title: Incidence and predictive factors for complications after uterine leiomyoma embolization.
abstract: OBJECTIVE
  What is the risk of complications after uterine leiomyoma embolization and what are the factors associated with complications?
  
  
  CONCLUSIONS
  The cumulative risk of complications after embolization is relatively low even in the long term, but submucosal leiomyoma location may increase the risk.
  
  
  BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  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.
  
  
  RESULTS
  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].
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The authors have no competing interests to declare. The study was not supported by any external grant.
authors.affiliation: Department of Obstetrics & Gynaecology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, Rome 00168, Italy giovanna.tropeano@rm.unicatt.it.
authors.forename: G
authors.initials: G
authors.lastname: Tropeano
authors.affiliation: Department of Obstetrics & Gynaecology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, Rome 00168, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Amoroso
authors.affiliation: Department of Radiology, Università Cattolica del Sacro Cuore, Rome 00168, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Di Stasi
authors.affiliation: Health Technology Unit, Università Cattolica del Sacro Cuore, Rome 00168, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Di Bidino
authors.affiliation: Department of Obstetrics & Gynaecology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, Rome 00168, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Monterisi
authors.affiliation: Department of Obstetrics & Gynaecology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, Rome 00168, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Petrillo
authors.affiliation: Department of Obstetrics & Gynaecology, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, Rome 00168, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Scambia
mesh_terms: D000328:Adult; D004621:Embolization, Therapeutic / Q000009:adverse effects*; D005260:Female; D006801:Humans; D015994:Incidence; D007889:Leiomyoma / Q000601:surgery*; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology*; D011446:Prospective Studies; D012307:Risk Factors; D016019:Survival Analysis; D014594:Uterine Neoplasms / Q000601:surgery*
keywords: complications; embolization; predictors; uterine leiomyoma