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PRIMARY Results of ADVISE ADenosine Vasodilation Independent Stenosis Evaluation

PRIMARY Results of ADVISE ADenosine Vasodilation Independent Stenosis Evaluation. Dr Justin Davies MD, PhD Imperial College London on behalf of the ADVISE investigators. Research Support/ Intellectual Property Rights Consulting Fees/Honoraria. Volcano Corporation

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PRIMARY Results of ADVISE ADenosine Vasodilation Independent Stenosis Evaluation

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  1. PRIMARY Results of ADVISEADenosine Vasodilation Independent Stenosis Evaluation Dr Justin Davies MD, PhD Imperial College London on behalf of the ADVISE investigators

  2. Research Support/ Intellectual Property Rights Consulting Fees/Honoraria Volcano Corporation Medtronic, Volcano Corporation Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company

  3. FFR is established in clinical practice At best it is only used in 6% of PCI in USA1 One barrier is the current requirement for vasodilator drugs such as adenosine Contraindicated or disliked by patients Adds to procedural time Adds to procedural costs 1 Kleiman NS. J Am Coll Cardiol 2011; 58:1291-21

  4. When coronary resistance is stable – pressure can be used as as a surrogate for flow to assess a coronary stenosis Velocity (m/s) 150 75 Pressure (mm Hg) Resistance (mm Hg s/m) 2 4 Time (s)

  5. If we can identify a period of naturally occurring stable resistance Why do we give drugs such as adenosine to calculate fractional flow reserve (FFR)?

  6. Marked damping of coronary pressure – necessitated the use of mean pressure in the development of FFR Pa Pd De Bruyne et al. JACC Vol. 22, No.1 July 1993:119-26

  7. Marked damping of coronary pressure – necessitated the use of mean pressure in the development of FFR Pa Pd De Bruyne et al. JACC Vol. 22, No.1 July 1993:119-26

  8. Phasic resistance during the cardiac cycle Velocity (m/s) 150 Pressure (mm Hg) 75 Resistance (mm Hg s/m) 2 4 Time (s) ADVISE study

  9. Phasic resistance during the cardiac cycle Velocity (m/s) 150 Pressure (mm Hg) 75 Resistance (mm Hg s/m) 2 4 Time (s) ADVISE study

  10. Velocity (m/s) 150 Pressure (mm Hg) 75 Resistance (mm Hg s/m) 2 4 Time (s)

  11. Identification of wave-free period Wave-free period Fully automated algorithms Identification of naturally low resistance period Uses pressure only Wave-free period Sen S, Escaned J, Davies JE et al. JACC (in press 2011) Davies JE et al. Circulation 2006;113:1767-1778 Davies JE et al. Circulation 2011;124:1565-1572

  12. Hypothesis 1 Resistance measured at rest during the resting wave-free periodis similar to mean resistance during hyperaemia. Hyperaemic mean resistance Resting wave-free resistance ADVISE study

  13. Hypothesis 2 The Pd/Pa ratio (iFR) during the resting wave-free period was similar to FFR. Wave-free period Wave-free period ADVISE study

  14. ADVISE Study ADenosine Vasodilation Independent Stenosis Evaluation Part 1 Proof of concept Part 2 Validation study Resting wave-free resistance vs. mean hyperaemic resistance n=39 iFR vs. FFR n=157 Intra-coronary pressure and flow velocity measurements Intra-coronary pressure measurements Baseline resistance assessment iFR & FFR assessment Resistance assessment under pharmacological vasodilatation

  15. ADVISE study demographics RISK FACTORS n=156 lesions age = 63 years VESSEL CHARACTERISTICS ADVISE study

  16. Hypothesis 1 Test stability and magnitude of resistance during wave-free period in comparison to during adenosine hyperaemia

  17. Stability of resistance is similar over the wave-free period and during hyperaemia Coefficient of Variation of resistance Resting wave-free resistance Hyperaemic mean resistance ADVISE study Sen S, Escaned J, Davies JE et al. JACC (in press 2011)

  18. Stability of resistance is similar over the wave-free period and during hyperaemia p=0.96 Coefficient of Variation of resistance Resting wave-free resistance Hyperaemic mean resistance ADVISE study Sen S, Escaned J, Davies JE et al. JACC (in press 2011)

  19. Magnitude of resistance is similar over the wave-free period and during hyperaemia 800 Resistance (mm Hg s/m) 0 Resting mean resistance Hyperaemic mean resistance Resting wave-free resistance ADVISE study

  20. Magnitude of resistance is similar over the wave-free period and during hyperaemia p<0.001 p<0.001 800 p=0.70 Resistance (mm Hg s/m) 0 Resting mean resistance Hyperaemic mean resistance Resting wave-free resistance ADVISE study

  21. Hypothesis 1 Resistance measured at rest during the wave-free period…

  22. Hypothesis 1 Resistance measured at rest during the wave-free period… is similar in both stability and magnitude to values achieved under adenosine hyperaemia.

  23. Hypothesis 2 Assess whether iFR was numerically similar to Fractional flow reserve.

  24. iFR = instantaneous wave-free ratio Definition: Instantaneous pressure gradient, across a stenosis during the wave-free period, when resistance is constant and minimised in the cardiac cycle Wave-free period Pa Pd

  25. Close relationship between iFR and FFR Regression coefficient y=1.022x + 0.03 iFR FFR ADVISE study Sen S, Escaned J, Davies JE et al. JACC (in press 2011)

  26. Close relationship between iFR and FFR r = 0.90 Regression coefficient y=1.022x + 0.03 iFR FFR ADVISE study Sen S, Escaned J, Davies JE et al. JACC (in press 2011)

  27. Close relationship between iFR and FFR r = 0.90 Regression coefficient y=1.022x + 0.03 iFR Left coronary artery Right coronary artery FFR ADVISE study Sen S, Escaned J, Davies JE et al. JACC (in press 2011)

  28. Magnitude of hyperaemia does not explain the small difference between iFR and FFR ΔFFR - iFR Δ Abs Hyperaemic – wave-free resistance (mmHg s/m)

  29. Diagnostic efficiency of iFR ADVISE study Sen S, Escaned J, Davies JE et al. JACC (in press 2011)

  30. Assessment of diagnostic efficiency of iFR False (+) False (-) FFR 88% 91% 85% 85% 91% Diagnostic accuracy (+) predictive value (-) predictive value Sensitivity Specificity Left coronary artery iFR positive iFR negative Right coronary artery ADVISE study Sen S, Escaned J, Davies JE et al. JACC (in press 2011)

  31. Assessment of diagnostic efficiency of iFR after adjustment for inherent variability in FFR False (+) 95% CI variability in FFR* False (-) FFR Adjusting for variability in FFR Diagnostic accuracy (+) predictive value (-) predictive value Sensitivity Specificity 88% 91% 85% 85% 91% 95% 97% 93% 93% 97% Left coronary artery iFR positive iFR negative Right coronary artery *De Bruyne B et al. Circulation. 1996;94:1842-1849 Circulation 2006;114;1321-1341 ADVISE study

  32. Summary Wave-free period Identified a wave-free period in cardiac cycle when resistance is naturally stabilized and minimal avoiding the need for administration of adenosine Wave-free period

  33. Summary iFR measured during this wave-free period gives a measure of stenosis severity similar to FFR

  34. Clinical implications of iFR Removes barriers to adoption of physiological assessment Increased applicability Improved work-flow in catheter lab Improves patient experience

  35. ADVISE team Hospital Clínico San Carlos Javier Escaned, Rafael Mila Royal Brompton Hospital Carlo Di Mario Imperial College Sayan Sen Iqbal Malik, Jamil Mayet, Alun Hughes, Darrel Francis, Ghada W Mikhail, Rodney A Foale, Jason Tarkin, Ricardo Petraco, Christopher Broyd, Richard Jabbour, Amarjit Sethi, Christopher Baker, Michael Bellamy, Mahmud Al-Bustami, David Hackett, Masood Khan, David Lefroy, and Kim H Parker.

  36. ADVISE team Hospital Clínico San Carlos Javier Escaned, Rafael Mila Royal Brompton Hospital Carlo Di Mario Imperial College Sayan Sen Iqbal Malik, Jamil Mayet, Alun Hughes, Darrel Francis, Ghada W Mikhail, Rodney A Foale, Jason Tarkin, Ricardo Petraco, Christopher Broyd, Richard Jabbour, Amarjit Sethi, Christopher S Baker, Micheal Bellamy, Mahmud Al-Bustami, David Hackett, Masood Khan, David Lefroy, and Kim H Parker. Wave-free period Wave-free period advisestudy.org justindavies@heart123.com

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