title: Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.
abstract: 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.
  
  
  METHODS
  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).
  
  
  METHODS
  University hospitals and private surgical centers.
  
  
  METHODS
  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).
  
  
  METHODS
  Laparoscopic ultrasound-guided RFVTA.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, Michigan. Electronic address: jberman@med.wayne.edu.
authors.forename: Jay M
authors.initials: JM
authors.lastname: Berman
authors.affiliation: Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical School, Magee-Women's Research Institute, Pittsburgh, Pennsylvania.
authors.forename: Richard S
authors.initials: RS
authors.lastname: Guido
authors.affiliation: Hospital Universitario Nuevo Leon, Monterrey, Mexico.
authors.forename: José Gerardo
authors.initials: JG
authors.lastname: Garza Leal
authors.affiliation: Hospital Universitario Esperanza, Universidad Francisco Marroquin, Guatemala City, Guatemala.
authors.forename: Rodolfo Robles
authors.initials: RR
authors.lastname: Pemueller
authors.affiliation: Innovative Analytics, Inc., Kalamazoo, Michigan.
authors.forename: Fredrick S
authors.initials: FS
authors.lastname: Whaley
authors.affiliation: Department of Obstetrics and Gynecology and Women's Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
authors.forename: Scott G
authors.initials: SG
authors.lastname: Chudnoff
mesh_terms: D000328:Adult; D000700:Analgesics / Q000627:therapeutic use; D017115:Catheter Ablation / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007889:Leiomyoma / Q000150:complications / Q000523:psychology / Q000601:surgery*; D008595:Menorrhagia / Q000209:etiology / Q000523:psychology / Q000601:surgery*; D010149:Postoperative Pain / Q000517:prevention & control; D017697:Premenopause; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000150:complications / Q000523:psychology / Q000601:surgery*
chemical_list: D000700:Analgesics
keywords: Ablation; Fibroids; Laparoscopic ultrasound; Myomas; Outcomes; Radiofrequency volumetric thermal ablation