92in wide Phyllis J. Gee, M.D., FACOG North Texas Uterine Fibroid Institute, Plano, Texas Presented at ACOG's 2007 Annual Clinical Meeting (ACM) San Diego, CA, May 5-9, 2007 Enhanced MR guided Focused Ultrasound Surgery (MRgFUS) Guidelines
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Phyllis J. Gee, M.D., FACOG
North Texas Uterine Fibroid Institute, Plano, Texas
Presented at ACOG's 2007 Annual Clinical Meeting (ACM)
San Diego, CA, May 5-9, 2007
Enhanced MR guided Focused Ultrasound Surgery (MRgFUS) Guidelines
Demonstrates Improved Efficacy and Durability for the Treatment of Uterine Myoma
Objective: Data were collected to confirm improved efficacy of Magnetic Resonance-guided focused ultrasound surgery (MRgFUS) treatment of uterine leiomyomata with expanded guidelines. Methods: From April 2003 to March 2006, 160 patients were treated in a continued access study (UF005), and 73 were treated in a study involving African-American patients exclusively (UF014). MRgFUS was performed using three different sets of treatment guidelines: 96 patients in UF005 were treated under pivotal study guidelines with limited treatment times and volumes (Group A), 64 patients in UF005 were treated with expanded guidelines (Group B), and the UF014 patients were treated using current commercial treatment guidelines (Group C). Results: Outcomes confirmed that patients treated under expanded and commercial treatment guidelines achieved greater nonperfused myoma volumes and greater symptom relief than those treated under the pivotal study guidelines. The symptom severity score, a component of the validated uterine leiomyoma quality of life questionnaire, was used to quantify these results. Approximately 85% of Group B patients achieved a greater than 10-point improvement in symptom severity score compared with 74% of Group A patients, which represents a 15% improvement in results. The number of alternative treatments for Group B patients at 12 and 24 months was also much less than that for Group A patients. Of the Group C patients, 43 have crossed the 3-month follow-up. Ninety-three percent (93%) of these patients have achieved symptom severity score improvement of 10 points or greater. Conclusions: These findings demonstrate that larger leiomyoma treatment volumes result in larger nonperfused tumor volumes after MR-guided focused ultrasound surgery. These enhanced treatments result in greater symptom relief and less need for alternative treatment.
Percent of patients exhibiting >10 points SSS improvement
Symptom Severity Score (SSS)
Treatment Guidelines and Patient Population
Limited Tx Volume Expanded Tx Volume
The purpose of this multi-center study trial is to compare the clinical outcomes of MRgFUS patients treated using expanded and commercial treatment guidelines with those patients treated using the pivotal treatment guidelines. Data were collected to confirm improved safety and efficacy of MRgFUS treatment of uterine leiomyoma with these expanded guidelines.
Reduction in Patient Symptoms Over Time
Group A patients: Pivotal study guidelines
Group B patients: Expanded treatment guidelines
Group C patients: Commercial treatment guidelines
Rate of Alternative Treatments
Focused Ultrasound Beam
Brigham and Women’s Hospital, John Hopkins Hospital, Mayo Clinic, Lahey Clinic, Radnet, North Texas Uterine Fibroid Institute, Sightline-Houston, University MRI, Virtua Hospital
This data confirms improved efficacy and durability of MR-guided Focused Ultrasound Surgery of uterine leiomyoma with expanded commercial guidelines. These enhanced treatments result in greater symptom relief and less need for alternative treatments.