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.).

Prophylactic occlusion balloon placement in internal iliac arteries for the prevention of postpartum haemorrhage due to morbidly adherent placenta: short term outcomes.

PURPOSE: To evaluate outcomes of uterine conserving surgery with occlusion balloon technique. A critical review of the complications was performed. MATERIALS AND METHODS: Between 2010 and 2016, pregnant women, with a prenatal diagnosis of morbidly adherent placenta (MAP), were treated with occlusion balloon catheters in both internal iliac arteries. Parameters such as need for hysterectomy, incidence of PPH, grade of MAP, estimated blood loss during delivery (EBL) and transfusion requirements, mean recovery time and duration of the balloon inflation, were collected and reviewed. Complications requiring further management were analysed. RESULTS: Thirty-seven women with MAP underwent prophylactic occlusion balloon placement (POBC). Mean recovery was 4.48 days (range 2-10). Catheters were successfully positioned and balloons inflated in obstetric theatre following caesarean delivery in 100% of the cases. The uterus was conserved in every case. The MAP grades were 20 percreta, 3 increta and 14 accreta. The EBL was not statistically different between the different grades of placentation. There was a statistically significant association in the number of patients requiring blood transfusions and the degree of placental invasion (p = 0. 0119). PPH occurred in 5 patients (13.5%) and arterial thrombosis in 4 patients (11%). The EBL during delivery was significantly higher (2811 mL) in patients with complications (p = 0.0102). Furthermore, the group of patients that had complications required statistically significant more blood transfusions compared to those without complications (p = 0.0001). No maternal mortality or foetal morbidity occurred. CONCLUSION: The utilisation of Prophylactic occlusion balloon catheters allows uterine conserving surgery to be performed safely with few maternal complications.

Infrainguinal angioplasty with drug-eluting stents and balloons.

OBJECTIVE: The objective of this study was to provide a systematic review and meta-analysis of outcomes of infrainguinal angioplasty with drug-eluting stent (DES) or balloon (DEB). METHODS: The EMBASE, MEDLINE, and Cochrane databases and the Current Controlled Trials register were systematically interrogated for articles reporting results of infrainguinal angioplasty with DESs or DEBs. Clinical and angiographic end points were included. RESULTS: The review included 26 studies that reported on 2407 limbs; 11 were prospective randomized controlled trials. Infrapopliteal angioplasty with DEB was reported in 109 limbs (claudication, 19; critical limb ischemia [CLI], 90) (limb salvage in CLI, 95.6%; target lesion revascularization [TLR], 17.3%; mortality, 16%; mean follow-up, 12.3 months). Infrapopliteal angioplasty with DES was reported in 882 limbs (claudication, 160; CLI, 590; unclear severity, 132) (limb salvage in CLI, 97.4%, TLR, 10.8%; mortality, 17%; mean follow-up, 22.9 months). Femoropopliteal angioplasty with DES was reported in 1174 limbs (claudication, 301; CLI, 58; unclear severity, 815) (limb salvage in CLI, 89.6%; TLR, 17.3%; mortality, 3%; mean follow-up, 10.6 months). Femoropopliteal angioplasty with DEB was reported in 242 limbs (claudication, 182; CLI, 12; unclear severity, 48) (TLR, 10.6%; mortality, 2%; mean follow-up, 11 months). Meta-analysis of studies comparing DEB with standard balloon angioplasty demonstrated a result in favor of DEBs for preventing binary primary restenosis (odds ratio [OR], 0.27; P = .005) and TLR (OR, 0.17; P = .001). The meta-analysis comparing DESs with bare-metal stents demonstrated a result in favor of DES with regard to preventing TLR (OR, 0.15; P = .001) and binary primary restenosis (OR, 0.23; P = .001). Drug-eluting technology did not prevent more deaths or amputations. CONCLUSIONS: Early angiographic data suggest that drug-eluting devices prevent restenosis in the short term, but there is as yet no evidence of an increase in limb salvage rates or a reduction in mortality. Further large randomized controlled trials with a focus on clinical outcomes and longer follow-up are needed.

MR imaging evaluation of fibroid clearance following open myomectomy for massive/multiple symptomatic fibroids.

PURPOSE: To evaluate the technical success of total fibroid clearance at open myomectomy for massive and/or multiple symptomatic fibroids using MR imaging (MRI) as the imaging modality. METHODS: The study group comprised 27 women [mean age 37.4 ± 6.9 years (range 27-53)] who underwent open myomectomy for the treatment of massive/multiple symptomatic fibroids at our institution between January 2009 and April 2010. Myomectomy was performed with the intention of achieving complete fibroid clearance. Pre- and postmyomectomy MRI was performed to assess changes in uterine volume and fibroid burden. Periprocedural data (including blood loss and complications) and relief of clinical symptoms at follow-up were also recorded. RESULTS: The mean time to MRI and clinical follow-up was 10 months (range 6-15 months). The mean uterine volume premyomectomy was 795 ± 580 cc and postmyomectomy was 123 ± 70 cc (p < 0.001). The mean percentage reduction in uterine volume was 80.3 % (range 43.0-98.1 %). Of the 10/27 (37.0 %) women with residual fibroids at follow-up: 7 patients had fibroids measuring up to 1 cc in volume, 3 patients had fibroids measuring up to 6 cc. Postoperative adnexal seromas were observed in 6/27 (22.2 %) patients. The clinical success rates of myomectomy amongst the 22/27 (81 %) responders were: 73 % for menorrhagia, 64 % for pain, and 36-64 % for mass-related symptoms. CONCLUSIONS: Using MRI, we have confirmed that open myomectomy can achieve total or near-total fibroid clearance in the majority of patients with massive and/or multiple fibroids.

Randomised Controlled Trial of Particles Used in Uterine fibRoid Embolisation (PURE): Non-Spherical Polyvinyl Alcohol Versus Calibrated Microspheres.

PURPOSE: The PURE study is a randomised controlled trial (RCT) comparing the clinical and MRI outcomes of patients treated with non-spherical polyvinyl alcohol, ns-PVA (Contour PVA-Boston Scientific-355-500 & 500-700 microns) versus calibrated hydrogel microspheres (Embozene-Varian Inc-700 & 900 microns) for symptomatic uterine fibroids. MATERIALS AND METHODS: Prospective, ethically approved non-sponsored RCT in 84 patients in a single UK tertiary IR unit, ISRCTN registry trial number ISRCTN18191539 in 2013 and 2014. All patients with symptomatic fibroid disease were eligible. UAE followed a standardised protocol with UFS-QOL and contrast-enhanced MRI before and 6 months post UAE. Outcome measures included: (1) Uterine Fibroid Symptom and Quality of Life questionnaire (UFS-QOL). (2) Percentage total and dominant fibroid infarction. (3) Uterine and dominant fibroid volume reduction. (4) Volume of embolics. RESULTS: Sixty-three patients completed the QOL follow-up (33 ns-PVA vs 30 Embozenes), the groups were equivalent at baseline. Patients were followed up for 6 months following UAE. There was no significant difference in symptom scores or HR-QOL between ns-PVA and Embozenes, p = 0.67 and 0.21, respectively. 92.7% of patients treated with ns-PVA achieved > 90% dominant fibroid infarction versus 61.8% treated with Embozenes (p = 0.0016). 66% of patients treated with ns = PVA achieved > 90% total fibroid percentage infarction compared with 35% in the Embozene group (p = 0.011). The mean vials/syringes used were 5.2 with Embozenes versus 4.1 using PVA (p = 0.08). CONCLUSION: The PURE study informs IRs regarding the efficacy of embolic agents in UAE, with superior fibroid infarction on MRI using ns-PVA versus Embozenes however no significant difference in clinical outcomes at 6 months after UAE.

Uterine artery embolisation versus myomectomy for premenopausal women with uterine fibroids wishing to avoid hysterectomy: the FEMME RCT.

BACKGROUND: Uterine fibroids are the most common tumour in women of reproductive age and are associated with heavy menstrual bleeding, abdominal discomfort, subfertility and reduced quality of life. For women wishing to retain their uterus and who do not respond to medical treatment, myomectomy and uterine artery embolisation are therapeutic options. OBJECTIVES: We examined the clinical effectiveness and cost-effectiveness of uterine artery embolisation compared with myomectomy in the treatment of symptomatic fibroids. DESIGN: A multicentre, open, randomised trial with a parallel economic evaluation. SETTING: Twenty-nine UK hospitals. PARTICIPANTS: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolisation were recruited. Women were excluded if they had significant adenomyosis, any malignancy or pelvic inflammatory disease or if they had already had a previous open myomectomy or uterine artery embolisation. INTERVENTIONS: Participants were randomised to myomectomy or embolisation in a 1 : 1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic. Embolisation of the uterine arteries was performed under fluoroscopic guidance. MAIN OUTCOME MEASURES: The primary outcome was the Uterine Fibroid Symptom Quality of Life questionnaire (with scores ranging from 0 to 100 and a higher score indicating better quality of life) at 2 years, adjusted for baseline score. The economic evaluation estimated quality-adjusted life-years (derived from EuroQol-5 Dimensions, three-level version, and costs from the NHS perspective). RESULTS: A total of 254 women were randomised - 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolisation (98 underwent embolisation). Information on the primary outcome at 2 years was available for 81% (n = 206) of women. Primary outcome scores at 2 years were 84.6 (standard deviation 21.5) in the myomectomy group and 80.0 (standard deviation 22.0) in the uterine artery embolisation group (intention-to-treat complete-case analysis mean adjusted difference 8.0, 95% confidence interval 1.8 to 14.1, p = 0.01; mean adjusted difference using multiple imputation for missing responses 6.5, 95% confidence interval 1.1 to 11.9). The mean difference in the primary outcome at the 4-year follow-up time point was 5.0 (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. Perioperative and postoperative complications from all initial procedures occurred in similar percentages of women in both groups (29% in the myomectomy group vs. 24% in the UAE group). Twelve women in the uterine embolisation group and six women in the myomectomy group reported pregnancies over 4 years, resulting in seven and five live births, respectively (hazard ratio 0.48, 95% confidence interval 0.18 to 1.28). Over a 2-year time horizon, uterine artery embolisation was associated with higher costs than myomectomy (mean cost £7958, 95% confidence interval £6304 to £9612, vs. mean cost £7314, 95% confidence interval £5854 to £8773), but with fewer quality-adjusted life-years gained (0.74, 95% confidence interval 0.70 to 0.78, vs. 0.83, 95% confidence interval 0.79 to 0.87). The differences in costs (difference £645, 95% confidence interval -£1381 to £2580) and quality-adjusted life-years (difference -0.09, 95% confidence interval -0.11 to -0.04) were small. Similar results were observed over the 4-year time horizon. At a threshold of willingness to pay for a gain of 1 QALY of £20,000, the probability of myomectomy being cost-effective is 98% at 2 years and 96% at 4 years. LIMITATIONS: There were a substantial number of women who were not recruited because of their preference for a particular treatment option. CONCLUSIONS: Among women with symptomatic uterine fibroids, myomectomy resulted in greater improvement in quality of life than did uterine artery embolisation. The differences in costs and quality-adjusted life-years are very small. Future research should involve women who are desiring pregnancy. TRIAL REGISTRATION: This trial is registered as ISRCTN70772394. FUNDING: This study was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme, and will be published in full in Health Technology Assessment; Vol. 26, No. 22. See the NIHR Journals Library website for further project information.

WHAT IS THE PROBLEM?: Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. Uterine fibroids are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (via myomectomy) or to completely remove the womb. A newer approach, known as uterine artery embolisation, involves blocking the blood supply to the fibroids in the womb. WHAT DID WE PLAN TO DO?: We compared myomectomy with uterine artery embolisation in women with fibroids who wanted to keep their womb. We wanted to see which treatment improved quality of life, was associated with the fewest complications and was the best value for money for the NHS. We also wanted to see if either treatment had an impact on women's ability to get pregnant and give birth. We included 254 women in a clinical trial. Women were assigned to have myomectomy or uterine artery embolisation at random to ensure a fair comparison. Women completed questionnaires about their symptoms and quality of life at intervals up to 4 years after treatment. WHAT DID WE FIND?: We found that myomectomy improved women's quality of life more than uterine artery embolisation. Complications from the treatments occurred in a similar proportion of women. There appeared to be no difference on reproductive hormone levels between treatments. Too few women in the trial got pregnant for any difference in the numbers of women having children to be seen. The differences in costs and overall disease burden were small. WHAT DOES THIS MEAN?: Both treatments improve quality of life and cost about the same to the NHS but, on average, myomectomy will provide greater benefit to women. There is no evidence to suggest that either treatment is unsuitable for women wanting to get pregnant, but more research is needed in younger women.

Uterine artery embolization or myomectomy for women with uterine fibroids: Four-year follow-up of a randomised controlled trial.

OBJECTIVE: To examine the quality of life experienced by women with symptomatic uterine fibroids who had been treated with UAE in comparison to myomectomy. We report the four-year follow-up of the FEMME randomised trial. Two-year follow-up data has been previously reported. STUDY DESIGN: Premenopausal women who had symptomatic uterine fibroids amenable to myomectomy or uterine artery embolization were recruited from 29 UK hospitals. Women were excluded if they had significant adenomyosis, any malignancy, pelvic inflammatory disease or had had a previous open myomectomy or uterine artery embolization.Participants were randomised to myomectomy or embolization in a 1:1 ratio using a minimisation algorithm. Myomectomy could be open abdominal, laparoscopic or hysteroscopic, according to clinician preference. Embolization of the uterine arteries was performed according to local practice, under fluoroscopic guidance.The primary outcome measure was the Uterine Fibroid Symptom Quality of Life questionnaire, adjusted for baseline score and reported here at four years post-randomisation. Subsequent procedures for fibroids, pregnancy and outcome were amongst secondary outcomes.Trial registration ISRCTN70772394 https://doi.org/10.1186/ISRCTN70772394. RESULTS: 254 women were randomized, 127 to myomectomy (105 underwent myomectomy) and 127 to uterine artery embolization (98 underwent embolization). At four years, 67 (53%) and 81 (64%) completed UFS-QoL quality of life scores. Mean difference in the UFS-QoL at 4 years was 5.0 points (95% CI -1.4 to 11.5; p = 0.13) in favour of myomectomy. There were 15 pregnancies in the UAE group and 7 in the myomectomy group, with a cumulative pregnancy rate to four years of 15% and 6% respectively (hazard ratio: 0.48; 95% CI 0.18-1.28). The cumulative repeat procedure rate to four years was 24% in the UAE group and 13% in the myomectomy group (hazard ratio: 0.53; 95% CI 0.27-1.05). CONCLUSIONS: Myomectomy resulted in greater improvement in quality of life compared with uterine artery embolization, although by four years, this difference was not statistically significant. Missing data may limit the generalisability of this result. The numbers of women becoming pregnant were too small draw a conclusion on the effect of the procedures on fertility.

Immediate and long-term outcomes of bronchial and non-bronchial systemic artery embolisation for the management of haemoptysis.

OBJECTIVE: To evaluate the immediate and long-term results of arterial embolisation in the management of haemoptysis and to identify factors influencing outcome. METHODS: A retrospective analysis was carried out of the medical records and angiograms of 50 patients who underwent transarterial embolisation for haemoptysis. RESULTS: The most frequent causes of haemoptysis included bronchiectasis (16%), active tuberculosis (12%) and aspergilloma (12%). A total of 126 bronchial and non-bronchial systemic arteries were embolised in 62 procedures. Immediate cessation of haemoptysis was achieved in 43 patients (86%). Haemoptysis was controlled in 36 patients (72%), recurred in 14 (28%) and 11 (22%) required repeat embolisation. The worst outcomes were observed in patients with aspergilloma: all six suffered recurrent bleeding and three (50%) died from massive haemoptysis. Aspergilloma was also associated with an increased risk of haemoptysis recurrence (p < 0.05). A good clinical outcome was achieved in those with active tuberculosis and malignancy. Complication rates were low and included transient chest pain, false aneurysm and one case of lower limb weakness. CONCLUSION: Bronchial artery embolisation (BAE) is an effective and safe procedure for haemoptysis control in most cases. However, high recurrence and mortality rates are associated with aspergilloma. Early intervention with repeat embolisation is recommended in these patients and elective surgery should be considered.

Outcomes of the first 50 patients with abnormally invasive placenta managed using the "Triple P Procedure" conservative surgical approach.

OBJECTIVE: To determine maternal outcomes for women with abnormally invasive placenta (AIP) managed using the Triple P Procedure and establish its safety as a conservative surgical management option. METHODS: A retrospective study of the outcomes of the first 50 patients who underwent the Triple P Procedure for AIP from September 2010 to May 2017 at St George's Maternity Unit. Maternity case notes and the database were reviewed to determine the volume of bleeding, procedure-related complications, hysterectomy rate, and postoperative hospitalization. RESULTS: Mean operative blood loss was 2318 mL (range, 400-7300 mL and the incidence of bladder and ureteric injuries was 2% (n=1) and 0%, respectively. Median length of hospital stay was 4 days (range, 2-8 days). Three women (6.0%) developed arterial thrombosis without any long-term complications and none of the patients required peripartum hysterectomy. CONCLUSION: The Triple P Procedure should be considered as a conservative, less risky alternative to a peripartum hysterectomy during counselling prior to surgery for women with AIP.

Predicting the Fibroid-Migratory Impact of UAE: Role of Pre-embolization MRI Characteristics.

AIM: To investigate potential factors on MR imaging that could be used to predict migration of uterine fibroids post-UAE. METHODS AND MATERIALS: We retrospectively reviewed patients referred for UAE having pre-procedural and 6 months post-procedural MRI, at a tertiary centre, over a 1-year period. Pre- and post-UAE images were reviewed in 64 women by two radiologists to identify the sub-type, dimensions, and infarction rate of each dominant fibroid. The shortest distance between the fibroid and the endometrial wall was measured to determine intramural fibroid movement. Paired sample T tests and two-sample T tests were used to compare between pre- and post-embolization variations and between migrated and non-migrated intramural fibroids, respectively. After preliminary results suggested potential predictors of intramural fibroids migration, we tested our findings against the non-dominant intramural fibroids in the same patients. RESULTS: Review of images revealed 35 dominant intramural fibroids, of which eight migrated to become submucosal fibroids, while five were either partially or completely expelled. These 13 migrated fibroids had a shorter pre-procedural minimum endometrial distance (range 1-2.4 mm) and greater maximum fibroid diameter (range 5.1-18.1 cm), when compared to non-migrating fibroids. On image reassessment, the migrated non-dominant intramural fibroids had a minimum endometrial distance and maximum fibroid diameter within the same range. CONCLUSION: Intramural fibroids with a minimum endometrial distance less than 2.4 mm and a maximum fibroid diameter greater than 5.1 cm have a high likelihood of migrating towards the endometrial cavity after UAE.