Coronary stenting: the appropriate use of FFR Morton J. Kern, MD Professor of Medicine Chief of...
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Transcript of Coronary stenting: the appropriate use of FFR Morton J. Kern, MD Professor of Medicine Chief of...
Coronary stenting: the appropriate use of FFR
Morton J. Kern, MDProfessor of Medicine
Chief of Cardiology LBVAAssociate Chief CardiologyUniversity California Irvine
Orange, California
To treat or not to treat?
Is this lesion producing Ischemia?Is PCI appropriate for situation?
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
Uncertainty in Critical Angiographic Based Decisions
• Intermediate Stenosis, no evidence ischemia
• Left Main Stenosis
• Multivessel CAD
• Serial Lesions
• Ostial and Branch Disease
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.
AdenosineResting pressures
5 Steps to Accurate FFR
1.Zero guide and wire on table to atmosphere2.Insert wire into guide and match wire/guide pressures in aorta3.Cross lesion 2-3cm distal4.Turn on IV adenosine 2-4 minutes5.Confirm accuracy with pressure pull back
Rely on FFR Avoid pitfalls of pressure and FFR
TechnicalTechnical• loose connectionsloose connections• Improper zeroImproper zero• Calibration offsetCalibration offset
AnatomicAnatomic• Extreme tortuosityExtreme tortuosity• Inability to wire vesselInability to wire vessel• SpasmSpasm
MechanicalMechanicalWire/artery impactWire/artery impact
PharmacologicPharmacologic• Inadequate hyperemiaInadequate hyperemia
Hemodynamic Artifacts:Hemodynamic Artifacts:• Damped pressure Damped pressure
waveforms. waveforms. • Guide obstructionGuide obstruction• Contrast media Contrast media • Very small guide (<5F)Very small guide (<5F)
• Pressure signal driftPressure signal drift• Side holes and ostial Side holes and ostial
‘pseudostenosis’ ‘pseudostenosis’
Rely on FFREffect of Wire Introducer
Rely on FFR – No Guide Catheter Side Holes or Damping
From Nico Pijls
Notch
Notch
Notch
No notch
Rely on FFR – Avoid Signal Drift
Drift Drift True Gradient
Distal wave form is one key to drift
Severe stenosis filters high frequency components – No dichrotic notch
Notch
No notch
IV vs IC Pharmacologic Hyperemic agents
Ref Diam (mm)
% Stenosis for an Cross Sectional Area of 4 mm²
< 4 mm² = significant stenosis ?
025502
3
4
5
Q: Why can we not use IVUS/OCT for functional assessment?A: A single cross-sectional area does not mean the same thing everywhere.
Single anatomic parameters do not predict FFR with confidence
IVUS v FFR
When can you NOT rely on FFR?
False Negative FFR 1. Pressure Damping2. No hyperemia - wrong drug, not mixed
not delivered (IV?) or side holes3.STEMI, culprit. STEMI – non-culprit OK4. LM + LAD when FFRepicardial <0.65. Serial lesion FFR of individual lesion (only gradient
useful)False Positive FFR1. Technical errors (Pressure signal drift,zero, etc.)
Application FFR
Ischemia detection, >15 studies Pos <0.75
Neg >0.80
Deferred angioplasty, >8 studies
(Key Study: Defer)
>0.75
Multivessel FFR guided PCI, LM, Ostial, Jailed Side Branch
(Key Study: FAME I, II)
(Key Study: Hamilos for LM)
(Key Study: Koo BW et al)
>0.80
Endpoint of stenting
*(IVUS better post stent)
>0.94*
Coronary Physiologic (FFR) Criteria and Clinical 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
DEFER Study – 5 year data
JACC 2007;49:2105
RW. 59 yo man with Angina, inferior perf defect3V CAD – CABG vs PCI?
FFR=0.71
2 QuestionsHow Accurate is Stress Test?If PCI needed, FFR directed?
JACC 2010;56:177
FAME study: Death and MI after 2 Years
10
0
5
2 year
12.7 12.7
8.48.4
%
FFR-guided
Angio-guided
P= 0.03
9.59.5
6.16.1
P= 0.03
2 year(exclusion of small
periprocedural infarction)
Tonino et al, NEJM 2009, Pijls et al, JACC 2010
Death or MI MI
-6000
-5000
-4000
-3000
-2000
-1000
0
1000
2000
3000
4000
5000
6000
-0.100 -0.075 -0.050 -0.025 0.000 0.025 0.050 0.075 0.100
Increm. QALYIn
cre
m. C
os
t [$
]
FFR Guidance Improves outcomes
FFR Guidance Saves Resources
ICER of 50,000 $ / QALY
Incremental QALY
FFR Guidance Improves Outcomes
FFR GuidanceSaves
Resources
Incr
emen
tal C
ost
[$]
DES
CABG
ROTO
BMS
Balloon
Economic Evaluation of FFR-guided PCI in pts with MVD.
Fearon WF et al. Circ 2010;122:25450-2550
FAME: Angiography vs FFRTonino, P. A. L. et al. J Am Coll Cardiol 2010;55:2816-2821
Angiographic 3- or 2-Vessel Disease does NOT equal Physiologic 3- or 2V CAD
3V CAD Angio = 14% physiol 2V CAD Angio= 43% physiol
FAME II – Ischemia directed PCI+OMT vs OMT alone
Stable patients scheduled for 1, 2 or 3 vessel DES stenting
FFR in all target lesions
When all FFR >0.80
OMT
At least 1 stenosiswith FFR ≤ 0.80
Randomisation 1:1
PCI + OMT OMT
Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years
Randomised Trial Registry
24
50% randomly assigned to FU
25
Rate of Any Revascularisation
131 88 41 40 40 40 35 4 1 1 1 1REGISTRY:OMT only352 256 144 141 140 139 114 25 18 18 18 18RCT:PCI+OMT339 238 123 119 115 112 83 20 10 10 10 8RCT:OMT only
No. at risk Months after randomisation
0
10
20
30
40
50
60
0 1 2 3 4 5 6 7 8 9 10 12
RCT:PCI+OMT vs. REGISTRY:OMT, p=0.54
RCT:OMT vs. RCT:PCI+OMT = 12.1% vs. 1.7% HR (95% CI): 7.63 (3.24-18.0); logrank p<.0001
Cu
mu
lati
ve i
nci
den
ce (
%)
FAME II
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. 2nd LAD lesion? All done?
?
FFR = 0.68
Physiologic Guidance
1. Appropriate need for Stents
2. Objective info re ischemia
3. Eliminates operator uncertainty
Chest pain, No objective evidence ischemia
FFR
FFR FFR
FFR FFR FFR
FFR
FFR
FFR FFR FFR
FFR FFR
Asymptomatic Patients
Revascularization Approaches per AUC
FFR reduces uncertainty and documents appropriateness
2v CAD with prox LAD
3v CAD
Isolated LM
LM and other CAD
Class IIa Guidelines - ACC/ AHA/ SCAI
Class IA Guidelines - ESC
The Mandate for Physiologic Guidance arises from a decade of outcomes studies and is supported by
guidelines