Radiofrequency Volumetric Thermal Ablation of Fibroids

Abstract

INTRODUCTION: Radiofrequency volumetric thermal ablation of fibroids has been reported in the literature, the procedure has been cleared by the U.S. Food and Drug Administration, but mid- to-long-term quality-of-life results in a heterogeneous population of premenopausal and symptomatic women are lacking. Our objective was to analyze the clinical success of radiofrequency volumetric thermal ablation through 3 years of study. METHODS: Prospective, multicenter, outpatient interventional clinical trial of radiofrequency volumetric thermal ablation fibroid treatment in 83 premenopausal women who were followed to 3 years and who had symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (160 mL or greater to 500 mL or less) at baseline. RESULTS: Eighty-three participants (mean age, 42.7±4.2 years) provided responses to validated questionnaires at 36 months of follow-up; four participants had surgical reinterventions and one participant became pregnant in the third year of analysis. Mean uterine fibroid symptom severity scores decreased (improved) from baseline (n=135) through 36 months (n=83) by 55.3% (61.35±18.39 to 25.98±22.10) and mean health-related quality-of-life scores likewise showed improvement (93.8%; 37.09±19.62 to 78.87±22.42). Health-related quality-of-life subscale scores demonstrated significant improvement over the same period (Table 1). Mean EQ-5D Health State scores also improved 22.7% from baseline through 36 months (70.7±19.1 to 86.7±11.2). Surgical reinterventions were 0.7% (1/135) at 12 months, 4.4% (6/129) between 12 and 24 months, and 4.5% (4/88) between 24 and 36 months.CONCLUSIONS: Radiofrequency volumetric thermal ablation of fibroids provides significant and sustained improvement in patient quality of life and significant reduction in symptom severity with low surgical reintervention rates through 36 months of follow-up.