title: Magnetic resonance-guided high-intensity focused ultrasound for uterine fibroids: Mid-term outcomes of 36 patients treated with the Sonalleve system.
abstract: OBJECTIVE
  This study sought to assess the mid-term efficacy of magnetic resonance-guided high-intensity focused ultrasound (MRgFUS) (Sonalleve system) for uterine fibroids.
  
  
  METHODS
  We retrospectively included patients treated by MRgFUS controlled by real-time MR-thermometry. Clinical efficacy was defined as the minimum reduction of ten points in the Transformed Symptom Severity Score (tSSS) without additional treatment. Fibroid volumes were assessed at 6 months, and patients were contacted to assess mid-term efficacy using tSSS.
  
  
  RESULTS
  Thirty-six patients were included; 22 patients (61.1%) exhibited clinical efficacy with a mean follow-up duration of 21.4 (95%CI: 16.3-26.5) months. In addition, the tSSS mean decreased significantly from 42.8 ± 16 to 25.4 ± 18 (p < 0.0001). MRgFUS exhibited a preferential effect on menorrhagia (p = 0.001) and symptoms related to pelvic heaviness and swelling (p = 0.004). The volume reduction was 27% (p < 0.001) and was correlated with the non-perfused volume (NPV) after treatment (r = 0.373; p = 0.028). Cumulative re-intervention rates (surgery or uterine artery embolisation) at 12 months, 18 months and 24 months were 2.8%, 8.5% and 21.6%, respectively. No serious adverse events were reported. Two pregnancies occurred during the follow-up period.
  
  
  CONCLUSIONS
  Treatment of uterine fibroids by MRgFUS is efficient and results in low morbidity and satisfactory clinical efficacy with a mean follow-up of 21.4 months.
authors.affiliation: a Department of Radiology , Saint-Andre Hospital , Bordeaux , France and.
authors.forename: Anne C
authors.initials: AC
authors.lastname: Thiburce
authors.affiliation: a Department of Radiology , Saint-Andre Hospital , Bordeaux , France and.
authors.forename: Nora
authors.initials: N
authors.lastname: Frulio
authors.affiliation: a Department of Radiology , Saint-Andre Hospital , Bordeaux , France and.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Hocquelet
authors.affiliation: a Department of Radiology , Saint-Andre Hospital , Bordeaux , France and.
authors.forename: Florent
authors.initials: F
authors.lastname: Maire
authors.affiliation: a Department of Radiology , Saint-Andre Hospital , Bordeaux , France and.
authors.forename: Cécile
authors.initials: C
authors.lastname: Salut
authors.affiliation: a Department of Radiology , Saint-Andre Hospital , Bordeaux , France and.
authors.forename: Pierre
authors.initials: P
authors.lastname: Balageas
authors.affiliation: a Department of Radiology , Saint-Andre Hospital , Bordeaux , France and.
authors.forename: Mounir
authors.initials: M
authors.lastname: Bouzgarrou
authors.affiliation: b Department of Obstetrics and Gynecology , Pellegrin Hospital , Bordeaux , France.
authors.forename: Claude
authors.initials: C
authors.lastname: Hocké
authors.affiliation: a Department of Radiology , Saint-Andre Hospital , Bordeaux , France and.
authors.forename: Hervé
authors.initials: H
authors.lastname: Trillaud
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D007889:Leiomyoma / Q000601:surgery*; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D014464:Ultrasonic Therapy
keywords: High-intensity focused ultrasound ablation; Ieiomyoma; interventional; magnetic resonance imaging; mid-term effects; patient outcome assessment