The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity)

Gilbert W M Wijntjens; Tim P van de Hoef; Robin P Kraak; Marcel A Beijk; Krischan D Sjauw; M Marije Vis; Maribel I Madera Cambero; Stijn L Brinckman; Jacobus Plomp; Jan Baan; Karel T Koch; Joanna J Wykrzykowska; José P Henriques; Robbert J de Winter; Jan J Piek

doi:10.1161/CIRCINTERVENTIONS.116.004645

The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity)

Gilbert W M Wijntjens, Tim P van de Hoef, Robin P Kraak, Marcel A Beijk, Krischan D Sjauw, M Marije Vis, Maribel I Madera Cambero, Stijn L Brinckman, Jacobus Plomp, Jan Baan, Karel T Koch, Joanna J Wykrzykowska, José P Henriques, Robbert J de Winter, Jan J Piek

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

BACKGROUND: The Navvus pressure sensor-equipped microcatheter allows to measure functional stenosis severity over a work-horse guidewire and is used as a more feasible alternative to regular sensor-equipped wires. However, Navvus is larger in diameter than contemporary sensor-equipped guidewires and may, thereby, influence functional measurements. The present study evaluates the hemodynamic influence of the Navvus microcatheter.

METHODS AND RESULTS: In patients with intermediate coronary stenosis, coronary pressure and flow velocity were measured using a dual sensor-equipped guidewire before and after introduction of Navvus. Patients were randomized to microcatheter-first or guidewire-first measurement. The primary end point was the difference in hyperemic stenosis resistance index between measurements before and after introduction of Navvus. Measurements were completed in 28 patients (28 stenoses). Mean hyperemic stenosis resistance was 0.37±0.19 Hg/cm/s for wire-only assessment and 0.48±0.26 Hg/cm/s after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of +0.11 Hg/cm/s (limits of agreement: -0.13 to 0.36), proportional to mean hyperemic stenosis resistance (Spearman ρ =0.61; P=0.001). Passing-Bablok analysis revealed absence of a constant difference but significant proportional difference between the methods. Mean fractional flow reserve was 0.86±0.06 for wire-only assessment and 0.82±0.07 after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of -0.033 (limits of agreement: -0.09 to 0.03), proportional to mean fractional flow reserve (Spearman ρ =0.40; P=0.036). Passing-Bablok analysis revealed significant constant and proportional differences between methods. Similar results were documented for resting indices of stenosis severity.

CONCLUSIONS: Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis.

Original language	English
Journal	Circulation. Cardiovascular Interventions
Volume	9
Issue number	12
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645
Publication status	Published - Dec 2016
Externally published	Yes

Keywords

Aged
Arterial Pressure
Blood Flow Velocity
Cardiac Catheterization/instrumentation
Cardiac Catheters
Coronary Angiography
Coronary Circulation
Coronary Stenosis/diagnosis
Coronary Vessels/diagnostic imaging
Equipment Design
Female
Hemodynamics
Humans
Male
Middle Aged
Miniaturization
Predictive Value of Tests
Prognosis
Reproducibility of Results
Severity of Illness Index
Transducers, Pressure

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10.1161/CIRCINTERVENTIONS.116.004645

Cite this

Wijntjens, G. W. M., van de Hoef, T. P., Kraak, R. P., Beijk, M. A., Sjauw, K. D., Vis, M. M., Madera Cambero, M. I., Brinckman, S. L., Plomp, J., Baan, J., Koch, K. T., Wykrzykowska, J. J., Henriques, J. P., de Winter, R. J., & Piek, J. J. (2016). The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity). Circulation. Cardiovascular Interventions, 9(12). https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645

@article{3ae22d9cb9cb45c69ee22b150d83f36c,

title = "The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity)",

abstract = "BACKGROUND: The Navvus pressure sensor-equipped microcatheter allows to measure functional stenosis severity over a work-horse guidewire and is used as a more feasible alternative to regular sensor-equipped wires. However, Navvus is larger in diameter than contemporary sensor-equipped guidewires and may, thereby, influence functional measurements. The present study evaluates the hemodynamic influence of the Navvus microcatheter.METHODS AND RESULTS: In patients with intermediate coronary stenosis, coronary pressure and flow velocity were measured using a dual sensor-equipped guidewire before and after introduction of Navvus. Patients were randomized to microcatheter-first or guidewire-first measurement. The primary end point was the difference in hyperemic stenosis resistance index between measurements before and after introduction of Navvus. Measurements were completed in 28 patients (28 stenoses). Mean hyperemic stenosis resistance was 0.37±0.19 Hg/cm/s for wire-only assessment and 0.48±0.26 Hg/cm/s after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of +0.11 Hg/cm/s (limits of agreement: -0.13 to 0.36), proportional to mean hyperemic stenosis resistance (Spearman ρ =0.61; P=0.001). Passing-Bablok analysis revealed absence of a constant difference but significant proportional difference between the methods. Mean fractional flow reserve was 0.86±0.06 for wire-only assessment and 0.82±0.07 after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of -0.033 (limits of agreement: -0.09 to 0.03), proportional to mean fractional flow reserve (Spearman ρ =0.40; P=0.036). Passing-Bablok analysis revealed significant constant and proportional differences between methods. Similar results were documented for resting indices of stenosis severity.CONCLUSIONS: Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis.",

keywords = "Aged, Arterial Pressure, Blood Flow Velocity, Cardiac Catheterization/instrumentation, Cardiac Catheters, Coronary Angiography, Coronary Circulation, Coronary Stenosis/diagnosis, Coronary Vessels/diagnostic imaging, Equipment Design, Female, Hemodynamics, Humans, Male, Middle Aged, Miniaturization, Predictive Value of Tests, Prognosis, Reproducibility of Results, Severity of Illness Index, Transducers, Pressure",

author = "Wijntjens, {Gilbert W M} and {van de Hoef}, {Tim P} and Kraak, {Robin P} and Beijk, {Marcel A} and Sjauw, {Krischan D} and Vis, {M Marije} and {Madera Cambero}, {Maribel I} and Brinckman, {Stijn L} and Jacobus Plomp and Jan Baan and Koch, {Karel T} and Wykrzykowska, {Joanna J} and Henriques, {Jos{\'e} P} and {de Winter}, {Robbert J} and Piek, {Jan J}",

note = "{\textcopyright} 2016 American Heart Association, Inc.",

year = "2016",

month = dec,

doi = "10.1161/CIRCINTERVENTIONS.116.004645",

language = "English",

volume = "9",

journal = "Circulation. Cardiovascular Interventions",

issn = "1941-7640",

publisher = "Lippincott Williams & Wilkins",

number = "12",

}

Wijntjens, GWM, van de Hoef, TP, Kraak, RP, Beijk, MA, Sjauw, KD, Vis, MM, Madera Cambero, MI, Brinckman, SL, Plomp, J, Baan, J, Koch, KT, Wykrzykowska, JJ, Henriques, JP, de Winter, RJ & Piek, JJ 2016, 'The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity)', Circulation. Cardiovascular Interventions, vol. 9, no. 12. https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645

The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity). / Wijntjens, Gilbert W M; van de Hoef, Tim P; Kraak, Robin P et al.
In: Circulation. Cardiovascular Interventions, Vol. 9, No. 12, 12.2016.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity)

AU - Wijntjens, Gilbert W M

AU - van de Hoef, Tim P

AU - Kraak, Robin P

AU - Beijk, Marcel A

AU - Sjauw, Krischan D

AU - Vis, M Marije

AU - Madera Cambero, Maribel I

AU - Brinckman, Stijn L

AU - Plomp, Jacobus

AU - Baan, Jan

AU - Koch, Karel T

AU - Wykrzykowska, Joanna J

AU - Henriques, José P

AU - de Winter, Robbert J

AU - Piek, Jan J

PY - 2016/12

Y1 - 2016/12

N2 - BACKGROUND: The Navvus pressure sensor-equipped microcatheter allows to measure functional stenosis severity over a work-horse guidewire and is used as a more feasible alternative to regular sensor-equipped wires. However, Navvus is larger in diameter than contemporary sensor-equipped guidewires and may, thereby, influence functional measurements. The present study evaluates the hemodynamic influence of the Navvus microcatheter.METHODS AND RESULTS: In patients with intermediate coronary stenosis, coronary pressure and flow velocity were measured using a dual sensor-equipped guidewire before and after introduction of Navvus. Patients were randomized to microcatheter-first or guidewire-first measurement. The primary end point was the difference in hyperemic stenosis resistance index between measurements before and after introduction of Navvus. Measurements were completed in 28 patients (28 stenoses). Mean hyperemic stenosis resistance was 0.37±0.19 Hg/cm/s for wire-only assessment and 0.48±0.26 Hg/cm/s after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of +0.11 Hg/cm/s (limits of agreement: -0.13 to 0.36), proportional to mean hyperemic stenosis resistance (Spearman ρ =0.61; P=0.001). Passing-Bablok analysis revealed absence of a constant difference but significant proportional difference between the methods. Mean fractional flow reserve was 0.86±0.06 for wire-only assessment and 0.82±0.07 after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of -0.033 (limits of agreement: -0.09 to 0.03), proportional to mean fractional flow reserve (Spearman ρ =0.40; P=0.036). Passing-Bablok analysis revealed significant constant and proportional differences between methods. Similar results were documented for resting indices of stenosis severity.CONCLUSIONS: Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis.

AB - BACKGROUND: The Navvus pressure sensor-equipped microcatheter allows to measure functional stenosis severity over a work-horse guidewire and is used as a more feasible alternative to regular sensor-equipped wires. However, Navvus is larger in diameter than contemporary sensor-equipped guidewires and may, thereby, influence functional measurements. The present study evaluates the hemodynamic influence of the Navvus microcatheter.METHODS AND RESULTS: In patients with intermediate coronary stenosis, coronary pressure and flow velocity were measured using a dual sensor-equipped guidewire before and after introduction of Navvus. Patients were randomized to microcatheter-first or guidewire-first measurement. The primary end point was the difference in hyperemic stenosis resistance index between measurements before and after introduction of Navvus. Measurements were completed in 28 patients (28 stenoses). Mean hyperemic stenosis resistance was 0.37±0.19 Hg/cm/s for wire-only assessment and 0.48±0.26 Hg/cm/s after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of +0.11 Hg/cm/s (limits of agreement: -0.13 to 0.36), proportional to mean hyperemic stenosis resistance (Spearman ρ =0.61; P=0.001). Passing-Bablok analysis revealed absence of a constant difference but significant proportional difference between the methods. Mean fractional flow reserve was 0.86±0.06 for wire-only assessment and 0.82±0.07 after Navvus introduction (P<0.001). Bland-Altman analysis documented a mean bias of -0.033 (limits of agreement: -0.09 to 0.03), proportional to mean fractional flow reserve (Spearman ρ =0.40; P=0.036). Passing-Bablok analysis revealed significant constant and proportional differences between methods. Similar results were documented for resting indices of stenosis severity.CONCLUSIONS: Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis.

KW - Aged

KW - Arterial Pressure

KW - Blood Flow Velocity

KW - Cardiac Catheterization/instrumentation

KW - Cardiac Catheters

KW - Coronary Angiography

KW - Coronary Circulation

KW - Coronary Stenosis/diagnosis

KW - Coronary Vessels/diagnostic imaging

KW - Equipment Design

KW - Female

KW - Hemodynamics

KW - Humans

KW - Male

KW - Middle Aged

KW - Miniaturization

KW - Predictive Value of Tests

KW - Prognosis

KW - Reproducibility of Results

KW - Severity of Illness Index

KW - Transducers, Pressure

U2 - 10.1161/CIRCINTERVENTIONS.116.004645

DO - 10.1161/CIRCINTERVENTIONS.116.004645

M3 - Article

C2 - 27899407

SN - 1941-7640

VL - 9

JO - Circulation. Cardiovascular Interventions

JF - Circulation. Cardiovascular Interventions

IS - 12

ER -

The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity)

Abstract

Keywords

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