Durable Symptom Relief With MR-Guided Ultrasound Removal of Uterine Fibroids
By Deborah Brauser
Medscape Medical News
March 24, 2010 (Tampa, Florida) — A minimally invasive treatment using magnetic-resonance-guided focused ultrasound (MRgFUS) is effective in removing uterine fibroids, provides lasting symptom relief, and eliminates the need for invasive surgical treatments such as myomectomy and hysterectomy, according to a study presented here at the Society of Interventional Radiology 35th Annual Scientific Meeting.
Results with MRgFUS were comparable with those seen with uterine fibroid embolization (UFE), said Gina Hesley, MD, a radiologist from the Mayo Clinic in Rochester, Minnesota, during her presentation of the results.
"Today, women have interventional radiology options that do not involve the use of a scalpel incision," she said in a release. "Women should ask for a consult with an interventional radiologist who can determine from [magnetic resonance] imaging whether they are candidates for [MRgFUS] or UFE."
Fibroids Common in Women Over 35
Approximately 20% to 40% of American women older than 35 years of age have uterine fibroids of a significant size. Although noncancerous, these commonly develop in the muscular wall of the uterus and can cause prolonged heavy menstrual bleeding that can lead to anemia, disabling pelvic pain, urinary frequency, miscarriage, and fertility problems.
"While UFE is a widely available treatment that blocks blood flow to fibroid tumors, [MRgFUS] uses high-energy ultrasound waves to generate heat at a specific point to destroy uterine fibroid tissue and relieve symptoms," explained Dr. Hesley.
"It is performed on an outpatient basis, it involves no radiation, patients leave the hospital about 1 hour after the last treatment is performed, and they report very mild postprocedural pain," she said.
Her team enrolled 119 premenopausal women with fibroids typically greater than 3?cm in size who completed MRgFUS at the Mayo Clinic between March 2005 and September 2008. Of these patients, 100 were available for 12 months of telephone follow-up interviews so that fibroid-related symptoms and symptomatic relief could be assessed.
Long-Lasting Relief
During the 12-month follow-up period, 97% of the women reported an improvement in their symptoms. Of these, 74% rated their improvement as excellent, 16% as considerable, 9% as moderate, and only 1% as insignificant.
A total of 8 of the women needed additional postprocedure treatments (6 hysterectomies and 2 myomectomies). "This rate is within values reported for myomectomy and [UFE]," reported Dr. Hesley.
When asked during a press conference about the cost difference between this procedure and UFE, Dr. Hesley said that MRgFUS is about half the cost of hysterectomies at the Mayo Clinic and a third the cost of UFE.
"I think it's important for patients to have lots of options, as each woman's experience is unique," said Dr. Hesley. "Typically, UFE is better for patients who have numerous similar-sized fibroids, and focused ultrasound is more of a fibroid-specific therapy, where you'd rather have fewer fibroids or more dominant fibroids."
She reported that the Mayo Clinic team will continue to follow these women to assess 2- and 3-year results for symptom relief. In addition, they've started a National Institutes of Health–sponsored trial comparing MRgFUS with UFE in a head-to-head design. They also hope to investigate the effectiveness of MRgFUS in other uterine conditions, such as adenomyosis, in the future.
Dr. Hesley noted that, although this treatment was approved by the US Food and Drug Administration in October 2004, it is still considered new and not all insurance companies cover it.
Exciting Results for Another Option
"The results are exciting. However, the issue with [MRgFUS] that we've found in our experience is that it's not currently covered by insurance. That is a very important impediment to its more widespread use," said press conference moderator John Lipman, MD, director of the Interventional Radiology Department at Emory Adventist Hospital in Atlanta, Georgia.
When asked to compare the 2 procedures, Dr. Lipman said: "I don't think it's an issue of focused ultrasound vs UFE. One isn't going to replace the other. UFE is a global therapy, treating all the fibroids in the uterus, whereas focused ultrasound, although it can treat more than 1 fibroid, is more of a localized treatment."
"Overall, I'd say this is very innovative and I think the technology will be applicable not only in fibroids but all over the body," concluded Dr. Lipman, who was not involved in the study. "I think the Mayo Clinic's efforts with this study are to be congratulated."
This study had no outside funding. Dr. Hesley reports participating in previous work supported by InSightec, "the company that makes the only MRgFUS device currently approved by the FDA." Dr. Lipman has disclosed no relevant financial relationships.
Society of Interventional Radiology (SIR) 35th Annual Scientific Meeting: Abstract?56. Presented March?14, 2010.
