Cost-effectiveness of Myomectomy versus Hysterectomy in Women with Uterine Fibroids.

STUDY OBJECTIVE: Increasing evidence suggests that hysterectomy to treat uterine fibroids (UFs), even with ovarian conservation (OC), is associated with a 33% increased risk of coronary artery disease (CAD). We sought to compare the cost-effectiveness of various treatment approaches for UFs to understand the trade-offs among development of CAD vs new fibroids. DESIGN: We developed a Markov model to include women with UFs who no longer desired pregnancy. The outcomes of interest were quality-adjusted life-years (QALYs) and total treatment costs. We conducted sensitivity analyses to test the effect of uncertain model inputs. SETTING: Health system perspective. PATIENTS: A hypothetical cohort of 10 000 40-year-old women. INTERVENTIONS: Myomectomy, hysterectomy with OC, and hysterectomy without OC. MEASUREMENTS AND MAIN RESULTS: Myomectomy was the best-value strategy, costing US$528 217 and providing 19.38 QALYs. Neither hysterectomy with OC nor hysterectomy without OC was found to be cost-effective, assuming a willingness-to-pay threshold of $100 000 per QALY gain as hysterectomy with OC provided more benefit than myomectomy at an average cost of $613 144 to gain one additional QALY. The sensitivity analyses showed that if the risk of new symptomatic UFs that required treatment after myomectomy was more than 13%, annually (base case, 3.6%), or the quality of life after myomectomy was less than 0.815 (base case, 0.834), then myomectomy would no longer be cost-effective, under a willingness-to-pay amount of US$100 000. CONCLUSION: Myomectomy is an optimal treatment of UFs compared with hysterectomy among women aged 40 years. The increased risk of CAD after hysterectomy and its associated costs and the effects on morbidity and quality of life made hysterectomy a costlier and less effective long-term strategy.

Utilization of Endovascular and Surgical Treatments for Symptomatic Uterine Leiomyomas: A Population Health Perspective.

PURPOSE: To conduct a population-level analysis of surgical and endovascular interventions for symptomatic uterine leiomyomata by using administrative data from outpatient medical encounters. MATERIALS AND METHODS: By using administrative data from all outpatient hospital encounters in California (2005-2011) and Florida (2005-2014), all patients in the outpatient setting with symptomatic uterine leiomyomata were identified. Patients were categorized as undergoing hysterectomy, myomectomy, uterine artery embolization (UAE), or no intervention. Hospital stay durations and costs were recorded for each encounter. RESULTS: A total of 227,489 patients with uterine leiomyomata were included, among whom 39.9% (n = 90,800) underwent an intervention, including hysterectomy (73%), myomectomy (19%), or UAE (8%). The proportion of patients undergoing hysterectomy increased over time (2005, hysterectomy, 53.2%; myomectomy, 26.9%; UAE, 18.0%; vs 2013, hysterectomy, 80.1%; myomectomy, 14.4%; UAE, 4.0%). Hysterectomy was eventually performed in 3.5% of patients who underwent UAE and 4.1% who underwent myomectomy. Mean length of stay following hysterectomy was significantly longer (0.5 d) vs myomectomy (0.2 d) and UAE (0.3 d; P < .001 for both). The mean encounter cost for UAE ($3,772) was significantly less than those for hysterectomy ($5,409; P < .001) and myomectomy ($6,318; P < .001). Of the 7,189 patients who underwent UAE during the study period, 3.5% underwent subsequent hysterectomy. CONCLUSIONS: The proportion of women treated with hysterectomy in the outpatient setting has increased since 2005. As a lower-cost alternative with a low rate of conversion to hysterectomy, UAE may be an underutilized treatment option for patients with uterine leiomyomata.

Uterine-Artery Embolization or Myomectomy for Uterine Fibroids.

BACKGROUND: Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options. METHODS: We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score. RESULTS: A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group. CONCLUSIONS: Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).

Ulipristal acetate for pre-operative management of uterine fibroids: Modeling outcomes and costs.

OBJECTIVES: The aim of this study was to evaluate the pharmacoeconomic profile in Italy of preoperative treatment with ulipristal acetate at the dose of 5 mg/day for 13 weeks in comparison with placebo prior to surgical management of symptomatic uterine fibroids. STUDY DESIGN: The pharmacoeconomic analysis was based on the calculation of incremental cost-effectiveness ratio (ICER). Effectiveness data were derived from the randomized-controlled trial PEARL-1, whilst costs data were retrieved from the published literature. A Markov model was employed to simulate the pattern of costs and two univariate sensitivity analyses tested the robustness of the results. RESULTS: In comparison with placebo, ulipristal acetate 5 mg for presurgical therapy was estimated to be associated with an incremental cost of €351 per patient. Costs per patient were €3836 for ulipristal acetate vs €3485 for placebo. The incremental effectiveness was 0.01931 QALYs per patient (around 7 quality-adjusted days per patient). Hence, the cost effectiveness ratio was calculated to be €18,177 per QALY gained. CONCLUSIONS: Preoperative use of ulipristal acetate 5 mg in patients with uterine fibroids has a favourable pharmacoeconomic profile.

[Clinical application and prognostic analysis of interventional treatment for cesarean scar pregnancy].

OBJECTIVE: To analyze the clinical value and prognosis of cesarean scar pregnancy (CSP) treated by uterine artery embolization (UAE). METHODS: In the study, 492 cases of patients in Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University diagnosed as CSP between January 2011 and December 2014 were chosen, of which 283 were of high-risk group and 209 of low-risk group. According to whether to take UAE, the high-risk group was subdivided into high-risk UAE group(UAE+laparoscopic group), 167 cases, and high-risk non UAE group (chemotherapy+laparoscopic group), 116 cases, while the low-risk group was subdivided into low-risk UAE group (UAE+curettage group), 113 cases, and low-risk non UAE group(chemotherapy+curettage group), 96 cases. The differences of the intraoperative bleeding, length of stay, blood beta human chorionic gonadotropin (ß-HCG) dropped to normal time, menstruation recovery time and the hospitalization expenses were compared. And multivariate regression analysis was used to predict the recurrence risk of CSP. RESULTS: The high-risk UAE group was better than the high-risk non UAE group in comparison of intraoperative bleeding [(36.5±14.8) mL vs.(76.5±39.7) mL], length of stay [(5.9±0.9) d vs.(9.6±1.3) d], blood ß-HCG dropped to normal time [(17.9±8.7) d vs.(28.7±10.1) d] and menstruation recovery time [(18.1±1.6) d vs.(24.3±1.8) d],while the low-risk UAE group was better than the low-risk non UAE group in comparison of intraoperative bleeding [(93.2±43.3) mL vs.(284.8±110.5) mL], length of stay [(10.2±1.4) d vs. (30.7±9.6) d], blood ß-HCG dropped to normal time [(50.1±17.6)d vs.(67.5±22.9)d] and menstruation recovery time[(56.3±6.7)d vs.(65.9±9.3) d], all P<0.05. The high-risk UAE group was higher than the high-risk non UAE group in comparison of hospitalization expenses [(20 140±1 520 )Yuan vs.(13 510±1 013) Yuan], and the low-risk group UAE was also higher than the low-risk non UAE group in comparison of hospitalization expenses [(10 095±962 )Yuan vs.(3 890±457) Yuan], all P<0.01. Multivariate Logistic regression analysis showed that the treatment method was independent predictor of CSP recurrence risk (OR 2.407, 95%CI 1.176-5.092, P<0.05), and using the comprehensive treatment including UAE could reduce the risk of recurrent CSP. CONCLUSION: As the efficacy of interventional therapy for CSP was rapid and reliable, fewer complications, faster recovery and lower recurrence, hospitalization with good conditions, and particularly for those patients with CSP who want to fertility again, the comprehensive treatment including UAE treatment should be the first choice.

Assessment of in vivo fetal growth and placental vascular function in a novel intrauterine growth restriction model of progressive uterine artery occlusion in guinea pigs.

Intra-uterine growth restriction (IUGR) is associated with short and long-term metabolic and cardiovascular alterations. Mice and rats have been extensively used to study the effects of IUGR, but there are notable differences in fetal and placental physiology relative to those of humans that argue for alternative animal models. This study proposes that gradual occlusion of uterine arteries from mid-gestation in pregnant guinea pigs produces a novel model to better assess human IUGR. Fetal biometry and in vivo placental vascular function were followed by sonography and Doppler of control pregnant guinea pigs and sows submitted to surgical placement of ameroid constrictors in both uterine arteries (IUGR) at mid-gestation (35 days). The ameroid constrictors induced a reduction in the fetal abdominal circumference growth rate (0.205 cm day(-1) ) compared to control (0.241 cm day(-1) , P < 0.001) without affecting biparietal diameter growth. Umbilical artery pulsatility and resistance indexes at 10 and 20 days after surgery were significantly higher in IUGR animals than controls (P < 0.01). These effects were associated with a decrease in the relative luminal area of placental chorionic arteries (21.3 ± 2.2% vs. 33.2 ± 2.7%, P < 0.01) in IUGR sows at near term. Uterine artery intervention reduced fetal (∼30%), placental (∼20%) and liver (∼50%) weights (P < 0.05), with an increased brain to liver ratio (P < 0.001) relative to the control group. These data demonstrate that the ameroid constrictor implantations in uterine arteries in pregnant guinea pigs lead to placental vascular dysfunction and altered fetal growth that induces asymmetric IUGR.

A randomised trial of treating fibroids with either embolisation or myomectomy to measure the effect on quality of life among women wishing to avoid hysterectomy (the FEMME study): study protocol for a randomised controlled trial.

BACKGROUND: Uterine fibroids are the most common tumour in women of reproductive age. By the time they are 50-years-old around 80% of women will have developed one. Of these, around half will experience symptoms which will impact negatively on their quality of life. Hysterectomy is the traditional treatment for women with symptomatic fibroids. For women who do not wish to undergo a hysterectomy, two invasive treatments are commonly available: myomectomy or uterine artery embolization (UAE). DESIGN: FEMME is a pragmatic, randomised, open, multi-centre trial examining the quality of life menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy. METHODS: After providing informed consent, 216 women with symptomatic fibroids from 43 NHS Hospital Trusts and Health Boards across the United Kingdom will undergo randomisation by a centralised computer system to treatment by either UAE or myomectomy. A minimisation algorithm will be used in order to balance the groups with respect to the following three parameters: the longest dimension of the largest fibroid, the number of fibroids present, and whether the woman currently desires pregnancy.Using validated questionnaires the women's quality of life will be compared between groups at six months, one year, two years and four years post-procedure, taking into account pre-procedure scores. An economic evaluation will be conducted alongside the trial to determine the cost-effectiveness of UAE compared with myomectomy.Validated diaries will also be used to compare menstrual blood loss at the same time-points. The plasma concentration of Anti-Müllerian hormone (AMH), which will act as a proxy measurement of ovarian reserve, will be recorded before the woman has her procedure and then again at six weeks, six months, and twelve months afterwards. Re-intervention rates will be recorded. DISCUSSION: The FEMME trial's primary outcome is the quality of life women with symptomatic uterine fibroids experience two years after they have been treated with either UAE or myomectomy, as measured by the disease-specific Uterine Fibroid Symptom Quality-of-Life (UFS-QoL) questionnaire. TRIAL REGISTRATION: Current Controlled Trials registration number: ISRCTN70772394, registered on 2 March 2013.

Readability assessment of internet-based patient education materials related to uterine artery embolization.

PURPOSE: To determine the readability of Internet-based patient education materials (IPEMs) created by United States hospitals and universities and clinical practices and miscellaneous health care-associated Web sites regarding uterine artery embolization (UAE) as a marker for IPEMs in general. METHODS AND METHODS: Two hundred unique Web sites were evaluated for patient-related articles on UAE. Web sites produced by US hospitals and universities and clinical practices, as well as miscellaneous health care-associated Web sites meeting the Health on the Net Foundation Code of Conduct criteria were included in the database. By using mathematical regression algorithms based on word and sentence length to quantitatively analyze reading materials for language intricacy, readability of 40 UAE-related IPEMs was assessed with four indices: Flesch-Kincaid Grade Level (FKGL), Flesch Reading Ease Score (FRES), Simple Measure of Gobbledygook (SMOG), and Gunning Frequency of Gobbledygook (GFOG). Scores were evaluated against national recommendations, and intergroup analysis was performed. RESULTS: None of the IPEMs were written at or below the sixth-grade reading level, based on FKGL. The mean readability scores were as follows: FRES, 43.98; FKGL, 10.76; SMOG, 13.63; and GFOG, 14.55. These scores indicate that the readability of UAE IPEMs is written at an advanced level, significantly above the recommended 6th grade reading level (P<.05) determined by the United States Department of Health and Human Services. CONCLUSIONS: IPEMs related to UAE generated by hospitals, clinical practices, and miscellaneous health care-associated Web sites are written above the recommended sixth grade level. IPEMs for other disease entities may also reflect similar results.

Randomised comparison of uterine artery embolisation (UAE) with surgical treatment in patients with symptomatic uterine fibroids (REST trial): 5-year results.

OBJECTIVE: To compare the long-term results of uterine artery embolisation (UAE) with surgery for women with symptomatic uterine fibroids. DESIGN: Pragmatic, open, multicentre, randomised trial. SETTING: Twenty-seven participating UK secondary care centres. SAMPLE: Women aged ≥18 years with symptomatic fibroids who were considered to justify surgical treatment. METHODS: In total, 157 women were randomised (in a 2:1 ratio): 106 to UAE and 51 to surgery (hysterectomy 42; myomectomy nine). MAIN OUTCOME MEASURES: Quality of life at 5 years, as assessed by the Short Form General Health Survey (SF-36). Secondary measures included complications, adverse events and the need for further intervention. RESULTS: There were no significant differences between groups in any of the eight components of the SF-36 scores at 5 years (minimum P = 0.45). Symptom score reduction and patient satisfaction with either treatment was very high, with no group difference. Rates of adverse events were similar in both groups (19% embolization and 25% surgery; P = 0.40). The 5-year intervention rate for treatment failure or complications was 32% (UAE arm) and 4% (surgery arm), respectively. The initial cost benefit of UAE over surgery at 12 months was substantially reduced because of subsequent interventions, with treatments being cost neutral at 5 years. CONCLUSIONS: We have found that UAE is a satisfactory alternative to surgery for fibroids. The less invasive nature of UAE needs to be balanced against the need for re-intervention in almost a third of patients. The choice should lie with the informed patient.

Provision of a mobile uterine artery embolization service to medically underserved areas in Brazil.

PURPOSE: To determine the feasibility, efficacy, and safety of a mobile uterine artery embolization (UAE) program for patients in medically underserved, socioeconomically deprived areas. MATERIALS AND METHODS: One hundred women with symptomatic uterine leiomyomas were treated with UAE. A small truck containing a mobile c-arm and all needed supplies visited one hospital per week during a 6-month period. Four public hospitals were visited in rotation. Pre- and postprocedural magnetic resonance (MR) imaging and validated quality of life (QOL) questionnaires were obtained, and procedural details and complications were recorded. RESULTS: Technical success was achieved in 97 of 100 women. Mean procedure time was 41 minutes (range, 15-140 min) and mean fluoroscopy time was 17 minutes (range, 6-45 min). Mean hospital stay was 1.03 days (range, 1-3 d) and mean time to resumption of normal activities was 8.2 days (range, 2-20 d). At 12 weeks, 88% of patients noted symptomatic improvement and 98% stated they would recommend the procedure to other women. Complete tumor ischemia was seen on postprocedural MR imaging in 92% of women, with a mean uterine volume reduction of 36.3% (range, -4.3% to 65%) and a mean tumor volume reduction of 57.1% (range, -23.4% to 95.8%). Health-related QOL scores increased from 41.4 points before UAE to 81.2 points at 12 weeks and 85.3 points at 1 year after UAE. Complications were recorded in seven women (7%): three puncture site hematomas, three readmissions for pain control, and one case of leiomyoma passage. CONCLUSIONS: A mobile interventional radiology unit is a feasible, efficient, and safe method to provide UAE to an underserved patient community. Outcomes and complications are similar to published results from centers with conventional angiographic facilities.

Uterine artery embolization, hysterectomy, or myomectomy for symptomatic uterine fibroids: a cost-utility analysis.

OBJECTIVE: To compare the cost and quality-adjusted life-years (QALYs) of hysterectomy, myomectomy, and uterine artery embolization (UAE) for symptomatic control of uterine fibroids. DESIGN: A cost-utility analysis conducted by using Markov modeling. SETTING: The analysis was conducted from the perspective of Hong Kong society. PATIENT(S): A hypothetical cohort of patients presenting with symptomatic uterine fibroids. INTERVENTION(S): Hysterectomy, myomectomy, or UAE. MAIN OUTCOME MEASURE(S): Health-care resource use and QALYs over 5 years. RESULT(S): The base-case analysis showed that hysterectomy was the most effective treatment (4.368 QALYs), followed by myomectomy (4.273 QALYs) and UAE (4.245 QALYs) over 5 years. Hysterectomy was less costly (USD8418) (1USD = 7.8HKD) than UAE (USD8847) and myomectomy (USD9036). Monte Carlo 10,000 simulations showed that the hysterectomy group was less costly than the UAE and myomectomy groups 84.1% and 79.1% of the time, and it also gained higher number of QALYs than the UAE and myomectomy groups over 97% of the time. CONCLUSION(S): Hysterectomy appears to be more cost-effective than myomectomy and UAE for management of symptomatic uterine fibroids over a 5-year period among patients who do not have a preference for uterus-conserving interventions.

What is the place of uterine artery embolisation in the management of symptomatic uterine fibroids?

BACKGROUND: Uterine artery embolisation (UAE) is an alternative to surgical management for symptomatic uterine fibroids and is increasingly performed in Australia. AIMS: To review the evidence for the efficacy, safety and acceptability of UAE and to evaluate the place of UAE in Australia. METHODS: The study used literature review. RESULTS: UAE compares favourably to hysterectomy and myomectomy in terms of short-term symptom relief, cost, patient satisfaction and complications. There is a paucity of evidence regarding fertility and pregnancy after UAE. A significant minority of women require re-intervention following UAE. CONCLUSIONS: UAE should be considered as an alternative to surgical management of symptomatic uterine fibroids in carefully selected and informed patients.