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: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)

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

13 Citations (Scopus)

Abstract

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

Original language	English
Pages (from-to)	e004645
Journal	Circulation. Cardiovascular interventions
Volume	9
Issue number	12
Early online date	2016
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645
Publication status	Published - 2016

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https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645

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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), e004645. https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645

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

abstract = "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. 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. Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis",

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.}",

year = "2016",

doi = "https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645",

language = "English",

volume = "9",

pages = "e004645",

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, pp. e004645. 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, 2016, p. e004645.

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

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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

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N2 - 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. 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. Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis

AB - 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. 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. Introduction of the Navvus microcatheter leads to clinically relevant stenosis severity overestimation in intermediate stenosis

U2 - https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645

DO - https://doi.org/10.1161/CIRCINTERVENTIONS.116.004645

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