While the options available for treatment of congenital heart disease continues to expand, rigorous evaluation of outcome has not always accompanied the introduction of new therapeutic modalities. For example, transcatheter implantation of the Rashkind double‐umbrella occluder for persistent patent ductus arteriosus had not previously been compared to conventional surgery in a rigorous fashion. Consequently, a 14‐center retrospective study compared outcomes of 631 prognostically similar patients treated concurrently with these two modalities. Particular efforts were made to reduce the bias and confounding that often plague nonrandomized comparisons. The study's design is described in detail as an example of the use of epidemiologic methods to enhance the rigor of observational studies of outcomes of cardiology interventions.
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