Robert L. Worthington-Kirsch

Uterine Artery Embolization for Treatment of Leiomyomata: Long-term Outcomes From the Fibroid Registry

OBJECTIVE: To assess long-term clinical outcomes of uterine artery embolization across a wide variety of practice settings in a large patient cohort. METHODS: The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization was a 3-year, single-arm, prospective, multi-center longitudinal study of the short- and long-term outcomes of uterine artery embolization for leiomyomata. Two thousand one hundred twelve patients with symptomatic leiomyomata were eligible for long-term follow-up at 27 sites representing a geographically diverse set of practices, including academic centers, community hospitals, and closed-panel health maintenance organizations. At 36 months after treatment, 1,916 patients remained in the study, and of these, 1,278 patients completed the survey. The primary measures of outcome were the symptom and health-related quality-of-life scores from the Uterine Fibroid Symptom and Quality of Life questionnaire. RESULTS: Mean symptom scores improved 41.41 points (P<.001), and the quality of life scores improved 41.47 points (P<.001), both moving into the normal range for this questionnaire. The improvements were independent of practice setting. During the 3 years of the study, Kaplan-Meier estimates of hysterectomy, myomectomy, or repeat uterine artery embolization were 9.79%, 2.82%, and 1.83% of the patients, respectively. CONCLUSION: Uterine artery embolization results in a durable improvement in quality of life. These results are achievable when the procedure is performed in any experienced community or academic interventional radiology practice. LEVEL OF EVIDENCE: III

The FIBROID Registry: symptom and quality-of-life status 1 year after therapy.

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. LEVEL OF EVIDENCE: II-3

The Fibroid Registry for outcomes data (FIBROID) for uterine embolization: short-term outcomes.

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

Initial experience with use of tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata.

PURPOSE To assess the safety and effectiveness of tris-acryl gelatin microspheres (Embospheres) in the treatment of leiomyomata by uterine artery embolization. MATERIALS AND METHODS This was a Phase I study of 30 patients with symptomatic leiomyomata. Each patient underwent ultrasound imaging and completed questionnaires regarding symptoms and health status at baseline and 3 and 6 months after treatment. Bilateral embolization was performed with use of tris-acryl gelatin microspheres. Summary statistics were used to characterize the demographic and procedure data. Paired t-tests were used to assess change in the severity of menstrual bleeding and health-related quality of life. RESULTS Bilateral embolization was technically successful in all patients. Three months after treatment, menstrual bleeding was markedly improved as assessed by menorrhagia questionnaire (P <.0001) and menstrual calendar (P <.0001). Pelvic pain and discomfort was improved in 92% of cases. Physical component summary scores of the SF-12 also increased from baseline at 3 months (P =.02) and at 6 months (P =.01). Minor complications occurred in nine patients; there were no major complications. CONCLUSION Although limited, this initial experience suggests that tris-acryl gelatin microspheres are an effective and safe embolic agent for the treatment of uterine leiomyomata.

A Prospective Multicenter Comparative Study between Myomectomy and Uterine Artery Embolization with Polyvinyl Alcohol Microspheres: Long-term Clinical Outcomes in Patients with Symptomatic Uterine Fibroids

PURPOSE To prospectively evaluate the safety and effectiveness of polyvinyl alcohol (PVA) microspheres in patients undergoing uterine artery embolization (UAE) to treat uterine fibroid tumors and to compare the long-term changes in health-related quality of life (QOL) after UAE with the changes seen after myomectomy. MATERIALS AND METHODS One hundred forty-six patients with uterine myomas were enrolled into this multicenter study, with 77 patients undergoing UAE with PVA and 69 patients undergoing myomectomy. Six-month follow-up was completed for the myomectomy, whereas 2-year follow-up was completed for the UAE group. Outcomes were assessed with the Uterine Fibroid QOL Questionnaire and based on adverse event incidence, time to return to normal activity, and changes in tumor symptom scores, QOL scores, and menorrhagia bleeding scores. For the UAE cohort, changes in total uterine volume and dominant tumor size on magnetic resonance (MR) imaging were assessed. RESULTS In the UAE cohort, 88.3% of patients experienced a reduction of tumor-related symptoms (increase >or=5 points from baseline measurement) at 6 months, with 75.4% of patients in the myomectomy group experiencing similar improvement. Median QOL questionnaire scores at 6 months were found to be significantly higher in patients treated with UAE (P = .041), with sustained improvement seen at 12 and 24 months. Both procedures resulted in significant reductions in 6-month menorrhagia bleeding scores, with sustained improvement in the UAE cohort at 12 and 24 months. MR imaging at 6 months revealed significant uterine and tumor volume reductions after UAE (P < .05). At least one adverse event occurred in 42% of patients in the myomectomy group, compared with 26% in the UAE group (P < .05). CONCLUSIONS UAE performed with PVA microspheres was associated with greater sustained improvements in symptom severity and health-related QOL and with fewer complications compared with myomectomy. Six-month MR imaging data demonstrated significant reductions in uterine and tumor volumes, although the degree of tissue infarction after UAE was not assessed with contrast medium-enhanced MR imaging.

Prospective data collection of a new procedure by a specialty society: the FIBROID registry.

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, χ2, 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

EMBOLOTHERAPY FOR MYOMA­ INDUCED MENORRHAGIA

Uterine fibroids are a common cause of abnormal uterine bleeding. Uterine artery embolization has proven to be highly effective in controlling fibroid related menorrhagia and triggering tumor degeneration.

Training Standards for Physicians Performing Uterine Artery Embolization for Leiomyomata: Consensus Statement Developed by the Task Force on Uterine Artery Embolization and the Standards Division of the Society of Cardiovascular & Interventional Radiology—August 2000

UTERINE artery embolization (UAE) is a therapy that offers an alternative to traditional surgical procedures such as myomectomy and hysterectomy for women with symptomatic leiomyomata (fibroids). The clinical experience and the published literature indicate that this is an effective and safe therapy (1–9). For patients to receive the best possible care before, during, and after the embolization procedure, the Society of Interventional Radiology Task Force on Uterine Fibroid Embolization has developed this consensus statement to define the appropriate qualifications for physicians practicing in this field.

Uterine artery embolisation for the management of myomata in patients without complaints of menorrhagia

SummaryUterine artery embolisation (UAE) has been performed largely in patients complaining of menorrhagia associated with myomata Many patients also suffer from bulk-related symptoms In this series, patients were retrospectively divided into three groups based upon their initial complaints menorrhagia alone, both menorrhagia and bulk-related symptoms, and patients complaining of only bulk-related symptoms UAE had similar rates of success for control of patient symptoms in all three groups and caused similar decreases in uterine volumes in all groups A large portion of patients who initially complained only of bulk-related symptoms also reported significant improvement in bleeding after UAE A smaller, but significant portion of patients who initially complained only of menorrhagia also experienced significant improvement in symptoms associated with fibroid bulk several months after UAE UAE shows significant success in control of menorrhagia and bulk-related symptoms, regardless of patient complaints.

Uterine Artery Embolization for Symptomatic Myomata

Fibroid disease is common and causes significant health problems in women of childbearing age. Over the past several years, uterine artery embolization (UAE) has emerged as a minimally invasive treatment for symptomatic uterine myomata. Embolotherapy is effective in relieving myoma-related symptoms in 80% to 90% of patients. It requires shorter hospitalizations than traditional surgical therapies for myoma disease and is associated with faster recovery and lower complication risks than surgery. Patient selection, the UAE procedure, and post-UAE management are reviewed.