Coronary stenting: the appropriate use of FFR

Transcription

1 Coronary stenting: the appropriate use of FFR Morton J. Kern, MD Professor of Medicine Chief of Cardiology LBVA Associate Chief Cardiology University California Irvine Orange, California

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

3 The rationale for using coronary physiology is the inability of the 2D images of angiogram to accurately depict the 3D lesion characteristics limiting flow. 75% Dia 20% Dia

4 Uncertainty in Critical Angiographic Based Decisions Intermediate Stenosis, no evidence ischemia Left Main Stenosis Multivessel CAD Serial Lesions Ostial and Branch Disease

5 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. Aortic, Pa FFR= Pd/Pa = 65/90 = 0.72 Resting pressures Coronary, Pd Adenosine

6 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 2-4 minutes 5. Confirm accuracy with pressure pull back

7 Rely on FFR Avoid pitfalls of pressure and FFR Hemodynamic Artifacts: Damped pressure waveforms. Guide obstruction Contrast media Very small guide (<5F) Pressure signal drift Side holes and ostial pseudostenosis Technical loose connections Improper zero Calibration offset Anatomic Extreme tortuosity Inability to wire vessel Spasm Mechanical Wire/artery impact Pharmacologic Inadequate hyperemia

8 Rely on FFR Effect of Wire Introducer

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

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

11 Severe stenosis filters high frequency components No dichrotic notch Notch No notch Distal wave form is one key to drift

12 IV vs IC Pharmacologic Hyperemic agents

13 Q: Why can we not use IVUS/OCT for functional assessment? A: A single cross-sectional area does not mean the same thing everywhere. 5 Ref Diam (mm) < 4 mm² = significant stenosis? % Stenosis for an Cross Sectional Area of 4 mm² 0

14 Single anatomic parameters do not predict FFR with confidence IVUS v FFR

15 When can you NOT rely on FFR? False Negative FFR 1. Pressure Damping 2. No hyperemia - wrong drug, not mixed not delivered (IV?) or side holes 3. STEMI, culprit. STEMI non-culprit OK 4. LM + LAD when FFRepicardial < Serial lesion FFR of individual lesion (only gradient useful) False Positive FFR 1. Technical errors (Pressure signal drift,zero, etc.)

16 Coronary Physiologic (FFR) Criteria and Clinical Outcome Studies Application FFR Ischemia detection, >15 studies Pos <0.75 Neg >0.80 Deferred angioplasty, >8 studies (Key Study: Defer) Multivessel FFR guided PCI, LM, Ostial, Jailed Side Branch >0.75 >0.80 (Key Study: FAME I, II) (Key Study: Hamilos for LM) (Key Study: Koo BW et al) Endpoint of stenting *(IVUS better post stent) >0.94*

17 62 yo Man, RCA stent occl 2yr ago with return of CP LAD FFR=0.86, 0.87 Now 1V CAD and new approach

18 DEFER Study 5 year data JACC

19 RW. 59 yo man with Angina, inferior perf defect 3V CAD CABG vs PCI? FFR= Questions How Accurate is Stress Test? If PCI needed, FFR directed?

20 JACC 2010;56:177

21 FAME study: Death and MI after 2 Years Tonino et al, NEJM 2009, Pijls et al, JACC 2010 Angio-guided % Death or MI P= P= 0.03 MI 6.1 FFR-guided 0 2 year 2 year(exclusion of small periprocedural infarction)

22 Incremental Cost [$] Increm. Cost [$] Economic Evaluation of FFR-guided PCI in pts with MVD. Fearon WF et al. Circ 2010;122: Balloon ROTO BMS DES ICER of 50,000 $ / QALY CABG FFR Guidance Improves Outcomes FFR Guidance Improves outcomes Incremental QALY Increm. QALY FFR Guidance Saves Resources FFR Guidance Saves Resources

23 Angiographic 3- or 2-Vessel Disease does NOT equal Physiologic 3- or 2V CAD FAME: Angiography vs FFR Tonino, P. A. L. et al. J Am Coll Cardiol 2010;55: V CAD Angio = 14% physiol 2V CAD Angio= 43% physiol

24 FAME II Ischemia directed PCI+OMT vs OMT alone Stable patients scheduled for 1, 2 or 3 vessel DES stenting Randomised Trial At least 1 stenosis with FFR 0.80 FFR in all target lesions When all FFR >0.80 Registry Randomisation 1:1 PCI + OMT OMT OMT 50% randomly assigned to FU 24 Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years

25 Cumulative incidence (%) Rate of Any Revascularisation FAME II RCT:OMT vs. RCT:PCI+OMT = 12.1% vs. 1.7% HR (95% CI): 7.63 ( ); logrank p< RCT:PCI+OMT vs. REGISTRY:OMT, p=0.54 No. at risk RCT:OMT only Months after randomisation RCT:PCI+OMT REGISTRY:OMT only

26 71 yo Man with typical angina, pos stress, CAD risk factors What s your best approach?

27 FFR CFX FFR CFX=0.88

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

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

31 Chest pain, No objective evidence ischemia Asymptomatic Patients FFR FFR FFR FFR FFR FFR FFR FFR FFR FFR FFR FFR FFR

32 Revascularization Approaches per AUC 2v CAD with prox LAD 3v CAD Isolated LM LM and other CAD FFR reduces uncertainty and documents appropriateness

33 The Mandate for Physiologic Guidance arises from a decade of outcomes studies and is supported by guidelines Class IA Guidelines - ESC Class IIa Guidelines - ACC/ AHA/ SCAI