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ORIGINAL RESEARCH |
From the Department of Radiology, Georgetown University Hospital, Washington, DC.
Address reprint requests to: James B. Spies, MD, Department of Radiology, 3800 Reservoir Road, NW, CG201, Washington DC 20007-2197; E-mail: spiesj{at}gunet.georgetown.edu
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: We analyzed 200 consecutive patients (61 reported previously) undergoing uterine artery embolization for the treatment of uterine leiomyomata at a single institution. After treatment, follow-up data were obtained by written questionnaire mailed to the patients at intervals of 2 weeks, 3 months, 6 months, and 12 months after treatment. Follow-up imaging was obtained at 3 months and 12 months after therapy. All complications and subsequent gynecologic interventions were recorded prospectively, obtained using the patient questionnaires and physician contact. The percentages and their 95% confidence intervals (CI) were calculated to compare the symptoms at follow-up. Proportional odds models for repeated ordinal responses were used to assess the stability of symptom improvement over time.
RESULTS: The mean follow-up was 21 months (minimum 12). Heavy menstrual bleeding improved in 87% (95% CI 82%, 92%) of patients at 3 months and in 90% (95% CI 86%, 95%) at 1 year after therapy. Bulk symptoms improved in 93% of patients (95% CI 88%, 96%) at 3 months and in 91% (95% CI 86%, 95%) at 1 year after treatment. Only one major periprocedural complication occurred (pulmonary embolus), which resolved with anticoagulant therapy. Subsequent gynecologic interventions occurred in 10.5% of the patients (95% CI 7.0%, 15.0%) during the follow-up period.
CONCLUSION: Uterine artery embolization is safe and controls the symptoms caused by leiomyomata in most patients.
Uterine artery embolization as the sole therapy for uterine leiomyomata was first reported in 1995.1 Subsequent published studies have shown embolization to be effective in the short and mid-term.2–8 Longer term reports9–11 have suggested a stability of symptom improvement in small numbers of patients for up to 5 years.
When we began our study, no studies of sufficient size and duration had been conducted to calculate the complication rates and stability of the symptom and imaging changes after therapy. In addition, few data were available about the need for additional gynecologic interventions after treatment. With these goals, we began our study of uterine embolization in July 1997 and report here the results of therapy.
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MATERIALS AND METHODS |
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All women with uterine leiomyomata and one or more of the following symptoms were included in this study: 1) heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, anemia, or a substantial prolongation of menstrual periods compared with the patient’s prior experience; 2) pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the leiomyomata; or 3) urinary frequency, an increase in nocturia, difficulty voiding or other bladder symptoms caused by compression of the bladder, or compression of the ureters with hydronephrosis. All but heavy menstrual bleeding were grouped as bulk symptoms. Exclusion criteria included patients currently pregnant, those with infertility attributed to leiomyomata by their gynecologist, women with a primary goal of becoming pregnant whose leiomyomata could be removed by myomectomy without extensive dissection of the uterus, those with pedunculated submucosal leiomyomata that were hysteroscopically resectable, and those with a greater than 24 weeks in size uterus.
Each subject underwent either a pelvic ultrasound or magnetic resonance imaging (MRI) study of the pelvis. After the first 14 patients, the protocol was changed to require pelvic MRI before the procedure. The imaging studies were obtained to confirm the diagnosis of leiomyomata, determine their size and position, and to identify adenomyosis or other concurrent disease. Follow-up MRI was obtained at 3 months and at 1 year after the procedure. The images were interpreted by the attending radiologists at the various imaging centers. Measurements provided in the radiographic reports were used to calculate the volumes. The volumes of the dominant leiomyoma and uterus both before and after treatment were calculated using the formula for a prolate ellipse (L x W x D x .5233) as described by Orsini et al.12 Leiomyoma location was determined by the location of the center of the leiomyoma.
Bilateral embolization was performed in each case. Polyvinyl alcohol particles (500–710 µm in size) (Contour, Boston Scientific, Boston, MA; Ivalon, Cook Inc., Bloomington, IN; and Trufill, Cordis, Miami, FL) were injected into each uterine artery until the leiomyoma vasculature was occluded and slow flow or near stasis occurred in the main uterine artery. After the procedure, the woman was admitted to an observation unit for post-procedure care. Pain was controlled with nonsteroidal anti-inflammatory agents and intravenous narcotics.
The number of nights of hospitalization was recorded for all patients. After discharge, patient progress was monitored by phone and a questionnaire mailed 2 weeks after treatment. To estimate the duration of recovery, patients were asked the number of days until their return to normal activity, defined as the longer of "days until return to work" or "days until return to normal activity." Complications were recorded prospectively. Minor complications were defined as adverse events that occurred within 30 days of therapy that required unanticipated office visits, emergency room visit, or rehospitalization for 1 day. Major complications included all those that required surgery or hospitalization for longer than 1 day. Subsequent gynecologic operative interventions were also recorded prospectively.
Symptom change was detected by a questionnaire at 3, 6, and 12 months after treatment. Initially, a simple questionnaire regarding symptom change for menstrual bleeding and bulk symptoms used a five-point Likert symptom scale (much better, slightly better, no change, slightly worse, much worse). After the initial group of 61 patients, this scale was expanded to an 11-point scale, extending from -5 (markedly worse) through 0 to +5 (markedly improved) to measure more subtle changes. To rate patient satisfaction, appropriate corresponding labels were used. All subsequent patients received only the new questionnaire; it was also used for all subsequent inquiries from the initial group of patients. For the purposes of this analysis, the old symptoms scale was merged with the new. The new questionnaire also inquired as to new gynecologic problems, any gynecologic procedures, and menstrual status.
Summary descriptive statistics were used to characterize the procedure parameters, uterine and leiomyoma volume changes, and questionnaire responses. For baseline parameters, the demographic data were summarized for age, race, presenting symptoms, and previous leiomyoma therapies. Baseline imaging indices were the volume of the uterus, dominant leiomyoma volume, number of leiomyomata, and location of the dominant leiomyoma. The dominant leiomyoma was defined as the largest.
Initial comparisons were made using percentages and their 95% CI. Exact confidence intervals were calculated using the binomial distribution in the Statistical Analysis System software, version 8 (SAS Institute, Cary, NC). Exact confidence intervals were calculated because of the small proportions for some of the variables examined.13 Repeated-measures analysis of variance was used to examine the percentage of reduction in uterine volume over time. Proportional odds models for repeated ordinal responses were used to assess the stability of the symptom improvement over time.14 Three measures of symptom improvement were modeled: heavy menstrual bleeding, bulk symptoms, and satisfaction. The original 11 levels of these measures were collapsed into three: improved, unchanged, and worse. These levels represented an ordinal response, with improved the highest level and worse the lowest. The responses were analyzed for three occasions: 3, 6, and 12 months after treatment. In these models, cumulative logits were modeled as a function of occasion, and the hypothesis of no change in marginal response distribution across occasions was tested using asymptotic 
2 tests.
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RESULTS |
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. The procedure was technically successful on both uterine arteries in 198 women. In one, neither uterine artery could be successfully catheterized and embolization was not performed. In another, one uterine artery had previously been ligated during myomectomy, and as a result, only one artery was embolized. Most (93%) had an overnight (23-hour) admission to the hospital. An additional 4% were discharged the day of the procedure. Admission for more than 1 night was required in 3% of patients. The average number of days until a return to normal activity was 8, including weekend days. The mean duration of study participation was 21 months. Follow-up questionnaires were obtained from 91% of subjects at 3 months, 82% at 6 months, 92% at 1 year, and 69% at 2 years. Each patient in the study had a minimum interval of 12 months from the procedure.
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provides a summary of the symptom outcome after therapy. Most patients had improvement in symptoms by 3 months after the procedure and the symptom control persisted in most cases for up to 2 years of follow-up. Patient satisfaction paralleled the symptom change. The stability of the symptom improvement did not change over time for heavy menstrual bleeding (P = .49), bulk symptoms (P = .97), or satisfaction (P = .76). The estimated odds ratios between the 3-month and 1-year occasions and the 6-month and 1-year occasions were as follows: heavy menstrual bleeding, 1.38 (95% CI 0.74, 2.56) and 1.4 (95% CI 0.77, 2.55); bulk symptoms, 1.05 (95% CI 0.35, 3.10) and 0.96 (95% CI 0.54, 1.68); and satisfaction, 1.29 (95% CI 0.57, 2.90) and 1.27 (95% CI 0.60, 2.70). Although the data demonstrate a slight shift in the distribution toward less improvement at 1 year of follow-up, this shift is not different than chance.
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Table 3 presents the periprocedural complications. Thirteen minor complications (6.5%) occurred, all treated with nominal therapy. Most of these complications were for additional pain management (n = 7). One major complication occurred. A patient developed a pulmonary embolus within 36 hours of the procedure. Her pulmonary embolus was diagnosed 2 days after discharge, prompting readmission for 4 days for anticoagulation therapy.
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Subsequent gynecologic interventions or readmissions occurred in 10.5% of patients (95% CI 7.0%, 15.0%) and are summarized in Table 4. Most gynecologic procedures occurred months after the procedure. In our experience, D&C or hysteroscopic resection were the most common interventions for acute gynecologic problems related to the treated leiomyomata. During follow-up, five of the subsequent interventions (2.5% of the study group) were for endometrial infection, fibroid tissue passage, or severe bleeding.
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DISCUSSION |
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To date, our results with uterine embolization for leiomyomata parallel those reported by others. Seven case series of more than 40 patients (including our own initial report) have been published detailing the results of this therapy.5–11 In these series, the symptoms improved in 81–95% of patients. Our results mirror those, with 87% of patients reporting improved menstrual bleeding and 93% of patients with pelvic pressure and other bulk symptoms improved at 3 months after treatment. These results remained stable during the course of follow-up. Patient satisfaction with symptomatic improvement paralleled the symptom results, with 93% satisfied to some degree 3 months after therapy.
The imaging studies at 3 and 12 months after embolization revealed a progressive reduction in uterine volume and, to a greater extent, dominant leiomyoma volume. We used MRI as the primary imaging method both before and after treatment to accurately characterize the size, location, and enhancement pattern of the leiomyomata. In addition, we wanted to be certain of the diagnosis of leiomyomata, and MRI is more accurate in distinguishing adenomyosis from leiomyomata.15 Preliminary evidence suggests that the degree of enhancement on MRI and fibroid location may be useful in predicting outcome.16,17 Additional analysis is needed to determine whether imaging characteristics at baseline or during follow-up predict outcome.
Complications were very infrequent, and serious complications were quite rare. We had only one serious complication within 30 days of the procedure, a pulmonary embolus. Although infection requiring hysterectomy has been reported,2,6 it did not occur in our experience and appears to be rare. Similarly, subsequent gynecologic intervention is very unusual and in only 5 patients (2.5% of the total study group) was it in response to an acute gynecologic problem.
On the basis of the results of our study, we found no group of patients with leiomyomata for whom this procedure is clearly contraindicated. With broader application of uterine artery embolization, there may be patient subgroups identified who have a poor outcome and for whom the procedure should not be considered. To date, we have not found any such subgroups.
No studies have compared the outcome of uterine artery embolization with other therapies for leiomyomata. As an invasive uterine-sparing treatment, myomectomy may be the best comparison procedure. In the recent ACOG Practice Bulletin on surgical alternatives to hysterectomy for leiomyomata, the reviewers concluded that less outcomes research is available for myomectomy than for hysterectomy.18 The review by Buttram and Reiter19 noted that menorrhagia was controlled in approximately 81% (range 40–93%). Similar rates of improvement were noted for pelvic pressure.
Although these data suggest that uterine artery embolization and myomectomy have similar rates of symptom control, studies directly comparing various therapies are necessary before conclusions can be reached. We would also note that no definitive studies comparing the outcome of hysterectomy and myomectomy have been performed nor any comparing myomectomy with medical therapies. With the growing interest in uterine-sparing therapies for leiomyomata, there is clearly a need to assess all current therapies in relation to alternatives.
We conclude that uterine artery embolization for leiomyomata is safe, with serious complications occurring rarely. Most patients report improved symptoms and satisfaction with the outcome from treatment.
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Footnotes |
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Received September 27, 2000. Received in revised form January 14, 2001. Accepted March 1, 2001.
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REFERENCES |
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2. Goodwin S, Vedantham S, McLucas B, Forno A, Perrella R. Preliminary experience with uterine artery embolization for uterine fibroids. J Vasc Interv Radiol 1997;8: 517–26.[Medline]
3. Bradley E, Reidy J, Forman R, Jarosz J, Braude P. Transcatheter uterine artery embolisation to treat large uterine fibroids. Br J Obstet Gynaecol 1998;105:235–40.[Medline]
4. Burn P, McCall J, Chinn R, Healy J. Embolization of uterine fibroids. Br J Radiol 1999;72:159–61.[Abstract]
5. Ravina J, Bouret J, Cirary-Vigneron N, Repiquet D, Herbreteau D, Aymard A, et al. Application of particulate arterial embolization in the treatment of uterine fibromyomata. Bull Acad Natl Med 1997;181:233–43.[Medline]
6. Worthington-Kirsch R, Popky G, Hutchins F. Uterine arterial embolization for the management of leiomyomas: Quality-of-life assessment and clinical response. Radiology 1998;208:625–9.
7. Spies J, Scialli A, Jha R, Imaoka I, Ascher S, Fraga V, et al. Initial results from uterine fibroid embolization for symptomatic leiomyomata. J Vasc Interv Radiol 1999;10: 1149–57.[Medline]
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12. Orsini L, Salardi S, Pilu G, Bovicelli L, Cacciari E. Pelvic organs in premenarcheal girls: Real-time ultrasonography.Radiology 1984;153:113–16.
13. Dudewicz E, Mishra S. Modern mathematical statistics.New York: John Wiley & Sons, 1988.
14. Agresti A. Categorical data analysis. New York: John Wiley & Sons, 1990.
15. Outwater EK, Siegelman ES, Van Deerlin V. Adenomyosis: Current concepts and imaging considerations. AJR Am J Radiol 1998;170:437–41.
16. Burn PR, McCall JM, Chinn RJ, Vashisht A, Smith JR, Healy JC. Uterine fibroleiomyoma: MR imaging appearances before and after embolization of uterine arteries.Radiology 2000;214:729–34.
17. Jha R, Ascher S, Imaoka I, Spies J. Symptomatic fibroleiomyomata: MR imaging of the uterus before and after uterine arterial embolization. Radiology 2000;217: 228–35.
18. American College of Obstetricians and Gynecologists.Surgical alternatives to hysterectomy in the management of leiomyomas. ACOG practice bulletin no. 16. Washington, DC: American College of Obstetricians and Gynecologists, 2000.
19. Buttram V, Reiter R. Uterine leiomyomata; etiology, symptomatology, and management. Fertil Steril 1981;36: 433–45.[Medline]
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