Background/Objectives: Transcervical fibroid ablation (TFA) is an incisionless method to treat symptomatic uterine fibroids. While safety regarding future pregnancy remains to be established, TFA does not preclude the possibility of pregnancy, and a previous 36-patient case series of post-TFA pregnancies reported normal outcomes. That prior series did not include postmarket cases in the United States, as the Sonata® System was initially cleared and used in Europe. This is a substantive update of known pregnancies with the Sonata System since June 2011, and includes pregnancies in Europe, Mexico, and the US. Methods: TFA was carried out under both clinical trial and postmarket use to treat symptomatic uterine fibroids. All post-TFA pregnancies reported by physicians with their patient\'s consent were included. Results: 89 pregnancies and 55 deliveries have occurred among 72 women treated with the Sonata System. This includes 8 women who conceived more than once after TFA. Completed pregnancies (n = 62 women) include 19 vaginal deliveries, 35 Cesarean sections, 5 therapeutic abortions, 1 ectopic pregnancy, and 1 delivery by an unknown route. Ten pregnancies are ongoing. Mean birthweight was 3276.7 ± 587.3 g. Ten women experienced 18 first-trimester spontaneous abortions (SAbs), with 10 of the 18 SAbs (55.6%) occurring between two patients with a history of recurrent abortion. The SAb rate was 22.8%, inclusive of these two patients, and 10.1% if they were excluded as outliers. There were no instances of uterine rupture, placenta accreta spectrum, or stillbirth. Conclusions: This case series, the largest to date for any hyperthermic ablation modality, suggests that TFA with the Sonata System could be a feasible, safe treatment option regarding eventual pregnancy in women with symptomatic uterine fibroids.

Fibroids are the most common type of benign uterine tumor, which occur up to 68.6% of women. Hypermenorrhea is the most common symptom with a general prevalence of 40%-54%, followed by dysmenorrhea and low abdominal pain. Transcervical fibroids ablation was developed as a minimally invasive, incisionless treatment of fibroids in a short time. This method is safe and effective with an excellent record of safety. We present the case of a 40-year-old woman, who attended in our fibroid excellence center. She reported severe hypermenorrhea and dysmenorrhea. Family planning was definitely completed. Using vaginal ultrasonography a FIGO 2-5 fibroid of 5 cm in diameter was detected. Different treatment options were discussed: medical treatment, laparoscopic fibroidectomy, hysterectomy, and transcervical radiofrequency ablation with Sonata System. Because of advantages of transcervical radiofrequency ablation (minimal invasive treatment without incision, effectivity of method, short surgical time) the patient decided on this method. Three months later, the patient came to the first follow up. She reported a significant improvement of hypermenorrhea. A vaginal ultrasonography was carried out. The fibroid changed its position from FIGO 2-5 to FIGO 2. The patient was very satisfied with the result. After 2 months, she attended in our department again because of severe clear vaginal discharge. She had no bleeding, no pain as well as no fever. We examined her immediately. A fibroid expulsion was detected. The fibroid was removed vaginally. There was no severe bleeding during the operation and the fibroid could be removed completely. The surgery time was 25 minutes.

UNASSIGNED: To describe pregnancy outcomes in women who conceived after undergoing transcervical fibroid ablation (TFA) as treatment for symptomatic uterine fibroids.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).

UNASSIGNED: To determine quality-adjusted life years (QALYs) over 3 years after transcervical fibroid ablation (TFA) with the Sonata System.
UNASSIGNED: The SONATA trial was a prospective multicenter interventional trial that assessed the safety and efficacy of TFA for treatment of women with symptomatic uterine fibroids. Change in generic health status was assessed with the EuroQol 5-Dimension questionnaire (0-1 scale). Fibroid-specific quality of life (QOL) was measured on a 0 to 100 scale with the health-related quality of life subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL). The number of QALYs gained relative to baseline and cumulative QALYs were calculated using the area under the curve at each follow-up visit over 3 years.
UNASSIGNED: Among 147 women receiving TFA, fibroid-specific QOL increased from 40 ± 21 at baseline to 84 ± 19 at 1 year and 83 ± 23 at 3 years (p < 0.001). Generic QOL increased from 0.72 ± 0.21 at baseline to 0.89 ± 0.12 at 1 year and 0.88 ± 0.16 at 3 years (p < 0.001). Over 3 years, TFA resulted in 1.24 ± 0.64 QALYs gained when using fibroid-specific health utility scores and 0.49 ± 0.61 QALYs gained when using generic health utility scores. Cumulative QALYs experienced at 3 years as a percentage of perfect health were 82% with fibroid-specific scores and 88% with generic health scores.
UNASSIGNED: Women treated by TFA with the Sonata System for symptomatic uterine fibroids reported durable improvements in generic and fibroid-specific QOL, as well as clinically meaningful increases in QALYs over 3 years. Clinical Trials.gov ID: NCT02228174. (J GYNECOL SURG 38:143).

UNASSIGNED: Transcervical 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.
UNASSIGNED: SAGE 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.
UNASSIGNED: The 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.
UNASSIGNED: https://clinicaltrials.gov, NCT03118037. Registered on 18 April 2017.

OBJECTIVE: To examine the role and benefits of transcervical fibroid ablation (TFA) in the treatment of submucous and large uterine fibroids.
METHODS: A subgroup of patients with submucous or large fibroids were analyzed from two prospective clinical trials (FAST-EU and SONATA) of sonography-guided TFA with the Sonata® system. Key outcomes were changes in menstrual blood loss, symptom severity and health-related quality of life on the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, health-related quality of life on the EQ-5D questionnaire, and surgical reinterventions for heavy menstrual bleeding.
RESULTS: Among 197 women (534 treated fibroids), 86% of women with only submucous fibroids and 81% of women with large fibroids (>5 cm) experienced bleeding reduction within 3 months post-ablation. Overall symptom severity and health-related quality of life showed sustained, significant improvements over 12 months. Additional fibroid mapping of large fibroids with magnetic resonance imaging in the FAST-EU trial showed an average volume reduction of 68%. Among women with only submucous fibroids, the rate of surgical reintervention through 1 year of follow up was 3.7% in FAST-EU and 0.0% in SONATA.
CONCLUSIONS: With the Sonata system, TFA is an effective single-stage treatment option for non-pedunculated submucous myomata, and larger or deeper uterine fibroids (including fibroid clusters) for which hysteroscopic treatment is not suitable. ClinicalTrials.gov: FAST-EU, NCT01226290; SONATA, NCT02228174.

Objective: This article reports on 3-year clinical outcomes of the Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) pivotal trial of transcervical fibroid ablation (TFA) in women with symptomatic uterine myomata. Materials and Methods: The SONATA, prospective, controlled, multicenter interventional trial enrolled 147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata® System (Gynesonics, Inc., Redwood City, CA, USA). Clinical outcomes were assessed over 3 years and included surgical reinterventions, Symptom Severity Score (SSS), and Health-Related Quality of Life (HRQoL) subscales of the Uterine Fibroid Symptom and Quality-of-Life Questionnaire, EuroQol 5-Dimension (EQ-5D) questionnaire, Overall Treatment Effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events. Results: The 3-year rates of surgical reintervention for heavy menstrual bleeding calculated by the binomial and Kaplan-Meier methods were 9.2% and 8.2%, respectively. Compared to baseline, mean SSS decreased from 55 ± 19 to 22 ± 21, HRQoL increased from 40 ± 21 to 83 ± 23, and EQ-5D increased from 0.72 ± 0.21 to 0.88 ± 0.16 (all p < 0.001). Treatment benefit on the SSS, HRQoL, and EQ-5Q exceeded the minimal clinically important difference at every follow-up visit over 3 years. At 3 years, 94% of the subjects reported treatment satisfaction, 88% reported reduced fibroid symptoms, work absenteeism due to fibroid symptoms decreased from 2.9% to 1.4%, and impairment due to fibroids decreased from 51% to 12% for work, and 58% to 14% for physical activity (all p < 0.001). No late complications occurred. Conclusions: Women treated with sonography-guided TFA in the SONATA pivotal trial experienced significant and durable reduction of fibroid-related symptoms, with low surgical reintervention rates over 3 years of follow-up.

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.

OBJECTIVE: The INSPIRE study compared perioperative and 12-month health economic and clinical outcomes associated with hysterectomy, myomectomy, and sonography-guided transcervical fibroid ablation (TFA) using the Sonata® system.
METHODS: Cost and health care resource utilization (HCRU) data for TFA were obtained from a prospective, multicenter, single-arm clinical trial. Data for hysterectomy and myomectomy arms were derived from the Truven Health MarketScan commercial payer claims database. The Truven data was used to determine health economic outcomes and costs for the hysterectomy and myomectomy arms. For each arm, payer perspective costs were estimated from the available charge and HCRU data.
RESULTS: TFA with Sonata had significantly lower mean length of stay (LOS) of 5 hrs versus hysterectomy (73 hrs) or myomectomy (79 hrs; all p< 0.001). The average payer cost for TFA treatment, including the associated postoperative HCRU was $8,941. This was significantly lower compared to hysterectomy ($24,156) and myomectomy ($22,784; all p< 0.001). In the TFA arm, there were no device- or procedure-related costs associated with complications during the peri- or postoperative time frame. TFA subjects had significantly lower costs associated with complications, prescription medications, and radiology.
CONCLUSIONS: Compared to hysterectomy and myomectomy, TFA treatment with the Sonata system was associated with significantly lower index procedure cost, complication cost, and LOS, contributing to a lower total payer cost through 12 months.