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Largest Study To Date Shows Minimally Invasive Uterine Artery Embolization Effective Treatment for Fibroids

British Journal of Obstetrics and Gynaecology Study Confirms Results and Low Complication Rates Reported in Previous Large, Prospective Study

Fairfax, VA (November 14, 2002) -- Results of the largest prospective study to date of uterine artery embolization as a treatment for uterine fibroids shows a high clinical success rate, low complication rate, low treatment failure or symptom recurrence, and no regrowth of treated fibroids, as reported in the November, 2002 issue of the British Journal of Obstetrics and Gynaecology.1 This study of 400 consecutive women showed an improvement in symptoms in 84 percent of women, and 97 percent of these women were pleased with the outcome and would recommend this treatment to others. These results are similar to and confirm the results of another large prospective study of 200 women, reported on in the July 2001 issue of Obstetrics & Gynecology.2 That study showed an improvement of symptoms in 90 percent of patients and a less than one percent complication rate.

British Journal Study Results
Four hundred consecutive women were treated with uterine artery embolization, an interventional radiology treatment, to relieve uterine fibroid symptoms. Indications included heavy menstrual bleeding, menstrual pain, abdominal swelling or bloating and other pressure effects. Eighty-four percent of women had improvement in symptoms. Only one percent (three patients) had infective complications requiring a hysterectomy. Six percent (23 patients) had clinical failure or symptom recurrence; of these nine patients, (2 percent) had a hysterectomy. Thirteen pregnancies occurred in 12 patients.

“This prospective study adds to the growing body of evidence that uterine artery embolization is a clinically effective treatment for fibroids. There have now been several large case series suggesting that uterine embolization is effective, with a low symptom recurrence rate, and safe,” says James B. Spies, MD, Associate Professor of Interventional Radiology and Vice Chairman of the Department of Radiology, Georgetown University Hospital, Washington, DC. “The complication rate of this new study is essentially the same as we reported from our own research.2 The next step is for us to complete the ongoing prospective studies comparing embolization to standard surgical therapies for fibroids.”

About Uterine Fibroids
Uterine fibroids are one of the most common medical conditions experienced by women ages 35 – 50. These benign tumors can cause prolonged bleeding that can lead to anemia, pelvic pain and pressure, and an abnormally large abdomen. Twenty to 40 percent of women 35 and older, and nearly 50 percent of African-American women, have uterine fibroids of a significant size. They are the most frequent indication for hysterectomy in pre-menopausal women and, therefore, are a major public health issue. Of the 600,000 hysterectomies performed annually in the United States, one-third of these are due to fibroids. Women who wish to preserve their fertility have traditionally been treated with myomectomy, the surgical removal of the fibroids. While both myomectomy and hysterectomy are established open surgical procedures, there has been very little study of these two treatments, or tracking of long-term results in patient registries.

About Uterine Artery Embolization
Uterine artery embolization, also known as uterine fibroid embolization, is performed by interventional radiologists, physicians who are fellowship trained to perform this and other types of embolization and minimally invasive targeted treatments. The interventional radiologist makes a tiny nick in the skin, less than a ¼ of an 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, each one the size of a grain of sand, into the specific artery that is supplying blood to the fibroid tumor. This blocks the blood flow and causes the fibroid tumor to shrink. The particles flow to the fibroids and wedge into the vessels and cannot travel to other parts of the body.
Because uterine fibroid embolization does not require open surgery or general anesthesia, the risks are less than with open hysterectomy or myomectomy. There is about a one percent chance of injury to the uterus or infection, potentially leading to hysterectomy. These complication rates are lower than those of hysterectomy and myomectomy.

About the Society of Interventional Radiology
The Society represents interventional radiologists — physicians who specialize in minimally invasive, targeted treatments performed using guided imaging. Interventional radiology procedures are a major advance in medicine that do not require large incisions – only a nick in the skin – and offer less risk, less pain and shorter recovery times compared to surgery. Interventional radiologists pioneered modern medicine with the invention of angioplasty, the first catheter-delivered stent and the coronary angiography technique most used worldwide -- state of the art treatments that are common place in medicine today. More information can be found at www.SIRweb.org.

1. Walker, W. J., Pelage, P. Uterine Artery Embolization for Symptomatic Fibroids: Clinical Result in 400 Women with Imaging Follow Up, British Journal of Obstetrics and Gynaecology, November 2002

2. Spies, James B., Ascher, Susan A, et al. Uterine Artery Embolization for Leiomyomata, Obstetrics & Gyneocology, vol. 98, No. 1 July 2001

Uterine artery embolisation for symptomatic fibroids: clinical results in 400 women with imaging follow up.
Walker WJ, Pelage JP.


BJOG 2002 Nov;109(11):1262-72

Department of Radiology, The Royal Surrey County Hospital, Guildford, UK.
OBJECTIVE: To evaluate the mid-term efficacy and complications of uterine artery embolisation in women with symptomatic fibroids. To assess reduction in uterine and dominant fibroid volumes using ultrasound and magnetic resonance imaging. DESIGN: Prospective observational single-centre study. SETTING: A district general hospital in Surrey and a private hospital in London. METHODS: Four hundred consecutive women were treated between December 1996 and February 2001. Indications for treatment were menorrhagia, menstrual pain, abdominal swelling or bloating and other pressure effects. Uterine artery embolisation was performed using polyvinyl alcohol particles and platinum coils. MAIN OUTCOME MEASURES: Imaging was performed before embolisation and at regular intervals thereafter. Clinical evaluation was made at regular intervals after embolisation to assess patient outcome. RESULTS: Bilateral uterine artery embolisation was achieved in 395 women, while 5 women had a unilateral procedure. With a mean clinical follow up of 16.7 months, menstrual bleeding was improved in 84% of women and menstrual pain was improved in 79%. Using ultrasound, the median uterine and dominant fibroid volumes before embolisation were 608 and 112 cc, respectively, and after embolisation 255 and 19 cc, respectively (P = .0001). Three (1%) infective complications requiring emergency hysterectomy occurred. Twenty-three (6%) patients had clinical failure or recurrence. Of these, nine (2%) had a hysterectomy. Twenty-six (7%) women had permanent amenorrhoea after embolisation including four patients under the age of 45 (2%). Of these, amenorrhea started between 4 and 18 months after embolisation, and only three had elevated follicle stimulating hormone levels when amenorrhea developed. Thirteen (4%) women had chronic vaginal discharge considered as a major irritant. Thirteen pregnancies occurred in 12 patients. Ninety-seven percent of women were pleased with the outcome and would recommend this treatment to others. CONCLUSIONS: Uterine artery embolisation is associated with a high clinical success rate and good fibroid volume reduction. Infective complications requiring hysterectomy, amenorrhoea under the age of 45 and chronic vaginal discharge may complicate the procedure.