Variability of area measurements obtained with different intravascular ultrasound catheter systems: Impact on clinical trials and a method for accurate calibration

Schoenhagen, Paul; Sapp, Shelly; Tuzcu, E. Murat; Magyar, William A.; Popovich, Jennifer; Boumitri, Mirna; Vince, D. Geoffrey; Crowe, Tim; Nissen, Steven E.

doi:10.1067/mje.2003.45

Cited by 48 publications

(29 citation statements)

References 13 publications

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“…The largest difference in measurements compared to a phantom model was found with a 30 MHz mechanical catheter [18]. In the study of Hiro et al, the phased array system showed a tendency towards a higher correlation with histology in comparison to mechanical systems [8].…”

Section: Discussionmentioning

confidence: 99%

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In vivo Variability in Quantitative Coronary Ultrasound and Tissue Characterization Measurements with Mechanical and Phased-array Catheters

Rodríguez-Granillo

Fadden

Aoki

et al. 2005

Int J Cardiovasc Imaging

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Quantitative IVUS analyses display significant catheter type-dependent variability. It is unclear whether the variability reflects overestimation of measurements with the phased-array or underestimation with the mechanical system. Although plaque burden measurements did not differ significantly between systems, it appears prudent to recommend the use of a single system for progression/regression studies.

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Section: Discussionmentioning

confidence: 99%

“…Three studies explored the variability between such systems and results were not determinant [7,18,19].…”

Section: Discussionmentioning

confidence: 99%

In vivo Variability in Quantitative Coronary Ultrasound and Tissue Characterization Measurements with Mechanical and Phased-array Catheters

Rodríguez-Granillo

Fadden

Aoki

et al. 2005

Int J Cardiovasc Imaging

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“…Intravascular ultrasound (IVUS) provides precise and highly reproducible measurements of coronary vessel dimensions [2][3][4][5][6][7]; it is increasingly used as a major endpoint in serial pharmacological progression-regression trials [8][9][10][11][12], drug eluting stent trials [13], and studies of coronary vascular remodeling [14,15]. Despite the high reproducibility of measurements by an individual IVUS system [6,7], there is a substantial variability of measurements obtained from different IVUS devices [16][17][18][19][20][21][22]. Based on a study in phantoms, Schoenhagen et al recently developed dedicated formulas for accurate post-hoc calibration to minimize these system-related differences [16].…”

mentioning

confidence: 99%

Dedicated calibration formulas permit correction of differences between measurements by different IVUS devices as demonstrated in atherosclerotic human coronary arteries in vitro

Hartmann

Birgelen

Mintz

et al. 2006

Int J Cardiovasc Imaging

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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.

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“…In phantoms of known diameters, the error of conductance catheter and intravascular ultrasound (IVUS) measurements were shown to be within 3 per cent and 13 per cent of actual dimensions, respectively [11]. A previous report [39] of IVUS measurements in phantoms using various IVUS catheters and systems reported CSA errors of 19 per cent depending on the imaging systems and catheters used where the differences in CSA measurements reach up to 27 per cent in some systems. In in vivo validations, the root mean square error in diameter for the conductance catheter measurements was shown to be 5 per cent in comparison with B-mode US [10] and 10 per cent [11] in comparison with IVUS.…”

Section: Discussionmentioning

confidence: 99%

Impact of surrounding tissue on conductance measurement of coronary and peripheral lumen area

Choi

Jansen

Zhang

et al. 2012

J. R. Soc. Interface.

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Parallel conductance (electric current flow through surrounding tissue) is an important determinant of accurate measurements of arterial lumen diameter, using the conductance method. The present study is focused on the role of non-uniform geometrical/electrical configurations of surrounding tissue, which are a primary source of electric current leakage. Computational models were constructed to simulate the conductance catheter measurement with two different excitation electrodes spacings (i.e. 12 and 20 mm for coronary and peripheral sizing, respectively) for different vessel -tissue configurations: (i) blood vessel fully embedded in muscle tissue, (ii) blood vessel superficially embedded in muscle tissue, and (iii) blood vessel superficially embedded in muscle tissue with fat covering half of the arterial vessel (anterior portion). The simulations suggest that the parallel conductance and accuracy of measurement is dependent on the inhomogeneous/anisotropic configuration of surrounding tissue, including the asymmetric dimension and anisotropy in electrical conductivity of surrounding tissue. Specifically, the measurement was shown to be accurate as long as the vessel was superficial, regardless of the considerable total surrounding tissue dimension for coronary or peripheral arteries. Moreover, it was shown that the unfavourable impact of parallel conductance on the accuracy of conductance catheter measurement is decreased by the combination of a lower transverse electrical conductivity of surrounding muscle tissue, a smaller electrode spacing and a larger lumen diameter. The present findings confirm that the conductance catheter technique provides an accurate platform for sizing of clinically relevant (i.e. superficial and diseased) arteries.

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Variability of area measurements obtained with different intravascular ultrasound catheter systems: Impact on clinical trials and a method for accurate calibration

Cited by 48 publications

References 13 publications

In vivo Variability in Quantitative Coronary Ultrasound and Tissue Characterization Measurements with Mechanical and Phased-array Catheters

In vivo Variability in Quantitative Coronary Ultrasound and Tissue Characterization Measurements with Mechanical and Phased-array Catheters

Dedicated calibration formulas permit correction of differences between measurements by different IVUS devices as demonstrated in atherosclerotic human coronary arteries in vitro

Impact of surrounding tissue on conductance measurement of coronary and peripheral lumen area

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