Cutting-edge application of ultrasound elastography and superb microvascular imaging in radiofrequency ablation of uterine fibroids.
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ABSTRACT:
SUBMITTER: Coutinho C
PROVIDER: S-EPMC8008196 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
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Cutting-edge application of ultrasound elastography and superb microvascular imaging in radiofrequency ablation of uterine fibroids.
Coutinho Cristiana C Werner Heron H Lopes Flávia Paiva FP Zelaquett Michel M Marchiori Edson E Araujo Edward E
Journal of ultrasonography 20210308 84
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Project description:ObjectiveTo describe pregnancy outcomes in women who conceived after undergoing transcervical fibroid ablation (TFA) as treatment for symptomatic uterine fibroids.Materials and methodsTFA was used to treat symptomatic uterine fibroids with radiofrequency energy, both under clinical trial protocol and commercial usage in hospitals in Europe, the United Kingdom, Mexico, and the United States. All women who reported pregnancies to their physicians after undergoing TFA with the Sonata® System and provided consent for use of their data were included.ResultsThere have been 36 pregnancies representing 20 deliveries among 28 women who were treated with TFA. Five women conceived more than once postablation, and four conceived as a result of assisted reproductive technology (ART). Outcomes include 8 vaginal deliveries, 12 Cesarean sections, 3 therapeutic abortions, and 8 first trimester spontaneous abortions (four occurring in a patient with a history of recurrent pregnancy loss and an immunologic disorder). Five women are currently pregnant, two of whom previously delivered after TFA. There were no 5-minute Apgar scores <7, and all neonates weighed >2500 g. All deliveries occurred at ≥37 weeks except for one delivery at 35 6/7 weeks. There were no uterine ruptures or abnormal placentation and no reports of postpartum hemorrhage or stillbirths. Ablated fibroids included transmural, submucous, and intramural myomata up to 7 cm in diameter.ConclusionsNormal pregnancy outcomes at term have occurred after TFA with the Sonata System, including in women with recurrent abortion and in those undergoing ART. There were no instances of low Apgar scores, low birthweight, stillbirth, postpartum hemorrhage, or uterine rupture (FAST-EU, NCT01226290; SONATA, NCT02228174; SAGE, NCT03 118037). (J GYNECOL SURG 38:207).
| S-EPMC9245720 | biostudies-literature
Project description: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.
| S-EPMC7937398 | biostudies-literature
Project description:BackgroundThe Sonata System is a new minimally invasive, transcervical, uterine-sparing treatment option for fibroids with a mainly intramural location. The device combines intrauterine ultrasonography with radiofrequency ablation. Long-term follow-up data are still lacking.ObjectiveThis study aimed to evaluate long-term outcomes of the Sonata System in terms of surgical reintervention and to identify factors predicting surgical reintervention. Moreover, patient satisfaction, fibroid size reduction, and complication rate were evaluated.Study designWe performed a retrospective single-center cohort study of 53 women who underwent Sonata treatment between December 2011 and April 2019. Medical chart review was conducted to collect data on surgical reintervention and patient, fibroid, and surgery characteristics. The follow-up period lasted from date of initial surgery until April 2020. In addition, women filled out a questionnaire at a single time point (April 2020) containing questions about surgical reintervention and patient satisfaction.Kaplan-Meier analysis was used to determine cumulative reintervention rates and median time without reintervention. Univariate Cox regression analyses were performed to identify factors predicting surgical reintervention.ResultsMedian follow-up period was 36 months (interquartile range, 22-58). Twenty-four women (45.3%) underwent a surgical reintervention, of which most were hysteroscopic myomectomies (45.8%). Surgical reintervention rates as determined by Kaplan-Meier analysis at 1-year and 2-year follow-up were 24.5% and 39.8%, respectively.Eventually, 7 women (13.2%) underwent a hysterectomy after the Sonata treatment. Univariate Cox regression analyses were performed, but did not show a significant association between surgical reintervention and age, preoperative fibroid size, type of ablated fibroid, number of ablated fibroids, and presence of other fibroids that could not be ablated during the Sonata procedure. Median fibroid diameter was 41 mm (interquartile range, 29-50) before and 29 mm (interquartile range, 20-40) after treatment (Z=-5.01; P<.001; 95% confidence interval, -13.0 to 7.0). Thirty-four women (69.4%) were satisfied with the treatment effect, and 42 women (85.7%) would recommend the Sonata treatment to other women. No device-related complications occurred.ConclusionThe Sonata System is a safe and minimally invasive treatment option for women suffering from (partly) intramural fibroids. The findings of this long-term follow-up study support counseling women for treatment with the Sonata System. More prospective studies with long-term follow-up are needed to investigate for which type and size of uterine fibroid the Sonata System is of most value.
| S-EPMC9758333 | biostudies-literature
Project description:Objective: To report 2-year results of sonography-guided transcervical fibroid ablation (TFA) using the Sonata® system in women with symptomatic uterine fibroids. Design: This is a prospective multicenter single-arm interventional trial. Methods: Premenopausal women with up to 10 clinically relevant uterine fibroids, each ranging from 1 to 5 cm in diameter, were treated with sonography-guided TFA on an outpatient basis and returned for regular follow-up visits for 2 years. Assessed outcomes included changes in symptom severity, heath-related quality of life, general health status, work and activity limitations, treatment satisfaction, adverse events, surgical reintervention, and occurrence of pregnancy and associated outcomes. Results: Among 147 enrolled women, 125 (85%) returned for follow-up at 2 years. Compared with baseline, symptom severity decreased from 55 ± 19 to 24 ± 18 (p < 0.001), health-related quality of life increased from 40 ± 21 to 83 ± 19 (p < 0.001), and EuroQol 5-Dimension scores increased from 0.72 ± 0.21 to 0.89 ± 0.14 (p < 0.001). Overall treatment satisfaction at 2 years was 94%. The mean percentage of missed work time, overall work impairment, and activity impairment significantly decreased at follow-up. Through 2 years, surgical reintervention for heavy menstrual bleeding was performed in 5.5% of patients. One singleton pregnancy occurred with a normal peripartum outcome. Conclusions: TFA treatment with the Sonata system provides significant clinical improvement through 2 years postablation, with a low incidence of surgical reintervention. Other favorable outcomes included a rapid return to work and substantial improvements in quality of life, symptom severity, work productivity, and activity levels.
| S-EPMC7099422 | biostudies-literature
Project description:IntroductionVaginal microbiota dysbiosis is closely related to diseases of the vagina and uterus. Uterine fibroids (UF) are the most common benign neoplasms of the uterus, and increased diversity in vaginal microbial of UF patients. High-intensity focused ultrasound (HIFU) is effective invasive treatment for fibroids in women who are not good surgical candidates. Whether HIFU of uterine fibroids will cause the change in vaginal microbiota has not been reported. We aimed to investigate the vaginal microbiota of UF patients with/without HIFU treatment using 16S rRNA gene sequencing.MethodsVaginal secretions were collected from 77 UF patients (pre-operative and post-operative) and were used for comparative composition, diversity, and richness analyses of microbial communities.ResultsThe microbial α-diversity was significantly lower in the vaginal of UF patients with HIFU treatment. The relative abundance of some pathogenic bacteria of UF patients with HIFU treatment were significantly decreased in the bacterial phylum and genus level. Proteobacteria were found to be significantly upregulated as a biomarker in the HIFU treatment group in our study.ConclusionThese findings might confirm the effectiveness of HIFU treatment from the point of view of microbiota.
| S-EPMC10150040 | biostudies-literature
Project description:ObjectiveTo evaluate whether transvaginal radiofrequency (RF) ablation of fibroids is a technique that can be offered to women with reproductive desires.DesignUnicentric, prospective, observational study.SettingUniversity Hospital.PatientsTwenty-seven individuals who desired to become mothers after undergoing RF ablation for symptomatic fibroids.InterventionsTransvaginal RF ablation for symptomatic fibroids with a maximum total volume of 145 cm3.Main outcome measuresThe reduction in the size of the fibroids, improvement of symptoms, and reproductive outcomes during the 24 months after the ablation. For patients who achieved pregnancy, we assessed the type of conception, course of gestation, type of delivery, neonatal outcomes, and occurrence of both maternal and fetal complications.ResultsA statistically significant reduction in symptoms related to the fibroids 6 months after the ablation was demonstrated through the implementation of the Symptom Severity Scale. No patient required hospitalization after the procedure, and on average from the third day after intervention, they resumed their work activities without the need for analgesics. Among those patients who attempted pregnancy during the 24-month follow-up period, 73.68 % (14/19) achieved motherhood. There were no cases of uterine rupture, premature birth, or intrauterine fetal death.ConclusionsRadiofrequency ablation for fibroids seems to be a promising, safe, and low-complexity alternative that does not appear to interfere with the development of a normal term gestation.
| S-EPMC11456661 | biostudies-literature
Project description:Purpose of reviewThis article provides the current evidence related to transcervical radiofrequency ablation of uterine fibroids under integrated intrauterine sonography guidance (the Sonata System).Recent findingsPublished data on the treatment of fibroids with the Sonata System has demonstrated significant median reductions in total (73.3%) and perfused (73.3%) uterine fibroid volume, menstrual bleeding (72.3%), symptom severity (62.5%), and improvements in health-related quality of life (127%) at 12 months post-ablation. A clinical trial under an FDA Investigational Device Exemption is in progress.SummaryThe Sonata System is a promising treatment modality for uterine fibroids. As an incisionless, minimally invasive treatment that does not require general anesthesia or hospitalization, it has the potential for redefining the current paradigm for management of symptomatic fibroids.
| S-EPMC5350207 | biostudies-literature
Project description:Background: The disease and treatment burden of uterine fibroids (UF) in Black women is substantially greater compared with other racial groups, with higher rates of complications and poorer outcomes with both hysterectomy and myomectomy. The inequities in the access Black women have to minimally invasive routes of surgery contribute to their burden of illness. Laparoscopic radiofrequency ablation (LAP-RFA) is a minimally invasive, safe, and effective uterine-sparing treatment option. Methods: This subgroup analysis of the LAP-RFA Pivotal Trial stratified outcomes by race comparing White women (n = 28, 21%) versus Black women (n = 46, 34%). Results: At baseline, Black women had more fibroids on average (7.3 vs. 3.7; P ≤ 0.001), a greater symptom severity score (SSS) (P ≤ 0.001), and a lower health-related quality of life (HRQoL) score (P = 0.005) than White women. At 36 months post-treatment with LAP-RFA, the statistical differences that existed with baseline SSS and HRQoL score were eliminated between Black and White women. Menstrual blood loss (140.1 mL vs. 127.02 mL; P = 0.44) and mean fibroid volume reduction (47.5 cm3 vs. 36.0 cm3; P = 0.17) were similar between Black and White women at 12 months. Although not statistically significant, the intraoperative total blood loss and uterine blood loss was lower in Black women than White women, despite greater operative time (160 minutes vs. 137 minutes; P = 0.09). Conclusions: These results are promising in providing an alternative uterine-sparing option for Black women and may help to provide a minimally invasive option that can address some of the racial inequities in care for Black women with UF.
| S-EPMC9063135 | biostudies-literature
Project description:This was a prospective, longitudinal, multicenter, single-arm controlled trial, using independent core laboratory validation of MRI results, to establish the effectiveness and confirm the safety of the VizAblate® System in the treatment of symptomatic uterine fibroids. The VizAblate System is a transcervical device that ablates fibroids with radiofrequency energy, guided by a built-in intrauterine ultrasound probe. Fifty consecutive women with symptomatic uterine fibroids received treatment with the VizAblate System. Patients had a minimum Menstrual Pictogram score of 120, no desire for fertility, and met additional inclusion and exclusion criteria. The VizAblate System was inserted transcervically and individual fibroids were ablated with radiofrequency energy. An integrated intrauterine ultrasound probe was used for fibroid imaging and targeting. Anesthesia was at the discretion of each investigator. The primary study endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months. Secondary endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life questionnaire (UFS-QOL), along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, medical reintervention for abnormal uterine bleeding, and procedure times. Fifty patients were treated, representing 92 fibroids. Perfused fibroid volumes were reduced at 3 months by an average of 68.8 ± 27.8 % (P < 0.0001; Wilcoxon signed-rank test). At 6 months, mean MP and SSS scores decreased by 60.8 ± 38.2 and 59.7 ± 30.4 %, respectively; the mean HRQOL score increased by 263 ± 468 %. There were two serious adverse events (overnight admissions for abdominal pain and bradycardia, respectively) and no surgical reinterventions. These 6-month results suggest that the VizAblate System is safe and effective in providing relief of abnormal uterine bleeding associated with fibroids, with appropriate safety and a low reintervention rate.
| S-EPMC4349947 | biostudies-literature
Project description:Laparoscopic myomectomy is regarded as the gold standard for women with symptomatic fibroids who wish to become pregnant. High-intensity focused ultrasound (HIFU or MRgFUS) ablation of uterine fibroids is also being discussed as a non-surgical, minimally invasive, therapeutic option. This review examines the available data on the impact of HIFU/MRgFUS on fertility and pregnancy, focusing particularly on potential direct side-effects of this type of intervention on ovaries, fallopian tubes and uterus and potential late effects on pregnancy and birth, based on the current literature. All pregnancies after HIFU/MRgFUS published to date (around 100 cases) were evaluated. The published case series suggest that HIFU/MRgFUS ablation has no impact on the rate of miscarriages or other obstetrical outcome parameters. Because no prospective studies exist which permit firm conclusions to be drawn on the impact of HIFU/MRgFUS on fertility and pregnancy outcome in women with symptomatic fibroids, this approach is currently only recommended for women with suspected fertility problems due to uterine fibroids who either decline surgery or who have an unacceptably high surgical risk.
| S-EPMC3973937 | biostudies-literature