Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 10-year outcomes from the randomized EMMY trial.

BACKGROUND: Since 1995 uterine artery embolization has been described as an alternative for hysterectomy in patients with symptomatic fibroids. Many studies including several randomized controlled trials established uterine artery embolization as a valuable treatment. These randomized controlled trials reported outcomes in terms of health-related quality of life, clinical outcomes, efficacy, and cost-effectiveness after 1, 2, and 5 years of follow-up. OBJECTIVE: The purpose of this study was to compare clinical outcome and health-related quality of life 10 years after uterine artery embolization or hysterectomy in the treatment of heavy menstrual bleeding caused by uterine fibroids in a randomized controlled trial. STUDY DESIGN: In all, 28 Dutch hospitals recruited patients with symptomatic uterine fibroids who were eligible for hysterectomy. Patients were 1:1 randomly assigned to uterine artery embolization or hysterectomy. The outcomes assessed at 10 years postintervention were reintervention rates, health-related quality of life, and patient satisfaction, which were obtained through validated questionnaires. Study outcomes were analyzed according to original treatment assignment (intention to treat). RESULTS: A total of 177 patients were randomized from 2002 through 2004. Eventually 81 uterine artery embolization and 75 hysterectomy patients underwent the allocated treatment shortly after randomization. The remaining patients withdrew from the trial. The 10-year questionnaire was mailed when the last included patient had been treated 10 years earlier. The mean duration of follow-up was 133 months (SD 8.58) accompanied by a mean age of 57 years (SD 4.53). Questionnaires were received from 131 of 156 patients (84%). Ten years after treatment, 5 patients underwent secondary hysterectomy resulting in a total of 28 of 81 (35%) (24/77 [31%] after successful uterine artery embolization). Secondary hysterectomies were performed for persisting symptoms in all cases but 1 (for prolapse). After the initial treatment health-related quality of life improved significantly. After 10 years, generic health-related quality of life remained stable, without differences between both groups. The urogenital distress inventory and the defecation distress inventory showed a decrease in both groups, probably related to increasing age, without significant differences between study arms. Satisfaction in both groups remained comparable. The majority of patients declared being (very) satisfied about the received treatment: 78% of the uterine artery embolization group vs 87% in the hysterectomy group. CONCLUSION: In about two thirds of uterine artery embolization-treated patients with symptomatic uterine fibroids a hysterectomy can be avoided. Health-related quality of life 10 years after uterine artery embolization or hysterectomy remained comparably stable. Uterine artery embolization is a well-documented and less invasive alternative to hysterectomy for symptomatic uterine fibroids on which eligible patients should be counseled.

[Summary of the practice guideline 'Heavy menstrual bleeding']. / Samenvatting richtlijn 'Hevig menstrueel bloedverlies'.

A new multidisciplinary practice guideline on heavy menstrual bleeding (HMB) has recently been published. HMB may occur with or without structural abnormalities. The pictorial blood loss assessment chart (PBAC) is the best method for estimating the amount of blood loss and for distinguishing between heavy and normal blood loss. Haemoglobin levels should be determined at least once. Transvaginal ultrasound is the preferred imaging technique. Saline or gel infusion sonography should be used in cases where ultrasound results are suspect for intracavitary abnormalities. A hysteroscopy should only be performed if sonography results are inconclusive. The very first treatment of choice should be placement of a hormone-impregnated intrauterine system. For HMB without structural abnormalities, endometrial ablation is an alternative to hysterectomy, whereby second-generation ablation techniques are preferred to first-generation techniques. For HMB with uterine fibroids, uterine artery embolisation is a good alternative to hysterectomy. For HMB with submucosal fibroids, hysteroscopic resection of the fibroids is recommended.

Epidural analgesia versus patient-controlled analgesia for pain relief in uterine artery embolization for uterine fibroids: a decision analysis.

PURPOSE: This study was designed to compare the costs and effects of epidural analgesia (EDA) to those of patient-controlled intravenous analgesia (PCA) for postintervention pain relief in women having uterine artery embolization (UAE) for systematic uterine fibroids. METHODS: Cost-effectiveness analysis (CEA) based on data from the literature by constructing a decision tree to model the clinical pathways for estimating the effects and costs of treatment with EDA and PCA. Literature on EDA for pain-relief after UAE was missing, and therefore, data on EDA for abdominal surgery were used. Outcome measures were compared costs to reduce one point in visual analogue score (VAS) or numeric rating scale (NRS) for pain 6 and 24 h after UAE and risk for complications. RESULTS: Six hours after the intervention, the VAS was 3.56 when using PCA and 2.0 when using EDA. The costs for pain relief in women undergoing UAE with PCA and EDA were 191 and 355, respectively. The costs for EDA to reduce the VAS score 6 h after the intervention with one point compared with PCA were 105 and 179 after 24 h. The risk of having a complication was 2.45 times higher when using EDA. CONCLUSIONS: The results of this indirect comparison of EDA for abdominal surgery with PCA for UAE show that EDA would provide superior analgesia for post UAE pain at 6 and 24 h but with higher costs and an increased risk of complications.

The effect of treatment preference and treatment allocation on patients' health-related quality of life in the randomized EMMY trial.

OBJECTIVES: To determine the effect of preference and treatment allocation on health-related quality of life (HRQOL) in patients in the randomized EMMY trial of hysterectomy versus uterine artery embolization (UAE) for symptomatic uterine fibroids. STUDY DESIGN: We invited 349 patients eligible for trial participation, of which 177 agreed to participate (the 'randomized group'). Within the randomized group, patients were allocated to. UAE (n=88) or hysterectomy (n=89). The remaining 172 patients refused randomization and received the treatment of their preference (varying from hysterectomy to no treatment at all), of which 103 patients agreed to fill in questionnaires (the 'preference group'). Patients' treatment preferences and HRQOL were assessed at baseline and the patients were prospectively followed to evaluate HRQOL at 12 months after treatment. RESULTS: At baseline, most patients in the randomized group preferred UAE: 115/177 (65%). In the preference group most patients preferred hysterectomy: 100/172 (58%). At 12 months there was no effect of having had the preferred treatment on HRQOL, neither in the randomized nor in the preference group. The randomized group improved significantly in both mental and physical health, compared to baseline. In the preference group, only mental health improved compared to baseline, while physical health did not improve significantly. CONCLUSIONS: In a randomized trial comparing UAE and hysterectomy for symptomatic fibroids, the pre-randomization preference for a specific treatment did not affect HRQOL. Trial participants improved better on physical HRQOL than women who refused to participate.

Review of nonsurgical/minimally invasive treatments for uterine fibroids.

PURPOSE OF REVIEW: Many nonsurgical and minimally invasive therapies for symptomatic uterine fibroids have been introduced. The purpose of this review is to summarize the recent evidence on these techniques, and their effect on fibroid volume, menorrhagia, health related quality of life (HRQOL), fertility and their risk of complications. RECENT FINDINGS: Laparoscopic or hysteroscopic myomectomy and uterine artery embolization (UAE) have been the most widely studied and all show significantly beneficial effects on menorrhagia and HRQOL, with a low incidence of complications. Magnetic resonance-guided high-intensity focused ultrasound (MRgFUS), myolysis/radiofrequency ablation (RFA) and laparoscopic or vaginal occlusion of uterine vessels (L/V-OUA) are newer interventions, with a smaller body of evidence.For women wishing to retain their childbearing possibilities, myomectomy is the best-studied intervention. Hysteroscopic myomectomy is specifically indicated in submucosal fibroids with subsequently beneficial effects on fertility. The use of UAE in fertile women has not been studied extensively, but evidence points toward an increase in adverse pregnancy outcomes after UAE compared with myomectomy. For MRgFUS, myolysis/RFA and L/V-OUA more evidence is needed. SUMMARY: Laparoscopic/hysteroscopic myomectomy and UAE are evidence-based beneficial alternative therapies for symptomatic uterine fibroids. Until more evidence is available, myomectomy stays the option of choice for women who wish to conceive in the future.

Uterine artery embolization versus surgery in the treatment of symptomatic fibroids: a systematic review and metaanalysis.

OBJECTIVE: To summarize the evidence on short-, mid-, and long-term results up to 5 years of uterine artery embolization in comparison to surgery. STUDY DESIGN: We searched the CENTRAL, MEDLINE and EMBASE databases for randomized clinical trials comparing uterine artery embolization with hysterectomy/myomectomy in premenopausal women with heavy menstrual bleeding caused by symptomatic uterine fibroids, written from September 1995 to November 2010. Two reviewers independently assessed methodologic quality and extracted data from included trials. RESULTS: Four randomized controlled trials with a total of 515 patients were included. On the short-term, uterine artery embolization showed fewer blood loss, shorter hospital stay, and quicker resumption of work. Mid- and long-term results showed comparable health-related quality of life results and a higher reintervention rate in the uterine artery embolization group, whereas both groups were equally satisfied. CONCLUSION: Uterine artery embolization has short-term advantages over surgery. On the mid- and long-term the benefits were similar, except for a higher reintervention rate after uterine artery embolization.

Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial.

OBJECTIVE: The purpose of this study was to compare clinical outcome and health related quality of life (HRQOL) 5 years after uterine artery embolization (UAE) or hysterectomy in the treatment of menorrhagia caused by uterine fibroids. STUDY DESIGN: Patients with symptomatic uterine fibroids who were eligible for hysterectomy were assigned randomly 1:1 to hysterectomy or UAE. Endpoints after 5 years were reintervention rates, menorrhagia, and HRQOL measures that were assessed by validated questionnaires. RESULTS: Patients were assigned randomly to UAE (n = 88) or hysterectomy (n = 89). Five years after treatment 23 of 81 UAE patients (28.4%) had undergone a hysterectomy because of insufficient improvement of complaints (24.7% after successful UAE). HRQOL measures improved significantly and remained stable until the 5-year follow-up evaluation, with no differences between the groups. UAE had a positive effect both on urinary and defecation function. CONCLUSION: UAE is a well-established alternative to hysterectomy about which patients should be counseled.