Coronary Stenting: Everyone should be using FFR Morton J. Kern, MD Chief of Medicine, VA Long Beach HCS 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 NameRelationship St. Jude Medical Inc. Speakers’ Bureau Volcano TherapeuticsSpeakers’ Bureau Merit Medical Inc.Consultant Acist Medical Inc.Consultant OpsensConsultant HeartflowConsultant

To treat or not to treat? Is this lesion producing Ischemia? Is PCI appropriate for situation?

Coronary Physiology (FFR as well as FFRCT) is needed because angiography/CTA does not always reflect the functional (i.e. ischemic) impact of a stenosis. LAO, RAO,

Aortic, Pa Coronary, Pd FFR= Pd/Pa = 65/90 = 0.72 Measurement of FFR correlates to the results of stress testing and ischemia out of the lab. FFR is a ‘stress test’ for that artery in the lab at time of cath. Adenosine Resting pressures

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 or variable 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

5 Steps to Accurate FFR 1.Zero guide and wire on table to atmosphere 2.Insert wire into guide and match wire/guide pressures in aorta 3.Cross lesion 2-3cm distal 4.Turn on IV adenosine: Use the ‘smart minimum FFR or lowest Pd/Pa 5.Confirm accuracy with pressure pull back

Rely on FFR – No Guide Catheter Side Holes or Damping From Nico Pijls

Notch No notch Rely on FFR – Avoid Signal Drift Drift Drift True Gradient

Pharmacologic Hyperemia IV Adenosine – 140mcg/kg/min IC Adenosine - LCA = mcg bolus - RCA = mcg bolus

When to measure the FFR? Take the lowest value Automated software records the lowest Pd/Pa as the FFR.

Ref Diam (mm) % Stenosis for an Cross Sectional Area of 4 mm² < 4 mm² = significant stenosis ? Q: Why can we not use IVUS/OCT for functional assessment? A: A single cross-sectional area does not mean the same thing everywhere.

FFR Outcome Studies N= Study DesignQuestionOutcomeJournal DEFER ( ) 325Prospective MC RCT Is it safe to defer stenting intermediate lesions with FFR>0.75 Less MACE, med rx when FFR >0.75 JACC FAME ( ) 750Prospective MC RCT Does FFR guided PCI vs. angio guided for MVD improve outcomes? Less MACE*, lower cost w FFR NEJM FAME II (2012) 1,220Prospective MC RCT Does FFR guided PCI + OMT vs. OMT alone improve outcomes? Less MACE w FFR, cost effective NEJM Mayo (2013) 7,358Retro SC Registry Does FFR vs angio-guided PCI improve outcomes in routine practice? Less MACE w FFREHJ R3F (France) (2014) 1.075Prospective MC Registry “”FFR reclass revasc decision in 47% Circulatio n Ripcord FFRCT (UK) (2015) 200Prospective MC Registry “”FFR reclass revasc decision in 36% EHJ, In press Asan FFR (Korea) (2013) Prospective SC Registry “”Fewer stents and less MACE w FFR EHJ FFR Outcome Studies

62 yo Man, RCA stent occl 2yr ago with return of CP LAD FFR=0.86, 0.87 Now 1V CAD and new approach

Kaplan–Meier survival curve for clinical events among 3 groups at 5-y follow-up. Sang Hyun Park et al. Circ Cardiovasc Interv. 2015;8:e002442

71 yo Man with typical angina, pos stress, CAD risk factors What’s your best approach?

FFR CFX FFR CFX=0.88

LAD Xience 3.5x18. 2 nd LAD lesion? All done? ? FFR = 0.68

Physiologic Guidance 1. Appropriate need for Stents 2. Objective info re ischemia 3. Eliminates operator uncertainty

FAME – 5yr F/U Nunen LX et al. Lancet, August 30, 2015 MACE Death Myoc Infarct Revascularization

FAME 2: Two Year Follow-Up Two year rate of primary endpoint: Death, MI, Urgent Revascularization De Bruyne, et al. NEJM 2014;371:

65 yo M, chest pain at rest and with exertion, ETT (ECG alone) positive at 8’ with minimal ST changes

FFR LAD Ostial Lesion = 0.77

FFR and Appropriate use Criteria. Moving to supported Decisions Prox LAD

iFR vs FFR: The Advise II study - International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II Escand J, JACC Interven 2015;8: IFR

Stable Coronary Artery Disease Symptoms of Ischemia Moderate/Severe Stenosis Evidence of ischemia New ECG changes Stress testing or FFR Acute Coronary syndrome - Evidence of ischemia - Stenosis, mild-severe ECG +/- WM abn FFR not needed in culprit, may help in non-culprit Components of PCI indications: Should FFR be part of every PCI?