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Weigh Advantages of UAE Vs. Failure Rate, Extra Risk


 

The choice between standard surgery to remove uterine fibroids and uterine artery embolization comes down to weighing the benefits and risks of the two procedures, because quality of life and other outcomes at 1 year are fairly comparable, according to Dr. Richard D. Edwards and his associates in the Randomized Trial of Embolization versus Surgical Treatment.

The advantages of uterine artery embolization (UAE)—significantly shorter hospital stay, less postprocedure pain, and faster return to usual activities—must be weighed against a treatment failure rate that may be as high as 20% and a small but still significantly increased risk of late adverse events, the researchers said.

“The results of our study make clear that the choice between surgery and uterine artery embolization for symptomatic uterine fibroids involves [trade-offs],” said Dr. Edwards of Gartnavel General Hospital, Glasgow, Scotland, and his associates.

The trial, specifically designed to assess quality of life and other outcomes at 1 year of follow-up, involved 140 women with one or more fibroids larger than 2 cm who were treated at 27 hospitals throughout the United Kingdom. Approximately twice as many subjects were randomly assigned to the UAE group as to the surgical group, to allow better characterization of outcomes of the embolization and minimal reduction in statistical power.

Quality of life—the primary outcome measure—was assessed using the Medical Outcomes Study's 36-item short-form general health survey (MOS SF-36). There were no significant differences between the two groups at 1 year on any of the eight components measured, the investigators said (N. Engl. J. Med. 2007;356:360–70).

Of the UAE group, 21 women (20%) required an additional invasive procedure—hysterectomy or repeat UAE—for continued or recurrent symptoms. Ten of them had the second intervention within 1 year and 11 had it within 2 years of the initial procedure. In contrast, symptom scores were significantly better in the surgery group at all time points assessed.

Women in the UAE group had significantly shorter hospital stays (1 day vs. 5 days), resumed their usual activities much sooner, and reported significantly less pain and better social function post procedure.

A similarly high percentage of women in both groups (93% of the surgical group and 88% of the UAE group) said they would recommend their procedure to a friend.

Rates of major adverse events and of minor complications did not differ significantly, but the timing and nature of these events did.

There were 16 major adverse events (15%) in the UAE group and 10 (20%) in the surgery group, results which did not differ significantly.

However, 15 of the 16 such events occurred after hospital discharge in the UAE group, whereas only one such event occurred after hospital discharge in the surgery group.

A total of 36 women in the UAE group (34%) developed minor complications, usually the pyrexia, pain, and elevated markers of inflammation of postembolization syndrome. Similarly, 10 women in the surgery group (20%) developed minor complications, usually infection.

Embolization was the more cost effective of the two procedures overall, even though it required more imaging studies in the year following the intervention and also required more secondary interventions after treatment failure, Dr. Edwards and his associates reported.

This study was supported in part by three companies that manufacture embolic agents: William Cook Europe, Cordis Corp., and Biocompatibles Ltd.

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