Response to Toub re: “Update on Conservative Surgery for Fibroids: Laparoscopic Radiofrequency and Transcervical Fibroid Ablation”

Dear Editor:

I am writing in reply to Dr. Toub's [David Toub, MD] response to my article “Update on Conservative Surgery for Fibroids: Laparoscopic Radiofrequency and Transcervical Fibroid Ablation.” I thank Dr. Toub for his commentary. ¹

My article does include a section under LAP-RFA—The Acessa ProVu^® System that refers to Pregnancy Outcomes. I do agree that the referenced article does include only TFA patients. ² The sentence should have read: “In a review of patients who conceived after TFA, not only were the Sonata procedures associated with 36 uncomplicated pregnancies, but some of the patients were able to carry to term twice without any subsequent complications.” ² Nonetheless, both the Sonata^® System and Acessa ProVu System radiofrequency procedures were notable for successful pregnancies with no identified accreta spectra.

It is correct that the U.S. Food and Drug Administration (FDA) did not have an upper limit for leiomyoma treatment by the TFA or for the RFA systems, these limits were, instead, imposed by the clinical trials and not the FDA. Additionally, there was a typographic error when referring to the Sonata System fibroid treatment size. The sentence should have read: “This makes it a resource for type 1 submucosal fibroids that are not candidates for Lap-RFA.” ³ Similarly, Table 2: Sonata^® (Transcervical Fibroid Ablation) System, third row, second column, should have read: “FIGO 1-6.” ³

While the study referred to by Dr. Toub quotes a higher patient satisfaction rate of 97% after treatment with the Sonata System, it is also correct to state that there is a range of patient satisfaction from treatment with TFA. ⁴ Despite a lower satisfaction rate identified by the more-recent 2022 publication by Piriyev et al., ⁵ compared to the 2020 article by Lukes et al., the satisfaction percentage does show positive patient feedback regarding the Sonata System. ⁵ Nonetheless, a range of 86%–97% patient satisfaction with the Sonata System can be cited.^4,5

The Uterine Myoma Position-based Radiofrequency Ablation study performed in Spain included 5 different approaches to RFA with single and combined access. Although the technique did not utilize the Sonata System or the Acessa ProVu System, the 36-month follow-up in addition to the 88.5% of patients who stated that they would undergo the procedure again, are suggestive of support for procedural-based management of fibroids using radiofrequency ablation. ⁶

While physicians strive to tailor management of symptomatic uterine fibroids to each individual patient, it is imperative that patients are given options that will not only reduce symptoms, but also contribute to patient goal-oriented outcomes when these patient are provided with information on the surgical risks and postoperative recovery expectations. The Acessa ProVu System and the Sonata System continue to be promising procedures with good patient outcomes. ³

I thank Dr. Toub for his response and would welcome any additional feedback.