The EMMY trial of uterine artery embolization for the treatment of symptomatic uterine fibroid tumors: randomized, yes, but a flawed trial nonetheless.
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Biomedical subjects
Publications and source records attributed to James B Spies.
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Uterine fibroid embolization (UFE) is a minimally invasive therapy for the treatment of symptomatic uterine fibroids and offers an alternative to conventional myomectomy and hysterectomy. This review focuses on recent publications evaluating UFE and concludes that it is a safe treatment option, providing substantial improvement in both health-related quality of life and symptom control for most patients, with a very low rate of major complications. The durability of these outcomes appears similar to those obtained with myomectomy; however, a direct comparative long-term study is needed. Recent comparative studies have begun to provide more insight in to UFE outcomes compared with outcomes achieved with myomectomy and hysterectomy. UFE should be considered a first line therapy for women with symptomatic uterine fibroids. Additional research will continue to provide us with information as to the ideal candidates for UFE and may provide us with better tools to predict patient outcomes.
PURPOSE: To determine the indications and technical aspects of procedures in patients undergoing repeat uterine artery embolization (UAE). MATERIALS AND METHODS: At a single center, 24 patients underwent repeat embolization for recurrent or persistent symptoms. The magnetic resonance (MR) imaging findings before repeat embolization were compared with those of earlier studies. The extent of tumor infarction after the first procedure was determined, and the status of existing or new tumors before the second procedure was assessed. The angiographic studies from the initial and repeat embolization studies were reviewed and summarized. These findings were assessed with the use of summary statistics. RESULTS: Twenty-four patients underwent repeat embolization 6-66 months after the initial embolization. The most common symptom at representation was pressure and/or bulk symptoms (n=15), followed by recurrent heavy bleeding (n=12) and pelvic pain or cramping (n=7). MR imaging studies before repeat embolization revealed incomplete infarction of tumors present before the first embolization in 22 of 24 patients. New tumors were identified in 12 patients, two of whom had new tumors only. During repeat embolization, nine patients (37%) required ovarian artery embolization to occlude ovarian supply to the uterus. Among 21 women with clinical follow-up after the second embolization, 19 (90%) had symptom control. CONCLUSIONS: Repeat embolization prompted by recurrent uterine leiomyomas usually occurs in the setting of regrowth of incompletely infarcted tumors. Although ovarian embolization was often needed, on the basis of this limited experience, symptoms appear to respond well to repeat embolization.
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OBJECTIVE: Our objective was to describe the MRI features of patients with pure or dominant adenomyosis treated with uterine artery embolization (UAE) and to correlate imaging features with symptoms. SUBJECTS AND METHODS: Nineteen patients with symptomatic pure or dominant adenomyosis on MRI were referred for UAE. All 19 patients had repeat MRI 4 months after UAE. The MR images obtained before and after UAE were evaluated for maximal junctional zone thickness, junctional zone-myometrial ratio, uterine volume, and the presence of avascular regions. Patients were asked to complete a questionnaire about their symptoms before and 3 and 12 months after UAE. RESULTS: Uterine volume decreased significantly after UAE (p < 0.01). The mean uterine volume reduction was 25.1%. Junctional zone thickness decreased significantly (p < 0.001). The junctional zone-myometrial ratio did not decrease significantly (p = 0.526). Fourteen (73.7%) of the 19 patients showed devascularized change within the adenomyotic region. Eighteen patients completed a questionnaire at 3 months. Sixteen (88.9%) of the 18 reported an improvement in symptoms, whereas the two remaining patients (11.1%) reported no change (p < 0.001). Of the 16 patients with clinical improvement, 11 had devascularized areas after UAE and five did not. Eleven of the 18 patients who completed a questionnaire 3 months after UAE also completed a questionnaire 12 months after UAE. Ten of these 11 patients still reported continued improvement, and one patient reported a worsening of symptoms. CONCLUSION: UAE in patients with pure or dominant adenomyosis results in decreased uterine volume and regions of devascularization. Most patients reported an improvement in clinical symptoms within 3 months after UAE. Some patients reported benefit for at least 1 year; however, the long-term durability of symptomatic relief remains unknown.
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OBJECTIVE: To describe registry methods and baseline patient demographics from a national sample of women undergoing uterine artery embolization for uterine leiomyomata. METHODS: Interventional radiology practices were recruited to submit data by a secure Web site on women undergoing uterine artery embolization for symptomatic leiomyomata. Baseline data included patient demographics, prior medical, surgical, and obstetrical history, uterine anatomy, and quality-of-life measures. Subsequent data collected included details of the uterine artery embolization procedure and hospital stay and outcomes at 30 days; patients were also offered the opportunity to participate in longer-term follow-up. Characteristics of white and African-American women were compared using t tests, chi(2), or Wilcoxon rank-sum tests as appropriate. RESULTS: As of December 31, 2002, 3,319 uterine artery embolization cases had been entered into the registry by 72 sites; number of patients entered by individual sites ranged from 1 to 514. Of these patients, 95.4% consented to participation in the short-term outcomes registry. Forty-eight percent of patients were African American, and 44.4% were white and non-Hispanic. Heavy menstrual bleeding was the single most bothersome symptom in 64.3% of patients. Compared with white non-Hispanic women, African-American women were significantly younger, more likely to be obese, had larger uteri and more numerous leiomyomata, more severe symptoms, and poorer quality-of-life scores before treatment. CONCLUSION: It is feasible to collect prospective data on new technologies. The FIBROID Registry prospectively collected data on more than 3,000 women undergoing uterine artery embolization for symptomatic leiomyomata. Baseline patient characteristics of this patient population seem to be similar to those of women undergoing other procedures for leiomyomata. LEVEL OF EVIDENCE: III.
OBJECTIVE: To investigate the short-term safety of uterine embolization for leiomyomata in a large cohort of patients treated in a variety of clinical settings. METHODS: Examining the FIBROID Registry, a multicenter prospective voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied the frequency of adverse events and predictors of adverse events within 30 days of the procedure. We also report on the technical aspects of the procedure, including details of periprocedural care, technique, and short-term recovery. All adverse events were recorded and classified using standard definitions, both in terms of type and severity. Summary statistics were used to describe the data set, and univariate and multivariate analyses were used to determine which factors might influence the incidence of adverse events. RESULTS: Of the 3,160 patients enrolled at 72 contributing sites, major in-hospital complications occurred in 0.66%, and postdischarge major events occurred in 4.8% within the first 30 days. The most common adverse event after discharge was inadequate pain relief requiring additional hospital treatment (2.4%). Thirty-one patients required additional surgical intervention within 30 days after treatment, 3 of whom required hysterectomy (0.1%). There were no deaths. Multivariate analysis showed modest increased odds for an adverse event for African Americans, smokers, and those with prior leiomyoma procedures. There were no differences in outcome based on the practice site experience, practice type, or any procedure-related factors. CONCLUSION: Uterine embolization for leiomyomata is a low-risk procedure with little variability in short-term outcome based on either patient demographics or practice setting. LEVEL OF EVIDENCE: II-3.
OBJECTIVE: To determine the long-term outcome from uterine artery embolization for leiomyomata. METHODS: In a prospective study, 200 consecutive patients treated with uterine embolization were each followed for 5 years. Outcome, including symptom status compared with baseline, reinterventions, menstrual status, and satisfaction were recorded. Summary statistics were used to report baseline characteristics and outcome at each interval. Predictors of subsequent interventions, failure, and satisfaction with treatment were analyzed using logistic regression and Cox proportional hazards models. Failure was defined as subsequent hysterectomy, definitive myomectomy, repeat embolization, or failure of symptom improvement at the patient's final follow-up interval. RESULTS: Of the 200 patients initially treated, 5-year follow-up was completed in 182 (91%), with 18 patients missing. At 5 years after treatment, 73% had continued symptom control, whereas 36 (20%) had failed or recurred. There had been 25 hysterectomies (13.7%), 8 myomectomies (4.4%), and 3 repeat embolizations (1.6%). Long-term failure was more likely in those not improved at 1 year (relative risk [RR] 5.73; 95% confidence interval [CI] 2.32-14.12, P < .001) and in those with baseline leiomyoma volumes greater than the median (RR 2.18; 95% CI 1.05-4.51, P = .036). After adjustment, patients in the first tertile of leiomyoma volume reduction (< or = 30.5%) were 3 times more likely to be dissatisfied with outcome compared with women in the third tertile (> or = 56.3% volume reduction) (RR 3.23; 95% CI 1 07-9.81, P = .037). CONCLUSION: Uterine embolization provides durable symptom relief for most patients, with a 25% chance of failure of symptom control or recurrence over the course of a 5-year follow-up. LEVEL OF EVIDENCE: II-3.
OBJECTIVES: To investigate the change in symptom severity and health-related quality of life among patients treated with uterine artery embolization for leiomyomata. METHODS: Using the Fibroid Registry for Outcomes Data (FIBROID), a multicenter, prospective, voluntary registry of patients undergoing uterine embolization for leiomyomata, we studied changes in symptom status, health-related quality of life, subsequent care, menstrual status, and satisfaction with outcome. Health-related quality-of-life and symptom status were measured using the Uterine Fibroid Symptom and Quality of Life, a leiomyoma-specific questionnaire. Summary statistics were used to describe the data set and multivariate analyses to determine predictors of outcome at 12 months. RESULTS: Of 2,112 eligible patients, follow-up data were obtained on 1,797 (85.1%) at 6 months and 1,701 (80.5%) at 12 months. At 12 months, the mean symptom score had improved from 58.61 to 19.23 (P < .001), whereas 5.47% of patients had no improvement. The mean health-related quality-of-life score improved from 46.95 to 86.68 (P < .001), whereas 5.0% did not improve. In the first year after embolization, hysterectomy was performed in 2.9% of patients, with 3.6% requiring gynecologic interventions by 6 months and an additional 5.9% between 6 and 12 months. Amenorrhea as a result of embolization occurred in 7.3% of patients. Of these, 86% were age 45 or older. Most patients were satisfied with their outcome (82% strongly agree or agree). Predictors of a greater symptom change score include smaller leiomyoma size, submucosal location, and presenting symptom of heavy menstrual bleeding. CONCLUSION: Uterine embolization results in substantial symptom improvement for most patients, with hysterectomy required in only 2.9% of patients in the first 12 months after therapy.
PURPOSE OF REVIEW: To summarize the literature on uterine embolization for fibroids published in 2004 and 2005. RECENT FINDINGS: During the last two years, our understanding of the outcome of uterine fibroid embolization has increased. The outcomes are comparable to those that occur after hysterectomy. Health-related quality-of-life studies have confirmed the positive impact of the procedure. Improvement in menorrhagia has been quantified using the alkaline hematin method, objectively confirming the outcome. Recovery is also better understood and quantified, with most patients experiencing only moderate pain over the first few days after embolization. In two pregnancy-outcome studies, an increased frequency of cesarean section occurred and possibly a greater likelihood of abnormal placentation, although the data are too few to draw conclusions at this time. Contrast-enhanced magnetic resonance imaging (MRI) has emerged as the primary tool for assessing the potential of complications following the procedure, and our understanding of vaginal discharge and uterine infarction has been increased as a result of its use. SUMMARY: Within the last few years, uterine embolization has become an accepted therapy for uterine fibroids. The increase in understanding gained in recent years has helped to confirm the effectiveness and relative tolerability of this therapy.
PURPOSE: To compare the outcomes of uterine artery embolization (UAE) for leiomyomas with use of tris-acryl gelatin microspheres (TAGM) versus spherical polyvinyl alcohol (PVA) particles. MATERIALS AND METHODS: Patients undergoing UAE were randomly assigned to receive TAGMs or PVA. Embolization was performed in a standardized manner. Outcome data were collected at 3 months after embolization, including assessment of clinical symptoms, scores from a fibroid tumor-specific symptom and quality of life (QOL) questionnaire, and findings on contrast material-enhanced magnetic resonance (MR) imaging, including the degree of tumor infarction and volume reduction. Data were analyzed with use of t tests, the Mann-Whitney U test, and chi2 tests as appropriate. RESULTS: Thirty-six patients were treated. There were no differences in the two treatment groups at baseline. Clinical follow-up was obtained in 35 patients. Among the clinical outcome measures, QOL score improvement was greater for UAE with TAGMs compared with PVA (49.0 vs 27.9; P = .02), but no other differences were noted. Of the 25 patients in whom 3-month MR imaging follow-up was completed, those treated with TAGM were significantly more likely to have complete infarction of all leiomyomas (six patients vs one patient; P = .02), were more likely to have at least 90% tumor infarction (eight patients vs four patients; P = .03), and had a lower mean percent of residual perfused fibroid tumor tissue (9.6% vs 44.3%; P = .004) compared with patients treated with PVA. Based on these differences between the embolic agents, enrollment in this study was terminated. CONCLUSION: The use of spherical PVA particles in the manner described herein results in an unacceptably high rate of failed tumor infarction in UAE.
Embolization has become a first-line treatment for symptomatic uterine fibroid tumors. Selective catheterization and embolization of both uterine arteries, which are the predominant source of blood flow to fibroid tumors in most cases, is the cornerstone of treatment. Although embolization for treatment of uterine fibroid tumors is widely accepted, great familiarity with the normal and variant pelvic arterial anatomy is needed to ensure the safety and success of the procedure. The uterine artery classically arises as a first or second branch of the anterior division of the internal iliac artery and is usually dilated in the presence of a uterine fibroid tumor. Angiography is used for comprehensive pretreatment assessment of the pelvic arterial anatomy; for noninvasive evaluation, Doppler ultrasonography, contrast material-enhanced magnetic resonance (MR) imaging, and MR angiography also may be used. After the uterine artery is identified, selective catheterization should be performed distal to its cervicovaginal branch. For targeted embolization of the perifibroid arterial plexus, injection of particles with diameters larger than 500 mum is generally recommended. Excessive embolization may injure normal myometrium, ovaries, or fallopian tubes and lead to uterine necrosis or infection or to ovarian failure. Incomplete treatment or additional blood supply to the tumor (eg, via an ovarian artery) may result in clinical failure. The common postembolization angiographic end point is occlusion of the uterine arterial branches to the fibroid tumor while antegrade flow is maintained in the main uterine artery.
Uterine artery embolization (UAE) is an increasingly performed, minimally invasive alternative to hysterectomy or myomectomy for women with symptomatic uterine fibroids. A growing body of literature documents symptomatic improvement in the majority of women who undergo UAE. Although UAE is usually safe and effective, there are a number of known complications associated with the procedure. Major complications include fibroid passage, infectious disease (endometritis, pelvic inflammatory disease-tubo-ovarian abscess, pyomyoma), deep venous thrombosis, pulmonary embolism, inadvertent embolization of a malignant leiomyosarcoma, ovarian dysfunction, fibroid regrowth, uterine necrosis, and even death. Minor complications include hematoma, urinary tract infection, retention of urine, transient pain, and vessel or nerve injury at the puncture site. As UAE takes its place in the treatment arsenal for women with symptomatic fibroids, radiologists need to be familiar with UAE-associated complications, which may require further treatment and may even be life threatening in some cases. Knowledge of these complications and their imaging features should lead to prompt diagnosis and appropriate treatment.
OBJECTIVE: The purpose of this study was to estimate the outcomes of uterine embolization and hysterectomy for uterine leiomyomas. Study design This was a multicenter prospective study of patients who were treated with embolization (n=102 patients) and hysterectomy (n=50 patients) for leiomyomas. Changes in symptoms, complications, and quality of life were measured. The data analysis included linear and logistic regression, the Student t and paired t test, Fisher's exact test, and chi-squared test. RESULTS: For patients who underwent embolization, there were marked reductions in blood loss scores (P <.001) and menorrhagia questionnaire scores (P <.001) compared with baseline. At 12 months, a larger proportion of the patients who had undergone hysterectomy experienced improved pelvic pain (P=.021). Both groups had marked improvement in other symptoms and quality of life scores, with no difference between groups. Complications were more frequent in patients who underwent hysterectomy (50% vs 27.5%; P=.01). CONCLUSION: Both procedures substantially improved symptoms for most patients, with an advantage for hysterectomy at 12 months for pelvic pain. Serious complications were infrequent in both groups.
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PURPOSE: To determine if the type of embolic material used for uterine artery embolization (UAE) for leiomyomas has an impact on short-term recovery or the effectiveness of embolization. MATERIALS AND METHODS: One hundred patients were randomly assigned to undergo UAE with polyvinyl alcohol (PVA) particles or tris-acryl gelatin microspheres. Short-term, in-hospital medication use and pain levels were recorded. After discharge, symptom severity, temperature, and medications used were recorded daily for 1 week and symptom levels were measured for weeks 2-4. Three months after embolization, contrast material-enhanced magnetic resonance imaging examinations were evaluated blindly to determine the extent of leiomyoma infarction. Symptom and quality of life (QOL) status was determined with use of questionnaires. Analysis was completed with use of chi(2) analysis, Fisher exact tests, Student t tests, and analysis of variance as appropriate. Regression analysis was used to analyze the impact on outcome of baseline factors (other than type of embolic agent). RESULTS: No significant differences were noted at baseline between the two treatment groups. On average, there were significantly higher volumes of tris-acryl microspheres used (9.0 mL vs 3.0 mL; P =.0001), whereas microcatheter occlusion was more common with PVA (28% vs 4%, P =.001). There were no differences in pain severity, other postprocedural symptoms, or medication use between the two treatment groups. There were also no differences in the frequency of incompletely infarcted leiomyomas, degree of improvement in symptom score, patient satisfaction, or QOL. CONCLUSION: No substantive differences were detected between outcomes of embolization with PVA particles or tris-acryl gelatin microspheres.