Purpose: To determine the influence of three factors involved in the angiographic assessment of balloon angioplasty-interobserver variability, operator bias, and the definition used to determine success-on the primary (technical) results of angioplasty in the peripheral arteries.
Materials and methods: Percent stenosis in 107 lesions in lower-extremity arteries was graded by three independent, experienced vascular radiologists ("observers") before and after balloon angioplasty and their estimates were compared with the initial interpretations reported by the physician performing the procedure ("operator") and an automated quantitative computer analysis. Observer variability was measured with use of intraclass correlation coefficients and SD. Differences among the operator, observers, and the computer were analyzed with use of the Wilcoxon signed-rank test and analysis of variance. For each evaluator, the results in this series of lesions were interpreted with three different definitions of success.
Results: Estimation of residual stenosis varied by an average range of 22.76% with an average SD of 8.99. The intraclass correlation coefficients averaged 0.59 for residual stenosis after angioplasty for the three observers but decreased to 0.36 when the operator was included as the fourth evaluator. There was good to very good agreement among the three independent observers and the computer, but poor correlation with the operator (P </= .001). The primary success rates for this series of lesions varied from a low of 47% to high of 99%, depending solely on which definition of success was used. Significant differences among the operator, the three observers, and the computer were not present when the definition of success was based on less than 50% residual stenosis.
Conclusions: Observer variability and bias in the subjective evaluation of peripheral angioplasty can have a significant influence on the reported initial success rates. This effect can be largely eliminated with the use of residual stenosis of less than 50% to define success. Otherwise, meaningful evaluation of angioplasty results will require independent panels of evaluators or computerized measurements.