The Fibroid Registry for Outcomes Data (FIBROID) for Uterine Embolization: Short-Term Outcomes

The Fibroid Registry for Outcomes Data (FIBROID) was founded in 1999 to serve as a prospective multicenter database of women undergoing uterine embolization for leiomyomata. This paper presents an analysis of the short-term outcomes of patients enrolled at 72 participating sites. Of a total 3005 patients, 2729 had a 30-day follow-up interview, which provided information on any further medical care, adverse events, time to return to work, and time to return to normal activities. The Registry defined an adverse event as an unexpected problem that required an unanticipated clinic visit or unanticipated therapy. Seventy-four percent of all patients received preprocedure antibiotics and one fourth was also given antibiotics postprocedure. Uterine embolizations were generally carried out under intravenous conscious sedation and supplemented with narcotics, two thirds of which were patient-controlled. In one participating center, regional analgesia was used in 12% of cases. Overall, 5% of patients had postprocedure deep vein thrombosis (DVT) prophylaxis with automated intermittent compression boots. Seventy-four percent of procedures were technically successful. Technical failures occurred when only one uterine artery could be identified for embolization or when bilateral uterine artery catheterization was unsuccessful. The average hospital stay was 1.68 days. During hospitalization, 90 patients experienced 94 adverse events, of which 20 were major. Eleven of these prolonged the hospital stay. Pain and nausea were the most common conditions, but one patient had a femoral nerve injury, which resulted in permanent leg pain. Other problems included drug reaction, urinary retention, and contrast reaction. Of 74 minor complications, groin hematomas were the most common (n = 22). Other minor complications included less severe nausea, pain, vessel injury, drug reaction, urinary retention, and contrast reaction, as well as device-related problems and nontarget embolization. Patients generally resumed normal activities after 2 weeks. Major and minor adverse events were combined for univariate analysis. Possible predictors for perioperative complications, including patient demographic variables, medical history variables, presenting signs and symptoms, medications used, procedure-related variables, and site-related variables, were included. Only length of procedure, site status (ie, core registry sites vs participating sites), and size of leiomyomata were found to have predictive value for operative complications (odds ratio [OR], 1.012; 95% confidence interval [CI], 1.005–1.019; OR, 0.334; 95% CI, 0.15–0.76; OR, 1.0173; 95% CI, 1.0131–0138; respectively). After multivariate analysis, site status was no longer predictive of perioperative adverse advents. By the 1-month postprocedure evaluation, 710 patients had reported adverse events. Major complications (n = 111; 4%) were persistent bleeding in 7 patients, infection or possible infection in 17, new hot flashes in 2, thromboembolism in 4, recurrent pain in 65, sloughing or passing leiomyomata in 19, and spinal headache in one patient. Twenty additional patients had unspecified adverse events. Six hundred ten women had minor postprocedure complications, which included less severe experiences of these symptoms. Pain, new hot flushes, and sloughing were the most common (n = 264, 156, and 123, respectively). One patient had a repeat uterine embolization after an initial failure. Another 31 patients required surgical intervention, including 3 hysterectomies, for resolution of postprocedure complications. Dilatation and curettage and hysteroscopy were the most common procedures for sloughing leiomyomata or passing leiomyomata tissue. History of therapy for leiomyomata, race listed as black, history of current or recent smoking, and comorbidity were predictive of complications in the 30 days postprocedure on univariate analysis. After adjusting for confounding factors in multivariate analysis, only smoking status (OR, 1.14; 95% CI, 1.007–1.293), black race (OR, 1.129; 95% CI, 1.019–1.251), history of prior procedures (OR, 1.23; 95% CI, 1.02–1.38), and duration of uterine embolization procedure (OR, 1.004; 95% CI, 1.004–1.006) were risk factors for complications in the 30-day postprocedure period. A decreased risk of adverse events was associated with use of DVT prophylaxis (OR, 0.757; 95% CI, 0.662–0.919).

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