Sonia Amoroso

Non-surgical management of uterine fibroids

BACKGROUND Efforts to develop alternatives to surgery for management of symptomatic uterine fibroids have provided new techniques and new medications. This review summarizes the existing literature on uterine artery embolization (UAE) and investigational studies on four newer approaches. METHODS PubMed, Cochrane and Embase were searched up to December 2007. Studies reporting side-effects and complications and presenting numerical data on at least one outcome measure were included. RESULTS Case studies report 50-60% reduction in fibroid size and 85-95% relief of symptoms following UAE. The largest of these studies reported an in-hospital complication rate of 2.7% (90 of 3041 patients) and a post-discharge complication rate of 26% (710 of 2729 patients). Eight studies compared UAE with conventional surgery. Best evidence suggested that UAE offered shorter hospital stays (1-2 days UAE versus 5-5.8 days surgery, 3 randomized controlled trials (RCTs)) and recovery times (9.5-28 days UAE versus 36.2-63 days surgery, 3 RCTs) and similar major complication rates (2-15% UAE versus 2.7-20% surgery, 3 RCTs). Four studies analysing cost-effectiveness found UAE more cost-effective than surgery. There is insufficient evidence regarding fertility and pregnancy outcome after UAE. Five feasibility studies after transvaginal temporary uterine artery occlusion in 75 women showed a 40-50% reduction in fibroid volume and two early studies using magnetic resonance guided-focused ultrasound showed symptom relief at 6 months in 71% of 109 women. Two small RCTs assessing mifepristone and asoprisnil showed promising results. CONCLUSIONS Good quality evidence supports the safety and effectiveness of UAE for women with symptomatic fibroids. The current available data are insufficient to routinely offer UAE to women who wish to preserve or enhance their fertility. Newer treatments are still investigational.

Long-term effects of uterine fibroid embolization on ovarian reserve: a prospective cohort study.

OBJECTIVE To determine whether uterine fibroid embolization may advance ovarian follicular depletion in reproductive-aged women with apparently normal baseline ovarian function. DESIGN Prospective cohort study. SETTING University tertiary care center. PARTICIPANT(S) Thirty-six patients aged 26 to 39 years with fibroids, regular menstrual cycles, and day 3 serum FSH levels<10 mIU/mL and 36 matched control women. INTERVENTION(S) Day 3 serum FSH and E2 levels and ultrasound-based antral follicle count and ovarian volume were determined before (baseline) and at 12, 24, 36, 48, and 60 months after embolization and compared with those of the control group. Menstrual status was determined annually on the basis of prospectively recorded menstrual calendars. MAIN OUTCOME MEASURE(S) Longitudinal changes in hormone levels, ultrasound measures, and bleeding patterns. RESULT(S) Although the FSH and E2 levels increased significantly and the antral follicle count and ovarian volume values declined significantly over time within the groups, no significant differences were found between the groups. The cycle remained regular in all but two women (one in the embolization group and one in the control group), who started having cycle irregularity after 24 months and 36 months follow-up, respectively. CONCLUSION(S) This long-term follow-up study suggests that fibroid embolization does not lead to an accelerated decline in ovarian reserve in younger patients.

Ovarian vein incompetence: a potential cause of chronic pelvic pain in women

OBJECTIVE(S) To evaluate whether ovarian vein incompetence may be a source of chronic pelvic pain (CPP) in women. STUDY DESIGN Twenty-two women, aged 19-50 years, with chronic pelvic pain, no laparoscopically detected pelvic pathology, and evidence of reflux in dilated pelvic veins on transvaginal color Doppler ultrasound underwent retrograde ovarian venography and sclerotherapy of the ovarian vein(s) if incompetent. The primary outcome was symptom change as assessed by a symptom questionnaire and visual analog pain scales (VAS) at 3, 6, and 12 months of follow-up. Changes in pelvic circulations after sclerotherapy procedure were also evaluated by serial ultrasound examinations. Differences between baseline and post-procedural VAS scores were analysed using the Wilcoxon signed-rank test. RESULTS Twenty (91%) of the 22 women had venographic evidence of incompetent ovarian vein(s) and received sclerotherapy. There were no immediate or late complications. Variable symptom relief was observed in 17 (85%) of the 20 treated women, with follow-up at 12 months showing marked-to-complete relief in 15 patients and mild-to-moderate relief in the remaining 2 patients. Three (15%) women had no improvement in symptoms. Median VAS scores at 3 (2.0), 6 (2.5), and 12 months (3.0) were significantly lower than at baseline (8.0) (P<.001). Follow-up ultrasound examinations showed absence of pelvic venous reflux in all but 3 patients, in whom recurrence of reflux was seen at 3 months. CONCLUSION(S) Ovarian vein sclerotherapy provided symptomatic relief and improved pelvic circulation in most patients. These findings suggest that ovarian vein incompetence was the likely source of chronic pain in these women, and that sclerotherapy was a safe and effective treatment for this condition. CONDENSATION Ovarian vein incompetence leading to pelvic circulatory changes may be a cause of chronic pelvic pain in women.

Incidence and risk factors for clinical failure of uterine leiomyoma embolization.

OBJECTIVE: To estimate the incidence of clinical failure after uterine leiomyoma embolization and identify possible risk factors. METHODS: One hundred seventy-six consecutive women undergoing uterine leiomyoma embolization were followed prospectively for a median of 48 months (range 12–84 months) to estimate the occurrence of clinical failure, defined as persistence or recurrence of leiomyoma symptoms, and any subsequent invasive treatment. Cumulative failure and reintervention rates were estimated by survival analysis and log-rank tests according to baseline patient characteristics. Multivariable Cox proportional hazards analysis was performed to adjust for confounders. RESULTS: Overall, there were 18 failures at a median of 36 months (range 3–84 months). The cumulative failure rate increased steadily over time, 3% at 1 year, 7% at 3 years, 14% at 5 years, and 18% at 7 years. Of the 18 failures, 11 had reintervention, including six hysterectomies, four myomectomies, and one repeat uterine leiomyoma embolization, at a median of 56 months (range 15–84 months). The cumulative reintervention rate was 0 at 1 year, 3% at 3 years, 7% at 5 years, and 15% at 7 years. Women aged 40 years or younger had a higher failure risk (hazard ratio [HR] 5.89, 95% confidence interval [CI] 2.50–20.02, P=.023) compared with older women. A history of previous myomectomy was also associated with an increased failure risk (HR 3.79, 95% CI 2.07–13.23, P=.037). CONCLUSION: The 7-year cumulative rates of clinical failure and reintervention after uterine leiomyoma embolization were 18% (95% CI 8.2–27.8) and 15% (95% CI 5.2–24.8), respectively. The failure risk was higher for younger patients and for those with a prior myomectomy. LEVEL OF EVIDENCE: III

Selective arterial embolization as a first-line treatment for postpartum hematomas.

BACKGROUND: Postpartum hematomas are a potentially serious obstetric complication for which management options are not standardized. We report successful treatment of a large postpartum hematoma using arterial embolization as primary approach. CASE: A 29-year-old woman at term gestation underwent vacuum-assisted vaginal delivery. Two hours later, marked rectal pain developed. Examination revealed a large left vaginal hematoma and no obvious bleeding sites. Computed tomography demonstrated a 10-cm supralevator hematoma and extrauterine arterial bleeding. Angiography revealed contrast extravasation from a branch of the left internal pudendal artery. Selective embolization of this branch stopped the bleeding. The patient was discharged on the third postpartum day. Eight weeks after delivery, there was no evidence of the hematoma. CONCLUSION: Arterial embolization can be used as a first-line treatment for large postpartum hematomas.

The timing of natural menopause after uterine fibroid embolization: a prospective cohort study

OBJECTIVE To determine whether uterine fibroid embolization before the age of 45 years advances the timing of natural menopause. DESIGN Prospective cohort study. SETTING University tertiary-care center. PARTICIPANT(S) Forty-three regularly cycling women aged 35-44 years who underwent embolization and 43 age-matched control subjects. INTERVENTION(S) Annual assessments of menopausal status using prospectively recorded menstrual diaries and hormonal (serum FSH and E(2)) and ultrasound measures (ovarian volume and antral follicle count). Women were followed for 7 years or until they reached menopause. MAIN OUTCOME MEASURE(S) Age at menopause as computed by subtracting the date of birth from the exact date of the last menstrual period. RESULT(S) Over the study period, 9 patients (25%) and 12 control subjects (33%) became menopausal, 19 patients (53%) and 18 control subjects (50%) entered the menopausal transition (irregular cycles), and 8 patients (22%) and 6 control subjects (17%) continued to menstruate regularly. Mean menopausal age in the embolization group (48.94 ± 2.48 years) was not significantly different from that in the control group (49.52 ± 1.25 years). There was no significant difference of menopause occurrence between the groups. Longitudinal changes in hormonal and ultrasound measures were similar for the two groups. CONCLUSION(S) This long-term follow-up study found no evidence for fibroid embolization advancing the timing of menopause in women before the age of 45 years.

Incidence and predictive factors for complications after uterine leiomyoma embolization

STUDY QUESTION What is the risk of complications after uterine leiomyoma embolization and what are the factors associated with complications? SUMMARY ANSWER The cumulative risk of complications after embolization is relatively low even in the long term, but submucosal leiomyoma location may increase the risk. WHAT IS KNOWN ALREADY A broad spectrum of complications after leiomyoma embolization have been described with widely varying rates. There is uncertainty over the actual risk of complications and the factors associated with this risk. STUDY DESIGN, SIZE, DURATION This was a prospective cohort study of 288 consecutive women undergoing leiomyoma embolization in the general gynaecology clinic of a university teaching hospital between January 2001 and December 2010. PARTICIPANTS/MATERIALS, SETTING, METHODS Complications occurring after embolization were categorized as major or minor according to the severity of their impact on health, the level of care required and the outcome. Cumulative complication rates were estimated by survival analysis and log-rank tests according to baseline variables. Multivariable Cox proportional hazards analysis was performed to adjust for confounders. MAIN RESULTS AND THE ROLE OF CHANCE There were 48 patients who experienced a complication at a median of 5 months (95% confidence interval, 4.1-11.4) after embolization. Complications were minor in 38 patients and major in 10 patients. The cumulative overall complication rate was 13% (95% CI, 9.0-17.0) at 6 months, 16% (95% CI, 11.0-20.0) at 1 year, 17% (95% CI, 12.0-22.0) at 3 years and 18% (95% CI, 12.9-22.8) at 5 years. The most frequent complication (19/48, 39.6%) was leiomyoma expulsion, which occurred spontaneously in 13 (68.4%) of these cases and required assistance in 6 (31.6%) cases. Eight (2.8%) patients underwent re-intervention, including six hysteroscopic myomectomies, one laparoscopic myomectomy and one hysteroscopic adhesiolysis, as a result of a complication. Submucosal leiomyoma location was the only baseline variable associated with an increased risk for complications [Hazard ratio (HR), 2.28, 95% CI, 1.24-4.18, P = 0.008]. LIMITATIONS, REASONS FOR CAUTION Our population did not include women of African descent, who have been reported to be at higher risk of post-procedural complications compared with Causcasian women. If such women were involved in the study, higher morbidity rates might have been observed. WIDER IMPLICATIONS OF THE FINDINGS Women with submucosal leiomyomas at the time of embolization are more likely to have post-procedural complications. This is important new information for counselling patients contemplating this therapeutic approach. STUDY FUNDING/COMPETING INTERESTS The authors have no competing interests to declare. The study was not supported by any external grant.

Is myomectomy always the best choice for infertile women with symptomatic uterine fibroids

Uterine artery embolization (UAE) is still regarded by most gynaecologists as contraindicated for women with symptomatic fibroids and otherwise unexplained infertility. For such patients, myomectomy is the usual option. We performed UAE as treatment of menorrhagia in an infertile woman with multiple subserosal and intramural fibroids who had previously failed multiple myomectomy. UAE resulted in durable symptom relief and substantial reduction of the uterine and fibroid size. The patient conceived spontaneously 20 months after UAE and progressed through pregnancy uneventfully. At 38 weeks of gestation, she underwent elective cesarean section and delivered a normal, healthy, 3180‐g fetus without complications. The present case demonstrates that in symptomatic women with multiple subserosal and intramural fibroids and otherwise unexplained infertility, UAE may have symptomatic and reproductive outcomes superior to those of myomectomy.