Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years-outcome from the Halt trial

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• 作者：Richard S Guido (12)
  James A Macer (13)
  Karen Abbott (14)
  Janice L Falls (15)
  Ian B Tilley (16)
  Scott G Chudnoff (15)
  
• 关键词：Radiofrequency ablation ; Ultrasound ; Laparoscopic ultrasound ; Fibroid ; Myoma ; Quality of life
• 刊名：Health and Quality of Life Outcomes
• 出版年：2013
• 出版时间：December 2013
• 年：2013
• 卷：11
• 期：1
• 全文大小：356KB
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• 作者单位：Richard S Guido (12)
  James A Macer (13)
  Karen Abbott (14)
  Janice L Falls (15)
  Ian B Tilley (16)
  Scott G Chudnoff (15)
  
  12. Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Gynecologic Specialties, University of Pittsburgh Medical Center, Magee-Women’s Research Institute, Pittsburgh, PA, USA
  13. Department of Obstetrics and Gynecology, Huntington Hospital, Pasadena, CA, USA
  14. Athena Gynecology Medical Group, Reno, NV, USA
  15. Department of Obstetrics and Gynecology and Women’s Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA
  16. Department of Clinical Obstetrics and Gynecology, Los Angeles County and University of Southern California Medical Center, Los Angeles, USA
  

文摘

Background Although 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. Methods Prospective, 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 (?60 to ?00 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. Results One hundred twelve subjects were followed through 24 months. Change in symptom severity from baseline was -5.7 (95% CI, -0.1 to -1.4; 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). Conclusion Radiofrequency 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 registration ClinicalTrials.gov: NCT00874029