Registry data shows long-term efficacy for uterine fibroid embolisation

Three-year data from the largest, multi-centre, prospective voluntary registry on any procedure for benign uterine fibroids showed that 90 percent of the women participating avoided a hysterectomy and of these, 85 percent had a substantial improvement in symptoms and quality of life. The registry included three-year data on 1,278 patients from 26 sites who had this minimally invasive interventional radiology treatment for symptomatic fibroids, showing uterine fibroid embolisation is a durable treatment for fibroids with sustained improvement in quality of life and symptom relief. Twenty to 40 percent of American women age 35 and older, and nearly 50 percent of pre-menopausal African American women, have uterine fibroids. Of the 600,000 hysterectomies performed annually in the United States, one-third of these are to relieve symptoms caused by fibroids. 'This registry data is great news for women. With uterine fibroid embolisation, we could significantly decrease the hysterectomy rate in the United States' says Scott Goodwin, MD, interventional radiologist and lead author.

Uterine fibroids are benign tumours that can cause prolonged, heavy menstrual bleeding that can be severe enough to cause anemia or require transfusion, disabling pelvic pain and pressure, urinary frequency, pain during intercourse, miscarriage, interference with fertility, and an abnormally large uterus resembling pregnancy. UFE is a minimally invasive interventional radiology treatment that blocks the blood supply to the fibroid tumours, causing them to shrink and die, and symptoms to subside.

The FIBROID Registry was designed to follow the 'real world' outcomes for uterine fibroid embolisation as it became a mainstream treatment widely available across the country. The purpose of the Registry was to assess the procedure's effectiveness in improving fibroid-related symptoms, to determine the durability of those improvements, and to assess the safety of the procedure in broad practice. The 1,278 women who completed the three-year follow-up had significant improvement in symptoms and in quality of life (QOL), moving them into the normal range on this validated survey instrument. The mean symptom scores before embolisation were 58.61, and post-procedure at three years were 16.54. Mean QOL scores pre-embolisation were 46.95 and at three years were 89.55. Eighty-five percent would recommend the procedure to a family member or friend. The study also identified subgroups of patients that appeared to have a greater likelihood of improvement.

This data shows that the long-term clinical outcomes of UFE are consistent when the procedure is performed in any experienced community or academic interventional radiology practice. 'The Registry's outcomes are important not only because of its size, but also because of the diversity of sites that participated. These results demonstrate that uterine fibroid embolisation is safe and very effective beyond the academic or specialised centres.' The Registry is one of the few efforts ever undertaken to study the efficacy of a procedure as it disseminates into broad practice, and this is the first such effort for a fibroid therapy by any speciality.

'It is important for women to know all of their treatment options in order to make an informed decision. Interventional radiologists can provide a second opinion and assess whether UFE is a treatment option. The vast majority of women are eligible for this treatment,' says Goodwin. Interventional radiologists use MRI to delineate the location of each fibroid, determine if a tumour can be embolised, detect alternate causes for the symptoms, identify pathology that could prevent a women from having UFE, and avoid ineffective treatments. The number of women requiring re-treatment after UFE in the registry is similar to the surgical re-intervention rates, of approximately five percent per year, following myomectomy.