Clinical implications of online and off-line interobserver variability in intracoronary ultrasound-guided interventions

Abstract

Intracoronary ultrasound (ICUS)-guided interventions imply online decision making. We investigated the on- and off-line interobserver variability in ICUS measurements and evaluated the clinical implication of the interobserver variability for ICUS-guided interventions in 40 lesions (38 patients). On the same recorded ICUS images, an online and an off-line observer independently selected and analyzed the proximal and distal reference images, the most severe stenosis image before intervention and the minimal lumen area (MLA) image after intervention. In addition, the off-line observer analyzed the online selected images. The interobserver variability (percentage difference between the two observers) of ICUS measurements was determined on images independently selected by both observers (Analysis A) and on images selected by the online observer (Analysis B). The balloon size was determined from ICUS measurements according to the CLOUT trial. After intervention, the CLOUT and MUSIC criteria for MLA by ICUS had to be fulfilled for PTCA and stent procedures, respectively. In Analysis A, the on- and off-line interobserver variability in diameter and area measurements was maximally 9% and 18%, respectively. In Analysis B, the on- and off-line interobserver variability was maximally 6% and 11%, respectively. The off-line observer would have chosen a balloon size differing by more than 0.25 mm in 25% (10 of 40) and 12.5% (5 of 40) of the procedures in Analysis A and B, respectively. After PTCA or stenting, the off-line observer would have taken different procedural decisions in 19% or 15% and in 13% or 7% of the procedures in Analysis A and B, respectively. In conclusion: when the same location was selected, the on- and off-line interobserver variability was low. When different locations were selected, however, the interobserver variability resulted in different balloon sizing in 25% of the cases. Interobserver variability may be a confounding factor in the analysis of ICUS-guided interventions.