June 16, 2008

Selecting the Best Fibroid Treatment
By Kathy Hardy
Radiology Today
Vol. 9 No. 12 P. 16

Interventional radiologists have a role in educating patients and other physicians about less-invasive image-guided procedures so women can make the best selection for their individual situation.

A restaurant menu can be a minefield of choices depending on what medical conditions hungry diners are dealing with—selecting low-salt entrées for high blood pressure prevention or low-cholesterol side dishes to keep arteries clear are just two considerations.

Similarly, women with uterine fibroids face a varied list of viable options when it comes to their treatment. For example, women of childbearing years need to consider options that would most likely maintain the uterus and not affect fertility. Women who want to avoid surgery but still seek relief from heavy menstrual bleeding and pelvic pain need to consider less-invasive procedures. And women nearing menopause may want to consider choices that merely reduce the symptoms of uterine fibroids. Further complicating the selection process is the fact that many women may not be aware of all the options available to them.

“Unfortunately, a lot of gynecologists are not telling patients about all of their options when it comes to uterine fibroid treatments,” says John C. Lipman, MD, FSIR, medical director of interventional radiology at Emory-Adventist Hospital in Atlanta. “They’re only telling them the options they can provide.”

Before women make a treatment choice, however, they need to consider whether they need any treatment at all. Lipman, a leader in uterine fibroid embolization (UFE), notes that many women have the misconception that they need to address fibroids before they suffer any symptoms from the benign growths that can occur on the muscle wall of the uterus. He cites numbers that show one out of every three women of childbearing age have fibroids; that ratio increases to three out of four for black women.

“A lot of women have fibroids, but they are not all symptomatic,” Lipman says. “Patients who are symptomatic will need attention. Those who are not should be monitored during regular annual gynecological exams, but they don’t need to undergo any treatment for their fibroids.”

The decision-making process changes once women begin to suffer from the excessive bleeding and cramping that can occur with fibroids. At that time, they need to consider whether to take a surgical path, a less-invasive interventional approach, or a noninvasive approach to find relief from their symptoms and return to an acceptable quality of life. Jim A. Reekers, MD, PhD, a professor of radiology and interventional radiology at Academic Medical Center in the University of Amsterdam (the Netherlands) radiology department, says women need to consider their health goals when making their fibroid treatment choice.

“If the patient has had bleeding problems for many years, she may still need a hysterectomy,” he says.

Lipman believes that as women go through the chain of fibroid therapy options, many end up undergoing surgery unnecessarily, primarily because they start their decision-making process with their gynecologists. Survey results that Lipman reported at this year’s Society of Interventional Radiology annual meeting showed that of 105 women who visited an Atlanta-area fibroid practice, only 35 were referred by a gynecologist. Of the 70 patients who were not told about UFE, 40 were aware of the procedure from radio ads or their own Internet research.

“Gynecologists need to take the lead on this,” Lipman says. “Women shouldn’t be diagnosing themselves on the Internet.”

UFE offers a less-invasive solution that eliminates the lengthy recovery time and risks involved with hysterectomy by using imaging guidance to insert catheters through the groin and into the uterine arteries. Small synthetic particles are then injected into the arteries to block blood flow to the fibroids. The fibroid tissue dies, the masses shrink, and the symptoms are reduced or eliminated.

“UFE is one of the biggest breakthroughs for women,” Lipman says. “The symptoms may be severe, but they’re caused by a benign condition. Surgery for something that’s benign is unnecessary.”

Lipman does see a turning of the tide concerning gynecologists’ awareness regarding nonsurgical options for uterine fibroid treatment. He frequently speaks to obstetrics and gynecology (OB/GYN) organizations about the benefits of UFE and cites recent articles in OB/GYN trade publications about gynecologists and interventional radiologists working together to offer women the best possible solutions for their gynecological needs.

“During the last few months, there has been more in print about UFE, and I’ve been speaking out more, but we still have a way to go when it comes to educating the profession,” he says.

Part of that educational process, Lipman believes, falls on the part of other interventional radiologists. “There are a number of interventional radiologists who want to perform UFE, but they abdicate clinical responsibility to the gynecologists,” he says. “The interventional radiologists need to step up clinically and take responsibility.”

Traditionally, Lipman says, gynecologists will “use the arrows in their quiver” when looking for uterine fibroid solutions rather than refer women to an interventional radiologist for less-invasive options. Those surgical tools typically consist of procedures that require removing the uterus via abdominal or laparoscopic hysterectomy or at least significantly altering the condition of the uterus with abdominal or laparoscopic myomectomy.

According to the National Women’s Health Information Center, fibroids account for approximately one third (199,000) of the 600,000 hysterectomies performed annually in the United States.

Despite his positive experience with UFE, Reekers notes in the results of a recent randomized clinical Embolization vs. Hysterectomy Trial on the treatment of symptomatic uterine fibroids that 20% of the women in the trial who had undergone UFE ultimately required hysterectomy due to insufficient improvement in their fibroid symptoms.

“If a woman really wants a 100% guarantee that her bleeding problems are over, a hysterectomy is her best chance of making that happen,” Reekers says.

Lipman notes that the statistics for hysterectomies and recovery time are significant when considering viable options for active women seeking relief from uterine fibroid symptoms. Hysterectomy can mean four to five days in the hospital after surgical removal of the uterus and any complications that could follow the effects of anesthesia, with a total recovery time of six to eight weeks.

A laparoscopic hysterectomy is less invasive than traditional hysterectomy, meaning a quicker recovery time for the patient. Less drastic surgical options include abdominal and laparoscopic myomectomy, which involves the surgical removal of just the fibroid, with the uterus remaining intact. Myomectomy can be performed through an abdominal incision, vaginal incision, or laparoscopically. Studies show that the risks of myomectomy are less than with hysterectomy, with less bleeding and reduced risk of life-threatening complications.

“With UFE, a woman is home the same day with nothing but a Band-Aid covering the catheter entry point,” he says.

A noninvasive option comes in the form of MR-guided focused ultrasound (MRgFUS), an outpatient procedure that allows radiologists to target fibroids with high doses of focused ultrasound waves to shrink or destroy uterine fibroids without damaging surrounding tissue. Approved by the FDA in 2004, this procedure combines MR imaging with targeted ultrasound therapy.

MRgFUS proponent Fiona Fennessy, MD, PhD, an assistant professor of radiology at Harvard Medical School and a staff radiologist at Brigham and Women’s Hospital in Boston, agrees that there is much to consider when a woman is evaluating her choices for uterine fibroid treatment, starting with the severity of her symptoms and how close she is to menopause.

“You can shrink the fibroids with hormones until a woman reaches menopause,” she says. “After menopause, fibroids shrink because of a naturally occurring decrease in estrogen levels.”

With MRgFUS, radiologists use MRI to locate fibroids and establish the proper ultrasound pathway. This is an important step in the process, Fennessy says, so that no normal tissue will be damaged by the ultrasonic energy used to attack fibroid tissue. MRI is also a good way to determine the size of fibroids.

During the procedure, patients are lightly sedated to minimize movement, another safeguard for maintaining the correct pathway to the fibroid. While patients lie on their stomachs in the MR imaging machine, radiologists use MR thermal imaging to guide ultrasound energy to target the fibroids. Ultrasound energy is then applied in pulses to kill the fibroid tissue, which is then absorbed into the bloodstream. Each sound wave pulse lasts about 20 to 30 seconds, with the entire procedure typically lasting three to four hours.

“The goal is to treat as much fibroid volume as possible,” Fennessy says. “Focused ultrasound kills 60% to 70% of fibroid tissue, but if there is a large fibroid, the percentage is not as high. If there are fibroids greater than 10 centimeters, we would shrink them medically first.”

Fennessy presented results of a study at RSNA 2007 that showed MRgFUS significantly decreased symptoms for up to 12 months. The study involved 160 women with symptomatic fibroids treated as part of a clinical trial at five medical centers. A majority of the participants were treated under study protocol, with about 50 patients treated under an optimized protocol that involved a greater treatment time and a higher treatment volume. Significant symptom relief was reported from both groups at three and six months, with sustained relief at 12 months. Women treated with the optimized protocol reported greater symptom relief.

“You’re not killing the entire amount of fibroid tissue,” she says. “How long it takes until the fibroids come back depends on the individual woman.”

Another factor in the decision-making process when it comes to MRgFUS is whether the patient can tolerate MRI. Women with pacemakers cannot undergo MRI, Fennessy says, and those with severe claustrophobia are not good candidates due to the closed nature of the imaging process.

MRgFUS is not FDA approved for women who plan to become pregnant, as it is unknown how this procedure affects fertility. Fennessy notes that studies are currently underway in Israel and Germany on this topic, and there is a U.S. study pending. “This is potentially a good option for women who wish to give birth, but it is not yet approved,” she says.

Two advances in MRgFUS create even more choices for fibroid treatment. The first, called manual interleaved MRgFUS, reduces the cooling time between sound wave pulses and therefore increases the number of fibroids that can be treated. Overall, this reduces the time required for the procedure. The second, which is still in the clinical trial stage, is a technique that produces enhanced energy pulses, providing greater energy to a targeted area and resulting in a greater area of cell depth.

With a full menu of choices, women have many options when it comes to treatment for uterine fibroids. Radiologists, interventional radiologists, and gynecologists, as the “chefs” in this process, continue to spread the word about those options, with the ultimate goal of eliminating women’s uncomfortable symptoms using the methods that work best for them—selected from a menu of all available options.

— Kathy Hardy is a freelance writer based in Phoenixville, Pa., and a frequent contributor to Radiology Today.