Study question: What is the risk for complications after uterine leiomyoma embolisation and what are the factors associated with complications? Summary answer: The cumulative risk of complications after embolisation is relatively low even in the long term, but submucosal leiomyoma location may increase the risk. What is known already: A broad spectrum of complications after leiomyoma embolisation have been described with widely varying rates. There is uncertainty over the actual risk of complications and the factors associated with this risk. Study design, size, duration: This was a prospective cohort study of 288 consecutive women undergoing leiomyoma embolisation set in the general gynaecology clinic of a university teaching hospital between January 2001 and December 2010. Participants/materials, setting, methods: Complications occurring after embolisation were categorized as major or minor according to the severity of their impact on health, the level of care required and the outcome. Cumulative complication rates were estimated by survival analysis and log-rank tests according to baseline variables. Multivariable Cox proportional hazards analysis was performed to adjust for confounders. Main results and the role of chance: Forty-eight patients experienced a complication at a median of 5 months (95% CI,4.1-11.4) after embolisation. Complications were minor in 38 and major in 10 patients. The cumulative overall complication rate was 13% (95% CI,9.0-17.0) at 6 months, 16% (95% CI,11.0-20.0) at 1 year, 17% (95% CI,12.0-22.0) at 3 years, 18% (95% CI,12.9-22.8) at 5 years. The most frequent complication (19/48, 39.6 %) was leiomyoma expulsion, which occurred spontaneously in 13 (68.4%) cases and required assistance in 6 (31.6%) cases. Eight (2.8%) patients underwent re-intervention, including 6 hysteroscopic myomectomies, 1 laparoscopic myomectomy, and 1 hysteroscopic adhesiolysis, as a result of a complication. Submucosal leiomyoma location was the only baseline variable associated with an increased risk for complications (HR,2.28, 95% CI,1.24-4.18, p=0.008). Limitations, reasons for caution: Our population did not include black women, who have been reported to be at higher risk for postprocedural complications compared to white women. Thus, if black women were involved in the study, higher morbidity rates might have been observed. Wider implications of the findings: Women with submucosal leiomyomas at the time of embolisation are more likely to have postprocedural complications. This is important new information when counselling patients contemplating this therapeutic approach. Study funding/competing interest(s): The authors have no competing interests to declare. The study was not supported by any external grant.
- leiomyoma embolization