfied at 1 year after the procedure. At 4 months after uterine artery embolization, 46 (96%) of 48 of patients commented that they would strongly recommend the procedure for other women with symptomatic fibroids, and at 1 year follow-up, 22 (96%) of 23 patients made the same comment.
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With regard to complications, menopausal symptoms and continued amenorrhea occurred 6 months after uterine artery embolization in a 48-year-old women, and sloughing fibroids requiring transvaginal intervention occurred in two women. These rates of complications were similar to those previously reported in the literature [1, 2, 4,5,6,7,8,9]; no other major complications were noted. We consider uterine artery embolization with gelatin sponge particles alone to be a safe treatment for symptomatic uterine fibroids. In our patients, the routine period of hospitalization was 4 days, which was longer than that previously reported in the literature. We think that most of our patients could have been discharged 1 day after the procedure. However, we considered 4 days hospitalization optimal for the treatment of symptoms resulting from the procedure. Generally, the hospitalization period is much longer for Japanese patients than for patients in other countries because of differences in the medical and insurance systems in Japan compared with other countries.
Gelatin sponge is an absorbable hemostatic agent; it is made of gelatin that has no toxic or antigenic effects on the body, and it can be absorbed by the body completely within approximately 1 month [12]. For these reasons, it is considered to be a safe and useful material and has been widely used surgically for more than 50 years [12, 13]. In embolotherapy, gelatin sponge has been widely used as a safe and effective embolic agent for more than 25 years. Gelatin sponge particles were absorbed, and arteries that had been occluded with gelatin sponge particles could be recanalized within several weeks [14, 15]. Thus, it is known that gelatin sponge particles are useful temporary embolic agents, although a study has reported that embolization induced permanent occlusion [16].
The advantages of gelatin sponge are many. Gelatin sponge is not expensive, and it has been used as a safe and useful embolic agent for more than 20 years in uterine artery embolization for some uterine disorders. Several articles reported that menstruation and fertility could be preserved and that pregnancy and delivery were achieved after uterine artery embolization with gelatin sponge particles for some uterine hemorrhagic disorders [17,18,19,20]. Because gelatin is an absorbable material, it presents no concern about long-term effects on the body. Recanalization of the embolized uterine arteries might be possible and thus repeated embolization might be performed, should the patient have other uterine diseases in the future.
Moreover, recanalization has no disadvantage for embolized fibroids, because follow-up enhanced MR imaging revealed that most fibroids were infarcted and decreased in volume without any regrowth, as reported previously [11]. In addition, gelatin sponge particles can be infused easily into the arteries through a microcatheter. Because gelatin sponge can also absorb fluid, gelatin sponge particles that absorb saline and contrast medium mixed with antibiotics remain in the embolized fibroids for a short time. We think this can possibly contribute to the prevention of infectious complications in the embolized fibroids. As we previously reported [11], follow-up enhanced MR imaging revealed that myometrium blood flow was preserved without any infarction after uterine artery embolization with gelatin sponge particles alone.
Some issues relating to uterine artery embolization with gelatin sponge particles alone for uterine fibroids remain to be addressed. First, the size of gelatin sponge particles can vary and they can expand and become gellike in fluid; therefore, the maximum and minimum diameters of the arteries that can be occluded by gelatin sponge particles are unknown. Second, it is still unknown whether human uterine arteries can be recanalized, although several animal experiments have reported the recanalization of embolized arteries within several weeks [14, 15]. Thus far, uterine artery embolization with gelatin sponge particles for uterine fibroid has been performed for only a limited number of patients with a limited follow-up period [10, 11].
Polyvinyl alcohol particles are safe and efficient embolic agents for use in uterine artery embolization of symptomatic uterine fibroids. The primary reason we used gelatin sponge particles as the embolic agent is that polyvinyl alcohol particles were not available commercially in Japan. Therefore, we chose gelatin sponge particles as an alternative.
Several pregnancies after uterine artery embolization using polyvinyl alcohol particles for women with uterine fibroids have been reported in the literature [21]. However, in our series, most patients had no desire for future pregnancy, and no women have become pregnant during our follow-up period. Therefore, we do not know whether gelatin sponge particles can be recommended for women potentially desiring pregnancy. We believe that further investigations are required.
We conclude that uterine artery embolization with gelatin sponge particles alone is a safe and effective treatment for symptomatic uterine fibroids. The outcomes bear comparison with those of uterine artery embolization with polyvinyl alcohol particles, which have been previously reported in the literature.
Acknowledgments
We thank Shirou Inoue and Shinsuke Watanabe of Saiseikai Shiga Hospital for
their kind support. We also thank Tadao K. Kobayashi of Saiseikai Shiga
Hospital for his kind assistance in preparing the manuscript.
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