Radiofrequency Ablation Of Uterine Fibroids Research Articles

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.

La myolyse par radiofréquence cœlioscopique guidée par échographie

La myolyse par radiofréquence cœlioscopique guidée par échographie

Long-term results of transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the Sonata System: a retrospective follow-up study

The 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. This 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. We 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. Median 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. The 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.

Radiofrequency Ablation of Uterine Fibroids

Uterine fibroids are a common occurrence in women. Treatment options range from medical management to surgeries, with hysterectomy providing the most effective treatment. Newer methodologies to treat fibroids continue to evolve, one being the use of radiofrequency ablation, which offers a minimally invasive and uterus-sparing technique to manage fibroids. This article provides a review of both laparoscopic and transvaginal approaches to radiofrequency ablation for the management of fibroids.

Pregnancy Outcomes After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System.

Objective:To describe pregnancy outcomes in women who conceived after undergoing transcervical fibroid ablation (TFA) as treatment for symptomatic uterine fibroids.Materials and Methods:TFA 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.Results:There 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.Conclusions:Normal 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)

Pregnancy Outcomes after Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata® System

<h3>Study Objective</h3> To describe pregnancy outcomes in women who conceived after undergoing transcervical fibroid ablation (TFA) as treatment for symptomatic uterine fibroids. <h3>Design</h3> Retrospective study. <h3>Setting</h3> Hospitals in Europe, the UK, Mexico and the US. <h3>Patients or Participants</h3> Women who reported pregnancies after undergoing TFA with the Sonata® System. <h3>Interventions</h3> TFA was used to ablate fibroids, both under clinical trial protocol and commercial usage. <h3>Measurements and Main Results</h3> To date, there have been 32 pregnancies representing 18 deliveries among 25 women who were treated with TFA. Four women conceived more than once post-ablation, and four conceived as a result of assisted reproductive technology (ART). Outcomes include 8 vaginal deliveries, 10 Cesarean sections, 3 therapeutic abortions, and 8 miscarriages (four occurring in a patient with a history of recurrent abortion and an immunologic disorder). Three women are either currently pregnant or have outcomes pending. There were no 5-minute Apgar scores <7, and all neonates weighed >2500 gms. 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. One patient developed HELLP syndrome and had an emergent C/S after a trial of labor at term, while another underwent C/S for fetal macrosomia. Ablated fibroids included transmural, submucous and intramural myomata up to 6.6 cm in diameter. <h3>Conclusion</h3> Normal pregnancy outcomes at term have occurred after TFA with the Sonata System, including in women with recurrent abortion and in those undergoing ART.

Radiofrequency Ablation of Uterine Fibroids and Pregnancy Outcomes: An Updated Review of the Literature

Study Objective The purpose of this article is to provide an updated review of pregnancy outcomes after laparoscopic and transcervical radiofrequency ablation of fibroids. Design Literature review using PubMed/Medline. Setting N/A. Patients or Participants Patients were identified from case reports and case series of pregnancies following trials of radiofrequency ablation (RFA) devices for symptomatic uterine fibroids. The pregnancies identified represented large trials of laparoscopic and transcervical ablation from North America, Asia, Europe, and Latin America. Interventions Laparoscopic and transcervical radiofrequency ablation of fibroids. Measurements and Main Results 6 publications met criteria for inclusion, representing 11 clinical trials and 3 reports from real-world settings. 593 patients underwent RFA of fibroids, with 46 total pregnancies identified. The average age of patients was 39 years old and ranged from 27 to 46 years old. The majority of patients had between one and three fibroids ablated, and the size varied from less than 2 centimeters up to 12.5 centimeters. In terms of pregnancy outcomes, among the 46 total pregnancies, there were 4 spontaneous abortions, 7 elective terminations of pregnancy, and 35 term pregnancies with 17 vaginal and 18 cesarean deliveries. The patients who experienced spontaneous abortion were 36 to 38 years old. There was one complication after cesarean delivery presenting as postpartum hemorrhage with resultant expulsion of degenerated myoma with no long-term sequelae. There were no cases of uterine rupture, uterine window, placenta accreta, placental abruption, or fetal growth restriction. Conclusion The majority of patients who had documented pregnancies after radiofrequency ablation of fibroids had full-term deliveries with no maternal or neonatal complications. Given the inherent obstetric risks with myomectomy (e.g., risk of uterine rupture, intrauterine scarring, possible need for cesarean delivery, etc.), these findings add to the growing consensus that radiofrequency fibroid ablation may offer a safe and effective minimally invasive treatment alternative to women seeking uterine-sparing fibroid treatment to preserve fertility. The purpose of this article is to provide an updated review of pregnancy outcomes after laparoscopic and transcervical radiofrequency ablation of fibroids. Literature review using PubMed/Medline. N/A. Patients were identified from case reports and case series of pregnancies following trials of radiofrequency ablation (RFA) devices for symptomatic uterine fibroids. The pregnancies identified represented large trials of laparoscopic and transcervical ablation from North America, Asia, Europe, and Latin America. Laparoscopic and transcervical radiofrequency ablation of fibroids. 6 publications met criteria for inclusion, representing 11 clinical trials and 3 reports from real-world settings. 593 patients underwent RFA of fibroids, with 46 total pregnancies identified. The average age of patients was 39 years old and ranged from 27 to 46 years old. The majority of patients had between one and three fibroids ablated, and the size varied from less than 2 centimeters up to 12.5 centimeters. In terms of pregnancy outcomes, among the 46 total pregnancies, there were 4 spontaneous abortions, 7 elective terminations of pregnancy, and 35 term pregnancies with 17 vaginal and 18 cesarean deliveries. The patients who experienced spontaneous abortion were 36 to 38 years old. There was one complication after cesarean delivery presenting as postpartum hemorrhage with resultant expulsion of degenerated myoma with no long-term sequelae. There were no cases of uterine rupture, uterine window, placenta accreta, placental abruption, or fetal growth restriction. The majority of patients who had documented pregnancies after radiofrequency ablation of fibroids had full-term deliveries with no maternal or neonatal complications. Given the inherent obstetric risks with myomectomy (e.g., risk of uterine rupture, intrauterine scarring, possible need for cesarean delivery, etc.), these findings add to the growing consensus that radiofrequency fibroid ablation may offer a safe and effective minimally invasive treatment alternative to women seeking uterine-sparing fibroid treatment to preserve fertility.

VP06.13: Uterine‐guided vaginal radiofrequency ablation of uterine fibroids

VP06.13: Uterine‐guided vaginal radiofrequency ablation of uterine fibroids

Cutting-edge application of ultrasound elastography and superb microvascular imaging in radiofrequency ablation of uterine fibroids.

Cutting-edge application of ultrasound elastography and superb microvascular imaging in radiofrequency ablation of uterine fibroids.

1624 Term Delivery in an Infertile Patient after Transcervical Radiofrequency Fibroid Ablation and Assisted Reproductive Technology

Study Objective Transcervical radiofrequency ablation of uterine fibroids is an incisionless procedure to treat nonpedunculated uterine fibroids, including those that are not amenable to operative hysteroscopy. However, its safety and effectiveness regarding fertility and fecundity have not been established, including among women with infertility. This is a report of a pregnancy that occurred in a woman after transcervical radiofrequency (RF) ablation of uterine fibroids and assisted reproduction. Design Case report. Setting Community hospital in Warendorf, Germany Patients or Participants A 38-year-old nullipara with infertility since 2008 and a recent complaint of refractory dysmenorrhea in association with a uterine fibroid Interventions Transcervical RF ablation with the Sonata® system to treat the symptomatic myoma. Unsuccessful assisted reproduction (intracytoplasmic sperm injection/embryo transfer; ICSI/ET) as confirmed by negative pregnancy testing had been attempted 1 month pre-ablation, and a second embryo transfer after thawing of the previously cryopreserved pronuclei was carried out 7 months post-ablation. Measurements and Main Results Transcervical RF ablation resulted in a 68% reduction in fibroid volume by sonography at 2 months post-treatment along with resolution of the patient's dysmenorrhea, and there was no residual fibroid noted on sonography at 7 months post-ablation. The second attempt at assisted reproduction produced an uncomplicated pregnancy that resulted in the vacuum-assisted vaginal delivery of a liveborn infant at term weighing 3670 gms with Apgar scores of 91/105/1010. Pelvic sonography four months postpartum revealed an unremarkable uterus, again with no evidence of a fibroid remnant. Conclusion This is the first report of a pregnancy and delivery in an infertile couple who underwent transcervical RF ablation of a uterine fibroid followed by assisted reproduction.

1623 Improvement in 24-Month Health-Related Quality of life and Work Productivity after Ultrasound-Guided Transcervical, Intrauterine Radiofrequency Ablation of Uterine Fibroids in the Sonata Pivotal IDE Trial

Study Objective To establish the long-term improvement in health-related quality of life and work productivity after use of ultrasound-guided transcervical, intrauterine radiofrequency (RF) ablation in the treatment of symptomatic uterine fibroids. Design Prospective, longitudinal, multicenter, single-arm trial. Setting 22 clinical sites (21 in the US and 1 in Mexico). Patients or Participants Premenopausal women between the ages of 25 and 50 with heavy menstrual bleeding secondary to fibroids. Interventions Ultrasound-guided transcervical RF ablation performed on up to 10 fibroids per subject with the Sonata® system; fibroids ranged from 1-5 cm in diameter as determined by transvaginal sonography. The EuroQOL EQ-5D-3L (which measures health utility) and Work Productivity and Activity Impairment (WPAI) surveys were administered at baseline, as well as at 24 months post-intervention. Paired t-tests were conducted to evaluate improvement in health utility and work productivity from baseline through 24 months. Measurements and Main Results One hundred forty-seven (147) patients were enrolled and followed through 24 months. Mean patient health utility significantly increased from 0.72 at baseline to 0.89 (p Conclusion Ultrasound-guided transcervical, intrauterine RF ablation with the Sonata system was shown to significantly increase patient health utility and work productivity during the first 24 months post-treatment.

Transcervical Radiofrequency Ablation of Uterine Fibroids: US Experience From the SONATA Pivotal IDE Trial [22J

Transcervical Radiofrequency Ablation of Uterine Fibroids: US Experience From the SONATA Pivotal IDE Trial [22J

Long-Term Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids: The VITALITY Study.

Objective: The aim of this research was to learn the long-term (> 5 years) clinical outcomes of transcervical radiofrequency ablation of uterine fibroids.Materials and Methods: For this retrospective, single-arm, long-term data-collection study, 23 women with heavy menstrual bleeding secondary to fibroids were treated with transcervical radiofrequency ablation guided by integrated intrauterine sonography (using the Sonata® System, Gynesonics, Redwood City, CA). This study was within the 12-month Fibroid Ablation Study-EU clinical trial in Mexico. Symptoms were assessed using the Uterine Fibroid Symptom and Quality-of-Life's Symptom Severity Score (SSS) and Health-Related Quality of Life (HRQoL) subscales. Patients were queried regarding pregnancy and surgical reinterventions.Results: Seventeen women (73.9%) provided long-term follow-up information, with a mean of 64.4 months ±4.5 months (range: 57–73 months). From baseline, mean SSS decreased significantly from 64.9 ± 16.9 to 27.6 ± 36.1, and mean HRQoL improved significantly from 27.2 ± 22.4 to 76.0 ± 32.6 (p = 0.002, and p = 0.0001, respectively). There were no surgical reinterventions through the first 3.5 years post-treatment. There was an 11.8% incidence of surgical reinterventions over 5.4 years of average follow-up, with 2 hysterectomies occurring after 3.5 and 4 years postablation, respectively (event rate: 2.2% per year; 95% confidence interval; 0.3%, 7.9%). Freedom from surgical reintervention at 1, 2, and 3 years was 100%, and, at 4 and 5 years, was 88.2% ± 7.8%. There was a single pregnancy occurring within the first year of treatment leading to a normal-term delivery by elective repeat cesarean section.Conclusions: Transcervical radiofrequency ablation with the Sonata System produced substantial durable clinical benefits beyond 5 years with a low reintervention rate.

Ultrasound-guided transvaginal radiofrequency ablation of uterine fibroids assisted by virtual needle tracking system: a preliminary study

Purpose: The purpose of this study was to assess the feasibility and outcome of transvaginal ultrasound (US)-guided radiofrequency ablation of uterine fibroids assisted by a real-time virtual needle tracking (VT) system.Methods: Between January 2017 and February 2018, 19 patients (age 45 ± 8 y, range 36–53 y) with 25 symptomatic uterine fibroids underwent transvaginal radiofrequency ablation (RFA) at a single center. Mean number of fibroids for patient was 1.7 (min, max: 1–3). Patients with more than one fibroid were 10 (52.6%). Uterine fibroids (mean volume: 13.6 mL; range: 5.3–41.9 mL) were treated with a dedicated internally cooled 17 G 35 cm RF needle with 1 cm or variable active tip and the moving shot technique. An electromagnetic system was used for showing a virtual needle during the procedure. Contrast-enhanced ultrasound evaluation was performed before and immediately at the end of procedure. Feasibility of the procedure, technical success rate, volume percentage reduction at 1, 3 and 6 months, clinical outcome (QOL score) and complications were analyzed.Results: Procedure was feasible in 19/19 patients (100%). Technical success was achieved in 100% of 25 treated fibroids. Mean fibroids volume decreased from 13.6 ml at baseline to 5.9 ml at 6 month (reduction rate 62.7%, range 48.5–76.9; p < .05). No major immediate or late complications occurred. Minor complications occurred in two patients. QOL score significantly improved from 68 ± 36 at baseline to 97 ± 16 at six-months follow-up (p < .05).Conclusion: Transvaginal US-guided RFA assisted by a real-time VT system is a feasible, safe and effective technique for the treatment of uterine fibroids.

Improvement in health utility after transcervical radiofrequency ablation of uterine fibroids with the sonata system: Health utility after radiofrequency ablation

ObjectivesTo establish the improvement in patient health utilities following treatment of symptomatic uterine fibroids with the Sonata™ System. Study designA prospective, single-arm trial was conducted in which 49 women in the United Kingdom, Netherlands and Mexico with fibroids were treated with transcervical, intrauterine ultrasound- guided radiofrequency ablation. The EQ-5D-3L system was utilized to collect patient health status at baseline, 3, 6, and, 12 months post-procedure. Patient-reported health states at each time point were converted into a health utility value using time-trade off methodology. ResultsIn the overall cohort, patient health utility increased from a mean of 0.745 at baseline, to means of 0.838, 0.852, and 0.914 at 3 months, 6 months, and 12 months, respectively. The change from baseline at 12 months was significant. When stratified by country, the 12-month improvement in health utility remained significant for both the Mexican and Dutch cohorts. ConclusionsTranscervical radiofrequency ablation of uterine fibroids with the Sonata System resulted in statistically significant 12-month improvements in health utility for the overall patient cohort and for the Mexican and Dutch sub-populations.

489 - Investigational Treatment of Uterine Fibroids with Transcervical Radiofrequency Ablation in a Patient with Concomitant Adenomyosis

Study Objective: To describe a case in which radiofrequency ablation of uterine fibroids led to symptom relief in a patient with adenomyosis.

Radiofrequency Ablation of Uterine Fibroids Is Safe and Efficacious in Symptomatic Patients with Uteri of 15 Weeks Gestational Size and Larger

Radiofrequency Ablation of Uterine Fibroids Is Safe and Efficacious in Symptomatic Patients with Uteri of 15 Weeks Gestational Size and Larger

Improvement in Health Utility After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System

Improvement in Health Utility After Transcervical Radiofrequency Ablation of Uterine Fibroids with the Sonata System

Normal Pregnancy Outcome After Transcervical Radiofrequency Ablation of Uterine Fibroids

Normal Pregnancy Outcome After Transcervical Radiofrequency Ablation of Uterine Fibroids

The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids.

The FAST-EU Trial was designed to establish the effectiveness and confirm the safety of transcervical intrauterine sonography-guided radiofrequency ablation with the VizAblate™ System in the treatment of symptomatic uterine fibroids. This was a multicenter, prospective, single-arm trial involving academic and community hospitals in the United Kingdom, the Netherlands, and Mexico. Women with qualifying uterine fibroids and heavy menstrual bleeding underwent intrauterine sonography-guided transcervical radiofrequency ablation (RFA) with the VizAblate System; anesthesia was individualized. Patients were required to have up to five fibroids from 1 to 5 cm in diameter. The primary trial endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months by an independent core laboratory. Secondary endpoints, evaluated at 6 and 12 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 (UFS-QOL) questionnaire, 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, nonsurgical reintervention for abnormal uterine bleeding, anesthesia regimen, patient satisfaction, and pain during the recovery period. An additional MRI study was performed at 12 months on a subgroup of patients. Fifty patients (89 fibroids) underwent transcervical radiofrequency ablation with the VizAblate System. At 3 and 12 months, perfused fibroid volumes were reduced from baseline by an average of 68.1 ± 28.6 and 67.4 ± 31.9 %, respectively, while total fibroid volumes were reduced from baseline by an average of 54.7 ± 37.4 and 66.6 ± 32.1 %, respectively (all P < .001 compared with baseline; Wilcoxon signed-rank test). At 12 months, mean MP score and SSS decreased by 53.8 ± 50.5 and 55.1 ± 41.0 %, respectively; the mean HRQOL score increased by 277 ± 483 %. There were four surgical reinterventions (8 %) within 12 months. This is the first report of the 12-month follow-up for patients in the FAST-EU Trial. In concert with previously reported 3- and 6-month endpoint data, the 12-month results of the FAST-EU Trial suggest that in addition to substantially reducing the perfused and total volume of targeted uterine fibroids, the VizAblate System is safe and effective through 12 months in providing relief of abnormal uterine bleeding associated with submucous, intramural, and transmural fibroids.