Purpose: To evaluate the effects and clinical outcome of MRI-guided focused ultrasound surgery (FUS) in the treatment of symptomatic uterine fibroids.
Methods and Materials: Patients with symptomatic fibroids enrolled into the prospective multicenter study for 6 months. Fibroids were identified and characterized on pretreatment MRI examination. Patients completed uterine fibroid symptom and health-related quality of life questionnaire (UFS-QOL). Targeted fibroids were identified using T2-weigthed images, and sonications from the high intensity ultrasound were delivered to ablate the target. MR-thermal images and phase-encoding MR images were obtained during each sonication to assess tissue temperature change and accurate targeting of the tissue. Patients were given IV conscious sedation and monitored. Diffusion and post-contrast MR images were obtained post FUS to correlates with treatment area. Clinic visit with UFS-QOL at 1 wk, 1, 3 and 6 month post FUS were obtained, and f/u MRI was performed at 6 month post FUS to assess efficacy and clinical outcome of the treatment.
Results: 16 pts (mean age 47 y.o. range 37-53) were treated, including 9 white and 7 black women. 5 pts had myomectomy. IV sedation given with Versed (mean 3mg, range 0.5-6) and Fentanyl (mean 150 microgram, range 25-300). 6 patients received treatments on 2 fibroids, while 10 patients received treatment on 1 fibroid. Total of 22 fibroids were treated with FUS. 100% initial technical success to localize and treat intended fibroids with sonication. One fibroid was not treated after initial sonication due to heavy calcification. 22 fibroids included 13 submucosal, 7 intramural and 2 subserosal fibroids. Mean volume of treated fibroid was 114.1cc (range 5.5-621.7). Mean ablated volume was 21cc (range 1-87.9). 88% (14 patients) had improved symptom severity score (UFS-QOL) with mean decrease in the score of 12.5 after FUS. Mean volume decrease in treated fibroids was 57%. No significant pain was noted during treatment. No unintended ablation or MR evidence of adjacent tissue damage/edema is noted. No report of bladder or bowel symptom was noted. One minor skin burn was observed. One patient developed leg paresthesia, which improved with conservative therapy. All were treated as outpatients. 81% (13 pts) had no loss of work post-FUS, and 19% (3 pts) lost average of 1 day of work.
Conclusion: Early experience of FUS in the treatment of uterine fibroids appears safe and accurate with minimal postoperative morbidity. Short-term results of FUS appear efficacious for uterine fibroids. (H.S.K. received a grant from TxSonics/Insightec. J.F.G. is on the board of TxSonics/Insightec.)
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