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May 22, 2006

Fighting Fibroids — Study Suggests UFE May Help Postmenopausal Women, Too
By Beth W. Orenstein
Radiology Today
Vol. 9 No. 10 P. 24

Gynecologists have been reluctant to suggest uterine fibroid embolization (UFE) to symptomatic menopausal women because they believe fibroids will regress on their own as a result of the changes in their hormone levels. The American College of Obstetrics and Gynecology does not recommend UFE for the treatment of uterine fibroids in postmenopausal women.

However, a new study suggests that UFE can be useful for postmenopausal women with uterine fibroids, which are also known as myomas or leiomyomas. At the 31st annual meeting of the Society of Interventional Radiology (SIR) in Toronto in April, Robert Vogelzang, MD, of the department of radiology at Northwestern Memorial Hospital in Chicago, reported on a small study of postmenopausal women who experienced bulk symptoms caused by uterine fibroids. Vogelzang pointed out that “the belief that postmenopausal women do not suffer from uterine fibroids turns out not to be true. It was our observation that this group of women can have considerable disabling symptoms. In fact, we have seen a number of postmenopausal women with bulk symptoms.”

Postmenopausal Study
Postmenopausal women have been included in previous UFE studies. However, Vogelzang’s study was the first where the entire cohort completed menopause. (For a short history of UFE, see box on page 27). In that way, the study helps fill a gap in the understanding of how to manage fibroids in postmenopausal women, he said. The small study is significant because it shows that postmenopausal women who suffer from uterine fibroids now have a safe and effective alternative to surgery just as their younger counterparts do, Vogelzang said.

“The bottom line is that it shows that nonsurgical uterine fibroid embolization effectively reduces fibroid-related symptoms in postmenopausal women and that they therefore should be offered UFE as a treatment choice,” he said.

Vogelzang added that the finding is also significant because the widespread use of hormone replacement therapy in past years may increase the prevalence of uterine fibroids in postmenopausal women.

Uterine fibroids are common noncancerous (benign) growths that develop in the muscular walls of the uterus. They can range in size from very tiny—1/4 inch—to larger than a melon. Physicians have no way of predicting whether fibroids will grow or cause symptoms.

Most women who have fibroids in their uterus have more than one. It is estimated that 20% to 40% of women aged 35 and older have uterine fibroids of significant size. African American women are at higher risk for fibroids—as many as 50% have fibroids of significant size.

However, fibroids do not cause symptoms in most women and therefore are not treated. In fact, only approximately 10% to 20% of women have fibroids that are painful enough to require treatment. Depending on their size and location, fibroids can cause a number of disabling symptoms, including heavy, prolonged menstrual bleeding, pelvic pain and pressure, back and leg pain, pain during sexual intercourse, bladder pressure leading to a frequent urge to urinate, pressure on the bowels leading to constipation and bloating, and an abnormally enlarged abdomen.

Traditionally, treatment has been surgery, either myomectomy to remove the biggest fibroid or collection of fibroids or hysterectomy, the removal of the uterus. Of the more than 600,000 hysterectomies performed each year in this country, uterine fibroids account for one third of them.

Myomectomy is usually the choice of women in their childbearing years because it preserves the uterus, while postmenopausal women typically undergo hysterectomy.

Interventional radiologists began offering UFE in 1995 as a safe and effective alternative to surgery for those women with uterine fibroids who required treatment. The procedure, which is also known as uterine artery embolization, is performed while the patient is conscious but sedated and feeling no pain. It does not require general anesthesia. Performed in a radiology suite, the procedure takes roughly 11/2 hours.

The physician makes a small nick—less than 1/4 inch—in the skin of the groin and inserts a catheter into the femoral artery. Using real-time imaging, the physician guides the catheter through the artery and then releases embolic particles the size of grains of sand into the uterine arteries that supply blood to the fibroid tumor. The embolic particles block the blood flow to the fibroid tumor, causing it to shrink and die over time.

As of 2004, an estimated 13,000 to 14,000 UFE procedures were performed annually in the United States. The procedure, which is covered by most major insurance companies and is widely available across the country, has proven to be very effective. On average, 85% to 90% of women who have had the procedure experience significant or total relief of heavy bleeding, pain, and/or bulk symptoms. The procedure has proven effective for multiple fibroids as well as large fibroids.

Study Details
Vogelzang’s study looked at 24 of 940 women who had undergone UFE at Northwestern between 2001 and 2004. The 24 women in the study were identified as postmenopausal according to the Stages of Reproductive Aging Workshop criteria. Women whose symptoms included bleeding were excluded from the study, Vogelzang said.

The patients ranged in age from 43 to 61; the average age was 52. The women in the study were followed prospectively at intervals of one, six, 12, and 24 months.

The patients had preoperative MRI to confirm the disease and rule out malignancies. They also underwent postprocedure imaging to help evaluate their clinical response. “We measured mean uterine and dominant fibroid volume reduction following UFE,” Vogelzang said.

90% Success Rate
While technically the UFE was 100% successful, Vogelzang said 22 of the 24 women showed full clinical improvement of their bulk symptoms, a clinical success rate of nearly 92%.

The two women who had persistent symptoms later opted for surgical intervention. One underwent a myomectomy of the dominant fibroid while the other had a hysterectomy.

The study found that the average uterine volume was reduced by 40%, from 1,343 to 870 cubic centimeters (cc); and the average dominant fibroid volume was reduced by 43%, from 423 to 243 cc. Vogelzang said the reductions were statistically significant at P < 0.0001 and P < 0.0015, respectively.

Vogelzang said there were three minor complications from the UFE and they cleared within two days.

“We had a couple of patients early in the study whom, as often happens, would say, ‘Under no circumstances do I want a hysterectomy,’” Vogelzang said. “This offers postmenopausal women with bulk symptoms a definite alternative.”

Vogelzang said postmenopausal women with symptomatic fibroids should consult an interventional radiologist to determine whether UFE is a treatment option for them. An ultrasound or MRI diagnostic test will help the interventional radiologist determine whether the woman is a candidate for this treatment, he said.

The advantages of UFE over hysterectomy are the same for postmenopausal women as they are for premenopausal women, Vogelzang said. Hysterectomy is major abdominal surgery and requires three to four days of hospitalization and an average recovery period of six weeks. Myomectomy can sometimes be performed as an outpatient surgery, but it typically requires two or three days in the hospital. Most women have multiple fibroids and it is not physically possible to remove all of them because it would remove too much of the uterus. While myomectomy is frequently successful in controlling symptoms, the more fibroids a patient has, generally the less successful the surgery. Also, the fibroids may grow back several years later.

According to the information provided by SIR, the cost of performing an embolization procedure is similar to that of a hysterectomy and myomectomy. However, because UFE has a shorter recovery period, the patient can be back to work sooner, so less time and earnings are lost.

UFE patients are admitted overnight for observation and to monitor pain. Women tend to experience some cramping following embolization. Their fibroids shrink over time. Most patients are able to resume light activities in a few days and the majority of women can resume normal activities within seven to 10 days, Vogelzang said.

Although postmenopausal women are older and thus may have other existing medical conditions, their response to UFE was as good as premenopausal women, Vogelzang said. “In our study, the postmenopausal women had the usual small percentage of usual complications. No infections were reported.” If women do develop infections, they can be controlled with antibiotics, Vogelzang noted.

Patient Selection
As with premenopausal women, the key is to select postmenopausal women who are good candidates for UFE, Vogelzang said. In both cases, good candidates include women with multiple small to moderate-sized fibroids. The long-term effect of UFE on fertility is not known; however, future fertility is obviously not an issue with postmenopausal women, Vogelzang said.

Vogelzang said another group not fully studied regarding safety and efficacy of UFE is young women with fibroids who want to maintain fertility and for whom myomectomy has been recommended.

“Currently, we are not sure about that group,” he said. However, he added, “This younger group of patients is now the subject of a lot of anecdotal experience that hopefully will provide more specific answers in the near future.”

— Beth W. Orenstein, who lives in Northampton, Pa., is a freelance health writer and regular contributor to Radiology Today.

A Short History of Uterine Fibroid Embolization (UFE)
Embolization of the uterine arteries is not new. It has been used successfully by interventional radiologists for more than 20 years to treat heavy bleeding after childbirth. Embolization has been used to treat tumors since 1966. A team of French physicians initiated the first clinical trial of UFE in 1992 after they noticed that fibroids were shrinking when they used the procedure in preparation for myomectomies. Three years later, interventional radiologists began performing the procedure in the United States.

The embolic particles used to treat uterine fibroid tumors have been approved by the FDA for more than 20 years. They have been used in thousands of patients without long-term complication.

— BWO

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