9/15/2015. Functional Assessment of Coronary Artery Stenosis Severity Significance Utility of FFR, IVUS and OCT

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1 IVUS/OCT = Anatomy vs FFR = Ischemia Functional Assessment of Coronary Artery Stenosis Severity Significance Utility of FFR, IVUS and OCT Morton J. Kern MD, MSCAI, FACC, FAHA Chief of Medicine, VA Long Beach Health Care System Professor of Medicine University California Irvine Orange, California Disclosure: Morton J. Kern, MD Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below. Company Name St. Jude Medical Inc. Volcano Therapeutics Merit Medical Inc. Acist Medical Inc. Opsens Relationship Speakers Bureau Speakers Bureau Consultant Consultant Consultant Answering the Questions about Intracoronary Imaging and Physiology Questions Tools Is this lesion flow limiting? (complex anatomy assessment too) Which is the culprit lesion? Is the stent optimally implanted? Is there another vulnerable plaque? Is this lesion associated with emoblization? What is the mechanism of in-stent restenosis FFR, ifr OCT, FFR, ifr (?) IVUS/OCT OCT/NIRS NIRS/OCT IVUS/OCT The Pathology Pressure derived Fractional Flow Reserve (FFR) measures the ischemic potential of a stenosis Obstructive, Thrombotic? Think Stable Angina Proximal Pressure (Pa) Distal Pressure (Pd) Non obstructive, Thrombotic? Think ACS STEMI, NSTEMI, UA Measures arterial pressure on both sides of an arterial blockage Fraction of normal flow = Pd/Pa at maximal flow (hyperemia)

2 FFR Outcome Studies N= Study Design Question Outcome Journal DEFER 325 Prospective MC ( ) RCT FAME 750 Prospective MC ( ) RCT FAME II (2012) 1,22 0 Prospective MC RCT Is it safe to defer FFR normal intermediate lesions? Does FFR guided PCI vs. angio guided for MVD improve outcomes? Does FFR guided PCI + OMT vs. OMT alone improve outcomes? Less MACE in FFR >0.75 when rx d medically Less MACE*, lower cost w FFR Less MACE w FFR, cost effective JACC NEJM NEJM When to measure the FFR? FAMOUS NSTEMI (2014) 350 Prospective MC Randomized (UK) Does FFR guided PCI in NSTEMI chane angio FFR reclass revasc decision decisions for revasc? Outcomes? in 22%. Less revasc w FFR. EHJ DANAMI3 PRIMULTI (2015) Mayo (2013) R3F (2014) POST IT (2015) 600 Prospective MC Randomized (Denmark) 7,358 Retrospective SC Registry Prospective MC Registry (France) 918 Prospective MC Registry (Portugal) Does FFR guided PCI in MV STEMI vs. IRA only revasc improve outcomes? Does FFR guidedi vs angio guided PCI improve outcomes in routine practice? Does FFR change angio decisions for revasc? Outcomes? Does FFR change angio decisions for revasc? Outcomes? Less MACE w FFR Less MACE w FFR FFR reclass revasc decision in 47%, similar ooutomes FFR reclass revasc decision in 44% (follow up data in press) Lancet EHJ Circulation In press Take the lowest value Automated software records the lowest Pd/Pa as the FFR. Wait for stable hyperemia Pijls, van Son, Kirkeeide, DeBruyne, Gould. Circulation : Take the Pd/Pa ratio at the lowest Pd Vranckx, Cutlip, McFadden, Kern, Mehran, Muller. Circ CV Interv : Asan registry (2013) Prospective SC Registry Does FFR guidedi vs angio guided PCI improve outcomes in routine practice? Fewer stents and less MACE EJHJ w FFR Quantitating the Visual Functional Mismatch Clinical outcomes superior with functional over visual decision making. Unstable hyperemia with IV Adenosine Johnson N, et al. J Am Coll Cardiol Intv. 2015;8(8): FFR=0.89 Tonino et al JACC 2010 Berry et al Eur Heart J 2014 Johnson, Johnson, Kirkeeide, Berry, De Bruyne, Fearon, Oldroyd, Pijls, Gould. JACC:Interv paired tracings from 206 pts in VERIFY study IV Adenosine produced stable hyperemia in only 57% of cases Curzen et al Circ Interven 2014 Toth et al EHJ 2014 within reason, always take the minimum FFR value Technique Counts: Confounding Factors for FFR 1. Equipment factors: Erroneous zero Incomplete pressure transmission (tubing/connector leaks) Faulty electric wire connection Pressure signal drift Hemodynamic recorder miscalibration 2. Procedural factors Guide catheter damping Incorrect placement pressure sensor Inadequate hyperemia 3. Physiological factors Serial lesion Reduced myocardial bed Acute myocardial infarction Theoretical conditions that might influence FFR Severe left ventricular hypertrophy Exuberant collateral supply Adenosine insensitivity IV adenosine Variability - When to accept FFR?? Take the Smart Minimum FFR, lowest Pd/Pa Kern M and Seto A. JACC Cardiovascular Interventions, 2015:8;

3 MACE Death Question: Is ischemia (FFR) guided PCI superior to angiographic only guided PCI? Answer: FAME I FFR vs Angiography Multivessel Evaluation FAME 5yr F/U Nunen LX et al. Lancet, August 30, 2015 Myoc Infarct Revascularization Fame Study: 2 year Follow- up P= 0.08 P= 0.30 Question: Is Medical rx equal or superior to Ischemic guided Revascularization for patients with MV CAD? Answer: FAME II P= 0.03 Pijls et al. JACC 2010 P=

4 Should I do PCI? Is this lesion flow limiting? FFR = Decision Making FAME 2: Two Year Follow-Up Two year rate of primary endpoint: Death, MI, Urgent Revascularization Outcome Impact of Coronary Revascularization Strategy Reclassification With FFR at Time of Diagnostic Angiography: Insights from a Large French Multicenter FFR Registry De Bruyne, et al. NEJM 2014;371: Van Belle E et al. Circulation 2014;129:

5 ifr and the RESOLVE study IVUS/OCT/NIRS Indications Guide PCI strategy Establish reference vessel size Determine lesion length / extent of disease Examine post PCI angiographic anomalies IVUS OCT NIRS No adeno,pci FFR No adeno,pci IFR Jeremias et al; JACC 2013 Ambiguous angiography Ostial Left main Unusual lesion morphology ACS Plaque Vunerabiity? In-stent restenosis - Mechanisms Stent underexpansion Neointimal hyperplasia Functional Lesion Assessment of Intermediate stenosis to guide Revascularisation Basic intravascular Imaging Measurements Intermediate lesion requiring physiological assessment In ACS : intermediate non-culprit lesion N=2500, 1:1 Randomisation FFR guided PCI ifr guided PCI FFR>0.8 Defer PCI FFR 0.8 Perform PCI ifr 0.9 Defer PCI ifr<0.9 Perform PCI 30 day, 1, 2 and 5yr follow-up McDaniel, M. C. et al. J Am Coll Cardiol Intv 2011;4: Coronary imaging devices in the Cath lab CAG IVUS NIRS Angioscopy OCT inadequate stentstrut apposition In Stent Restenosis Resolution μm) Probe Size(μm) Contact Ionizing Radiation Other = <200 N/A No Yes Yes Yes Yes No No No Lumen only N/A N/A Surface Only Yes No plaque character Intracoronary Thrombi coronary dissection 5

6 62 yo Man with ACS and inferior ST changes. Prior RCA stent 4 years ago Acute Coronary Syndrome 72 year-old Man Plaque crater, erosion Thrombus Calcific nodule PCI then OCT Utilization of NIRS and IVUS Data to Identify Lipid-rich Plaque Burden NIR detection of lipid core for Peri stenting MI, stent length, culprit lesion in NSTEMI, UA,Determine cause of MI (?) Lipid-rich Plaque Burden Image courtesy of Drs..Tomotaka Dohi, Gary S. Mintz, Bo Zheng, and Akiko Maehara Post Stent Adapt- DES Study: Reason for IVUS Use IVUS: 3349 pts No IVUS: 5234 pts Larger Size of Stent/Balloon Clinical Outcomes Witzenbichler, et al. Circulation, in press Higher Pressure Longer Stent (%) How IVUS changed Document Missing Link the procedure? >1 Procedure Underexpansion (26%) year FAME-like Post Dilation Guide and Optimize Procedure (74%) Malapposed Added Stent 6

7 Matching of Optical Coherence Tomography and Intravascular Ultrasound Pullbacks Gonzalo, N. et al. J Am Coll Cardiol 2012;59: EuroIntervention 2015;10: Guidelines on myocardial revascularization 7

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