The significance of transcervical ultrasound-guided radiofrequency ablation in the treatment of symptomatic fibroids: results of an expert consensus from German-speaking countries.

Uterine fibroids are one of the most common diseases in female patients, lead mainly to bleeding disorders and lower abdominal pain, and reduce the chance of having children. In recent years we have seen a trend towards more and more pharmacotherapies and minimally invasive organ-preserving treatments. One novel and innovative procedure for an organ-preserving treatment of symptomatic uterine fibroids is the transcervical ultrasound-guided radiofrequency ablation (TRFA). TRFA has been used in Germany since 2013 and later found use in other German-speaking countries as well. There have now been more than 1200 TRFA treatments performed in Germany, Austria, and Switzerland. Experts from these three countries came together for a consensus meeting to analyze the significance of the procedure in the overall concept of the treatment of symptomatic uterine 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).

Transcervical intrauterine radiofrequency ablation of fibroids in high-risk patients with bleeding disorder.

OBJECTIVES: To show the advantages of transcervical radiofrequency ablation (TRFA) in high-risk patients with bleeding disorder. MATERIAL AND METHODS: It is a retrospective analysis. The study included only patients with known pre-existing conditions (obesity, cardiac and neurological disease, coagulation disorder, anaemia) or post-surgical conditions who were treated with the Sonata® System for fibroid-related bleeding complaints at Academic Hospital Cologne Weyertal between January 2015 and March 2021. These patients were classified as high-risk patients. The fibroids were mostly determined due transvaginal sonography. Thirty patients were included, and 43 fibroids were determined. RESULTS: Therapy with the Sonata® system could be performed without complications in all cases. In our analysis, improvement of fibroid-related symptoms was observed in 89% of cases. CONCLUSIONS: The Sonata® System is on the one hand minimally invasive, uncomplicated and fast and on the other hand a successful method of fibroid therapy, which is particularly suitable for high-risk patients with various pre-existing conditions, for whom a minimally invasive, bloodless and short surgical procedure has great advantages.

Transcervical radiofrequency ablation of fibroids that are 5 cm or larger in women with abnormal uterine bleeding.

INTRODUCTION: Fibroids are the most common benign uterine tumors. Transcervical radiofrequency ablation with the Sonata® System offers a minimally invasive, incisionfree, organ-preserving therapy, with intraoperative visualization of fibroids using intrauterine ultrasound guidance. To demonstrate the effectiveness of transcervical radiofrequency ablation of fibroids that are 5 cm or larger using the Sonata® System, this retrospective analysis was collected. METHOD: 151 patients have been treated with this method in our department up to the time of this analysis. Only patients with at least one fibroid of ≥5 cm and with bleeding symptoms, who were treated with the Sonata® System were included in this retrospective study. A total of 50 patients were included in the study and 57 fibroids were treated. RESULTS: A total of 57 fibroids were detected and treated, however FIGO 1 and 2 fibroids (in total three fibroids were excluded). The smallest fibroid was 4 cm and the largest fibroid was 12 cm. A single ablation was performed in 18 cases, two ablation steps in 16 cases, three ablation steps in 13 cases, and more than three ablation steps in three cases. Depending on ablation steps, the shortest ablation time was 3 min 15 s and the longest ablation time was 25 min 6 s, with an average time of 9 min 12 s. 86% of patients reported an improvement of symptoms Conclusion: Thus, the Sonata® System is a simple, minimally invasive, rapid and successful method that shows significant improvement of symptoms even in large myomas from ≥5 cm.

Normal spontaneous vaginal delivery after transcervical radiofrequency ablation of uterine fibroids: a case report.

Transcervical radiofrequency ablation of uterine fibroids was performed on a patient in Germany, who subsequently conceived. This is the first report of a normal spontaneous vaginal delivery after fibroid ablation with the Sonata® System.