Reproductive Outcomes in Women Following Radiofrequency Volumetric Thermal Ablation of Symptomatic Fibroids. A Retrospective Case Series Analysis.

OBJECTIVE: To report reproductive outcomes in women who underwent radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids. STUDY DESIGN: Retrospective analysis of fibroid characteristics, treatment parameters, and pregnancy outcomes of 6 subjects in 3 prospective trials of laparoscopic ultrasound-guided RFVTA. RESULTS: Despite the requirement that women enrolled in the RFVTA studies did not desire current or future childbearing and were to continue contraception, 6 subjects conceived at between 3.5 and 15 months postreatment. The number of fibroids treated per patient ranged from 1 to 7, measured between 1.0 cm and 7.6 cm at the greatest diameter, and included multiple types (submucosal, intramural, transmural, and subserosal). Five patients (5/6, 83%) delivered full-term healthy infants: 1 by vaginal delivery and 4 by cesarean section. One patient (1/6, 17%) had a spontaneous miscarriage in the first trimester. CONCLUSION: Viable, full-term pregnancies are possible after RFVTA. Further, in-depth study of pregnancy outcomes following laparoscopic ultrasound-guided radiofrequency, volumetric ablation of fibroids is warranted.

Laparoscopic radiofrequency fibroid ablation: phase II and phase III results.

BACKGROUND AND OBJECTIVES: To review phase II and phase III treatments of symptomatic uterine fibroids (myomas) using laparoscopic radiofrequency volumetric thermal ablation (RFVTA). METHODS: We performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasound-guided laparoscopic RFVTA of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied. RESULTS: From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8 (P < .001) (n = 57), health-related quality-of-life scores improved from 48.5 to 92.0 (P < .001) (n = 57), and mean uterine volume decreased from 204.4 cm(3) to 151.4 cm(3) (P = .008) (n = 58). Patients missed a median of 4 days of work (range, 2-10 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related quality-of-life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 1-29 days). The rate of periprocedural device-related adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment. CONCLUSIONS: RFVTA does not require any uterine incisions and provides a uterine-sparing procedure with rapid recovery, significant reduction in uterine size, significant reduction or elimination of myoma symptoms, and significant improvement in quality of life.

Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.

STUDY OBJECTIVE: To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas. DESIGN: Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1). SETTING: University hospitals and private surgical centers. PATIENTS: One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL). INTERVENTIONS: Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN RESULTS: One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial. CONCLUSION: RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.