title: Adverse events in transcatheter interventions for congenital heart disease: a population-based long-term study.
abstract: OBJECTIVE
  Few studies have reported procedure complications or adverse events for transcatheter interventions in unselected congenital heart disease cohorts. We report our 23-year experience with transcatheter interventions in congenital heart disease and examine predictors for adverse events.
  
  
  METHODS
  This study was a population-based cohort study of children and adults with congenital heart disease, covering a population of 3 million inhabitants in western Denmark. Adverse events were subdivided into 5 levels according to their severity. Procedure-type risk category, age, weight, and year of procedure were included in multivariate logistic models to identify risk factors for adverse events.
  
  
  RESULTS
  Between 1990 and 2012, 1595 patients had 1878 catheter-based interventions performed. We identified 241 adverse events, corresponding to 13% of the procedures; 58 (3%) were considered to be of high severity. During the study period, there was an increase in number of procedures per year (P < .001) and a decrease in frequency of adverse events (P = .01). Procedure-type categories 3 and 4 had increased risk of adverse events when compared with category 2, with odds ratios of 1.7 (95% confidence interval [CI]: 1.2-2.3) for category 3 and 2.3 for category 4 (95% CI: 1.4-3.6). Age and weight at catheterization were not independently associated with adverse events.
  
  
  CONCLUSIONS
  We found an increase in number of procedures over time and a decrease in frequency of adverse events. Higher procedure-type risk categories were associated with increased risk of adverse events.
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark; Department of Cardiothoracic Surgery, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Signe Holm
authors.initials: SH
authors.lastname: Larsen
authors.forename: Kristian
authors.initials: K
authors.lastname: Emmertsen
authors.forename: Vibeke Elisabeth
authors.initials: VE
authors.lastname: Hjortdal
authors.forename: Jens Erik
authors.initials: JE
authors.lastname: Nielsen-Kudsk
mesh_terms: D000293:Adolescent; D006328:Cardiac Catheterization / Q000009:adverse effects*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D005260:Female; D006330:Heart Defects, Congenital / Q000601:surgery*; D006331:Heart Diseases / Q000151:congenital* / Q000601:surgery*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D011379:Prognosis; D012189:Retrospective Studies; D013997:Time Factors
keywords: Adverse Events; Complications; Congenital Heart Disease; Outcome; Transcatheter Interventions