7
Uterine Artery Embolization for the Treatment of Uterine Leiomyomata Midterm ~esults' Scott C. Goodwin, MD INTRODUCTION: The authors review their midterm experience Bruce McLucas, MD with uterine artery embolization for the treatment of uterine fi- Margaret Lee, MD broids. Gary Chen, BS Rita Perrella, MD MATERIALS AND METHODS: Sixty patients were referred for per- Suresh Vedantham, MD manent polyvinyl alcohol (PVA) foam particle uterine artery embo- Susie Muir, MD lization during an 18-month period. Detailed clinical follow-up and Annie Lai, MD ultrasound follow-up were obtained. James W. Sayre, PhD RESULTS: Bleeding was a presenting symptom in 56 patients and Mabel DeLeon, BS pain was a presenting symptom in 47 patients. All patients under- went a technically successful embolization. One of the patients un- derwent unilateral embolization. Fifty-nine patients underwent bi- Index terms: Fibroid g Uterine arteries, lateral embolization. Of all patients undergoing bilateral emboliza- therapeutic tion, at last follow-up (mean, 16.3 months), 81%had their uterus JVIR 1999; 10:1159-1165 and had moderate or better improvement in their symptoms. Nine- Abbreviation: PVA = polyvinyl alcohol ty-two percent of these patients also had reductions in uterine and dominant fibroid volumes. Overall, the mean uterine and dominant fibroid volume reduction were 42.8% and 48.8%, respectively (mean follow-up, 10.2 months). One infectious complication that necessi- tated hysterectomy occurred. CONCLUSION: Uterine artery embolization for the treatment of uterine fibroids is a minimally invasive technique with low compli- cation rates and very good clinical efficacy. CLINICAL and autopsy studies other alternative treatment for fi- have demonstrated that the inci- broids is hormonal therapy with dence of fibroid tumors in women progestational compounds or gona- older than 35 years is 20%-40% (1). dotropin-releasing hormone ago- Symptomatic leiomyomata are typi- nists. This pharmacologic approach cally treated by hysterectomy, and dramatically improves symptoms are responsible for nearly one-third and reduces fibroid size; however, of all hysterectomies performed in leiomyomata typically regrow to From the Departments of Radiological the United States (2). There are their original size within a few Sciences (S.C.G., M.L., G.C., R.P., S.V., Several alternatives to hysterec- months of discontinuing the treat- S.M., A.L., J.W.S., M.D.) and Obstetrics and Gynecology (B,M,), UCLA Medical tomy. The alternative treatment of ment (1). Because long-term hor- Center, L~~ Angeles, California. Received choice is m~omectomy, a procedure monal therapy has side effects, such May 5, 1999; revision requested June 11; that is associated with increased as osteoporosis, menopausal symp- revision received June 28; accepted June blood loss, operating time, pain, toms, and amenorrhea, these agents 29. Address correspondence to S.C.G., Department of Radiological Sciences, postoperative morbidity, and longer are currently used primarily as a Center for the Health Sciences, hospital stays than hysterectomy temporizing measure in perimeno- ROO^ BL-423, 10833 LeConte Avenue, (3). Furthermore, 20%-25% of pausal women or as a method of LOS Angeles, CA 90095; e-mail: women undergoing myomectomy reducing tumor size and vascularity [email protected]. will ultimately require an addi- prior to surgery. Because of the lim- o SCVIR, 1999 tional surgical procedure (3). An- itations of the available therapies, 1159

Uterine Artery Embolization for the Treatment of Uterine Leiomyomata Midterm Results

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Uterine Artery Embolization for the Treatment of Uterine Leiomyomata Midterm ~esults '

Scott C. Goodwin, MD INTRODUCTION: The authors review their midterm experience Bruce McLucas, MD with uterine artery embolization for the treatment of uterine fi- Margaret Lee, MD broids. Gary Chen, BS Rita Perrella, MD MATERIALS AND METHODS: Sixty patients were referred for per-

Suresh Vedantham, MD manent polyvinyl alcohol (PVA) foam particle uterine artery embo-

Susie Muir, MD lization during an 18-month period. Detailed clinical follow-up and

Annie Lai, MD ultrasound follow-up were obtained.

James W. Sayre, PhD RESULTS: Bleeding was a presenting symptom in 56 patients and Mabel DeLeon, BS pain was a presenting symptom in 47 patients. All patients under-

went a technically successful embolization. One of the patients un- derwent unilateral embolization. Fifty-nine patients underwent bi-

Index terms: Fibroid g Uterine arteries, lateral embolization. Of all patients undergoing bilateral emboliza- therapeutic tion, at last follow-up (mean, 16.3 months), 81% had their uterus JVIR 1999; 10:1159-1165 and had moderate or better improvement in their symptoms. Nine-

Abbreviation: PVA = polyvinyl alcohol ty-two percent of these patients also had reductions in uterine and dominant fibroid volumes. Overall, the mean uterine and dominant fibroid volume reduction were 42.8% and 48.8%, respectively (mean follow-up, 10.2 months). One infectious complication that necessi- tated hysterectomy occurred.

CONCLUSION: Uterine artery embolization for the treatment of uterine fibroids is a minimally invasive technique with low compli- cation rates and very good clinical efficacy.

CLINICAL and autopsy studies other alternative treatment for fi- have demonstrated that the inci- broids is hormonal therapy with dence of fibroid tumors in women progestational compounds or gona- older than 35 years is 20%-40% (1). dotropin-releasing hormone ago- Symptomatic leiomyomata are typi- nists. This pharmacologic approach cally treated by hysterectomy, and dramatically improves symptoms are responsible for nearly one-third and reduces fibroid size; however, of all hysterectomies performed in leiomyomata typically regrow to

From the Departments of Radiological the United States (2). There are their original size within a few Sciences (S.C.G., M.L., G.C., R.P., S.V., Several alternatives to hysterec- months of discontinuing the treat- S.M., A.L., J.W.S., M.D.) and Obstetrics and Gynecology (B,M,), UCLA Medical tomy. The alternative treatment of ment (1). Because long-term hor- Center, L~~ Angeles, California. Received choice is m~omectomy, a procedure monal therapy has side effects, such May 5, 1999; revision requested June 11; that is associated with increased as osteoporosis, menopausal symp- revision received June 28; accepted June blood loss, operating time, pain, toms, and amenorrhea, these agents 29. Address correspondence to S.C.G., Department of Radiological Sciences, postoperative morbidity, and longer are currently used primarily as a Center for the Health Sciences, hospital stays than hysterectomy temporizing measure in perimeno- ROO^ BL-423, 10833 LeConte Avenue, (3). Furthermore, 20%-25% of pausal women or a s a method of LOS Angeles, CA 90095; e-mail: women undergoing myomectomy reducing tumor size and vascularity [email protected]. will ultimately require an addi- prior to surgery. Because of the lim- o SCVIR, 1999 tional surgical procedure (3). An- itations of the available therapies,

1159

1160 Uterine Artery Embolization

October 1999 JVIR

uterine leiomyomata remain a cause of menorrhagia and chronic pelvic pain in a significant number of patients.

The first reported use of transar- terial embolization for the success- ful treatment of obstetric gyneco- logic hemorrhage appeared in 1979 (4). Embolization has been used subsequently to treat a wide variety of obstetric and gynecologic diseases associated with hemorrhaging (5). Embolization has also been used successfully for presurgical prophy- laxis (6). Overall clinical success rates have varied between 86% and 100% (5). Dr. Jacques Ravina and his colleagues began to perform uterine artery embolization as a primary therapy for symptomatic uterine fibroids in 1991 and have subsequently reported excellent re- sults in two case series (7,8).

Our group began offering uterine artery embolization as a primary therapy for the treatment of symp- tomatic uterine fibroids in 1996. We report our results in 60 consecutive patients, which includes 11 patients described previously in this journal (9). This study is based on a retro- spective medical records review.

MATERIALS AND METHODS

Patients

The first 60 consecutive patients referred to an interventional radiol- ogist by an obstetricianlgynecologist for permanent polyvinyl alcohol (PVA) foam particle uterine artery embolization during an 18-month period are reported. Eleven of these patients have been described previ- ously (9).

Preprocedural Evaluation

The pre-embolization work-up included an obstetric and gyneco- logic history and physical examina- tion, as well as an ultrasound eval- uation of the uterus.

Procedure

Ten of the first 11 patients were administered general anesthesia.

The procedure was performed under consiious sedation for the subse- quent 49 patients. The most fre- quently used medications for con- scious sedation were midazolam (Roche Labs, Nutley, NJ) and/or fentanyl (Elkins-Sinn, Cherry Hill, NJ). Fifty-eight of 60 patients re- ceived 30-60 mg of ketorolac (Roche Labs) intravenously or intra- muscularly prior to, during, or im- mediately after the procedure. All patients except one received pro- phylactic intravenous antibiotics, typically 1 g cefazolin (Smith Kline Beecham, Pittsburgh, PA, Eli Lilly, Indianapolis, IN).

The technique for performing uterine artery embolization has been described previously (9). In general, the right common femoral artery approach was used. After standard preparation and draping and the administration of 1% lido- caine (Abbott Industries, N. Chi- cago, IL) for local anesthesia, a vis- ceral selective catheter was intro- duced utilizing standard Seldinger technique. The left common iliac artery was then selectively cathe- terized. In some cases in which a patient had a steep aortic bifurca- tion, a Waltman's loop was formed either in one of the renal arteries or in the superior mesenteric artery and brought down into the left com- mon iliac arterv. The left internal iliac artery was then catheterized with the primary visceral-shaped catheter and a 0.035-inch Angled Glidewire (Boston Scientific Vascu- lar, Natick, MA). Digital subtrac- tion angiography was then per- formed in multiple projections. Af- ter identifying the left uterine ar- tery, the left uterine artery was catheterized. This catheterization was most frequently done with a microcatheter and a microwire (usu- ally a FasTracker-325 and a Taper-22 wire; Boston Scientific Vascular). The tip of the catheter was placed close to the most infe- rior extent of the artery and arte- riography was performed to assess the presence of any nontarget organ supply or other abnormality. PVA foam particles were then injected until there was complete stasis of flow. The microcatheter was re-

moved and. with use of a Waltman's loop, the right ipsilateral internal iliac artery was catheterized. The procedure was then continued in the same fashion as performed on the left side.

Postprocedural Care and Follow-Up

After the ~rocedure and the at- tainment of hemostasis, the pa- tients were transferred to the out- patient observation unit. All pa- tients received oral andlor intrave- nous analgesics andlor antiemetics as needed to ensure patient com- fort. Some patients received addi- tional doses of antibiotics.

Patients were kept at bed rest for 6 hours after the procedure, and then evaluated for possible dis- charge. All patients received pre- scriptions for narcotics, nonsteroidal antiinflammatories. antiemetics. and antibiotics, as necessary.

All patients underwent follow-up gynecologic examination within 2 weeks of the procedure and at regu- lar intervals (approximately 6 weeks, 6 months, 12 months, 18 months, and 2 years) thereafter. Their clinical improvement in ab- normal bleeding and in pelvic pain was evaluated. The grading system used to evaluate symptom control was altered during the follow-up period. Thirteen patients had their clinical improvement in both post- procedural bleeding and pain graded as: 1 = marked or complete; 2 = moderate; or 3 = none or insig- nificant. Forty-four patients had both their change in bleeding and pain graded as: 1 = resolvedtnearly resolved; 2 = much or significantly improved; 3 = slightly improved; 4 = no change; 5 = slightly worse; or 6 = much worse. The grading was based on interviews at the time ~~ ~ - -

of clinical follow-up evaluation. Ultrasound follow-UD evaluations

were scheduled a t r e k l a r intervals (approximately 6 weeks, 6 months, 12 months, 18 months, and 2 years) and were obtained in 57 patients. Measurements of the uterus and fibroids were obtained. Uterine vol- ume and volume of the dominant fibroid were calculated. The percent

Goodwin et a1 1161

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volume reduction was calculated for each patient.

Statistical Analysis

For analysis, patients were strat- ified into five failure groups: 1 =

hysterectomy; 2 = clinical failure (ie, category 3 or below on clinical follow-up [according to the grading system described in materials and methods]); 3 = hysterectomy andlor clinical failure; 4 = increase in uterine or fibroid size after the pro- cedure; and 5 = any of the above. Multi~le characteristics were ana- lyzed >or their value as prognostic indicators for each failure group. Student t test was used to evaluate the continuous variables. Fisher's exact test was used to evaluate the binary variables. The 2 test was utilized to evaluate race. A P value of less than .05 was considered sta- tistically significant.

RESULTS

The clinical history of the 59 pa- tients who underwent bilateral em- bolization is summarized in Table 1. Table 2 lists comorbid pelvic dis- eases that were present in 51 of the patients. Many of the patients had multiple comorbid pelvic disease processes. Forty of the patients had undergone previous hormonal ther- apy. Previous surgical procedures had been performed on all patients (Table 3). Many patients had un- dergone multiple previous proce- dures.

Four patients desiring preserva- tion of their fertility had either failed a previous myomectomy or had been advised that because of the size, number, andlor location of their fibroids, there would be a sig- nificant chance of hysterectomy as an outcome of attempted myomec- tomy. Previous hysteroscopies were performed on 57 patients, and 56 had undergone laparoscopies. Histo- pathology results were available on endometrial biopsies in 41 patients and leiomyomata biopsies in 57 pa- tients. None of the biopsies demon- strated cancer.

Table 1 Patient Clinical History Bilateral Embolization Group (59 Patients)

Previous myomectomy 46 Previous hormonal 40

therapy Previous pregnancy 42 Abnormal bleeding 56 Pelvic pain 47 Post menopausal 2 Premenopausal 57 Fertility desired 4 Fertility not desired 55 Submucosal fibroid(s) 20 Race

White 28 Black 19 Other 12

Age (y) Mean 43.5 Range 27-66 SD 6.1

Initial Uterine Volume (in mL)

Mean 844.1 Range 120.2-9,272.8 SD 1,280.5*

* Standard deviation; This is large primarily because of one patient with a 9.2-L uterus. Most patients had a much smaller uterus.

Table 3 Previous Surgical Procedures

No. of Procedure Patients*

Myomectomy or myolyses 57 Dilatation and curettage 16 Adhesion lyses 7 Ovarian cystectomy 7 Endometrial ablation or 6

fulguration Endometrial polypectomy 6 Tuba1 ligation 2 Salpingo-oophorectomy 2 Endocervical cystectomy 1 Ovarian cyst aspiration 1 Right tuba1 fulguration 1 Synechiae resection 1

* Multiple patients had more than one previous procedure.

Table 2 Comorbid Disease Processes

No. of Disease Patients*

Ovarian cysts 23 Endometrial polyps 20 Pelvic adhesions 15 Endometriosis 5 Adenomyoses 3 Cervical polyps or cysts 3 Asherman syndrome 1 Hydrosalpinx 1 Endometrial septum 1 Uterine synechiae 1

* 51 patients had comorbid disease. Many patients had more than one.

in all patients. In three patients, a position in either the right or left uterine artery was difficult to se- cure with the microcatheter because of the steep angle of the uterine ar- tery off of the internal iliac artery followed by marked tortuosity. In these patients, the primary visceral selective catheter was exchanged for a 5-F, angled Glidecatheter (Boston Scientific Vascular), and the tip of this catheter was posi- tioned at or near the origin of the uterine artery prior to placement of the microcatheter. Sheaths were used in four patients to improve control of the primary catheter. Technical facts of interest are listed in Table 4.

No immediate complications were encountered. Subsequent complica- tions included permanent amenor- rhea with a documented follicle stimulating hormone increase to menopausal levels in one patient, a moderate groin hematoma in one patient, and a delayed infectious complication resulting in hysterec- tomy in one patient. The infectious complication resulting in hysterec-

All 60 patients underwent a tech- tomy has been reported previously nically successful uterine artery em- (9). All patients had crampy pelvic bolization, 59 bilateral and one uni- pain after the procedure. Twenty- lateral. Arteriography demonstrated two (37%) of the 59 patients who bilateral single uterine arteries underwent a bilateral embolization arising from the proximal anterior required a same-day admission for trunk of the internal iliac arteries pain management. Postprocedural

1162 Uterine Artery Embolization

October 1999 JVIR

Table 4 Procedural Technical Facts

Right common femoral artery approach 60 patients Vascular sheath used 4 patients Primary catheter - 5F Visceral (typically 60 patients

Levin 1; Cook Inc., Bloomington, IN) Microcatheter (typically FasTracker 325; 54 patients

Boston Scientific Vascular, Natick, MA) PVA 500-700 micron* 57 patients PVA 300-500 micron* 3 patients Gelatin sponge pledgets in addition to PVA 3 patients

(Gelfoam; Upjohn, Kalamazoo, MI) Intra-arterial lidocaine 5 patients Vasodilators 11 patients PVA amount? (available in 51 patients) -100-1,900 mg (mean, 533 mg) Procedure time 40-165 minutes (mean, 72 minutes)

* Contour, Boston Scientific Vascular; PVA, Cook; or Trufil, Cordis Endovascular, Warren, NJ. t Assuming 100 mg PVA per vial. There is some variability in this figure depending on the manufacturer.

Table 5 Hysterectomy Results

Interval from Embolization to Principal Reason

Patient Hysterectomy for Hysterectomy Histopathology

1. 5 weeks Infectious Endometritis complication Necrotic fibroids

Adenomyoses Chronic salpingitis

2.* 7 months Renal cell Fibroid degeneration carcinoma

3. 5 months, 2 weeks Ureteral Fibroid degeneration compression Dermoid cyst

4. 14 months Failure of therapy Adenomyoses Fibroid degeneration Cervical squamous metaplasia Nabothian cyst

5. 4 months, 2 weeks Hematometra Adenomyoses Chronic hematometra Tuba1 ligation Intraovarian hemorrhage Hemorrhagic peritubal cyst

6. Lost to detailed follow-up

Note.-In all cases there was no evidence of myometrial ischemia. * Removing the fibroid uterus improved access to the kidney and ureters.

fever of 100.4"F or greater was re- ported by 20 (34%) patients. Six pa- tients (10%) experienced postembo- lization syndrome sufficiently se- vere enough to require a delayed admission. These patients had high fevers and high white blood cell count and frequently had malaise as well. Five of these patients re- ceived broad spectrum antibiotics,

and all six patients recovered com- pletely.

Four patients who had submuco- sal fibroids passed their fibroids vaginally after the procedure. Two of these patients, who had other nonpedunculated fibroids, ulti- mately failed therapy and two had a successful outcome. Three pa- tients who had a pre-existing diag-

Table 6 Clinical Results for Abnormal Bleeding

Three-Point Scale (13 Patients)*

1. Marked or complete 7 improvement

2. Moderate improvement 5 3. No improvement or no 0

significant improvement

Six-Point Scale (44 Patients)?

1. Resolved or nearly resolved 20 2. Much or significantly 20

improved 3. Slightly improved 0 4. No change 2 5. Slightly worse 0 6. Much worse 0

* Bleeding was part of presenting symptoms in 12 of 13 patients. t Bleeding was part of presenting symptoms in 42 of 44 patients.

nosis of adenomyosis had a clini- cally successful outcome. Six pa- tients in the bilateral embolization group had hysterectomies after the embolization procedure. Table 5 details the findings in these pa- tients. In addition, therapy was un- successful in the patient who had the unilateral embolization, which required the patient to undergo a hysterectomy.

Tables 6 and 7 delineate the clinical follow-up results. Two pa- tients had hysterectomies prior to being graded clinically and one was lost to follow-up (unable to be con- tacted). The time period between embolization and last clinical fol- low-up varied between 3 and 30 months (mean, 16.3 ? 6.26 months). Three patients who ini- tially had a good clinical response had a recurrence of svm~toms and ., L

were moved into the failure group. One ~ a t i e n t was lost to ultra-

sound illow-up (unable to be con- tacted), and two patients had hys- terectomies (prior to ultrasound fol- low-up). The time interval between embolization and the final ultra- sound follow-up ranged from 3.5 to 28.5 months (mean, 10.2 months). In the 59 patients who underwent bilateral uterine artery emboliza-

Goodwin et a1 1163

Volume 10 Number 9

Table 7 Clinical Results for Pain

Three-Point Scale (13 patients)*

1. Marked or complete 7 improvement

2. Moderate improvement 5 3. No improvement or no 0

significant improvement

Six-Point Scale (44 Patients)?

1. Resolved or newly resolved 15 2. Much or significantly 14

improved 3. Slightly improved 1 4. No change 3 5. Slightly worse 0 6. Much worse 0

* Pain was part of presenting symptoms in 12 of 13 patients. t Pain was part of presenting symptoms in 33 of 44 patients.

tion, the mean preprocedural uter- ine volume was 844 mL (range, 120 to 9,273 mL), the mean uterine vol- ume reduction was 42.8% (range, -129%-87%), and the mean percent dominant fibroid volume reduction was 48.8% (range, -522% [five fold increase] to 100% [total elimina- tion]). For the overall success group, the average uterine volume reduc- tion was 47.3% (range, 1%-87%) and the average dominant uterine fibroid volume reduction was 67.7% (range, 18%-100%). A vascularity index was calculated by dividing the mg of PVA utilized during the embolization by the initial uterine volume. The mean vascularity was 1.03 (range, 0.09-2.91).

Two patients did not have a suc- cessful response to embolization ini- tially and presented for a repeated embolization procedure (6 and 8 months after initial embolization). In both patients, the uterine arter- ies had recanalized, although they were much smaller in size than during the original procedure. The amount of PVA for the second em- bolization in both patients was 100 mg compared to 500 mg and 400 mg on the initial embolizations, respec- tively. Therapy was ultimately un- successful in one of these patients and this patient required a hyster-

Table 8 Procedural and Postprocedural Results (59 Patients)

Postembolization 10% hysterectomies

Clinical failures 12% Hysterectomy and/or 19%

clinical failures Ultrasound failures 12% Any failure 27% Uterine reduction

Mean 42.8% Range - 129-87%* S.D. 31.7%

Fibroid reduction Mean 48.8% Range -522-loo%* S.D. 84.2%

Vascularity? Mean 1.03 Range .9-2.91 S.D. .64

* Negative numbers indicate increase in size and positive numbers indicate decrease in size. i Milligrams of PVAIuterine volume in cubic centimeters.

ectomy; the other patient had a suc- cessful outcome.

For analysis, patients were strat- ified into five failure groups: 1 = hysterectomy; 2 = clinical failure (ie, category 3 or below on clinical follow-up [according to the grading system described in materials and methods]); 3 = hysterectomy andlor clinical failure; 4 = increase in uterine or fibroid size after the pro- cedure; and 5 = any of the above. The failure rates in these five groups were lo%, 12%, 19%, 12%, and 27%, respectively.

Table 8 summarizes procedural and postprocedural results. Table 9 lists characteristics analyzed for their value as prognostic indicators for each failure group. There were three statistically significant re- sults. Patients with a larger percent uterine reduction were less likely to undergo hysterectomy (P < .001). Patients who were younger were more likely to be in the clinical fail- ure group (P < .02). Patients who had a previous myomectomy were less likely to have a hysterectomy after embolization (P < .02). Forty- six patients had a previous myo-

Table 9 Statistically Analyzed Characteristics

Previous myomectomy* Previous hormonal therapy* Previous pregnancy* Bleeding history* Pain history* Menopausal status* Submucosal fibroid* Race? Postembolization syndrome

admission* Same day admission for pain* Age$ % Uterine reduction$ % Fibroid reduction$ PVA mg$ Initial uterine volume$ Vascularity$ Procedure time$

* Fisher's exact test. t Chi square test. $ Students t test.

mectomy. Two of these patients had a hysterectomy after embolization. Thirteen patients had not had a previous myomectomy. Four of these patients had a hysterectomy after embolization.

DISCUSSION

Uterine artery embolization as a treatment for uterine fibroids is a relatively new treatment option that has had only limited testing for safety and efficacy in the United States. This report describes the results of embolization treatment in a consecutive series of 60 women with symptomatic uterine fibroids.

Of all patients undergoing bilat- eral embolization, at last follow-up (mean, 16.3 months), 81% had their uterus and had moderate or better improvement in their symptoms. Ninety-two percent of these patients also had reductions in uterine and dominant fibroid volumes. Overall, the mean uterine and dominant fi- broid volume reduction were 42.8% and 48.8%, respectively.

Our results are not quite as fa- vorable as those reported previously (8,101. Ravina et a1 have reported a clinical success rate of 89% (8). One

1164 Uterine Artery Emboli

October 1999 JVIR

zation

possible reason for the difference between our results and those of Ravina et a1 may be the difference in the size of PVA utilized. Their group typically used a smaller size of PVA. This is known to result in more ischemia and, therefore, possi- bly a more efficacious result with more tumor infarction acutely, and less potential for collateral regrowth and recurrence of fibroids in the long-term. Worthington-Kirsch et a1 reported an 88% clinical success rate for bleeding symptoms and a 94% clinical success rate for im- provement in bulk symptoms (10). If patients who initially had both bleeding and pain and who eventu- ally failed therapy for either symp- tom were combined into one group, the overall failure rate would have been higher. In addition, the fol- low-up period in their report was shorter and higher failure rates can be expected in the long-term. An- other possible contributing factor to the difference in reported results is the complexity of our group of pa- tients: 51 patients had comorbid disease.

In this study, all of the patients had single uterine arteries arising bilaterally from the anterior trunk of the internal iliac artery just dis- tal to the superior gluteal artery. We experienced no technical fail- ures. Other investigators have re- ported technical failures (8,lO). These occurred because of small uterine arteries in patients under- going hormonal therapy or because of marked tortuosity of the uterine arteries.

Multiple patient characteristics, as listed in Table 9, were statisti- cally analyzed as possible prognos- tic factors. As would be expected, patients with poor reductions in uterine volume after embolization were more likely to require a hys- terectomy. Young age was a predic- tor of clinical failure. This was an unexpected result. We do not have a satisfactory explanation of this find- ing at this point. Possible avenues of study include the hormonal dif- ferences between younger and older women, and genetic differences that may predispose some women to de- velop fibroids at a young age. Pa-

tients who underwent previous myomectomy were more likely to have a successful outcome after em- bolization. One possibility to ex- plain this is that a combined myo- mectomy and embolization ap- proach may be more efficacious.

The lack of correlation of initial uterine volume, vascularity, and postprocedural pain, with outcome was unexpected. We had suspected that patients with very large fi- broid~ might have poorer outcomes. However, Bradley and Reidy have also reported a good outcome in a small series of seven patients with particularly large fibroids with fun- dal heights varying between 14 and 28 weeks gestational size (11). Be- cause the effect of embolization is to devascularize a structure, we thought that patients with particu- larly hypervascular fibroids might fare better. This did not prove to be so. The simple explanation is that if a fibroid can be infarcted, whether it be relatively hypervascular or hy- povascular, a therapeutic result can be attained. Because the goal of therapy is fibroid infarction, pain might be a predictor of outcome. We did not find this. However, we looked only a t severe pain, not a t minimal pain, which may still prove to be a predictor of failure.

The single patient in this series who had a unilateral embolization was a clinical failure. Because the uterine bed is richly collateralized from one side to the other, unilat- eral embolization probably results in immediate recruitment of collat- erals from the contralateral uterine artery, with continuation of enough blood flow into the uterus to pre- vent infarction of the fibroids in most patients. This has been sub- stantiated by other investigators (8).

Four patients who had peduncu- lated submucosal fibroids subse- quently passed their fibroid vagi- nally. Two of these patients who had additional nonpedunculated fibroids eventually failed therapy. These types of patients might be better served by hysteroscopic myo- mectomy. Embolization could imme- diately precede myomectomy to re- duce bleeding. Embolization could

also follow myomectomy of pedun- culated fibroids to treat remaining fibroids, if present.

In our series, three patients who were diagnosed with adenomyosis ~ r i o r to embolization had a success- ful outcome. However, adenomyosis was subsequently diagnosed by postsurgical histopathology in three of the six ~a t i en t s who had hvster- ectomies. In addition, adenomyosis tissue appears to be viable on histo- pathology after embolization (12). This suggests that adenomyosis may be a condition that predisposes the patient to clinical failure after the embolization procedure.

Six patients had hysterectomies after the embolization procedure. One ~ a t i e n t had an infectious com- plicaiion 5 weeks after the emboli- zation (9). Another had renal cell carcinoma, and a third patient had ureteral obstruction. Two of the re- maining three patients had adeno- myosis, as did the patient who had the infectious complication. Histo- pathology was not available for the sixth patient. Necrosis of the fibroid tissue was seen in all five histopa- thology specimens examined, while no evidence of necrosis or ischemia was seen in the myometrium. This is consistent with previously re- ported results (13).

In previous reports, complica- tions of pelvic embolization proce- dures fall into three general catego- ries: complications of angiography, pelvic infection, and ischemic phe- nomena. For example, the complica- tion rate has run as high as 6%-7% for patients undergoing emboliza- tion for postpartum or postcesarean hemorrhage (5). In this series, there was one complication of angiogra- phy, a moderate groin hematoma.

Postembolization endometrial ischemia or infarction may have contributed to the development of acute endometritis in one patient. This complication occurred despite careful clinical screening, adminis- tration of prophylactic antibiotics, and the use of 500-700 micron PVA particles. ?tYo additional infectious complications have been reported in another series. Of 88 patients, two had Escherichia coli infections, leading to hysterectomy (14). One

Goodwin et a1 1165

Volume 10 Number 9

patient had a tubo-ovarian abscess, and the other patient had an infec- tion in the fibroid itself, which eventually resulted in perforation of the fundal myometrium.

Several investigators have re- ported both transient and perma- nent amenorrhea after uterine ar- tery embolization, with an incidence of permanent amenorrhea of less than 2% in one large series (8,15). One patient in our series experi- enced this as well. Because of the collateral bed between the ovaries and the uterus, nontarget emboliza- tion of the ovaries is possible, po- tentially resulting in ovarian infarc- tion and subsequent menopause. Despite this potential for ovarian damage, successful pregnancy after embolization has been reported (8,161.

All patients experience some de- gree of crampy pelvic pain after the embolization procedure. Of our 60 patients treated on an outpatient basis, 22 required admission princi- pally for pain management. Conse- quently, we now routinely admit these patients overnight, using pa- tient controlled anesthesia with hy- dromorphone for pain control, which is discontinued early the day after embolization. The patient is then switched to oral analgesics, and given prescriptions for a nonsteroi- dal anti-inflammatory and a nar- cotic upon discharge. The peak of the pain episode typically occurred on the first day, diminished rapidly, and was usually resolved within a week.

One concern about the emboliza- tion procedure is that PVA is per- manently implanted. We have found no reports specifically attributing significant adverse effects to the administration of PVA in more than 20 years of experience with this ma- terial.

Overall, uterine artery emboliza-

tion for the treatment of uterine fibroids is minimally invasive, pre- serves the uterus, and requires shorter hospitalization and recovery times than hysterectomy and myo- mectomy. The clinical success rate exceeds 80%. The disadvantages are postprocedural pain, the utilization of radiation, the utilization of a per- manently implanted material, possi- ble negative impact on fertility, and the risk of uterine or ovarian malig- nancy in patients who would other- wise have undergone a hysterec- tomy.

Acknowledgments: The authors would like to thank Diane Etchison, Jeanne Yamaguchi, Marian Mizokami, and Cherine Quan for their invaluable help with data collection and manu- script preparation.

References 1. Wallach EE. Mymomectomy. In:

Thompson JD, Rock JA, eds. Te Linde's operative gynecology, 7th ed. Philadelphia: JB Lippincott, 1992; 47-62.

2. Lepine LA, Hillis SD, Marchbanks PA, et al. Hysterectomy surveil- lance-United States, 1980-1993. MMWR CDC Surveil1 Summ 1997; 46:l-15.

3. Nezhat FR, Roemisch M, Nezhat CH, Seidman DS, Nezhat CR. Re- currence rate after laparoscopic myomectomy. J Am Assoc Gynecol Laparosc 1998; 5:237-240.

4. Heaston DK, Mineau DE, Brown BJ, Miller FJ. Transcatheter arte- rial embolization for control of per- sistent massive puerperal hemor- rhage after bilateral surgical hypo- gastric artery ligation. AJR 1979; 133:152-154.

5. Vedantham S, Goodwin SC, McLu- cas B, Mohr G. Uterine artery em- bolization: an underused method of controlling pelvic hemorrhage. Am J Obstet Gynecol 1996; 176:938-948.

6. Ravina JH, Bouret JM, Fried D, et al. Interet de l'embolisation pre- operatoire des fibromes uterins: a propos d'une serie multicentrique de

31 cas. Contracept Fertil Sex 1995; 23(1):45-49.

7. Ravina JH, Herbreteau D, Ciraru- Vigneron N, et al. Arterial embo- lisation to treat uterine myomata. Lancet 1995; 346:71-72.

8. Ravina JH, Bouret JM, Ciraru-Vign- eron N, et al. Recourse to particu- lar arterial embolization in the treatment of some uterine leiomy- oma. Bull Acad Natl Med 1997; 181: 233-243.

9. Goodwin SC, Vedantham S, McLu- cas B, Forno AE, Perrella R. Pre- liminary experience with uterine artery embolization for uterine fi- broid~. JVIR 1997; 8:517-526.

10. Worthington-Kirsch RL, Popky GL, Hutchins FL Jr . Uterine arterial embolization for the management of leiomyomas: quality-of-life assess- ment and clinical response. Radiol- ogy 1998; 208:25-29.

11. Bradley EA, Reidy JF, Forman RG, JaroszJ, Braude PR. ran scathe-' ter uterine artery embolisation to treat large uterine fibroids. Br J Ob- stet Gynecol 1998; 105:235-240.

12. McLucas B, Goodwin SC, Kaminsky D. The embolised fibroid uterus. Minim Invasive Ther Allied Technol 1998; 7:267-271.

13. Cornelis F, Ferrand J , Ravina JH. Embolized uterine myomata: mor- phologic features [abstract]. Minim Invasive Ther Allied Technol 1998; 7(suppl 1):27.

14. Walker WJ, Dover R, Sutton C. Bi- lateral uterine artery embolization for fibroids, results and complica- tions [abstract]. Minim Invasive Ther Allied ~ e c h n o l 1998; 7(suppl): 26.

15. Katz RN, Mitty HA, Stancata-Pasik, A, Cooper JM, Ahn J. Comparison of uterine artery embolization for fibroids using gelatin sponge pledgets and polyvinyl alcohol [abstract]. JVIR 1998; 9(suppl 1): 184.

16. Ravina JH, Ciraru-Vigneron N. Pregnancy after arterial emboliza- tion of uterine myomata: prelimi- nary results in 7 cases [abstract]. Minim Invasive Ther Allied Technol 1998; 7(suppl 1):27.