Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids

Gregory Shifrin, Matthias Engelhardt, Phyllis Gee, Gregor Pschadka, Gregory Shifrin, Matthias Engelhardt, Phyllis Gee, Gregor Pschadka

Abstract

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.

Conclusion: 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.

Keywords: SONATA; leiomyoma; radiofrequency ablation; transcervical fibroid ablation; uterine fibroid.

Conflict of interest statement

The authors have no conflicts of interest.

© 2021 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.

Figures

FIGURE 1
FIGURE 1
Percentage of patients with reductions in menstrual blood loss over 12 months after transcervical fibroid ablation in uterine fibroids among all patients (a), submucous fibroids (b), and large fibroids (c)
FIGURE 2
FIGURE 2
Change in menstrual blood loss over 12 months after transcervical fibroid ablation in submucous fibroids (a) and large fibroids (b)
FIGURE 3
FIGURE 3
Change in Symptom Severity Score (SSS) over 12 months after transcervical fibroid ablation in submucous fibroids (a) and large fibroids (b)
FIGURE 4
FIGURE 4
Change in Health‐related Quality of Life (HRQL) over 12 months after transcervical fibroid ablation in submucous fibroids (a) and large fibroids (b)
FIGURE 5
FIGURE 5
Change in general health‐related quality of life (measured as EuroQol 5‐Dimension [EQ‐5D]) over 12 months after transcervical fibroid ablation in submucous fibroids (a) and large fibroids (b)

References

    1. Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188(1):100‐107.
    1. Munro MG, Critchley HO, Broder MS, Fraser IS. Disorders FWGoM: FIGO classification system (PALM‐COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011;113(1):3‐13.
    1. Donnez J, Polet R, Smets M, Bassil S, Nisolle M. Hysteroscopic myomectomy. Curr Opin Obstet Gynecol. 1995;7(4):311‐316.
    1. Loffer FD. Removal of large symptomatic intrauterine growths by the hysteroscopic resectoscope. Obstet Gynecol. 1990;76(5 Pt 1):836‐840.
    1. Polena V, Mergui JL, Perrot N, Poncelet C, Barranger E, Uzan S. Long‐term results of hysteroscopic myomectomy in 235 patients. Eur J Obstet Gynecol Reprod Biol. 2007;130(2):232‐237.
    1. Emanuel MH, Wamsteker K, Hart AA, Metz G, Lammes FB. Long‐term results of hysteroscopic myomectomy for abnormal uterine bleeding. Obstet Gynecol. 1999;93(5 Pt 1):743‐748.
    1. Yang JH, Chen MJ, Wu MY, Chao KH, Ho HN, Yang YS. Office hysteroscopic early lysis of intrauterine adhesion after transcervical resection of multiple apposing submucous myomas. Fertil Steril. 2008;89(5):1254‐1259.
    1. Haber K, Hawkins E, Levie M, Chudnoff S. Hysteroscopic morcellation: review of the manufacturer and user facility device experience (MAUDE) database. J Minim Invasive Gynecol. 2015;22(1):110‐114.
    1. Brolmann 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;13:27‐35.
    1. Chudnoff S, Guido R, Roy K, Levine D, Mihalov L, Garza Leal JG. Ultrasound‐guided transcervical ablation of uterine leiomyomata. Obstet Gynecol. 2019;133:13‐22.
    1. Miller CE, Osman K. Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2‐year results of the SONATA pivotal trial. J Gynecol Surg. 2019;35(6):345‐349.
    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(1):67‐73.
    1. Bongers M, Brolmann H, Gupta J, Garza‐Leal JG, Toub D. Transcervical, intrauterine ultrasound‐guided radiofrequency ablation of uterine fibroids with the VizAblate(R) System: three‐ and six‐month endpoint results from the FAST‐EU study. Gynecol Surg. 2015;12(1):61‐70.
    1. Garza‐Leal JG, Toub D, León IH, et al. Transcervical, intrauterine ultrasound‐guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting. Gynecol Surg. 2011;8:327‐334.
    1. Lukes A, Green M. Three‐year results of the SONATA pivotal trial of transcervical fibroid ablation for symptomatic uterine myomata. J Gynecol Surg. 2020;36(5):228‐233.
    1. Harding G, Coyne KS, Thompson CL, Spies JB. The responsiveness of the uterine fibroid symptom and health‐related quality of life questionnaire (UFS‐QOL). Health Qual Life Outcomes. 2008;6:99.
    1. Goldfarb HA. Myoma coagulation (myolysis). Obstet Gynecol Clin North Am. 2000;27(2):421‐430.
    1. Goldfarb HA. Bipolar laparoscopic needles for myoma coagulation. J Am Assoc Gynecol Laparosc. 1995;2(2):175‐179.
    1. Lukes AS, Muse K, Richter HE, Moore KA, Patrick DL. Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding. Curr Med Res Opin. 2010;26(11):2673‐2678.
    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;242:122‐125.
    1. Liang Y, Ren Y, Wan Z, et al. Clinical evaluation of improved MyoSure hysteroscopic tissue removal system for the resection of type II submucosal myomas. Medicine (Baltimore). 2017;96(50):e9363.
    1. Jansen FW, Vredevoogd CB, van Ulzen K, Hermans J, Trimbos JB, Trimbos‐Kemper TC. Complications of hysteroscopy: a prospective, multicenter study. Obstet Gynecol. 2000;96(2):266‐270.
    1. Davis MR, Soliman AM, Castelli‐Haley J, Snabes MC, Surrey ES. Reintervention rates after myomectomy, endometrial ablation, and uterine artery embolization for patients with uterine fibroids. J Womens Health (Larchmt). 2018;27(10):1204‐1214.
    1. Wegienka G, Baird DD, Hertz‐Picciotto I, et al. Self‐reported heavy bleeding associated with uterine leiomyomata. Obstet Gynecol. 2003;101(3):431‐437.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner