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1
Service de Radiologie Adultes (Pr Rouleau),
Hôpital Bretonneau, CHRU Tours, F.37044 Tours,
Cedex 01, France.
2
Service de Neuroradiologie (Pr Herbreteau),
Hôpital Bretonneau, Cedex 01, France.
3
Départment de
Gynécologie-Obstétrique
(Pr Lansac), Hôpital Bretonneau, Cedex 01,
France.
4
Service de Médecine
Nucléaire et Ultrasons (Pr Pourcelot),
Hôpital Bretonneau, Cedex 01, France.
Received February 14, 2000;
accepted after revision May 3, 2000.
Address correspondence to L. Brunereau.
Abstract
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SUBJECTS AND METHODS. Fifty-eight women (age range, 33-65 years; mean age, 44.5 years) with symptoms caused by uterine leiomyomas (abnormal bleeding, bulk-related symptoms, pelvic pain) were included in this prospective study. We performed embolization with a single catheter using the single-femoral artery approach, injection of particles (150-250 mm), and an absorbable gelatin sponge. Postprocedural pain was assessed using a visual analog scale. Systematic follow-up included clinical and sonographic examinations at 3 months for 58 patients, at 6 months for 46 patients, at 1 year for 27 patients, and at 2 years for seven patients.
RESULTS. Embolization was performed without problems in 84% of the patients. Post-procedural pain control was excellent in 90% of the patients. In most patients, symptoms were improved or had resolved at 3 months (90%), 6 months (92%), and 1 year (93%), and all patients were symptom-free at 2 years. Clinical failure of treatment occurred in only two patients (3%). Progressive reduction in leiomyoma size was revealed during sonographic follow-up, and new leiomyomas were seen in one patient at 2 years.
CONCLUSION. Uterine artery embolization is an endovascular method for the treatment of uterine leiomyomas that is clinically effective in most patients and that induces a progressive reduction in the size of the largest leiomyomas.
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After undergoing a clinical examination performed by a gynecologist, all women without contraindications for embolization were interviewed by an interventional radiologist who explained the current technique and the risks of the embolization procedure. After this consultation patients were allowed to choose freely between embolization and surgery. All patients accepting endovascular treatment were required to sign an informed consent form.
Sixty-four patients were included in this study. However, six patients were lost to follow-up; we therefore analyzed data for 58 patients.
Patients
The study population comprised 58 adult women (age range, 33-65 years; mean
age, 44.5 years). Fifty-five patients preferred embolization to surgery (i.e.,
myomectomy or hysterectomy) because of a strong desire to keep the uterus or
to avoid a surgical procedure. Embolization was indicated by potential
operative risks in three patients (thomboembolic disease in one patient,
severe obesity in two patients).
Symptoms related to leiomyomas were classified in three categories: abnormal bleeding (menorrhagia, metrorrhagia), bulk-related symptoms (frequency of urination, sensation of pressure or mass, uni- or bilateral hydronephrosis), and pelvic pain. The distribution of symptoms was as follows: abnormal bleeding (n = 29), bulk-related symptoms (n = 11), pelvic pain (n = 5), abnormal bleeding with bulk-related symptoms (n = 8), abnormal bleeding with pelvic pain (n = 2), bulk-related symptoms with pelvic pain (n = 2), and abnormal bleeding with bulk-related symptoms and pelvic pain (n = 1). Moreover, abnormal bleeding was responsible for anemia in 10 patients (range of hemoglobin levels, 40-115 g/L).
The size of the uterus (longitudinal axis) and the size of the leiomyomas (largest diameter) were assessed by a sonographic examination including both abdominal and transvaginal approaches that was performed during the weeks before embolization. The mean uterus size was 105.6 ± 36.6 mm (range, 39-240 mm), and the mean size of the largest leiomyoma was 57 ± 29.1 mm (range, 13-140 mm).
Sedation and Analgesia
The first 22 embolizations were performed with epidural anesthesia with
0.5% bupivacaine hydrochloride (Marcaine; Astra-Zeneca, Rueil-Malmaison,
France) in 20 patients and with local anesthesia of the groin with 2%
lidocaine (Xylocaine; Astra-Zeneca) combined with mild sedation (IV injection
of midazolam [Hypnovel; Roche, Neuilly-sur-Seine, France]) in two patients.
The last 36 embolizations were performed using general anesthesia, including
IV injection of propofol (Diprivan; Zeneca-Pharma, Cergy, France), atracurium
besylate (Tracrium; Glaxo-Wellcome, Marly-le-Roi, France), and sufentanil
(Sufenta; Jansen-Cilag, Issy-les-Moulineaux, France) and inhalation of
isoflurane (Forene; Abbott, Rungis, France). All patients were monitored using
pulse oximetry, electrocardiography, and arterial pressure measurements.
Prophylactic antibiotics (amoxicillin and clavulanate potassium [Augmentin; SmithKline-Beecham, Nanterre, France]) were administered systematically before arteriography.
For the first 24 hr after embolization, patients were treated with IV injections of paracetamol (Pro-Dafalgan [2 g]; UPSA, Rueil-Malmaison, France), ketoprofen (Profenid [300 mg]; Rhone-Poulenc Roger, Montrouge, France), and nefopam (Acupan [100 mg]; Biocadex, Montrouge, France) and subcutaneous injections of morphine (Morphine [30 mg]; Aguettant, Lyon, France) for pain control. After being discharged from the hospital, patients were treated with oral paracetamol (Dafalgan; UPSA) and oral morniflumate (Nifluril; UPSA) for 7 days.
Arteriography and Embolization
We used a 1024 x 1024 matrix angiographic unit (ADVANTX; General
Electric Medical Systems, Milwaukee, WI). Vascular access was obtained via the
right common femoral artery, and bilateral catheterization of uterine arteries
was achieved using a single 4- or 5-French cobra catheter, introduced with an
angled hydrophilic wire. The tip of the catheter was placed in the origin of
the hypogastric arteries. By means of road mapping performed with an injection
of 300 mg/mL iobitridol (Xenetix; Guerbet, Roissy, France), uterine arteries
were catheterized via the anterior trunks of the hypogastric arteries.
Diagnostic injection was performed in each uterine artery to show the
hypervascularization of the uterus. The left uterine artery was cannulated
first. On the right side, a Simmons curve was applied to the cobra catheter to
cannulate the hypogastric and then the uterine arteries. Free-flow
embolization was performed just beyond the junction of the descending and
horizontal portions of the uterine arteries using 150- to 250-µm polyvinyl
alcohol particles and an absorbable gelatin sponge. Stagnation of contrast
medium was evidenced in the uterine capillary network at the end of
embolization, and an absence of flow was depicted in either uterine artery by
injecting contrast medium into the hypogastric arteries.
Technical difficulties and complications occurring during the procedure were recorded systematically.
Follow-Up
We analyzed follow-up during and after hospitalization.
A clinical examination was performed for each patient each day during hospitalization. All symptoms were recorded: fever, pain, headache, and bleeding. Moreover, postprocedural pelvic pain was evaluated using a visual analog scale—that is, a 10-cm horizontal line with two extremes (left extreme, no pain; right extreme, very intense pain) on which patients could quantify pain [11]. Pain score was determined by either a nurse or an anesthesist by measuring the distance in centimeters between the left extreme and the pain level shown by patients.
Systematic follow-up after discharge from the hospital included clinical and sonographic examinations at 3 months, 6 months, 1 year, and 2 years. Sonographic examinations were always performed with a 3.5-MHz abdominal probe and with a 4-8-MHz transvaginal probe. Evolution of clinical symptoms was classified as increased, unchanged, improved, or absent (i.e., symptom-free). Evolution of sonographic findings was analyzed by measuring the size of the uterus (longitudinal axis) and the largest diameter of the largest leiomyoma. At the time of writing this article, 58 patients had been examined at 3 months, 46 at 6 months, 27 at 1 year, and seven at 2 years.
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Difficulties of catheterization.—Catheterization of the right hypogastric artery was impossible via the right common femoral artery in one patient (2%). A contralateral femoral puncture was therefore performed to cannulate the right uterine artery. Severe unilateral vasospasm prevented catheterization of either the right (n = 4) or the left (n = 2) uterine artery with a 5-French catheter in six patients (10%). This technical problem was resolved in five of these patients with the use of a 0.018-inch microcatheter (Tracker; Target Therapeutics, Fremont, CA). In the last patient, the right uterine artery remained occluded, and embolization was impossible despite the use of the microcatheter and local injection of papaverine hydrochloride. Fortunately, in this patient there was a solitary leiomyoma that was probably supplied mainly by the left uterine artery because the procedure was clinically successful with resolution of abnormal bleeding 6 months after the procedure.
Complications of catheterization.—A subintimal dissection of the right external iliac artery occurred during catheterization of the right hypogastric artery in one patient (2%). The procedure was immediately stopped, and dilatation of the narrowed iliac artery was attempted with a 7-mm inflated balloon. Postdilatation opacification of the right external artery performed via a left femoral artery approach showed improved arterial flow at the level of the dissection. IV injections of heparin were administered for 6 days, and no ischemic complication occurred in the right lower limb. Embolization of the right uterine artery was successfully performed 2 months later with a left femoral artery approach, and a moderate residual stenosis of the previously dissected right iliac artery was also revealed during this second procedure.
A small leak of contrast medium occurred in one patient (2%) during catheterization of the right uterine artery. This complication, which was caused by vascular perforation, was immediately and sucessfully treated by embolization of the uterine artery with an absorbable gelatin sponge.
Follow-Up
During hospitalization.—Fifty-four patients (93%) had no
postprocedural complications. Three patients (5%) were feverish
(
38.5°C) for 48 hr after embolization. Fever resolved spontaneously
without specific treatment. One patient (2%) developed severe headaches
related to leakage of cerebrospinal fluid caused by the epidural
anesthesia.
Postprocedural pain control was excellent in 52 patients (90%), and pelvic pain was rated from 0 to 1 on the visual analog scale. Only six patients (10%) developed pelvic pain, rated from 3 to 4. The average duration of hospitalization was 2.3 days (range, 2-6 days).
After discharge from the hospital.—One patient (2%) consulted a gynecologist at our institution 1 week after embolization for a diffuse cutaneous eruption that might have been related to the injection of amoxicillin. One patient (2%) was readmitted to the hospital 3 weeks after treatment for fever and flank pain related to acute pyelonephritis. This patient was successfully treated with appropriate antibiotics.
At 3 months.—Of 58 patients, symptoms remained unchanged in six patients (10%), were improved in 44 (76%), and had resolved in eight (14%). Sonographic examinations revealed a mean reduction in uterus size of 13% (range, 0-50%) and in leiomyoma size of 23% (range, 0-100%).
At 6 months.—Of 46 patients, abnormal bleeding had increased in two patients (4%) after a period of stability. Hysterectomy was necessary for one patient and a second embolization procedure for the other. Symptoms remained unchanged in two patients (4%), were improved in 10 (22%), and had resolved in 32 (70%). Sonographic examinations showed a mean reduction in uterus size of 23% (range, 0-55%) and in leiomyoma size of 43% (range, 0-100%).
At 1 year.—Of 27 patients, symptoms remained unchanged in two patients (7%) and were improved in three (11%). The other 22 patients (82%) were symptom-free. Sonographic examinations showed a mean reduction in uterus size of 26% (range, 0-60%) and in leiomyoma size of 51% (range, 25-100%).
At 2 years.—Of seven patients, all were symptom-free. Sonographic examinations revealed a mean reduction in uterus size of 38% (range, 0-60%) and in leiomyoma size of 65% (range, 20-75%). However, new small leiomyomas were seen on sonography in one patient (14%).
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Because superselective catheterization of the small arteries supplying leiomyomas is not possible, embolization with polymerizing liquid emboli is contraindicated. Free-flow selective injection of calibrated particles (polyvinyl alcohol) is therefore preferred and can be performed in both uterine arteries to induce devascularization of leiomyomas. In our series, we always used smaller particles (150-250 µm) than those used in other series (500-700 µm in the series of Worthington-Kirsch et al. [6] and 300-500 µm in the series of Burn et al. [7]). We chose this type of particle because they would provide longer occlusion of the capillary network of leiomyomas and they could therefore be more effective in long-term follow-up. The risk associated with these small particles is the occurrence of complications such as endometrial or cervicovaginal necrosis. However, no ischemic complications occurred in this series.
Progressive reduction in both leiomyoma and uterus size was revealed on sonographic examinations in our systematic follow-up (Fig. 3A,3B,3C,3D,3E). The mean size reduction of leiomyomas observed in our series during the first 3 months after embolization (23%) was less than that reported by Worthington-Kirsch et al. [6] (46%) and that by Burn et al. [7] (43%). We are not able to explain these discrepancies, but we conclude that in our series injection of small particles did not induce sudden and massive tumor necrosis but progressive size reduction related to chronic and durable ischemia.
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Our clinical follow-up showed that the outcome was satisfactory in most patients. Post-procedural pain control was excellent during hospitalization in 52 patients (90%) with a therapeutic protocol including analgesic and narcotic drugs and nonsteroidal antiinflammatory drugs. Worthington-Kirsch et al. [6] have already reported that postprocedural pain control should include a nonsteroidal antiinflammatory drug to provide the best results.
The average duration of hospital stay was 2.3 days in our series and was similar to those previously reported [5,6,7]. Most patients were discharged from the hospital the first day after embolization. However, two patients were obliged to remain in hospital for 6 days because of intraprocedure complications. In the first patient, dissection of the right external iliac artery occurred during the catheterization of the right hypogastric artery. This procedure, performed with epidural anesthesia, was immediately stopped, and dilatation of the dissected artery was successful. IV injections of heparin were carefully administered subsequently because of epidural anesthesia. In the second patient, injury of the dura matter occurred during epidural puncture resulting in severe headaches. After these complications occurred, the anesthetists at our institution decided to perform all subsequent embolizations with general anesthesia rather than epidural anesthesia, in contrast to other series in which procedures were performed with local anesthesia combined with mild sedation [5, 7, 9]. The choice of general anesthesia was justified by the various durations of procedures, some of which exceeded 2 hr.
We did not observe vaginal expulsion of any leiomyoma after embolization, as reported by Berkowitz et al. [13] and Abbara et al. [14]. However, acute pyelonephritis occurred in one patient during the first month after treatment. The cause of this infection was not clear. Vashisht et al. [15] recently reported a patient's death that was related to a severe infection after embolization of a large fibroid uterus (14 x 12 x 11 cm). In this patient, a urinary tract infection, which was treated with antibiotics, developed 3 days after treatment. Seven days later, the patient developed fatal septicemia caused by Escherichia coli. The authors suggested that the presence of a urinary tract infection and the resulting gram-negative septicemia were perhaps not coincidental, although the infection was treated with appropriate antibiotics. The complications of this endovascular technique can therefore be serious and potentially fatal. We conclude that the main risk of this treatment is the delayed occurrence of severe genitourinary infection because a necrosing leiomyoma is probably an ideal medium for bacterial development. To reduce the risk of infection, it is advisable to extend treatment with antibiotics for several days after embolization in patients with a large or submucosal leiomyoma. Furthermore, performing hysteroscopy just before or after the procedure appears to be contraindicated.
At least 90% of our patients were clinically improved or symptom-free at 3 months, 6 months, and 1 year after treatment, and all patients were symptom-free at 2 years. Improvement of symptoms after endovascular treatment has already been reported in most previous series [5, 6, 8,9,10]. Bradley et al. [8] reported one case of amenorrhea related to ovarian failure caused by embolization. In our series, postprocedural amenorrhea was recorded in two patients: the first case occurred in a 50-year-old woman 1 year after embolization, and the second case occurred in a 53-year-old woman 2 years after treatment. In both patients, the gynecologists of our institution thought that amenorrhea was related to normal menopause because of the patients' ages and the long time interval between treatment and occurrence of amenorrhea. Two cases of embolization failure (3%) occurred in our series. They were revealed by recurrence of abnormal bleeding 6 months after treatment, and surgical treatment (hysterectomy) was needed in one patient and a second embolization procedure was needed in the other. This second patient was a 50-year-old woman with severe abnormal bleeding. Six months after endovascular treatment, symptoms remained unchanged and a second embolization procedure was therefore performed. Six months after the second embolization procedure, abnormal bleeding was only moderately improved. The failure rate in our series was close to that reported earlier in large series: 4% for Worthington-Kirsch et al. [6] and 11% for Ravina et al. [9].
The occurrence of new leiomyomas was seen on sonography in one patient
after embolization (Fig.
4A,4B).
To our knowledge, this finding has never previously been reported. This
patient remained symptom-free 2 years after the endovascular procedure. The
new leiomyomas were small (
1 cm) and probably existed before treatment but
were too small to be visualized on the first sonographic examination. This
finding indicates that the uterus always has the capacity to develop new
leiomyomas after endovascular embolization with 150- to 250-µm particles.
Embolization cannot therefore be considered a radical treatment compared with
hysterectomy, and all patients should be monitored with clinical and
sonographic examinations for more than 2 years after the endovascular
procedure.
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In conclusion, our study shows that uterine artery embolization is an effective primary treatment of leiomyomas. Both uterine arteries were easily cannulated and successfully embolized in most patients. A single catheter with the single-femoral artery approach was used systematically to decrease the cost of the procedure, and small (150-250 µm) calibrated particles were injected without ischemic complication. Most patients were clinically improved at 3 months, 6 months, and 1 year, and all were symptom-free at 2 years. Sonography was an ideal method to show and follow the progressive reduction in the size of the main leiomyoma. However, we recommend prescribing appropriate treatment for pain control to improve the comfort of patients after the procedure and monitoring patients with clinical and sonographic examinations for more than 2 years after treatment.
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