Fibroid Volume Reduction Research Articles

Impact of ultrasound-guided high-intensity focused ultrasound for the treatment of uterine fibroids on ovarian reserve and quality of life: a single-center prospective cohort study

BackgroundWe aimed to evaluate changes in ovarian reserve and quality of life in women treated with ultrasound-guided high-intensity focused ultrasound (USgHIFU) for uterine fibroids.MethodsIn this single-center prospective study, a total of 69 patients with uterine fibroids treated with USgHIFU from October 2018 to November 2021 were enrolled. Fibroid volume, anti-Müllerian hormone (AMH) levels, uterine fibroid symptom scores, and uterine fibroid symptoms and quality of life (UFS-QOL) questionnaire scores before and 1, 3, and 6 months after USgHIFU treatment were analyzed. Correlations between AMH levels and age, fibroid type, and fibroid location were assessed.ResultsData from 54 of the 69 patients included in the present study were analyzed. The UFS-QOL scores at baseline and at 1 month and 6 months after USgHIFU treatment were 70 (50.75–87.50), 57 (44.75–80.00), and 52 (40.75–69.00) points, respectively (p < 0.001). The rate of fibroid volume reduction increased significantly at the 3-month follow-up compared with the 1-month follow-up (p < 0.001), and no significant change was observed between the 3-month and 6-month follow-ups (p > 0.99). The median AMH levels before and at 1, 3 and 6 months after treatment were 1.22 (0.16–3.28) ng/ml, 1.12 (0.18–2.52) ng/ml, 1.15 (0.19–2.08) ng/ml and 1.18 (0.36–2.43) ng/ml, respectively (p = 0.2). Multivariate linear regression analyses revealed that age was independently associated with AMH levels.ConclusionsUSgHIFU treatment for uterine fibroids can significantly improve quality of life with minimal adverse effects on ovarian function.

Obstetric outcome after ultrasound guided transvaginal radiofrequency ablation of uterine myomas

Purpose: The objective is to report the obstetric outcome of 8 pregnancies with uterine fibroids who conceived after RFA. Methods: A study was conducted on 115 women with symptomatic uterine fibroids undergoing transvaginal RFA using a bipolar radiofrequency generator and an internally cooled electrode. Data on pregnancies and outcomes were collected. Results: After the procedure, eight pregnancies occurred. Fibroid volume reduction exceeded 50% in half of the patients, with an average reduction rate of 43%. Six resulted in live births, with a cesarean section rate of 2/3, one in an ectopic pregnancy, and one in a miscarriage. Pregnancy complications were limited, and all newborns showed normal development. Conclusion: Minimally invasive ultrasound-guided RFA is effective in shrinking the myomas and may not carry an obstetric risk. Although the number of reported cases is low, no obstetric complications specifically associated with transvaginal radiofrequency ablation of uterine fibroids have been observed.

An Evaluation of Ultrasound-Guided Percutaneous Microwave Ablation for the Treatment of Symptomatic Uterine Fibroids

PurposeTo evaluate the feasibility and effectiveness of ultrasound-guided percutaneous microwave ablation (MWA) for the treatment of symptomatic uterine fibroids. Materials and MethodsA single-center retrospective study was conducted on 17 patients, mean age 37.5 years (SD ± 7.3; range 19-47 years) with symptomatic uterine fibroid who underwent MWA between September 2018 and December 2022. Outcomes included volume reduction of uterine fibroids, hemoglobin levels, uterine fibroid symptoms, and health-related quality-of-life questionnaire scores before and 12 months after ablation. ResultsPreoperative fibroid diameter was a mean of 6.7 cm (SD ± 1.1; range 5–9 cm), and volume was a mean of 101.9 cm3 (SD ± 63.3; range 16.9–264.1 cm3). The mean ablation time was 12.2 minutes (SD ± 3.1; range, 8–20 minutes). The mean reduction of volume at 12 months after treatment was 70.9% (SD ± 23.8). The hemoglobin level increased significantly from 9.96 g/dL ± 2.33 before treatment to 12.14 g/dL ± 1.34 at 12 months after treatment (P = .002). The symptom severity score and health-related quality-of-life scores were significantly improved at follow-up (P < .001). ConclusionsThe application of MWA as a standalone treatment method might provide an effective, minimally invasive option for Federation of Gynecology and Obstetrics Types 1–6 symptomatic uterine fibroids with the potential to enhance patients’ quality of life.

Can an apparent diffusion coefficient of uterine fibroid before uterine artery embolization predict potential fibroid response?

ACOG guidance confirms the use of uterine artery embolisation (UAE) as an alternative to hysterectomy or myomectomy. The main objective of this article is to evaluate the ability of preoperative magnetic resonance ımaging (MRI) to study the relationship between uterine fibroid reduction and diffusion coefficient (ADC) value after UAE. This is a relevant topic with the growing interest in using ADC as a noninvasive imaging biomarker for monitoring tissue changes and predicting uterine fibroid response to UAE over the past years. In this prospective controlled non-randomized trial; uterine fibroid volume, fibroid diameter, uterine volume, fibroid ADC and normal myometrium ADC were recorded before and after UAE. Wilcoxon test was used in the analysis of the dependent quantitative data. Pearson correlation coefficients were calculated between post-UAE uterine volume, fibroid volume, and average fibroid diameter reduction and the patient's age, parity, gravidity, fibroid ADC and myometrial ADC before UAE. The mean fibroid volume reduction was 36.0% (range between 17.3-77.7%). Mean fibroid diameter, fibroid volume, uterine volume, and myometrium ADC values after UAE were significantly lower than before the procedure (p = 0.002, < 0.001, 0.001, 0.006 respectively), but the decrease in fibroid ADC is not significant. As a result decrease in fibroid volume was greater as pre-UAE fibroid ADC values increased, and that finding may contribute to the selection of the patients for the procedure. The ADC value before UAE was positively correlated with fibroid volume reduction.

Efficacy of different doses of mifepristone in the management of uterine leiomyoma in a tertiary care centre

Leiomyoma or uterine fibroid are benign tumours that arise from the smooth muscles of the uterus. The leiomyomas are common gynaecological problem encountered among reproductive age group women. Mifepristone is the commonly used drug in the management of uterine leiomyoma. The objective of the study were to study the efficacy and safety of 10mg and 25mg of Mifepristone in the management of uterine fibroid. This is a randomized controlled Trial conducted in tertiary care centre. Hundred women with the diagnosis of uterine fibroid were taken up for the study. Group-A (n=50) were given Mifepristone 10mg and Group-B (n=50) were given Mifepristone 25mg daily for a period of 3 months. Reduction in the size of fibroid were assessed at the end of 3 months. At the end of 3months there was a significant reduction in both menstrual blood loss and fibroid volume in both the groups (p&amp;#60;0.001). There was a also significant improvement in haemoglobin levels in both the groups. When compared to Group –A (10mg Mifepristone) more side effects were noted in Group-B (25mg Mifepristone). Nausea and vomiting developed in 90% and 60% of patients in group A and B.Gastrointestinal discomfort developed in 80% and 50% of patients in group A and B. Both Mifepristone 10mg and 25mg had similar clinical outcomes but 10mg had better compliance and lower side effects. Hence, 10mg can be preferred over 25mg in order to bring about effective management of uterine fibroid.

ULIPRISTAL ACETATE VERSUS PLACEBO FOR FIBROID TREATMENT

Background: The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. Methods: We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of &gt;100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to &gt;500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of &lt;75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. Results: At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, and 19% of those receiving placebo (P&lt;0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were −21%,, and +3% (P = 0.002 for the comparison of 5 mg of ulipristal acetate with placebo. Serious adverse events occurred in one patient during treatment with 5 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo. Conclusions: Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids.

ULIPRISTAL ACETATE VERSUS PLACEBO FOR FIBROID TREATMENT

Background: The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. Methods: We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of &gt;100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to &gt;500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of &lt;75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. Results: At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, and 19% of those receiving placebo (P&lt;0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were −21%,, and +3% (P = 0.002 for the comparison of 5 mg of ulipristal acetate with placebo. Serious adverse events occurred in one patient during treatment with 5 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo. Conclusions: Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids.

Measurement of changes in uterine and fibroid volume during treatment of heavy menstrual bleeding (HMB).

Does application of an unbiased method for analysis of magnetic resonance (MR) images reveal any effect on uterine or fibroid volume from treatment of heavy menstrual bleeding (HMB) with three 12-week courses of the selective progesterone receptor modulator ulipristal acetate (SPRM-UPA)? Application of an unbiased method for analysis of MR images showed that treatment of HMB with SPRM-UPA was not associated with a significant reduction in the volume of the uterus or in the volume of uterine fibroids. SPRM-UPA shows therapeutic efficacy for treating HMB. However, the mechanism of action (MoA) is not well understood and there have been mixed reports, using potentially biased methodology, regarding whether SPRM-UPA has an effect on the volume of the uterus and fibroids. In a prospective clinical study (with no comparator), 19 women with HMB were treated over a period of 12 months with SPRM-UPA and uterine and fibroid size were assessed with high resolution structural MRI and stereology. A cohort of 19 women aged 38-52years (8 with and 11 without fibroids) were treated with three 12-week courses of 5 mg SPRM-UPA given daily, with four weeks off medication in-between treatment courses. Unbiased estimates of the volume of uterus and total volume of fibroids were obtained at baseline, and after 6 and 12 months of treatment, by using the Cavalieri method of modern design-based stereology in combination with magnetic resonance imaging (MRI). Bland-Altman plots showed good intra-rater repeatability and good inter-rater reproducibility for measurement of the volume of both fibroids and the uterus. For the total patient cohort, two-way ANOVA did not show a significant reduction in the volume of the uterus after two or three treatment courses of SPRM-UPA (P = 0.51), which was also the case when the groups of women with and without fibroids were considered separately (P = 0.63). One-way ANOVA did not show a significant reduction in total fibroid volume in the eight patients with fibroids (P = 0.17). The study has been performed in a relatively small cohort of women and simulations that have subsequently been performed using the acquired data have shown that for three time points and a group size of up to 50, with alpha (Type I Error) and beta (Type II Error) set to 95% significance and 80% power, respectively, at least 35 patients would need to be recruited in order for the null hypothesis (that there is no significant reduction in total fibroid volume) to be potentially rejected. The imaging protocol that we have developed represents a generic paradigm for measuring the volume of the uterus and uterine fibroids that can be readily incorporated in future studies of medical treatments of HMB. In the present study, SPRM-UPA failed to produce a significant reduction in the volume of the uterus or the total volume of fibroids (which were present in approximately half of the patients) after either two or three 12-week courses of treatment. This finding represents a new insight in respect of the management of HMB using treatment strategies that target hormone-dependence. The UPA Versus Conventional Management of HMB (UCON) trial was funded by the EME Programme (Medical Research Council (MRC) and National Institutes of Health Research (NIHR)) (12/206/52). The views expressed in this publication are those of the authors and not necessarily those of the Medical Research Council, National Institute for Health Research, or Department of Health and Social Care.Medical Research Council (MRC) Centre grants to the Centre for Reproductive Health (CRH) (G1002033 and MR/N022556/1) are also gratefully acknowledged. H.C. has clinical research support for laboratory consumables and staff from Bayer AG and provides consultancy advice (All paid to Institution) for Bayer AG, PregLem SA, Gedeon Richter, Vifor Pharma UK Ltd, AbbVie Inc., and Myovant Sciences GmbH. H.C. has received royalties from UpToDate for an article on abnormal uterine bleeding. L.W. has received grant funding from Roche Diagnostics (Paid to Institution). All other authors have no conflicts to declare. The study reported here is an embedded mechanism of action study (no comparator) within the UCON clinical trial (registration ISRCTN: 20426843).

Associations of Pregnancy Per- and Polyfluoroalkyl Substance Concentrations and Uterine Fibroid Changes across Pregnancy: NICHD Fetal Growth Studies - Singletons Cohort.

Fibroids (hormonally responsive benign tumors) often undergo volume changes in pregnancy. Because per- and polyfluoroalkyl substances (PFAS) disrupt hormonal signaling, they might affect fibroid growth. We assessed associations between PFAS and fibroid changes in pregnancy. We analyzed seven PFAS, including perfluorohexanesulfonic acid (PFHxS), perfluorooctanesulfonic acid (PFOS), perfluorodecanoic acid (PFDA), and perfluoroundecanoic acid (PFUnDA), in plasma collected at 10-13 wk gestation from 2,621 women in the NICHD Fetal Growth Studies - Singletons cohort (2009-2013). Sonographers recorded fibroid number and volume of the three largest fibroids during up to six timed ultrasounds. Generalized linear models assessed associations of baseline PFAS and fibroid number, volume, and presence, and weighted quantile sum regression evaluated the PFAS mixture. Generalized linear mixed models with random intercepts assessed associations of PFAS and longitudinal fibroid number and total volume. Volume analyses were stratified by total volume at first visualization [equivalent to a fibroid (small), (medium), or (large) in diameter]. Fibroid prevalence was 9.4% ( women). PFAS were not associated with changes in fibroid number, but were associated with volume trajectory, depending on baseline volume. Among women with small volume, PFAS were associated with fibroid growth: Each doubling in PFHxS and PFOS concentrations was associated with 3.6% [95% confidence interval (CI): 0.2, 7.0 and 5.2% (95% CI: , 11.1)] greater weekly fibroid growth, respectively. Among women with medium volume, PFAS were associated with shrinking: Doublings in PFOS, PFDA, and PFUnDA concentrations were associated with 1.9% (95% CI: 0.4, 3.3), 1.2% (95% CI: 0.1, 2.4), and 1.6% (95% CI: 0.4, 2.8) greater weekly fibroid volume reduction, respectively. Certain PFAS were associated with fibroid growth among women with small fibroids and decreases among women with medium fibroids. PFAS were not associated with fibroid prevalence or number; therefore, PFAS may influence prevalent fibroids rather than initiating fibroid development. https://doi.org/10.1289/EHP11606.

High-intensity Focused Ultrasound for the Treatment of Fibroids: A Single-center Experience in Singapore.

Uterine fibroids and adenomyosis are common gynecological conditions that often require surgical treatment. Minimally invasive interventions such as ultrasound-guided high-intensity focused ultrasound (USgHIFU) are gaining popularity as they avoid surgical morbidity and conserve the uterus. We present a single-center experience on the use of USgHIFU for the treatment of fibroids and adenomyosis. This was a retrospective study of 167 patients who underwent USgHIFU for uterine fibroids and adenomyosis between July 2018 and December 2020. Relevant demographic data and pre- and post-intervention fibroid volume, symptom severity scores (SSS), and health-related quality of life (QOL) scores were collected and compared. The paired t-test or Wilcoxon signed-rank test was used to compare the difference before and after treatment. P < 0.001 was considered statistically significant. One hundred and sixty-seven patients with fibroids or adenomyosis were included in this study. The mean age of the cohort was 42-year-old. USgHIFU treatment led to a reduction in mean fibroid volume, improvement in SSS, and health-related QOL scores. The average reduction in mean fibroid volume was 68% and 75% at 6 and 12 months, respectively. There was a significant reduction in SSS (46.9 [pre] vs. 15.6 [post], P < 0.001) and improvement in health-related QOL scores at 6 months (58 [pre] vs. 86 [post], P < 0.001). The re-intervention rate following USgHIFU was 7.7% and successful pregnancy post USgHIFU was reported in 6 patients. USgHIFU is safe and effective. In women who desire fertility or are not suitable for surgery, it is a good alternative option. It should be included in the armamentarium for the treatment of uterine fibroids and adenomyosis.

Magnetic resonance imaging parameter-based machine learning for prognosis prediction of high-intensity focused ultrasound ablation of uterine fibroids

Objectives: To develop and apply magnetic resonance imaging (MRI) parameter-based machine learning (ML) models to predict non-perfused volume (NPV) reduction and residual regrowth of uterine fibroids after high-intensity focused ultrasound (HIFU) ablation. Methods: MRI data of 573 uterine fibroids in 410 women who underwent HIFU ablation from the Chongqing Haifu Hospital (training set, N = 405) and the First Affiliated Hospital of Chongqing Medical University (testing set, N = 168) were retrospectively analyzed. Fourteen MRI parameters were screened for important predictors using the Boruta algorithm. Multiple ML models were constructed to predict NPV reduction and residual fibroid regrowth in a median of 203.0 (interquartile range: 122.5–367.5) days. Furthermore, optimal models were used to plot prognostic prediction curves. Results: Fourteen features, including postoperative NPV, indicated predictive ability for NPV reduction. Based on the 10-fold cross-validation, the best average performance of multilayer perceptron achieved with R2 was 0.907. In the testing set, the best model was linear regression (R2 =0.851). Ten features, including the maximum thickness of residual fibroids, revealed predictive power for residual fibroid regrowth. Random forest model achieved the best performance with an average area under the curve (AUC) of 0.904 (95% confidence interval (CI), 0.869–0.939), which was maintained in the testing set with an AUC of 0.891 (95% CI, 0.850–0.929). Conclusions: ML models based on MRI parameters can be used for prognostic prediction of uterine fibroids after HIFU ablation. They can potentially serve as a new method for learning more about ablated fibroids.

OUTCOME OF UTERINE ARTERY EMBOLIZATION – A 12 MONTH FOLLOW UP OF CLINICAL OUTCOME AND FIBROID VOLUME REDUCTION

Background :Uterine fibroid or leiomyomas are the most common benign uterine tumors and may be seen in upto 40 % of women in reproductive age. Though benign, fibroids are usually symptomatic and the associated menorrhagia hampers routine activities. Uterine artery embolisation [UAE] is an accepted alternative to surgical and medical treatment for symptomatic fibroids Objective : To analyze the efficacy of uterine artery embolization with reference to fibroid volume reduction as assessed by ultrasound. Methods: 32 patients between 21 to 45 years of age underwent UAE between 2010 and 2016. Following biochemical evaluation, preprocedure ultrasound with fibroid volume estimation was done using a Siemens Antares machine. Embolization of bilateral uterine arteries was carried out using gelfoam and Polyvinylalcohol spheres[330-500 ].Post procedure ultrasound was done at 1,3,6 and 12 months . Results:Of the 32 patients ,pre procedure ultrasound revealed fibroids in 26,molar pregnancy in 2,retained products in 2, adenomyosis and arteriovenous malformation in one each. Co morbidities included cardiac problems, uncontrolled diabetes, severe anemia and thyroid cancer. Post procedure 2 patients underwent hysterectomy, 2 developed amenorrhea,rest regained regular menstrual flow. 3. Of the 26 patients with fibroids pre procedure mean fibroid volume was 253cm Mean reduction in Fibroid volume was 34%,66%,79% and 81% at 1,3,6 and 12 months.The mean reduction in fibroid volume was statistically significant. Conclusion: UAE is an effective method in treatment of Fibroids and Ultrasound with volume estimation is adequate for follow up.

Should Ultrasound-Guided High Frequency Focused Ultrasound Be Considered as an Alternative Non-Surgical Treatment of Uterine Fibroids in Non-Asiatic Countries? An Opinion Paper.

Minimally invasive interventions for myomata treatment have gained acceptance due to the possibility of preserving fertility with reduced trauma induced by laparotomy as way of entrance. There are insufficient data regarding outcomes of high intensity focused ultrasound (HIFU) in non-Asiatic women. Therefore, we revised the available evidence to present an expert opinion that could support physicians, patients and policy-makers for considering this approach in other populations. We revisited systematic reviews, randomized controlled trials and cohort studies from January 2018 to August 2021 using PubMed and Google scholar, regarding short and long term outcomes after ablation with focused ultrasound waves. In total, 33 studies, including 114,810 adult patients showed that outcomes of this approach depend on several parameters directly related with resistance to thermal ablation, especially fibroid size and vascularization. Two studies report satisfactory outcomes in Afro-American women. In accordance to the technique used, fibroid volume reduction showed to be higher in fibroids <300 cm3 after ultrasound guided HIFU than after MRI guided. Compared to myomectomy and uterine artery embolization, HIFU seems to have shorter hospital stay, higher pregnancy rates and similar adverse events rates, with skin burn being the most reported. Symptoms and quality of life improvement is similar to myomectomy but lower than embolization, however reintervention rate is higher after HIFU. Lacks evidence about long-term sarcoma risk after ablation. Available evidence shows that HIFU can be considered as a uterine sparing treatment for women of different ethnicities suffering of uterine myomatosis, especially for those wishing to preserve their fertility.

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

PurposeThe 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 MethodsProspective, 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.ResultsSixty-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).ConclusionThe 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.

Multidisciplinary management to optimize outcome of ultrasound-guided high-intensity focused ultrasound (HIFU) in patients with uterine fibroids

Little is known about the specific anaesthesiological and multidisciplinary management of high-intensity focused ultrasound (HIFU) in uterine fibroids. This observational single-center study is the first reporting on an interdisciplinary approach to optimize outcome following ultrasound (US)-guided HIFU in German-speaking countries. A sample of forty patients with symptomatic uterine fibroids was treated by HIFU. Relevant treatment parameters such as total treatment time for intervention, anaesthesia, and sonication time as well as total energy, body temperature, peri-interventional medication and complications were analyzed. Interventional variables did not correlate significantly either with opioid dose or with body temperature. The average fibroid volume reduction rate was 37.8% ± 23.5%, 48.5% ± 22.0% and 70.2% ± 25.5% after 3, 6 and 12 months, respectively. No major anaesthesiological complications occurred apart from an epileptic seizure prior to HIFU treatment in one patient. Peri-procedural hyperthermia (> 37.5 °C) occurred in two patients. Post-procedural two patients experienced a sciatic nerve irritation up to one year; one patient with very large treated fibroid experienced strong short-lasting post-procedural pain. There were two complication-free pregnancies of HIFU-treated patients. Multidisciplinary management is crucial to optimize safety and outcome of US-guided HIFU for uterine fibroids. Peri-procedural pain and temperature management are critical points where an adequate collaboration between anesthesiologist and interventionalist is mandatory.

Potential benefit of GnRH-agonist treatment before uterine artery embolization for large fibroids: MRI prediction of fibroid volume reduction.

Signal intensity (SI) of predominant fibroid (F1) on T2-weighted (T2W) images is useful for predicting the volume reduction response after gonadotropin-releasing hormone (GnRH)-agonist treatment. Few studies have been published regarding when and how to use GnRH agonist before UAE. To investigate magnetic resonance imaging (MRI) prediction of volume reduction rate (VRR) of large fibroids after GnRH-agonist treatment before uterine artery embolization (UAE) as well as the efficacy of UAE based on MRI. Data from 30 patients with a large fibroid and MRI results both before and after GnRH-agonist treatment were retrospectively analyzed. Indications for GnRH-agonist treatment are fibroids with a maximum diameter ≥10 cm or pedunculated submucosal fibroids ≥8 cm. GnRH agonist (3.75 mg leuprolide acetate) was administered subcutaneously once per month 2-6 times. SI of F1 on T2W imaging was measured: the SI was referenced to the SI of the rectus abdominis muscle (F/R). Mean maximum fibroid diameter was 11.1 ± 1.9 cm (range = 8.0-15.5 cm). Mean number of GnRH-agonist injections before UAE was 2.8 (range = 2-6). For predicting VRR ≥50% and <30%, the optimal cut-off values of F/R were 2.58 (sensitivity 80%, specificity 80%) and 1.69 (sensitivity 100%, specificity 70%), respectively. Of the 30 patients, fibroid infarction was complete in 29 (96.7%). SI of F1 on T2W imaging is useful for predicting the volume reduction response after GnRH-agonist treatment. After GnRH-agonist treatment for large fibroids, UAE is effective to achieve complete infarction of fibroids.

Uterine and Fibroid Imaging Analysis from the FIRSTT Study.

Background: Women with uterine fibroids often seek uterine-preserving treatments, rather than hysterectomy. Imaging-defined endpoints following nonsurgical treatments for fibroids are limited. Materials and Methods: Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT), a randomized controlled trial of uterine artery embolization (UAE) versus magnetic resonance imaging-guided focused ultrasound surgery (MRgFUS), enrolled premenopausal women with symptomatic uterine fibroids. In this subanalysis, we report imaging results up to 36 months after UAE or MRgFUS. Magnetic resonance imaging (MRI) was performed at baseline for all women and during the 36 months after treatment if they did not meet other study endpoints. The main outcome of this subanalysis was fibroid volume reduction (defined both in terms of total fibroid load and volume of the largest fibroid), uterine volume reduction, and nonperfused volume. Results: During 2010-2014, 25 of the 37 women who were randomized and treated at Mayo Clinic had a 24-month follow-up MRI (11 UAE; 14 MRgFUS); among these women, 15 (7 UAE and 8 MRgFUS) had a 36-month follow-up MRI. Average age for the cohort was 44.1 (standard deviation, SD = 4.4) years. Nine patients had a second fibroid procedure by 36 months (seven in the MRgFUS arm and two in UAE arm). Median total fibroid load reduction was ∼50% in both treatment arms at both 24- and 36-month follow-up. Volume of the largest fibroid decreased more in the MRgFUS arm, whereas uterine volume decreased more in the UAE arm (neither reached statistical significance). At 24 months, median nonperfused volume was higher in the UAE arm (92%) than the MRgFUS arm (10%). Conclusions: Similar fibroid volume reduction was seen for the MRgFUS and UAE treatments in this comparative effectiveness study. Nonperfused volume 24 months after the procedure was higher in the UAE arm than in the MRgFUS arm. Clinical Trial Registration Number: NCT00995878, clinicaltrials.gov.

Association between adipose tissue thickness and fibroid shrinkage using ultrasound-guided high‑intensity focused ultrasound

Background. Ultrasound-guided high-intensity focused ultrasound (USgHIFU) is used to noninvasively treat symptomatic uterine fibroids. The thickness of the adipose tissue that the HIFU beam travels through is thought to be associated with decreased treatment outcome, although the evidence is anecdotal. Objectives. To determine whether the thickness of adipose tissue affects the percentage volume shrinkage of the uterine fibroid after treatment. Method. A retrospective study was performed at Chris Hani Baragwanath Academic Hospital (CHBAH) on patients who were treated with USgHIFU for symptomatic uterine fibroids between 11 October 2015 and 11 April 2018. Magnetic resonance imaging (MRI) images were used to measure the adipose tissue thickness and the percentage volume shrinkage of the uterine fibroid. Linear regression was used to determine an association between adipose tissue thickness and the percentage volume shrinkage of the uterine fibroid after treatment. Results . A total of 71 female patients who attended the CHBAH HIFU clinic were included in the study. Mean adipose tissue thickness was 17.49 mm (95% confidence interval (CI) 14.86 - 19.73). Mean pre- and post-treatment volume of the fibroid was 176 mL (95% CI 123.26 - 208.57) and 109 mL (95% CI 71.75 - 141.73), respectively. The mean fibroid volume reduction was 44.68% ( p &lt;0.0001). We found no significant relationship between adipose tissue thickness and change in volume ratio of the fibroid. Conclusion . It is unclear whether adipose thickness affects treatment outcome when symptomatic uterine fibroids are ablated using USgHIFU. This study found no correlation between adipose tissue thickness and uterine fibroid shrinkage after HIFU treatment. Our findings suggest that the exclusion criteria for USgHIFU treatment of uterine fibroids should be reviewed.

Management of women with uterine fibroids in reproductive center: retrospective analysis of clinical and reproductive outcomes.

Uterine fibroids are the most common benign tumor in women. According to literature, submucosal myomas have a negative effect on reproductive outcomes in women undergoing assisted reproductive techniques (ART) but there are fewer data concerning intramural fibroids. During last years, ulipristal acetate (UPA) 5 mg was widely used as medical option of fibroid's treatment, but from 2020, the Pharmacovigilance Risk Assessment Committee (PRAC) has revoked the marketing authorization after some cases of liver toxicity. In this observational, retrospective study we collected data from a sample of 23 women affected by symptomatic uterine fibroids (from type 1 to type 7 according FIGO classification) followed in our center for assisted reproduction from 2016-2019. All patients received 5 mg/day UPA for three months, followed by two months of wash-out therapy. A group of 13 women treated with UPA, with intramural fibroid not distorting the uterine cavity, after wash-out therapy, affected by tubal or idiopathic factors of infertility too, underwent ART. We also evaluated a control group of women, not affected by fibroids, randomly selected from a general group of our ART patients, similar by age, BMI, and cause of infertility only idiopathic or tubal factors. We evaluated the impact of UPA on reduction of fibroid volume, symptomatology and distortion of the cavity in all the women treated, and the IVF (in-vitro fertilization) outcome between the fibroid group of women affected by intramural fibroids who underwent ART, and the control group. In all the women treated with UPA the overall median fibroid volume pretreatment was 45.168±35.360 mm3, that decreased to a mean value of 22.592±22.116 mm3 post one cycle of UPA, with an overall mean decrease of -22.586 mm3 (of 49%) statistically significant (P=0.00001). After treatment, the distortion of the uterine cavity reduced in high percentage of cases: 85,71% (type 1-2), χ2 difference in respect to the value pretreatment of 0.3941, and 86.96% of patients subjectively referred an improvement in the symptomatology. In the group of 13 women that undergone ART, after one IVF cycle for each patient, we obtained 61% of positivity of dosage of beta human chorionic gonadotropin (hCG) after UPA treatment, and we obtained a similar value in the control group. In our little sample we have observed that UPA represented a valid non-invasive medical treatment strategy for fibroids in women candidate for (IVF, not only in women affected by sub-mucosal, but also by intramural fibroids not distorting uterine cavity. After a single, three months course of treatment, we obtained good results in terms of reduction of fibroid's volume and improvement of symptomatology, without side effects, preparing a more favorable environment for ART.

Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results.

BackgroundTranscervical fibroid ablation (TFA) is a minimally invasive, effective treatment of symptomatic uterine fibroids that utilizes intrauterine ultrasound for imaging and radiofrequency energy for ablation. Outcomes reported with TFA have been positive, with significant reductions in fibroid volume, improvements in symptom severity and health-related quality of life, and low complication and surgical reintervention rates. The SAGE registry characterizes the long-term (5-year) outcomes of TFA when used to treat symptomatic uterine fibroids in real-world usage.Methods/DesignSAGE is an ongoing postmarket global registry involving up to 50 sites and up to 500 women who select TFA with the Sonata system for treatment of symptomatic uterine fibroids. Patients are followed for 5 years. Main outcomes include symptom severity score and health-related quality of life subscales of the UFS-QoL, general health status on the EQ-5D, perceived treatment benefit, treatment satisfaction, work and activity patterns, overall patient treatment outcome, adverse events, pregnancy incidence and outcomes, and surgical reinterventions for heavy menstrual bleeding.DiscussionThe SAGE registry represents the largest known study of TFA for uterine fibroids and will generate up to 2500 patient-years of outcome data. Preliminary results from the first 160 treated women suggest broad applicability of TFA to a wide range of fibroid types and sizes and an excellent safety profile, with a device-related adverse event rate of 0.6% and a serious procedure-related adverse event rate of 0.6%. Of the 241 fibroids treated, 10% were submucous, 52% transmural, 28% intramural, and 10% subserous. Ablated fibroid diameters ranged from <1 cm to >10 cm, with 27% of fibroids having maximum diameters >5 cm. The real-world experience from SAGE will strengthen the existing evidence on the durability of TFA in providing meaningful relief from uterine fibroid symptoms and will have important clinical and economic implications for patients, physicians, and healthcare payers.Trial Registrationhttps://clinicaltrials.gov, NCT03118037. Registered on 18 April 2017.