ABSTRACT
OBJECTIVE: Many women with myomas desire uterine conservation. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a new non-invasive therapy. We describe our early results regarding efficacy and safety of MRgFUS for the treatment of uterine leiomyomas. PATIENTS AND METHODS: Fifty-two French women, over 18 years of age, who were candidates for surgical myomectomy, hysterectomy or uterine artery embolization due to symptomatic myomas were treated by MRgFUS (ExAblate 2000(®), InSightec) and followed up for at least 6 months. Intramural or subserous myomas with a size between 4-12 cm and a T2 low intensity MRI image were selected in women with no abdominal scar and no bowel interposition. The modified symptom severity score (SSS) was examined before and after the treatment at 6 months. Second treatment rate during the first follow-up year was reported. RESULTS: No serious complications were recorded during the treatments or follow-up period. Seven women had initial failure mostly because of bowel interposition, six of them had uterine artery embolisation. The mean modified SSS value for patients before MRgFUS was 41/100 and the values diminished significantly to a mean value of 22/100. A total of 65% of women had a reduction of at least 10 points (n=22) (initial score of 41 [29; 62] and 22 [16; 46] at 6 month follow-up). Good correlation was observed between myomas destruction and the symptoms score. During the follow-up period, ten patients (19%) required invasive interventions (six hysterectomies, two embolisations and two myomectomies). The average reduction in myoma volume determined by MR imaging at 6 months after treatment was 14%. This volume reduction is poorly correlated with the myoma's treated volume of 36.4% (6-74%). CONCLUSION: MRgFUS can safely be used for symptomatic treatment and avoid the need for surgical intervention in most patients. Additional follow-up is needed to determine the long-term durability of this promising non-invasive approach and to obtain reimbursement.
