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.

Objective: Adenomyosis is a common gynecological disease, which occurs in women in reproductive age and is characterized by the presence of endometrial glands and stroma within the myometrium. Abnormal uterine bleeding, pelvic pain as well as infertility can be associated with adenomyosis. There are two main types of adenomyosis: diffuse and focal. Previously, adenomyosis was diagnosed only upon histopathological examination after hysterectomy and/or adenomyomectomy. However, the development of imagining techniques such as transvaginal ultrasound and magnetic resonance imaging enables the diagnosis of adenomyosis (diffuse and focal) without any surgical intervention. When medical therapy is contraindicated or ineffective, or if patients have a fertility desire, a surgical treatment may be necessary.Methods: In this study, a total of 13 patients with 16 areas of focal adenomyosis were treated. All patients provided their informed consent to undergo transcervical adenomyosis ablation treatment with the Sonata System, aware that the safety and effectiveness of transcervical radiofrequency (RF) ablation for the treatment of adenomyosis has not been established. Follow-up was performed six months after Sonata treatment.Results: The positive results relating to the improvement of symptoms and reduction of adenomyosis lesion size were observed in our study.Conclusion: Transcervical RF ablation with the Sonata System may be a promising therapeutic alternative method to conventional procedures such as hysterectomy for the treatment of focal adenomyosis, disease which has limited therapeutic approach, and may enable a minimally invasive, uterine preserving option.

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).

Background: Transcervical radiofrequency (RF) 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. Case: A 38-year-old nullipara with infertility since 2008 and a recent complaint of refractory dysmenorrhea in association with a uterine fibroid underwent transcervical RF ablation with the Sonata® System (Gynesonics, Redwood City, CA) to treat the symptomatic myoma. Unsuccessful assisted reproduction (intracytoplasmic sperm injection/embryo transfer) as confirmed by negative pregnancy testing had been attempted 1 month preablation, and a second embryo transfer after thawing the previously cryopreserved pronuclei was performed 7 months postablation. Results: RF ablation with the Sonata System resulted in a 68% reduction in fibroid volume noted on sonography 2 months post-treatment along with resolution of the patient\'s dysmenorrhea. No residual fibroid was noted on sonography 7 months postablation. A second attempt at assisted reproduction produced an uncomplicated pregnancy that resulted in vacuum-assisted vaginal delivery of a liveborn infant at term weighing 3670 g with Apgar scores of 91/105/1010. Pelvic sonography 4 months postpartum an unremarkable uterus, again, with no evidence of a fibroid remnant. Conclusions: 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.

UNASSIGNED: The prospective SONATA pivotal Investigational Device Exemption (IDE) trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical fibroid ablation (TFA) in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort.
UNASSIGNED: TFA with the Sonata® System was performed on women with symptomatic uterine fibroids. The 12-month co-primary endpoints were reduction in menstrual blood loss and freedom from surgical reintervention. Symptom severity, quality of life, patient satisfaction, safety, and reductions in uterine and fibroid volumes were also evaluated.
UNASSIGNED: One hundred twenty-five patients were enrolled and treated in the US. Both co-primary endpoints were achieved in this US-based cohort, as 65.3% of patients reported ≥50% reduction in menstrual bleeding and 99.2% of patients were free from surgical reintervention. Symptom improvement was noted by 97.4% of patients and 98.3% were satisfied. Ninety-five percent of patients reported reduced menstrual bleeding at 12 months, and 86.8% noted >20% reduction. Significant mean improvements at 12 months were realized in both symptom severity and health-related quality of life (33.8 points and 45.8 points, respectively; all P<0.0001). Mean maximal fibroid volume reduction per patient was 63.8%. There was a 0% incidence of device related adverse events. Mean length of stay was 2.5 hrs and 50% of patients returned to normal activity within 1 day.
UNASSIGNED: This analysis of US patients in the SONATA pivotal IDE trial demonstrates results consistent with those in the full cohort. TFA with Sonata significantly reduced fibroid symptoms with a low surgical reintervention rate through 12 months. These results support the efficacy and safety of the Sonata system as a first-line treatment for women affected by symptomatic uterine fibroids.