Short-term outcomes of uterine artery embolization: early results of the national CIRREF FIBROID registry.

Abstract

Objective: To describe prospectively collected short-term outcomes of uterine artery embolization in a national multicenter registry. Design: Prospective observational study. Materials/Methods: Members of the Society of Interventional Radiology performing uterine artery embolization (UAE) were invited to participate. A web-based data entry form was used to collect baseline characteristics, procedural details, and 30-day follow-up information on patients undergoing UAE for symptomatic fibroids. All sites in the registry received local IRB approval, and all patients provided informed consent for participation. Results: Immediate procedure data was available for 1,421 subjects as of February 28, 2002. Thirty-nine sites provided data, with a range of patient volume from 1 to 306. UAE’s were performed by 114 different radiologists, with a range of volumes from 1 to 306. The median patient age was 44 years. Heavy menstrual bleeding was reported as the predominant or primary symptom in 63%, intermenstrual or menstrual pain in 12%, and bulk-related symptoms in 23%. Median uterine volume measured radiographically was 1038 cc, with a 25th percentile of 598 cc and a 75th percentile of 1688 cc. Twenty-three percent had only one demonstrable fibroid, 41% between 2 and 4, and 33% had five or more. Mean length of stay was 1.3 days (median 1.0 days). Forty patients (3%) experienced an adverse event during hospitalization: 9 groin hematomas, 6 vessel injuries, 3 contrast reactions, 1 adverse drug reaction, 3 pain requiring hospitalization greater than 48 hours, 1 nausea/vomiting greater than 48 hours, 3 episodes of urinary retention, 1 device-related event, and 14 “other”. Only 4 events required hospitalization greater than 48 hours. Thirty-day follow-up data was available on 1,225 (86%) of patients. Mean number of days missed from work was 9.3 days (median 8.0), mean days until return to normal activity was 12.8 (median 10). Eighteen patients (1%) required reintervention within 30 days: 1 myomectomy, 3 hysteroscopies, 6 D&C’s, 2 hysterectomies, and 8 “other”. Three-hundred fifteen (26%) of patients reported an adverse or unanticipated event within 30 days, with 75 (6%) reporting more than one event. However, only 64 (5% of all patients treated) required treatment with a physician’s office visit, emergency room visit or rehospitalization. The most common adverse events were recurrent pain, fibroid tissue passage, and new hot flashes or night sweats. Seventy percent of all events had resolved by 30 days post-procedure. Conclusions: Immediate peri-procedural complications of UAE are rare, with only a minority requiring hospitalization greater than 48 hours. Only 1% of all patients required re-intervention with an invasive procedure. Although 26% of patients reported at least one unanticipated event within 30 days of the initial procedure, most did not require unanticipated office, emergency room, or hospital visits. Seventy percent of these events had resolved by 30 days. These results suggest that safety of UAE is comparable to other invasive therapies for fibroids. Continued follow-up will provide valuable information on long-term outcomes, including symptom relief and need for additional therapy. Supported by: Cardiovascular and Interventional Radiology Research and Education Foundation.