Sustained Relief of Leiomyoma Symptoms by Using Focused Ultrasound Surgery

Harvard University, Cambridge, Massachusetts, United States
Obstetrics and Gynecology (Impact Factor: 5.18). 08/2007; 110(2 Pt 1):279-87. DOI: 10.1097/01.AOG.0000275283.39475.f6
Source: PubMed


To assess several measures of the long-term outcome of magnetic resonance-guided focused ultrasound surgery for symptomatic uterine leiomyomata.
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.
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.
Magnetic resonance-guided focused ultrasound surgery is an effective treatment for uterine leiomyomata and results in sustained symptomatic relief.

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    • "Unlike invasive surgical approaches for uterine fibroids treatment, MRgFUS is a new, safe and effective technique for uterine fibroid treatment, which is not aggressive for the patient [13][30]. Compared to other alternatives, the non-invasiveness of the MRgFUS technique is also associated with minimal risks and complications [4]. "
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    ABSTRACT: Uterine fibroids are benign tumors that can affect female patients during reproductive years. Magnetic resonance-guided focused ultrasound (MRgFUS) represents a noninvasive approach that uses thermal ablation principles to treat symptomatic fibroids. During traditional treatment planning, uterus, fibroids, and surrounding organs at risk must be manually marked on MR images by an operator. After treatment, an operator must segment, again manually, treated areas to evaluate the non-perfused volume (NPV) inside the fibroids. Both pre- and post-treatment procedures are time-consuming and operator-dependent. This paper presents a novel method, based on an advanced direct region detection model, for fibroid segmentation in MR images to address MRgFUS post-treatment segmentation issues. An incremental procedure is proposed: split-and-merge algorithm results are employed as multiple seed-region selections by an adaptive region growing procedure. The proposed approach segments multiple fibroids with different pixel intensity, even in the same MR image. The method was evaluated using area-based and distance-based metrics and was compared with other similar works in the literature. Segmentation results, performed on 14 patients, demonstrated the effectiveness of the proposed approach showing a sensitivity of 84.05 %, a specificity of 92.84 %, and a speedup factor of 1.56× with respect to classic region growing implementations (average values).
    Medical & Biological Engineering 11/2015; DOI:10.1007/s11517-015-1404-6 · 1.73 Impact Factor
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    • "Only MRI-guided focused ultrasound seems to be targeted to fibroids in a manner similar to that of UAE, whereas the other therapies are more or less focused on bleeding. Despite the encouraging results of many trials addressing safety, low invasiveness, and the symptomatic effects of this new thermoablative therapy, retrospective comparisons show significantly greater reduction of symptom severity and improvement in total health-related quality of life scores in patients treated with UAE, resulting in a significantly lower reintervention rate when compared with patients undergoing MRI-guided focused ultrasound.53,54 However, there are no prospective randomized trials comparing MRI-guided focused ultrasound with other minimally invasive treatments for uterine myomas, such as UAE, laparoscopic hysterectomy, or myomectomy. "
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    ABSTRACT: Uterine artery embolization (UAE) is a minimally invasive procedure with large symptomatic potential in treatment of women with uterine leiomyomas. Due to specificities of this method and possible complications the appropriate indication is crucial. Patient' symptoms, age, plans for pregnancy, and surgical and reproductive history play a major role in decision-making regarding appropriate subjects for UAE. Close cooperation between the gynecologist and the interventional radiologist is necessary. UAE is usually offered as an alternative to surgical treatment. In patients with no fertility plans, it is a less invasive option than abdominal hysterectomy, with a comparable effect on fibroid-related symptoms and quality of life. The need for reintervention is markedly greater in patients after UAE (up to 35% within 5 years) than after hysterectomy. Women with large symptomatic fibroids wishing to retain the uterus and ineligible for minimally invasive (laparoscopic or vaginal) hysterectomy are good candidates for UAE. However, studies comparing UAE with minimally invasive hysterectomy are lacking. Use of UAE in younger women desiring pregnancy is more controversial, mainly because of the significant risk of miscarriage (as high as 64% in some studies) as well as the increased risk of other complications of pregnancy, such as preterm delivery, abnormal placentation, and post-partum hemorrhage. The risk of infertility or subfertility following UAE is unknown. Even poor candidates for myomectomy should be carefully selected for UAE after counseling about all possible adverse effects on fertility. Good prospective studies focused on fertility comparing UAE with no treatment or with myomectomy are needed but would be ethically questionable. This review summarizes the current knowledge regarding the benefits and potential risks of UAE from the point of view of the gynecologist, who should be responsible for proper indication of this treatment.
    International Journal of Women's Health 06/2014; 6(1):623-9. DOI:10.2147/IJWH.S43591
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    • "MRgFUS is already an established treatment for other clinical applications such as uterine fibroid therapy (under FDA and CE approval and the approval of the Ministries of Health in Israel, Japan, and Korea, as well as other regulatory bodies around the world), with an excellent record of safety and efficacy [14-16]. MRgFUS is also under clinical investigation as a treatment for tumors of the breast [17-20], prostate [21], liver [22,23], and brain [24-27]. "
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    ABSTRACT: Study design A phantom experiment, two thermocouple experiments, three in vivo pig experiments, and a simulated treatment on a healthy human volunteer were conducted to test the feasibility, safety, and efficacy of magnetic resonance-guided focused ultrasound (MRgFUS) for treating facet joint pain. The goal of the current study was to develop a novel method for accurate and safe noninvasive facet joint ablation using MRgFUS. Summary of background data Facet joints are a common source of chronic back pain. Direct facet joint interventions include medial branch nerve ablation and intra-articular injections, which are widely used, but limited in the short and long term. MRgFUS is a breakthrough technology that enables accurate delivery of high-intensity focused ultrasound energy to create a localized temperature rise for tissue ablation, using MR guidance for treatment planning and real-time feedback. We validated the feasibility, safety, and efficacy of MRgFUS for facet joint ablation using the ExAblate 2000® System (InSightec Ltd., Tirat Carmel, Israel) and confirmed the system's ability to ablate the edge of the facet joint and all terminal nerves innervating the joint. A phantom experiment, two thermocouple experiments, three in vivo pig experiments, and a simulated treatment on a healthy human volunteer were conducted. The experiments showed that targeting the facet joint with energies of 150–450 J provides controlled and accurate heating at the facet joint edge without penetration to the vertebral body, spinal canal, or root foramina. Treating with reduced diameter of the acoustic beam is recommended since a narrower beam improves access to the targeted areas. MRgFUS can safely and effectively target and ablate the facet joint. These results are highly significant, given that this is the first study to demonstrate the potential of MRgFUS to treat facet joint pain.
    02/2014; 2(1):9. DOI:10.1186/2050-5736-2-9
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