Importance of calibration for diameter and area determination by intravascular ultrasound

Background: Intravascular ultrasound (IVUS) permits quantitative assessment of the lumen diameter and area of coronary arteries. The experimental study was performed to evaluate the accuracy of diameter and area measurements. Methods and results: Lumen quantitation (lumen diameter D and cross-sectional area A) in lucite tubes (lumen diameter 2.5 to 5.7 mm, Plexiglas(TM)) was performed using a mechanical IVUS system (HP console, 3.5F catheter, Boston Scientific, 30 MHz). The influence of fluid type (blood, water and saline solution), fluid temperature (20 degrees C/37 degrees C), catheter to catheter variation, gain setting and ultrasound frequency (12, 20 and 30 MHz) was determined. In blood at 20 degrees C there was a constant deviation of the measured diameter from the true luminal diameter of -0.29 +/- -0.04 mm (p<0.06). In water and saline solution at 20 degrees C the mean deviation from true diameter was -0.21 +/- -0.06 mm (p<0.06). At 37 degrees C, the deviation in blood was greater than at 20 degrees (-0.34 +/- -0.02 mm) which is >10% in a 3mm tube (p<0.06). Three of the ten catheters tested in water at 20 degrees C underestimated true diameter by more than -0.3 mm. The deviation from true diameter (5mm tube) with varying gain settings was -0.14 mm to -0.23 mm compared to -0.19 mm at standard settings (p>0.288). At 12 MHz diameter measured was overestimated. The error in absolute area estimation increased with increasing diameter tested in blood at 37 degrees C (-1.21 to -2,72mm(2)), whereas the relative error ([Measured Area-True Area]/True Area x 100 [%]) was more striking at smaller diameters (up to -25% in the 2.5 mm tube). Conclusion: Luminal diameters and areas are underestimated by this particular IVUS system. When IVUS imaging and measurements are made during coronary interventions this error should be taken into account with regard to appropriate sizing of the device and the assessment of the postprocedure result. Because systematic errors might also occur in other IVUS systems (not tested in this study), it is advisable to ensure that each system is validated prior to clinical use, especially when exact measurements are required.