G Tropeano1, S Amoroso2, C Di Stasi3, R Di Bidino4, A Monterisi2, M Petrillo2, G Scambia2. 1. Department of Obstetrics & Gynaecology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, Rome 00168, Italy giovanna.tropeano@rm.unicatt.it. 2. Department of Obstetrics & Gynaecology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, Rome 00168, Italy. 3. Department of Radiology, Università Cattolica del Sacro Cuore, Rome 00168, Italy. 4. Health Technology Unit, Università Cattolica del Sacro Cuore, Rome 00168, Italy.
Abstract
STUDY QUESTION: What is the risk of complications after uterine leiomyoma embolization and what are the factors associated with complications? SUMMARY ANSWER: The cumulative risk of complications after embolization 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 embolization 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 embolization in the general gynaecology clinic of a university teaching hospital between January 2001 and December 2010. PARTICIPANTS/MATERIALS, SETTING, METHODS: Complications occurring after embolization 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: There were 48 patients who experienced a complication at a median of 5 months (95% confidence interval, 4.1-11.4) after embolization. Complications were minor in 38 patients 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 and 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%) of these cases and required assistance in 6 (31.6%) cases. Eight (2.8%) patients underwent re-intervention, including six hysteroscopic myomectomies, one laparoscopic myomectomy and one hysteroscopic adhesiolysis, as a result of a complication. Submucosal leiomyoma location was the only baseline variable associated with an increased risk for complications [Hazard ratio (HR), 2.28, 95% CI, 1.24-4.18, P = 0.008]. LIMITATIONS, REASONS FOR CAUTION: Our population did not include women of African descent, who have been reported to be at higher risk of post-procedural complications compared with Causcasian women. If such 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 embolization are more likely to have post-procedural complications. This is important new information for counselling patients contemplating this therapeutic approach. STUDY FUNDING/COMPETING INTERESTS: The authors have no competing interests to declare. The study was not supported by any external grant.
STUDY QUESTION: What is the risk of complications after uterine leiomyoma embolization and what are the factors associated with complications? SUMMARY ANSWER: The cumulative risk of complications after embolization 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 embolization 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 embolization in the general gynaecology clinic of a university teaching hospital between January 2001 and December 2010. PARTICIPANTS/MATERIALS, SETTING, METHODS: Complications occurring after embolization 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: There were 48 patients who experienced a complication at a median of 5 months (95% confidence interval, 4.1-11.4) after embolization. Complications were minor in 38 patients 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 and 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%) of these cases and required assistance in 6 (31.6%) cases. Eight (2.8%) patients underwent re-intervention, including six hysteroscopic myomectomies, one laparoscopic myomectomy and one hysteroscopic adhesiolysis, as a result of a complication. Submucosal leiomyoma location was the only baseline variable associated with an increased risk for complications [Hazard ratio (HR), 2.28, 95% CI, 1.24-4.18, P = 0.008]. LIMITATIONS, REASONS FOR CAUTION: Our population did not include women of African descent, who have been reported to be at higher risk of post-procedural complications compared with Causcasian women. If such 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 embolization are more likely to have post-procedural complications. This is important new information for counselling patients contemplating this therapeutic approach. STUDY FUNDING/COMPETING INTERESTS: The authors have no competing interests to declare. The study was not supported by any external grant.