Synopsis: Transcutaneous MR-guided High Focus Ultrasound (HIFUS) ablation of
uterine fibroids was performed in 38 symptomatic women scheduled for
hysterectomy. Accurate targeting of the ultrasound beam and assessment of heat
generation were achieved by real-time MRI monitoring. The aim of the present study
was to determine the safety, feasibility and clinical efficacy of this novel non-invasive
alternative to hysterectomy. This outpatient procedure was well tolerated by all
women, with only 3 women subsequently undergoing their scheduled hysterectomy.
The treated fibroids demonstrated a statistically significant reduction in size on
follow-up MRI, and the majority of women reported an improvement in their
symptoms.
Objective: Thermal ablation of uterine fibroids using HIFUS (High intensity focused
ultrasound) under MR-guidance was evaluated for feasibility and clinical efficacy.
Materials and Methods: 38 women with symptomatic uterine fibroids of 5-10 cm
were included in this study under Helsinki criteria. Women underwent diagnostic ultrasound and MR studies previous to treatment. MRguided HIFUS thermal ablations at energies of 1400-3600J were performed. Followup MR studies at 1 month (for the first 25 women) and at 3-6 months were performed. Clinical examinations were performed monthly after treatment.
Results: Results from the first 25 women are now available. 28 fibroids were treated
in 25 women. Mean fibroid volume was 250ml. Mean ablated volume was 30ml and
mean non-perfused volume after ablation was 70ml. At follow-up MRI, mean fibroid
volume decreased to 88% of pretreatment volume at 1 month (p<0.001), and to 83.2%
at 3-6 months (p<0.005). There was a statistically significant correlation between the
ablated volume and the reduction in fibroid volume. 16/25 women reported clinical
improvement in their fibroid-related symptoms. None of the women experienced any
significant adverse side effect after the procedure or during the follow-up period.
Conclusions: Non-invasive thermal ablation of uterine fibroids by MR-guided
HIFUS induced a significant regression in mean fibroid size and caused clinical
improvement in a majority of women at 3-6m after therapy. The correlation between
the ablated volume and the reduction in fibroid volume suggests that larger coagulated
volumes will result in even better results.