Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas: Clinical Outcomes during Early Adoption into Surgical Practice.

STUDY OBJECTIVE: To assess surgical outcomes, clinical effectiveness, and gynecologist experience of introducing laparoscopic radiofrequency ablation (RFA) of leiomyomas into surgical practice. DESIGN: Uncontrolled clinical trial. SETTING: Five academic medical centers across California. PATIENTS: Premenopausal women with symptomatic uterine leiomyomas, uterus size ≤16 weeks size, and all leiomyomas ≤10 cm with no more than 6 total leiomyomas. INTERVENTIONS: Laparoscopic RFA of leiomyomas. MEASUREMENTS AND MAIN RESULTS: We assessed intraoperative complications, blood loss, operative time, and adverse events. Gynecologists reported the operative difficulty and need for further training after each case. Participants reported leiomyoma symptoms preoperatively and at 6 and 12 weeks after surgery. We analyzed all outcome data from the first case performed by gynecologists with no previous RFA experience. Patient demand for RFA was high, but poor insurance authorization prevented 74% of eligible women from trial participation; 26 women underwent surgery and were enrolled. The mean age of the participants was 41.5 ± 4.9 years. The mean operating time was 153 ± 51 minutes, and mean estimated blood loss was 24 ± 40 cc. There were no intraoperative complications and no major adverse events. Menstrual bleeding, sexual function, and quality of life symptoms improved significantly from baseline to 12 weeks, with a 25 ± 18-point, or 47%, decrease in the Leiomyoma Symptom Severity Score. After the first procedure, the mean difficulty score was 6 (95% confidence interval [CI], 4-7.5) on a 10-point scale, and 89% of surgeons felt "very or somewhat" confident in performing laparoscopic RFA. The difficulty score decreased to 4.25 (95% CI, 1.2-6) after the fourth procedure, with all gynecologists reporting surgical confidence. CONCLUSION: Laparoscopic RFA of leiomyomas can be introduced into surgical practice with good clinical outcomes for patients. Gynecologists with no previous experience are able to gain confidence and skill with the procedure in fewer than 5 cases.

Misdiagnosis of Leiomyosarcoma after Radiofrequency Ablation of Uterine Myomas.

Minimally invasive therapies to treat symptoms of uterine myomas can be effective alternatives to major surgery. Such modalities include pharmacologic agents, uterine artery embolization, magnetic resonance-guided focused ultrasound, and laparoscopic radiofrequency ablation, known as the Acessa procedure. Acessa is used to treat women with symptomatic myomas and was approved by the US Food and Drug Administration in 2012. This case describes a patient who underwent Acessa and subsequently required hysterectomy for refractory symptoms. Pathology of her tumor was initially classified as epithelioid leiomyosarcoma but on subsequent review was classified as benign. This report highlights the challenges of accurate histologic diagnosis in the setting of using new therapeutic modalities. Clinicians should report such interventions to pathologists at the time of surgery to allow for accurate diagnosis.

Myoma Imaging by Gynecologic Surgeons Training in Intraoperative Ultrasound Technique.

STUDY OBJECTIVE: To compare preoperative transvaginal ultrasound (TVUS) and magnetic resonance imaging (MRI) with intraoperative ultrasound (IOUS) in surgeons first learning to use this technique. DESIGN: A prospective study of IOUS accuracy for mapping the size and location of myomas compared with TVUS or MRI (Canadian Task Force classification II-2). SETTING: Five University of California academic centers (Davis, Irvine, Los Angeles, San Diego, and San Francisco). PATIENTS: Twenty-six premenopausal women seeking uterine-sparing surgical treatment of myomas. Eligible participants could have no more than 6 myomas ≥2 cm and <10 cm and a uterine size no larger than 16 weeks by pelvic examination. INTERVENTIONS: Measurement of myomas by IOUS followed by radiofrequency ablation (RFA) of fibroids. MEASUREMENTS AND MAIN RESULTS: Eligible participants had to have imaging with TVUS or MRI within the last year to assess myoma characteristics. During the RFA operation, surgeons who had undergone a 1-day training on RFA and IOUS measured all myomas visualized with IOUS. Surgeons measured more myomas than were reported on MRI (12 on MRI and 16 on IOUS) or TVUS (41 on TVUS and 62 on IOUS) in all positions (anterior, posterior, lateral, and fundal). In particular, they identified more myomas <2 cm (4 on MRI, 9 on IOUS, 1 on TVUS, and 19 on IOUS). They located 2.3 times as many myomas in the anterior position as TVUS. For the myomas ≥2 cm identified by IOUS and MRI or IOUS and TVUS, there was no statistically significant difference in the mean myoma number or the mean myoma diameter measurements. CONCLUSION: Surgeons first learning to use IOUS detect the same number of myomas ≥2 cm as identified by TVUS and MRI and find a greater number of myomas <2 cm on IOUS compared with radiologist-reported TVUS.

Pregnancy Outcomes After Laparoscopic Radiofrequency Ablation of Uterine Leiomyomas Compared With Myomectomy.

OBJECTIVE: To compare pregnancy outcomes after laparoscopic radiofrequency ablation and myomectomy. METHODS: The ULTRA (Uterine Leiomyoma Treatment With Radiofrequency Ablation) study is an ongoing multicenter prospective cohort study with longitudinal follow-up up to 5 years comparing outcomes of radiofrequency ablation with myomectomy in premenopausal women older than age 21 years with symptomatic uterine leiomyomas. Participants were queried every 6 months after surgery to assess the incidence of pregnancy and pregnancy outcomes. RESULTS: Among 539 women enrolled in ULTRA, a total of 37 participants (mean age at first pregnancy 35.0±4.7 years) conceived 43 times as of March 2023 (22 radiofrequency ablation, 21 myomectomy). The average length of follow-up time after all procedures was 2.5±1.0 years. The baseline miscarriage rate in the study population was 33.3%. In participants who underwent radiofrequency ablation, 9 of 22 pregnancies (40.9%, 95% CI, 20.3-61.5%) ended in first-trimester miscarriage, 11 resulted in live births (50.0%, 95% CI, 29.1-70.9%), one resulted fetal death at 30 weeks of gestation, and one resulted in uterine rupture during miscarriage treatment with misoprostol 10 weeks after radiofrequency ablation. Among the live births in the radiofrequency ablation group, 45.5% were by vaginal delivery. In the myomectomy group, 9 of 21 pregnancies (42.9%, 95% CI, 21.7-64.0%) ended in first-trimester miscarriage and 12 resulted in live births (57.1%, 95% CI, 36.0-78.3%). There were no significant differences in the likelihood of live birth or miscarriage between the study groups. CONCLUSION: Full-term pregnancy and vaginal delivery are achievable after radiofrequency ablation of leiomyomas. However, in this interim analysis, the miscarriage rate in both radiofrequency ablation and myomectomy groups was higher than expected for women in this age group. Long-term data collection in the ongoing ULTRA study aims to further understand pregnancy outcomes after radiofrequency ablation compared with myomectomy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT0210094.

Complementary and Alternative Medicine Use Among Women with Symptomatic Uterine Fibroids.

Objective: The aim of this study is to examine complementary and alternative medicine (CAM) use among women with symptomatic uterine fibroids in the United States. Materials and Methods: In this cross-sectional analysis of baseline data from a multicenter, prospective cohort study of premenopausal women undergoing surgery for symptomatic fibroids and who enrolled in the Uterine Leiomyoma Treatment with Radiofrequency Ablation study from 2017 to 2019, we contrast women indicating use of at least one CAM modality specifically for fibroid symptoms against women using CAM for other reasons and CAM nonusers. Multivariable logistic regression models were performed to identify participant characteristics independently associated with CAM use for fibroids. Results: Among 204 women, 55% were Black/African American and the mean age was 42 (standard deviation 6.6) years. CAM use was common (67%), with 42% (95% confidence interval [CI]: 35%-49%) reporting use of CAM specifically to treat fibroid symptoms. Most commonly, CAM treatments used for fibroids were diet (62%) and herbs (52%), while CAM treatments for other reasons were exercise (80%) and massage (43%). On average, each participant who reported CAM use utilized three different types of CAM modalities. In a multivariable model, participants were more likely to use CAM for fibroids if they had pelvic pressure (odds ratio [OR] 2.50, 95% CI: 1.07-5.87, p = 0.04), a body-mass index lower than average (OR 0.76, 95% CI: 0.60-0.97, p = 0.03), and a lower health-related quality of life score (OR 0.61, 95% CI: 0.46-0.81, p = 0.001). Conclusions: In this diverse sample of women with symptomatic fibroids, CAM use was highly prevalent. Our findings highlight the need for providers to query patients about CAM use and understand the role of CAM in fibroid management. ClinicalTrials.gov Identifier: NCT02100904.

Obstacles to Studying Emerging Technologies.

Laparoscopic radiofrequency ablation of uterine leiomyomas with a new Federal Drug Administration (FDA)-approved device, a device that delivers radiofrequency energy, is a novel procedure that aims to meet patient and physician demand for effective, minimally invasive leiomyoma treatment. However, as a new procedure, the durability of symptom relief, the safety in widespread use, and ultimately the comparative effectiveness of radiofrequency ablation of leiomyomas need further study. In June 2013, the University of California Fibroid Network, a collaboration of the five University of California Departments of Obstetrics and Gynecology, launched the Uterine Leiomyoma Treatment with Radiofrequency Ablation Study, an investigator-initiated early postmarket approval clinical trial of radiofrequency ablation of leiomyomas. In this commentary, we provide a review of the FDA approval process for medical devices using the device that delivers radiofrequency energy as a case study and describe significant limitations of this process that may adversely affect clinical care. We show how the deficiencies in the FDA process have challenged our ability to conduct independent early postmarket research evaluating the safety and long-term effectiveness of this novel technology. Our experience validates the Institute of Medicine's recommendation that advancements in surgical technology introducing new treatments without long-term effectiveness data, comparative study, or both should emerge onto the market under research conditions. Until the FDA requires more rigorous study of novel devices, we suggest ways of working together as a community of gynecologic surgeons to evaluate promising new technologies in early postmarket studies, putting research before widespread adoption of surgical innovation.