Three-Year Outcome of the Halt Trial: A Prospective Analysis of Radiofrequency Volumetric Thermal Ablation of Myomas

摘要

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 36months 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 ≤500mL). Interventions: Laparoscopic ultrasound-guided RFVTA. Measurements and Main Results: One hundred four participants were followed prospectively for 36months 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 36months 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 36months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36months 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 36months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36months 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 36months after ablation. The low repeat intervention data through 36months is a positive outcome for patient well-being.