James B. Spies

Uterine artery embolization for leiomyomata

Abstract Objective: To determine whether uterine artery embolization is safe and effective for treating uterine leiomyomata. 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.

Complications after uterine artery embolization for leiomyomas

OBJECTIVE To determine the frequency and severity of complications that occur as a result of uterine artery embolization for leiomyomas. METHODS As part of an ongoing study of outcome after uterine embolization, prospective data regarding complications that occurred in 400 consecutive patients were gathered. Each patient had a minimum of a 3‐month interval from the procedure at the time of analysis. Each complication was categorized and graded as to severity and outcome using the complication classification developed by the Society of Cardiovascular and Interventional Radiology (SCVIR) and a modified set of The American College of Obstetricians and Gynecologists (ACOG) criteria for complications of hysterectomy and myomectomy. All adverse events that occurred during the follow‐up period were included, including those that occurred after the 3‐month minimum interval. Confidence intervals (CIs) were calculated for each complication. RESULTS There were no deaths and no major permanent injuries. One patient required hysterectomy as a result of a complication, and one patient had an undiagnosed leiomyosarcoma. There were ten in‐hospital complications and an additional 27 complications within the first 30 days, with 34 patients experiencing a periprocedural complication for a rate of 8.5% (95% CI 6.0%, 11.7%). There were five serious complications (SCVIR class D), comprising 1.25% (95% CI 0.3%, 2.5%) of the study group. Using ACOG definitions for perioperative complications, the overall morbidity was 5% (95% CI 3.1%, 7.7%). CONCLUSION The short‐term complication rate was low in women undergoing uterine embolization.

Long-Term Outcome of Uterine Artery Embolization of Leiomyomata

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 (≤ 30.5%) were 3 times more likely to be dissatisfied with outcome compared with women in the third tertile (≥ 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

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

Guidelines for Peripheral Percutaneous Transluminal Angioplasty of the Abdominal Aorta and Lower Extremity Vessels

A Statement for Health Professionals From a Special Writing Group of the Councils on Cardiovascular Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and Epidemiology and Prevention, the American Heart Association

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

Quality Improvement Guidelines for Percutaneous Transhepatic Cholangiography and Biliary Drainage

PERCUTANEOUS transhepatic cholangiography is a safe and effective technique for evaluating biliary abnormalities. It reliably demonstrates the level of abnormalities and sometimes can help diagnose their etiologies. Percutaneous transhepatic biliary drainage is an effective method for the primary or palliative treatment of many biliary abnormalities demonstrated with cholangiography. Participation by the radiologist in patient follow-up is an integral part of percutaneous transhepatic biliary drainage and will increase the effectiveness of the procedure. Close follow-up, with monitoring and management of the patients’ drainage-related problems, is appropriate for the interventional radiologist. These guidelines are written to be used in quality improvement programs to assess percutaneous biliary procedures. The most important processes of care are (a) patient selection, (b) performing the procedure, and (c) monitoring the patient. The outcome measures or indicators for these processes are indications, success rates, and complication rates. Outcome measures are assigned threshold levels.

Ovarian function after uterine artery embolization for leiomyomata: assessment with use of serum follicle stimulating hormone assay.

PURPOSE To determine if uterine artery embolization (UAE) for leiomyomata causes a change in ovarian function as measured by serial basal follicle stimulating hormone (FSH) assay. MATERIALS AND METHODS Sixty-three patients undergoing UAE for symptomatic leiomyomata had blood samples obtained on day 3 of a menstrual cycle before UAE and on day 3 during menstrual cycles 3 and 6 months after treatment. Analysis of variance was used to detect differences in FSH levels among age groups at each interval. Repeated measures analysis of variance was used to determine if individual mean change occurred for the group as a whole and for each age group. Onset of new menopausal symptoms was compared between groups with use of the chi(2) test. RESULTS There was no significant change in basal FSH levels for the group as a whole (P =.16), but there was a statistically significant difference when age groups were compared (P =.03). Individual change of >2 SD from baseline mean FSH level occurred at 6 months in seven patients, all 45-50 years of age. Four of these patients (15% of patients over age 44) had FSH levels increase to more than 20 IU/L. chi(2) analysis did not reveal any difference among the groups studied in the onset of menopausal symptoms. CONCLUSIONS Most patients had no change in ovarian function as measured by basal FSH after UAE. For patients aged 45 or older, there is approximately a 15% chance of an increase in basal FSH into the perimenopausal range.

Polyvinyl Alcohol Particles and Tris-acryl Gelatin Microspheres for Uterine Artery Embolization for Leiomyomas: Results of a Randomized Comparative Study

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.

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