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Obstetrics & Gynecology 2007;110:279-287
© 2007 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Sustained Relief of Leiomyoma Symptoms by Using Focused Ultrasound Surgery

Elizabeth A. Stewart, MD1,3, Bobbie Gostout, MD3, Jaron Rabinovici, MD4, Hyun S. Kim, MD5, Lesley Regan, MD6, Clare M. C. Tempany, MD2 for the Magnetic Resonance Imaging Guided Focused Ultrasound for Uterine Fibroid Group*

From the Departments of 1Obstetrics, Gynecology and Reproductive Biology and 2Radiology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts; 3Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota; 4Department of Obstetrics and Gynecology, Sheba Medical Center, Tel-Hashomer, Israel; 5Department of Radiology, Johns Hopkins School of Medicine, Baltimore, Maryland; and 6Department of Obstetrics and Gynecology, St. Mary's Hospital and Imperial College School of Medicine, London, England.

OBJECTIVE: To assess several measures of the long-term outcome of magnetic resonance–guided focused ultrasound surgery for symptomatic uterine leiomyomata.

METHODS: Data on 359 women completing 24-month follow-up in all clinical trials of magnetic resonance–guided focused ultrasound surgery for uterine leiomyomata were analyzed. Quality of life outcomes, measured by the symptom severity score of the Uterine Fibroid Symptoms Quality Of Life Questionnaire were assessed for 24 months after treatment. Clinical endpoints, including uterine shrinkage, the need for additional leiomyoma treatment, and the time to additional leiomyoma treatment, were all assessed. The nonperfused volume ratio after treatment, calculated from the gadolinium-enhanced magnetic resonance imaging after treatment and the best measure of tissue necrosis after treatment, was used to assess outcome based on completeness of leiomyoma ablation.

RESULTS: Women undergoing magnetic resonance–guided focused ultrasound surgery for symptomatic uterine leiomyomata have durable symptom relief, as measured by the symptom severity score at 24 months, with significantly greater improvement with more complete ablation (P<.001). Survival analysis demonstrates a significant reduction in the percentage of women undergoing additional leiomyoma treatment (P=.001) in women in the high nonperfused volume group. The mean shrinkage and mean residual nonperfused volume ratio are both significantly above zero at 6 months in the high nonperfused volume group (P<.001). The incidence of adverse events is low. However, for women with minimal treatment, the risk of additional procedures is high.

CONCLUSION: Magnetic resonance–guided focused ultrasound surgery is an effective treatment for uterine leiomyomata and results in sustained symptomatic relief.

LEVEL OF EVIDENCE: III




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