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.

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.

Hysteroscopic sterilization in an immunosuppressed patient.

Essure sterilization produces a local benign tissue response resulting in bilateral occlusion of the fallopian tubes 3 months after insertion. There is a precautionary warning about performing this procedure on immunosuppressed patients. We present a case of successful bilateral tubal occlusion with Essure in a patient with a history of kidney transplantation and receiving immunosuppressive medications.

Robotic-assisted laparoscopy in gynecological surgery.

BACKGROUND: Laparoscopic surgery has revolutionized the concept of minimally invasive surgery for the last 3 decades. Robotic-assisted surgery is one of the latest innovations in the field of minimally invasive surgery. Already, many procedures have been performed in urology, cardiac surgery, and general surgery. In this article, we attempt to report our preliminary experience with robotic-assisted laparoscopy in a variety of gynecological surgeries. We sought to evaluate the role of robotic-assisted laparoscopy in gynecological surgeries. METHODS: The study was a case series of 15 patients who underwent various gynecologic surgeries for combined laparoscopic and robotic-assisted laparoscopic surgery. The da Vinci robot was used in each case at a tertiary referral center for laparoscopic gynecologic surgery. An umbilicus, suprapubic, and 2 lateral ports were inserted. These surgeries were performed both using laparoscopic and robotic-assisted laparoscopic techniques. The assembly and disassembly time to switch from laparoscopy to robotic-assisted surgery was measured. Subjective advantages and disadvantages of using robotic-assisted laparoscopy in gynecological surgeries were evaluated. RESULTS: Fifteen patients underwent a variety of gynecologic surgeries, such as myomectomies, treatment of endometriosis, total and supracervical hysterectomy, ovarian cystectomy, sacral colpopexy, and Moskowitz procedure. The assembly time to switch from laparoscopy to robotic-assisted surgery was 18.9 minutes (range, 14 to 27), and the disassembly time was 2.1 minutes (range, 1 to 3). Robotic-assisted laparoscopy acts as a bridge between laparoscopy and laparotomy but has the disadvantage of being costly and bulky. CONCLUSION: Robotic-assisted laparoscopic surgeries have advantages in providing a 3-dimensional visualization of the operative field, decreasing fatigue and tension tremor of the surgeon, and added wrist motion for improved dexterity and greater surgical precision. The disadvantages include enormous cost and added operating time for assembly and disassembly and the bulkiness of the equipment.

Predictive value of magnetic resonance imaging in differentiating between leiomyoma and adenomyosis.

OBJECTIVE: We evaluated the role of MRI as a preoperative diagnostic tool for leiomyoma and adenomyosis. METHOD: This is a retrospective chart review at a university-based hospital. The study included 1517 women who underwent hysterectomy or myomectomy over a 5-year period, and 153 women with a preoperative pelvic MRI were included. Comparisons were made between the results of the MRI and postoperative pathology reports. RESULTS: The MRI and pathology report were the same for 136 of 144 women with leiomyoma and 12 of 31 women with adenomyosis. The MRI had 94% sensitivity and 33% specificity for leiomyoma and 38% sensitivity and 91% specificity for adenomyosis. Positive and negative predictive values of MRI for leiomyoma were 95% and 27% with 90% accuracy. Positive and negative predictive values of MRI for adenomyosis were 52% and 85%, respectively, with 80% accuracy. CONCLUSION: MRI has a high sensitivity and a low specificity for diagnosing leiomyoma and a high specificity and a low sensitivity for diagnosing adenomyosis. Due to the high cost and technical variations, we suggest using MRI only as an adjunctive diagnostic tool when ultrasound is not conclusive and differentiation between the 2 pathologies ultimately affects patient management.

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.