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

J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):767-74. doi: 10.1016/j.jmig.2014.02.015. Epub 2014 Mar 5.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01563783 NCT01750008.

Keywords: Ablation; Fibroids; Laparoscopic ultrasound; Myomas; Outcomes; Radiofrequency volumetric thermal ablation.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Analgesics / therapeutic use
  • Catheter Ablation* / methods
  • Female
  • Follow-Up Studies
  • Humans
  • Leiomyoma / complications
  • Leiomyoma / psychology
  • Leiomyoma / surgery*
  • Menorrhagia / etiology
  • Menorrhagia / psychology
  • Menorrhagia / surgery*
  • Pain, Postoperative / prevention & control
  • Premenopause
  • Prospective Studies
  • Quality of Life / psychology*
  • Surveys and Questionnaires
  • Treatment Outcome
  • Uterine Neoplasms / complications
  • Uterine Neoplasms / psychology
  • Uterine Neoplasms / surgery*

Substances

  • Analgesics

Associated data

  • ClinicalTrials.gov/NCT01563783
  • ClinicalTrials.gov/NCT01750008