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.
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Gilbert W M
authors.initials: GW
authors.lastname: Wijntjens
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.). t.p.vandehoef@amc.uva.nl.
authors.forename: Tim P
authors.initials: TP
authors.lastname: van de Hoef
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Robin P
authors.initials: RP
authors.lastname: Kraak
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Marcel A
authors.initials: MA
authors.lastname: Beijk
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Krischan D
authors.initials: KD
authors.lastname: Sjauw
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: M Marije
authors.initials: MM
authors.lastname: Vis
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Maribel I
authors.initials: MI
authors.lastname: Madera Cambero
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Stijn L
authors.initials: SL
authors.lastname: Brinckman
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Jacobus
authors.initials: J
authors.lastname: Plomp
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Jan
authors.initials: J
authors.lastname: Baan
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Karel T
authors.initials: KT
authors.lastname: Koch
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Joanna J
authors.initials: JJ
authors.lastname: Wykrzykowska
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: José P
authors.initials: JP
authors.lastname: Henriques
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Robbert J
authors.initials: RJ
authors.lastname: de Winter
authors.affiliation: From the AMC Heart Center, Academic Medical Center, University of Amsterdam, The Netherlands (G.W.M.W., T.P.v.d.H., R.P.K., M.A.B., K.D.S., M.M.V., J.B., K.T.K., J.J.W., J.P.H., R.J.d.W., J.J.P.); and Department of Cardiology, Tergooi Hospital, Blaricum, The Netherlands (T.P.v.d.H., M.I.M.C., S.L.B., J.P.).
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Piek
mesh_terms: D000368:Aged; D062186:Arterial Pressure; D001783:Blood Flow Velocity; D006328:Cardiac Catheterization / Q000295:instrumentation*; D062906:Cardiac Catheters; D017023:Coronary Angiography; D003326:Coronary Circulation; D023921:Coronary Stenosis / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000503:physiopathology; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000503:physiopathology*; D004867:Equipment Design; D005260:Female; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D008904:Miniaturization; D011237:Predictive Value of Tests; D011379:Prognosis; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D014160:Transducers, Pressure
keywords: coronary stenosis; fractional flow reserve; hyperemic stenosis resistance; pressure sensor–equipped rapid exchange monorail microcatheter; sensor-equipped guidewire