Dedicated calibration formulas permit correction of differences between measurements by different IVUS devices as demonstrated in atherosclerotic human coronary arteries in vitro.
Serial intravascular ultrasound (IVUS) measurements of coronary vessel dimensions are major endpoints of studies focusing on pharmacological interventions, efficiency of drug eluting stents, and vascular remodeling. In serial studies measurement variability among different IVUS devices may cause substantial misinterpretation and error. We analyzed 33 human coronary plaques in vitro using two different IVUS systems (mechanical IVUS system with a 40 MHz Atlantis SR catheter; solid-state electronic IVUS system with a 20 MHz Invision catheter) and repeatedly measured the total vessel, lumen, and plaque + media cross-sectional area and plaque burden (plaque + media area divided by total vessel area). Between the "raw" measurements made by the two devices, there was a significant difference for both plaque + media area (2.35+/-1.86 mm(2), P < 0.01) and plaque burden (5.39+/-3.68%, P < 0.05). Measurements were then corrected by use of recently introduced calibration formulas; as a result the differences decreased significantly for all IVUS parameters measured ( P < 0.0001). After correction, the remaining differences between the corrected mechanical and solid-state IVUS measurements similar to differences between repeated measurements with the same IVUS device (i.e., the intraobserver variability). Thus, in serial studies the use of different IVUS devices at index and follow-up procedure may introduce a substantial error as a result of system-related differences. The application of dedicated calibration formulas allows for correction for these differences by decreasing such differences to the level of intraobserver variability.
Hartmann
Marc
M
Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Haaksbergerstraat 55, Enschede, 7513, ER, The Netherlands.
von Birgelen
Clemens
C
Mintz
Gary S
GS
Deppermann
Nadine
N
Dirsch
Olaf
O
Stoel
Martin G
MG
van Houwelingen
Gert K
GK
Louwerenburg
Hans W
HW
Verhorst
Patrick M J
PM
Erbel
Raimund
R
D000368:Aged; D002138:Calibration; D002986:Clinical Trials as Topic; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging*; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D007090:Image Interpretation, Computer-Assisted / Q000379:methods*; D066298:In Vitro Techniques; D016014:Linear Models; D008297:Male; D015588:Observer Variation; D015203:Reproducibility of Results; D012107:Research Design; D018084:Ultrasonography, Interventional / Q000295:instrumentation*