Adjustment method for mechanical Boston scientific corporation 30 MHz intravascular ultrasound catheters connected to a Clearview® console -: Mechanical 30 MHz IVUS Catheter Adjustment

Intracoronary ultrasound (ICUS) is often used in studies evaluating new interventional techniques. It is important that quantitative measurements performed with various ICUS imaging equipment and materials are comparable. During evaluation of quantitative coronary ultrasound (QCU) software, it appeared that Boston Scientific Corporation (BSC) 30 MHz catheters connected to a Clearview(R) ultrasound console showed smaller dimensions of an in vitro phantom model than expected. In cooperation with the manufacturer the cause of this underestimation was determined, which is described in this paper, and the QCU software was extended with an adjustment. Evaluation was performed by performing in vitro measurements on a phantom model consisting of four highly accurate steel rings (perfect reflectors) with diameters of 2, 3, 4 and 5 mm. Relative differences (unadjusted) of the phantom were respectively: 15.92, 13.01, 10.10 and 12.23%. After applying the adjustment: -0.96, -1.84, -1.35 and -1.43%. In vivo measurements were performed on 24 randomly selected ICUS studies. These showed differences for not adjusted vs. adjusted measurements of lumen-, vessel- and plaque volumes of -10.1 +/- 1.5, -6.7 +/- 0.9 and -4.4 +/- 0.6%. An off-line adjustment formula was derived and applied on previous numerical QCU output data showing relative differences for lumen- and vessel volumes of 0.36 +/- 0.51 and 0.13 +/- 0.31%. 30 MHz BSC catheters connected to a Clearview(R) ultrasound console underestimate vessel dimensions. This can retrospectively be adjusted within QCU software as well as retrospectively on numerical QCU data using a mathematical model.