Adverse events in transcatheter interventions for congenital heart disease: a population-based long-term study

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.

DESIGN AND SETTING: 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.