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Registry Shows That Uterine Fibroid Embolization Is Safe, Effective: Presented at ISET

By Ed Susman

HOLLYWOOD, FL -- February 5, 2007 -- The 1-year analysis of a registry that included more than 3,000 uterine fibroid embolization procedures indicates that the minimally-invasive therapy is safe and well tolerated, researchers said here at the 19^th International Symposium on Endovascular Therapy (ISET).

Out of the 3,000-plus women in the registry, major adverse events occurred 20 times in 18 of the women -- a complication rate of 0.66%, reported Matthew Mauro, MD, professor of radiology and surgery, University of North Carolina, Chapel Hill, North Carolina.

"No deaths were reported in this registry," Dr. Mauro said in his oral presentation on February 1^st.

"There was a striking, marked improvement in both symptom scores and quality of life scores," he said. "Patient satisfaction was high and most patients believed their treatment was a success and would recommend it to other women."

In the 30 days after discharge from hospital, there were 135 major adverse events reported by 111 women (4.1%) and 65 of those incidents included recurrent pain (2.4%).

The registry was undertaken as a way to answer skepticism from gynecologists and others who had questions regarding long-term pain associated with the procedure and how it might affect women who wanted to have babies after getting rid of fibroids.
Howard Chrisman, MD, associate professor of radiology, Northwestern University School of Medicine, Chicago, Illinois, said these registry figures should put to rest the question of whether embolization puts a woman at high risk for complications. "We have a great bulk of literature that proves the safety of this procedure," he said.

Although 31% of the women in the registry reported some kind of minor problem in the year after the procedure, Dr. Mauro said that their symptom scores -- based on standard questionnaire tests -- showed durable results.

Among the 2,666 women in the registry who performed the test, the median symptom score before treatment was 59.83. The score was 19.87 for 1,797 women after 6 months; and was 19.23 for 1,701 women who had their procedure done 12 months earlier. The average individual in the control group scored 22.5. The control scores were those determined during the validation of the questionnaire.

The mean quality of life score increased from 47.32 at baseline to 85.0 at 6 months and 86.7 at 12 months. The average control individual scored 86.4.

Dr. Mauro said the registry researchers are planning a study that scrutinizes outcomes in pregnancy and also at how well the women fare as far as symptoms are concerned 2 and 3 years down the road.


[Presentation title: Results from the UFE Registry: What Have We Learned?]

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