Volumetric MR-guided High-Intensity Focused Ultrasound Ablation with a One-Layer Strategy to Treat Large Uterine Fibroids: Initial Clinical Outcomes

Abstract
To evaluate initial clinical outcomes of volumetric magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation by using a one-layer strategy to treat large (>10 cm in diameter) uterine fibroids, with investigation of the correlation between effectiveness of the one-layer strategy and dynamic contrast material-enhanced (DCE) MR parameters. Institutional review board approval and informed consent were obtained. Twenty-seven women (mean age, 44.5 years) with 27 large uterine fibroids (mean diameter, 11.3 cm ± 1.4 [standard deviation] [range, 10.1-16.0 cm]; fibroid volume, 502.5 mL ± 214.3 [range, 253.8-1184.0 mL]) underwent volumetric MR-guided HIFU ablation with a one-layer strategy. (All treatment cells were placed in one coronal plane at a depth of half to anterior two-thirds of the anteroposterior dimension of fibroids.) Treatment time, immediate nonperfused volume (NPV), and effectiveness of a one-layer strategy (ratio of immediate NPV to total volume of treatment cells planned) correlating with baseline DCE MR parameters (volume transfer constant [K(trans)], fractional extravascular extracellular space, and fractional blood plasma volume [Pearson correlation test]), complications, 3-month follow-up volumes, and symptom severity score (SSS) changes (paired t test) were assessed retrospectively. All treatments showed technical success in one session (mean treatment time, 166.2 minutes ± 38.9). NPV was 301.3 mL ± 119.1, which was 64.2% ± 19.9 (<50%, n = 4; ≥ 50%, n = 23) of fibroid volume. Ratio of immediate NPV to total volume of treatment cells (1.79 ± 0.61) negatively correlated with DCE MR imaging K(trans) values (r = -0.426, P = .017). Minor complications occurred in five patients (18.5% [thermal injury of abdominal wall, n = 3; 30-day leg numbness, n = 1; cystitis, n = 1]). At 3-month follow-up (n = 18), mean SSS had decreased from 37.4 at baseline to 24.0 (P < .001), and volume reduction ratio was 0.64 ± 0.15 (P < .001). Volumetric MR-guided HIFU ablation with a one-layer strategy is safe and effective for treatment of large uterine fibroids. Effectiveness of this strategy showed a significant negative correlation with K(trans) values at baseline DCE MR imaging.