Evaluation of Transcervical Ultrasound Guided Radiofrequency Ablation of Symptomatic Uterine Fibroids in a Single Center

Abstract

Study Objective

Most published data on the Sonata System® for transcervical radiofrequency ablation (RFA) of uterine fibroids is from the initial clinical trials. We report our initial experience and surgical/medical reintervention rates 18 months post-procedure to examine the utility of RFA as an alternative to hysterectomy.

Design

Single center retrospective chart review.

Setting

One clinical site.

Patients or Participants

All patients who underwent ultrasound-guided RFA for symptomatic fibroids using the Sonata System® at our institution between April 2021 and March 2023 (n=51).

Interventions

A retrospective chart review was conducted on all patients who underwent transcervical RFA of symptomatic fibroids.

Measurements and Main Results

51 patient charts reviewed, with a median of 4 fibroids treated per patient. Patient demographics and operative outcomes were similar to initial trials for the device. Treated fibroids ranged from 1-12cm, considerably larger those in the device clinical trials ranging 1-5cm. There were no device related complications. Cumulative surgical re-intervention rates at 6mo, 12mo, and 18mo postoperatively were calculated using Kaplan Meier analysis and found to be 2%, 7.8%, and 24.3%. Of the nine patients requiring surgical reintervention, four resulted in major gynecologic surgery, hysterectomy or myomectomy. Additionally, 68.6%, 62.7%, and 53.3% of patients maintained a medication free interval through 6mo, 12mo, and 18mo. 85.3% of patients discontinued hormonal therapy immediately postoperatively.

Conclusion

The Sonata System® for RFA can be considered an effective minimally invasive modality to treat symptomatic fibroids for the appropriate patient. We ablated considerably larger fibroids than in the initial trials while maintaining low surgical reintervention rates through 18months, suggesting more patients may be eligible for this treatment than initially described. This review provides insight into practical use of the Sonata System® in the ambulatory setting, to guide patient selection and preoperative counseling. Further studies are warranted to test the system in expanded patient populations, and to understand long-term outcomes and likelihood of true hysterectomy avoidance.