Abstract
BackgroundAlthough most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease. Twelve-month outcomes from the Halt Trial have been reported in the literature. Here we analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids at two years of follow up.MethodsProspective, multicenter, outpatient interventional clinical trial of fibroid treatment by RFVTA in 124 premenopausal women (mean age, 42.4 ± 4.4 years) with symptomatic uterine fibroids and objectively confirmed heavy menstrual bleeding (≥160 to ≤500 mL).Outcome measures included: subject responses to validated questionnaires, treatment-emergent adverse events, and surgical re-intervention for fibroids at 24 months postprocedure. Continuous and categorical variables were summarized using descriptive statistics and means and percentages. Comparisons between visits were based on t-tests using repeated measures models. P-values < 0.05, adjusted for multiplicity, were statistically significant.ResultsOne hundred twelve subjects were followed through 24 months. Change in symptom severity from baseline was –35.7 (95% CI, –40.1 to –31.4; p<.001). Change in health-related quality of life (HRQL) was 40.9 (95% CI, 36.2 to 45.6; p < .001). HRQL subscores also improved significantly from baseline to 24 months in all categories (concern, activities, energy/mood, control, self-consciousness, and sexual function) [p<.001]. Six patients underwent surgical re-intervention for fibroid-related bleeding between 12 and 24 months providing a re-intervention rate of 4.8% (6/124).ConclusionRadiofrequency volumetric thermal ablation of myomas significantly reduces symptom severity and improves quality of life with low surgical re-intervention through 24 months of follow up.Trial registrationClinicalTrials.gov: NCT00874029
Highlights
Most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease
Materials and methods For this prospective, interventional clinical trial [ClinicalTrials.gov Identifier: NCT00874029], in which subjects served as their own controls, we recruited and enrolled premenopausal women with ≤ 6 treatable fibroids with no single fibroid exceeding 7 cm in any diameter; these parameters were confirmed by transvaginal ultrasound
Despite resolution of fibroid symptoms achieved in his early trials using other radiofrequency ablation systems, Lee found the characteristic bending of the needles an obstacle to accurate and dependable fibroid ablation
Summary
Most myomas are asymptomatic, quality of life is compromised for many women with uterine fibroid disease. Twelve-month outcomes from the Halt Trial have been reported in the literature. We analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids at two years of follow up. Most uterine fibroids are asymptomatic, heavy menstrual bleeding presents as the most common complaint among women who undergo myomectomy [1]. Our objectives were analyses of qualitative clinical outcomes, as evidenced by subject responses to validated questionnaires [6,7], as well as the incidence of device- and/or procedure-related adverse events and surgical re-intervention for fibroid treatment among those subjects followed to 24 months post RFVTA with the Acessa System (Halt Medical, Inc., Brentwood, California USA)
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