| |||||||||||||
|
Home
|
For other articles and previous issues click here. December 13, 2004 New
Treatments for Uterine Fibroids Uterine artery embolization and focused ultrasound provide less invasive alternatives to hysterectomy and myomectomy. Twenty percent to 40% of all women over the age of 35 have uterine fibroids. Also known as fibroid tumors, leiomyomas, fibromas, or myomas, these rubbery nodules begin as a single abnormal cell in the muscular layer of the uterus and grow slowly into tumorlike masses of connective tissue and smooth muscle. Uterine fibroids can range in size from a pea to
a basketball; their growth is Fibroids account for one-fifth of gynecological visits in the United States, according to the National Uterine Fibroids Foundation. According to a report by the nonprofit Rand Corp., more than $1 billion is spent annually to treat uterine fibroids. Fibroids that don’t cause symptoms are rarely treated. If they do not cause pain, bleeding, or discomfort, they probably should be monitored but left alone, says John C. Lipman, MD, FSIR, an interventional radiologist at Piedmont Hospital in Atlanta. Traditional treatment for symptomatic fibroids has been surgery—myomectomy to remove the fibroids from the uterus or hysterectomy to remove the uterus itself. Hysterectomy is the most common surgical procedure for uterine fibroids. The National Institutes of Health estimates that more than 200,000 women undergo hysterectomy each year as a treatment for uterine fibroids. That’s approximately one-third of the 600,000 hysterectomies performed annually in the United States. Whether a woman undergoes a hysterectomy or myomectomy often depends on the size and location of the fibroids and the woman’s desire for future fertility. The more fibroids a patient has, generally the less successful a myomectomy will prove. 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, Lipman says. “The problem is the fibroids that are left behind grow back and become symptomatic. Up to 40% of women can require another procedure because the fibroids that were left grew.” Outpatient Options Myomectomies can sometimes be performed with telescopes (hysteroscopes or laparoscopes) in a minimally invasive way, provided they’re in specified locations. Some women have found that hormonal therapy offers temporary relief from symptoms, but the fibroids grow back once therapy is terminated. The most commonly used hormonal therapy is Lupron, but it can’t be used for more than six months because of bone-loss issues, Lipman says. Studies are underway to develop alternative drug therapies. In recent years, a minimally invasive procedure, known as uterine artery embolization (UAE), or uterine fibroid embolization (UFE), has proven to be a safe and effective alternative treatment for many women. The treatment performed by interventional radiologists blocks the blood supply to the fibroid tumors, causing them to shrink. In recent months, a new noninvasive treatment, focused ultrasound surgery (FUS), has also shown promise in treating uterine fibroids. Interventional radiologists believe that UAE, which has been widely available for roughly six years in the United States, offers many advantages for patients. “For the vast majority of women, it is an excellent way of treating symptomatic uterine fibroids,” says Robert L. Vogelzang, MD, of the department of radiology at Northwestern Memorial Hospital in Chicago. “It involves a much shorter hospital stay—typically one night—and much quicker recovery.” A study presented at the annual meeting of the Society of Interventional Radiology in Phoenix in March found that UFE offered a much lower adverse rate compared with myomectomy. Highly Successful Additionally, recurrence of treated fibroids is rare, he says. Short-term and midterm data show UFE to have a low rate of recurrence. Long-term data are not available, but in one study where patients were followed for six years, no fibroid that had been embolized regrew. Embolization of fibroids is performed while the patient is sedated but conscious. It does not require general anesthesia, and the procedure takes less than one hour, Lipman says. The interventional radiologist makes a tiny nick (less than 1/4 inch) in 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 tiny particles the size of grains of sand into the uterine arteries that supply blood to the fibroid tumor. The embolic particles, approved by the FDA specifically for UFE, block the blood flow to the fibroid tumors, causing them to shrink. Painkilling medications and drugs that control swelling are typically prescribed following an embolization to treat cramping and pain. Many women resume light activities in a few days and the majority of women are able to resume normal activities within one week to 10 days, Vogelzang says. Lipman, who started performing UFE in 1997, has had a success rate comparable with the studies. “Roughly 90% of the patients I treated have had either 100% or significant improvement in symptoms,” he says. Occasionally, Lipman adds, a patient has required retreatment because her fibroids were not completely infarcted. “Her symptoms went away because the rest of the tumor was dead, but the area that remained alive grew over time and became symptomatic again.” Future Pregnancy Several studies also suggest that there is an age-related effect on ovarian function, causing some women to go into menopause following UFE. This is rare in younger women but can be as high as 40% in women over the age of 50. According to the Society for Interventional Radiology, the cost of performing an embolization is similar to the cost of performing hysterectomy and myomectomy. However, because UFE has a shorter recovery, the patient can be back to work sooner, so less time and earnings are lost. UFE has proven to have few side effects. A small number of patients have experienced infection, which usually can be controlled by antibiotics. There is also a less than 1% chance of injury to the uterus, which could lead to a hysterectomy. These complication rates are lower than those of hysterectomy and myomectomy, Lipman says. Turf Issues Vogelzang agrees: “It’s quite clear women are not being offered it, and that to me is inappropriate and embarrassing as a physician.” A study of 100 women who underwent UAE at Northwestern Memorial Hospital found that 79 had learned about the procedure from a source other than a gynecologist. A survey by the Yale University School of Medicine in 2003 found that 13 of 21 embolization patients had learned about the procedure from the Internet. Only roughly 15,000 women with fibroids have UFE performed annually in the United States. “That’s a fraction of the 200,000 hysterectomies done annually for fibroids, not to mention the number of myomectomies being performed,” Vogelzang says. The American College of Obstetricians & Gynecologists published a report this past February noting that UFE effectively provides fibroid relief with a low rate of complications, but it has not taken a position on the procedure, which is covered by most major insurance companies. The issue was raised in the lay press in August when an article appeared in the Wall Street Journal calling UFE the “silent treatment.” New Option: FUS The ExAblate 2000 is manufactured by InSightec Ltd., a privately held company owned by Elbit Medical Imaging of Tel-Aviv, Israel, and GE Medical Systems of Waukesha, Wis. The ExAblate System is the first FUS thermal ablation system and the first using MR guidance to be approved by the FDA. The device is also available in Israel, Europe, and Asia. The FDA’s approval came after a clinical trial conducted in 109 women with symptomatic uterine fibroids at seven medical centers in the United States, Europe, and Israel. Sites in the United States included Brigham and Women’s Hospital in Boston; the Mayo Clinic in Rochester, Minn.; and Johns Hopkins Hospital in Baltimore. After six months, 70.6% of the women reported a significant improvement in fibroid-related symptoms. Patients treated with ExAblate missed 1.2 working days on average compared with an average of 19.2 days for the hysterectomy group in the first 30 days postsurgery. The ExAblate patients returned to normal activity in less than three days compared with 17 days for the hysterectomy group. The women in the study had between one and five fibroids treated. Adverse effects, while rare, included minor skin burns and a few instances of nerve injury, all of which were resolved within one year, says Elizabeth A. Stewart, MD, clinical director of the Center for Uterine Fibroids at Brigham and Women’s, and coprincipal investigator, with her colleague Clare M. Tempany, MD, professor of radiology and clinical director of magnetic resonance imaging (MRI) at Brigham. The ExAblate system attaches to a standard 1.5-Tesla MRI system used in many hospitals. Offered as an outpatient procedure, the patient lies on her stomach inside the MRI scanner and highly focused ultrasound waves ablate the fibroids. In most cases, the dead fibroid tissue liquefies, softens, and shrinks to a size where it no longer causes symptoms. MRI Guided Of the women treated with FUS at Brigham and Women’s, some find fairly quick relief of symptoms while others notice improvement after a few menstrual cycles. “That seems to be similar with uterine artery embolization,” Stewart says. A major advantage to FUS as a treatment for fibroids is that it is noninvasive, meaning that not only can women recover quickly but they also experience less discomfort than with other treatments, Stewart says. FUS can target a wide range of fibroids, whereas the effectiveness of other treatments depends on the size and location of the fibroids, she says. Yet another advantage to FUS is that “you’re not treating the normal lining of the uterus,” Stewart says. “The complications from uterine artery embolization seem to be the result of injury to normal tissue.” The major drawback to FUS as a treatment for uterine fibroids is that it is time-consuming. Procedures can take several hours; the average treatment time for the women in the ExAblate study was four hours. At this point, Stewart says, FUS is probably not practical for women with many fibroids because the time to treat would be prohibitive. Fibroids close to sensitive organs such as the bowel or bladder and those outside the image area cannot be treated either. The challenge, Stewart adds, is to improve the FUS system so the treatment times are faster. However, she says, when considering the treatments available for fibroids, the key is determining which are the most important fibroids to treat “and who is going to have recurrent problems and who is going to be well-served with a single treatment.” Gina K. Hesley, MD, of Mayo Clinic in Rochester, found that FUS worked best in women who have a few larger fibroids rather than patients with many small ones. “Certainly, the technology and its applications will continue to evolve as more patients are treated,” she says. Short History “Focused ultrasound is a local therapy,” he says. “The problem is you’re treating some fibroids and leaving behind others as you are with a myomectomy, whereas with hysterectomies and uterine fibroid embolization, all fibroids are treated at once.” However, he agrees with Stewart that over time, the technology will improve and FUS may be an effective therapy for women with problematic fibroids. “I don’t believe it’s going to replace uterine fibroid embolization, but it’s going to have its niche,” Lipman says. Vogelzang says he has not been overwhelmed by the data he has seen to date on FUS for uterine fibroids. His concern is that the technology is cumbersome and the procedure is lengthy. Also, he says, “not everyone is a candidate.” However, he, too, agrees that it holds promise “because you have something that is very powerful yet minimally invasive.” The FDA is requiring InSightec to conduct a three-year postmarket study to better assess the long-term safety and effectiveness of the ExAblate System. The study will include additional numbers of African American women because, as a group, these women have a greater incidence of uterine fibroids but were underrepresented in the original study. — Beth W. Orenstein of Northampton, Pa., is a freelance writer. |
 |
3801 Schuylkill Rd • Spring City, PA 19475 Publishers of For the Record All rights reserved. |