Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas

Abstract

has been reviewed by the Editorial Board and by special expert referees. Although it is judged not acceptable for publication in Obstetrics & Gynecology in its present form, we would be willing to give further consideration to a revised version.If you wish to consider revising your manuscript, you will first need to study carefully the enclosed reports submitted by the referees and editors. Each point raised requires a response, by either revising your manuscript or making a clear and convincing argument as to why no revision is needed. To facilitate our review, we prefer that the cover letter include the comments made by the reviewers and the editor followed by your response. The revised manuscript should indicate the position of all changes made. We suggest that you use the "track changes" feature in your word processing software to do so (rather than strikethrough or underline formatting). Your paper will be maintained in active status for 21 days from the date of this letter. If we have not heard from you by Oct 08, 2018, we will assume you wish to withdraw the manuscript from further consideration. REVIEWER COMMENTS: REVIEWER #1:This is a prospective cohort study evaluating the safety and effectiveness of transcervical radiofrequency ablation for the treatment of symptomatic uterine fibroids.

Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies

“…Several systematic reviews have reported results of RFA for uterine fibroids. Lim et al 5 reported that laparoscopic Bongers et al 15 39 -23 -4.4 -3.1 -Brölmann et al 16 Garza-Leal 17 ----Braun et al 18 114 -60 6.8 -3.2 --Brucker et al 19 66 -24 10.0 -5.5 20.5 (5, 103) a 10.0 (2, 86) a Hahn et al 20 Krämer et al 21 Carrafiello et al 22 20 (15, 25) b ---Cho et al 23 -(10, 40) ---Cho et al 24 ----Chudnoff et al 25 126 -60 -9.0 (2, 60) a 5.0 (0, 29) a Galen et al 26 Guido et al 27 Berman et al 28 Chudnoff et al 29 47 -30 2. 30 Galen et al 31 140 (42, 290) a -4.5 (1, 11) b 4.0 (2, 10) a Garza-Leal et al 32 Robles et al 33 Ghezzi et al 34 25 (20, 45) a 18 c --Bergamini et al 35 Iversen and Dueholm 36 ----Iversen et al 37 Jiang et al 38 25 (20, 30) b ---Kim et al 39 18 -5 ---Lee et al 40 ----Marcos et al 41 36 -11 12.0 (8, 24) b --Meng et al 42 ----Rattray et al 43 73 -26 6.7 -3.0 -11.1 -7.6 Rey et al 44 17 (11, 44) b ---Turtulici et al 45 28 (16, 43) b ---Wu et al 46 -(20, 40) 2.5 c --…”

<p>The INSPIRE Comparative Cost Study: 12-Month Health Economic and Clinical Outcomes Associated with Hysterectomy, Myomectomy, and Treatment with the Sonata System</p>

“…In an environment of increasing health care costs, it is important to understand the outcomes and costs associated with innovative new treatment options relative to the current standard(s) of care. While the safety and effectiveness of the Sonata procedure has been verified, 13 there have yet to be published data comparing health economic outcomes, medical resource utilization, and payer costs of the procedure to the current standard treatments of hysterectomy and myomectomy. This is the first study to examine 12-month payer costs and HCRU for TFA using the Sonata system and compared to those for hysterectomy and myomectomy for treatment of uterine fibroids.…”

“…SONATA was a prospective, longitudinal, multicenter, single-arm cohort clinical trial to assess the safety and efficacy of the Sonata system in the treatment of symptomatic uterine fibroids and enrolled patients between April 2015 and October 2016. 13 Procedural and 12-month postoperative cost and outcomes data for the hysterectomy and myomectomy arms were obtained from a nationally representative administrative claims database (the Truven Health MarketScan commercial payer claims database) for the period from July 1, 2012 to June 30, 2014 as it was the most recent data available from Truven at the time of the data request. There were no specific sample size calculations due to the need to retrospectively obtain charge data from sites that had already participated in the prospective SONATA trial.…”

“…TFA arm included patients who were enrolled in the prospective clinical trial of the Sonata procedure (SONATA pivotal IDE trial) and consisted of premenopausal women 25-50 years of age, with heavy menstrual bleeding (HMB) associated with up to 10 fibroids from 1-5 cm in maximal diameter. 13 The hysterectomy and myomectomy patients included in the claims database analysis were women 25-50 years of age who reported one of the following: a claim with a uterine fibroid diagnosis on the same day as the index procedure; an inpatient claim with a uterine fibroid diagnosis at any time in the 12-month pre-index period; or at least two outpatient claims, occurring 30 days apart or more, with a uterine fibroid diagnosis at any time in the 12-month preindex period. Hysterectomy and myomectomy procedures of interest were identified using appropriate International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), International Classification of Disease, Tenth Revision, and Current Procedural Terminology (CPT) codes describing the procedures (Table 1).…”

Term Delivery in an Infertile Patient after Transcervical Radiofrequency Fibroid Ablation and Assisted Reproductive Technology

“…T ranscervical radiofrequency (RF) ablation is a technology that has demonstrated safety and efficacy for treating symptomatic uterine fibroids. [1][2][3][4][5] While the clinical outcomes of RF ablation with regard to fertility and fecundity have not yet been definitively established, there are reports of pregnancies after both laparoscopic and transcervical RF ablations. [6][7][8][9][10] In addition, a similar hyperthermic ablation technology, magnetic resonance-guided focused ultrasound (MRgFUS), has resulted in normal pregnancy outcomes and received an indication in women desiring future fertility by the U.S. Food and Drug Administration (FDA).…”