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

Ladina Christoffel, Ralf Bends, David Toub, Sven Schiermeier, Gregor Pschadka, Matthias Engelhardt, Stephen Quinn, Michael Hartmann, Marwan Habiba, Ricardo Felberbaum, Anke Brössner, Cordula Schippert, Thomas Römer, Ladina Christoffel, Ralf Bends, David Toub, Sven Schiermeier, Gregor Pschadka, Matthias Engelhardt, Stephen Quinn, Michael Hartmann, Marwan Habiba, Ricardo Felberbaum, Anke Brössner, Cordula Schippert, Thomas Römer

Abstract

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).

Keywords: Sonata System; leiomyoma; radiofrequency ablation; transcervical fibroid ablation; uterine fibroid.

Conflict of interest statement

L.C., S.S., G.P., M.E., S.Q., M.H., M.H., R.F., A.B., and C.S. report no conflicts of interest. R.B. and T.R. have served as consultants to Gynesonics, Inc. D.T. is the Medical Director of Gynesonics, Inc.

© Ladina Christoffel et al. 2022; Published by Mary Ann Liebert, Inc.

References

    1. Baird DD, Dunson DB, Hill MC, et al. . High cumulative incidence of uterine leiomyoma in black and white women: Ultrasound evidence. Am J Obstet Gynecol 2003;188:100.
    1. Cardozo ER, Clark AD, Banks NK, et al. . The estimated annual cost of uterine leiomyomata in the United States. Am J Obstet Gynecol 2012;211:e1.
    1. Lukes AS, Soper D, Harrington A, et al. . Health-related quality of life with ulipristal acetate for treatment of uterine leiomyomas: A randomized controlled trial. Obstet Gynecol 2019;133:869.
    1. Stewart EA, Gedroyc WM, Tempany CM, et al. . Focused ultrasound treatment of uterine fibroid tumors: Safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol 2003;189:48.
    1. Stewart EA, Rabinovici J, Tempany CM, et al. . Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril 2006;85:22.
    1. Stewart EA, Gostout B, Rabinovici J, et al. . Sustained relief of leiomyoma symptoms by using focused ultrasound surgery. Obstet Gynecol 2007;110:279.
    1. Taran FA, Tempany CM, Regan L, et al. . Magnetic resonance-guided focused ultrasound (MRgFUS) compared with abdominal hysterectomy for treatment of uterine leiomyomas. Ultrasound Obstet Gynecol 2009;34:572.
    1. Arnreiter C, Oppelt P. A systematic review of the treatment of uterine fibroids using transcervical ultrasound-guided radiofrequency ablation with the Sonata® System. J Minim Invasive Gynecol 2021;28:1462.
    1. Bradley LD, Pasic RP, Miller LE. Clinical performance of radiofrequency ablation for treatment of uterine fibroids: systematic review and meta-analysis of prospective studies. J Laparoendosc Adv Surg Tech A 2019;29:1507.
    1. Brölmann H, Bongers M, Garza-Leal JG, et al. . The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids. Gynecol Surg 2016;13:27.
    1. Chudnoff SG, Berman JM, Levine DJ, et al. . Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol 2013;121:1075.
    1. Toub DB. A new paradigm for uterine fibroid treatment: transcervical, intrauterine sonography-guided radiofrequency ablation of uterine fibroids with the Sonata System. Curr Obstet Gynecol Rep 2017;6:67.
    1. Jones S, O'Donovan P, Toub D. Radiofrequency ablation for treatment of symptomatic uterine fibroids. Obstet Gynecol Int 2012;2012:194839.
    1. Miller CE, Osman KM. Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2-Year results of the SONATA Pivotal Trial. J Gynecol Surg 2019;35:345.
    1. Lukes A, Green MA. Three-year results of the SONATA Pivotal Trial of transcervical fibroid ablation for symptomatic uterine myomata. J Gynecol Surg 2020;36:228.
    1. Berman JM, Guido RS, Garza Leal JG, et al. . Three-year outcome of the Halt trial: A prospective analysis of radiofrequency volumetric thermal ablation of myomas. J Minim Invasive Gynecol 2014;21:767.
    1. Chudnoff S, Guido R, Roy K, et al. . Ultrasound-guided transcervical ablation of uterine leiomyomas. Obstet Gynecol 2019;13.
    1. Garza-Leal JG. Long-term clinical outcomes of transcervical radiofrequency ablation of uterine fibroids: The VITALITY Study. J Gynecol Surg 2019;35:19.
    1. Shifrin G, Engelhardt M, Gee P, Pschadka G. Transcervical fibroid ablation with the Sonata® system for treatment of submucous and large uterine fibroids. Int J Gynaecol Obstet 2021;155:79.
    1. ACOG. Management of symptomatic uterine leiomyomas: ACOG Practice Bulletin, Number 228. Obstet Gynecol 2021;137:e100.
    1. Römer T, Bends R, Christoffel L, et al. . Treatment of Symptomatic Fibroids with Transcervical Ultrasound-guided Radiofrequency Ablation-Indication, procedure, results, and complications—2020 expert consensus. Part 2: Transcervical Radiofrequency Ablation (TRFA)—Methods, indications, results, and comparison with other therapies. Frauenarzt 2021;62:162.
    1. Jiang Z, Li Q, Li W, et al. . A comparative analysis of pregnancy outcomes of patients with uterine fibroids after high intensity focused ultrasound ablation and laparoscopic myomectomy: A retrospective study. Int J Hyperthermia 2021;38:79.
    1. Bends R, Toub DB, Römer T. Normal spontaneous vaginal delivery after transcervical radiofrequency ablation of uterine fibroids: A case report. Int J Womens Health 2018;10:367.
    1. Garza-Leal JG, León IH, Toub D. Pregnancy after transcervical radiofrequency ablation guided by intrauterine sonography: Case report. Gynecol Surg 2014;11:145.
    1. Pschadka G, Engelhardt M, Niehoff C, Toub D. Term delivery in an infertile patient after transcervical radiofrequency fibroid ablation and assisted reproductive technology. J Gynecol Surg 2019;35:253.
    1. Berman JM, Puscheck EE, Diamond MP. Full-term vaginal live birth after laparoscopic radiofrequency ablation of a large, symptomatic intramural fibroid: A case report. J Reprod Med 2012;57:159.
    1. Berman JM, Bolnick JM, Pemueller RR, Garza Leal JG. Reproductive outcomes in women following radiofrequency volumetric thermal ablation of symptomatic fibroids. A retrospective case series analysis. J Reprod Med 2015;60:194.
    1. Berman JM, Shashoua A, Olson C, et al. . Case series of reproductive outcomes after laparoscopic radiofrequency ablation of symptomatic myomas. J Minim Invasive Gynecol 2020;27:639.
    1. Keltz J, Levie M, Chudnoff S. Pregnancy outcomes after direct uterine myoma thermal ablation: Review of the literature. J Minim Invasive Gynecol 2017;24:538.
    1. Christoffel L, Römer T, Schiermeier S. Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study protocol and preliminary results. Med Devices (Auckl) 2021;14:77.
    1. Cohain JS, Buxbaum RE, Mankuta D. Spontaneous first trimester miscarriage rates per woman among parous women with 1 or more pregnancies of 24 weeks or more. BMC Pregnancy Childbirth 2017;17:437.
    1. Rabinovici J, David M, Fukunishi H, et al. . Pregnancy outcome after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril 2010;93:199.
    1. Homer H, Saridogan E. Pregnancy outcomes after uterine artery embolisation for fibroids. Obstet Gynaecol 2009;11:265.
    1. Khaw SC, Anderson RA, Lui MW. Systematic review of pregnancy outcomes after fertility-preserving treatment of uterine fibroids. Reprod Biomed Online 2020;40:429.
    1. Pron G, Mocarski E, Bennett J, et al. . Pregnancy after uterine artery embolization for leiomyomata: The Ontario multicenter trial. Obstet Gynecol 2005;105:67.
    1. ASRM. Removal of myomas in asymptomatic patients to improve fertility and/or reduce miscarriage rate: A guideline. Fertil Steril 2017;108:416.
    1. Bai X, Lin Y, Chen Y, Ma C. The impact of FIGO type 3 fibroids on in-vitro fertilization outcomes: A nested retrospective case-control study. Eur J Obstet Gynecol Reprod Biol 2020;247:176.
    1. Brady PC, Stanic AK, Styer AK. Uterine fibroids and subfertility: An update on the role of myomectomy. Curr Opin Obstet Gynecol 2013;25:255.
    1. Bongers M, Brölmann H, Gupta J, et al. . Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: Three- and six-month endpoint results from the FAST-EU study. Gynecol Surg 2015;12:61.
    1. Takahashi N, Harada M, Tanabe R, et al. . Factors associated with successful pregnancy in women of late reproductive age with uterine fibroids who undergo embryo cryopreservation before surgery. J Obstet Gynaecol Res 2018;44:1956.
    1. Bongers M, Quinn SD, Mueller MD, et al. . Evaluation of uterine patency following transcervical uterine fibroid ablation with the Sonata system (the OPEN clinical trial). Eur J Obstet Gynecol Reprod Biol 2019;242:122.
    1. Bongers M, Gupta J, Garza-Leal JG, et al. . The INTEGRITY Trial: Preservation of uterine-wall integrity 12 months after transcervical fibroid ablation with the Sonata System. J Gynecol Surg 2019;35:299.

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