Chun & McGeeAm J Med 2004;117:334
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3 Chun & McGeeAm J Med 2004;117:334
4 Tests non invasifs et vie réelle patients Pas d ATCD coronaire non invasive test before 83.9% Sténose >70% = 37.6% - multivessel disease 53% Un test non invasif positif augmente modérément la probabilité de coronaropathie par rapport à l absence de test (41% vs 35%; OR 1.28) Patel et al. NEJM 2010; 362:886
5 Capacitéd informations avant coronarographie Patel et al. NEJM 2010; 362:886 + results non invasive tests + symptoms + Clinical risk factors Framingham risk score
6 La cascade ischémique Sténose Perfusion Métabolisme Contraction Electrogénèse Angor Coronarographie (QCA) Échographie endocoronaire (IVUS) Scanner coronaire Guide de pression (FFR) Isotopes (TEPS TEP) IRM Tomographie d émission de positons (TEP) Écho IRM de repos et de stress ECG de repos et d effort
7 La sténose coronaire: significativité chez l Homme Gould KL. JACC Cardiovasc Imaging: 2009;2:1009
8 QCA
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10 Limits of visual estimation Subjective interpretation of what the stenosis should be: Before PTCA, stenosis are found more severe After PTCA, stenosis are found less severe Dichotomous analysis High inter-observer variability Can be trained/perform QCA Not suitable for multicentric trials/+++
11 Caliper Methods Calibration: Guiding catheter Use magnified images High interobserver variability (r=0.6 to 0.7) Used in the BARI trial
12 Quantitative angiographic methods Calibration: Guiding catheter Use magnified images Orthogonal views or worst view Automated edge detection algorithms Process : film digitization, image calibration, arterial contour detection Interobserver variability 3.1% for diameter stenosis 0.1 to 0.18 mm for MLD
13 QCA techniques
14 QCA techniques
15 QCA techniques
16 QCA techniques
17 Quantitative angiographic systems ARTREK Quinton imaging, Ann Arbor, MI Edges = 75% weighted thresh. between 1st and 2nd derivative User defined Average reference diameter Interobserver variability: MLD : 0.2 mm, Percent stenosis : 8% CAAS : Cardiovascular Angiography Analysis System Pie Data Medical, Maastricht, The Netherlands Edges = 50% weighted threshold Interpolated reference diameter CMS : Cardiovascular Measurement System MEDIS, The Netherlands Edges = 50% weighted threshold Interpolated reference diameter Interobserver variability: MLD : 0.15 mm, Percent stenosis : 4%
18 Correctable sources of imaging error during acquisition Biologic variation in lumen diameter Cardiac cycle : end-diastolic diastolic frames Vasomotor tone : nitroglycerin : 0.2 mg Image acquisition : single study Respiration : Breath holding Vessel foreshortening : Multiple angiographic projections Insufficient contrast injection : use 6-French catheters Branch vessel overlap : Multiple angiographic projections Pincushion distortion : Image objects in center of image Image acquisition : Sequential studies X-ray generator, X-ray X tube, Image intensif.. : use same Cath Lab Differences in angle and gantry height = Record gantry height/angle/skew on worksheet Image calibration : use the same catheter diameter
19 QCA techniques
20 Correctable sources of errors during image analysis Electronic noise Recurzing digitization and frame averaging Quantum noise Spatial filtering of digital image data Automated edge detection Selection of reference positions Identification of lesion length : use of side branches, oth. landmarks Frame selection : F F End-diastolic diastolic frame Use of worst view (or orthognal views)
21 On-line QCA Several systems are available: Automated coronary analysis (ACA) :Philips CMS CAAS-II Infrequently used: Quality of data recording Analysis performed by a technician Limited ability to check for the quality of the analysis Use of QCA: Allow to train for qualitative assessment of vessel diameter and % stenosis
22 Methodologic limitations of QCA Limited ability to detect the presence and the severity of coronary atherosclerosis and its evolution overtime : Progression/regression studies Definition of Vessel reference diameter when using stents Use of radiopaque stents decrease reliability of QCA : Accuracy of MLD falling from 0.07 mm to 0.12 mm Accuracy of RVD not affected Modified algorithms have been designed (e.g. CMS- GFT)
23 Reference vessel diameter
24 Radiopaque stents
25 Radiopaque stents Without stent Within stent - no stenosis
26 Radiopaque stents
27 Radiopaque stents Without stent Within stent stenosis
28 Analyse angiographique L angiographie coronaire reste l outil d évaluation de routine de l arbre coronaire Il est important d en connaître les limites (techniques, analyse qualitative) pour l utiliser à bon escient L analyse quantitative n est pas indispensable en routine (int( intérêt dans la formation des médecins, dans la réalisation des études multicentrique)
29 FFR
30 La sténose coronaire: significativité chez l Homme Gould KL. JACC Cardiovasc Imaging: 2009;2:1009
31 Aorta coronary artery Myocardium P a P d Q normal Max. hyperemia Normal perfusion pressure 100 P d 0 P a Q stenosis Stenotic perfusion pressure Q stenosis Stenotic perfusion press. P d FFR = = = Q normal Normal perfusion press. P a
32 Characteristics of FFR FFR is not influenced by changes in blood pressure, heart rate, or contractility FFR has a unique normal value of 1.0 in every patient and every coronary artery FFR incorporates the contribution of collateral flow to myocardial perfusion
33 FFR threshold for ischemia No ischemia Yes ischemia FFR FFR < 0.75 inducible ischemia (spec. 100 % ) FFR > 0.75 no inducible ischemia (sens. 90 % ) Pijls, De Bruyne et al, NEJM 1996
34 Angiography and functional significance DEFER Study FAME Study 325 lesions 1329 lesions Bech et al. Circulation 2001 Tonino et al. TCT 2009
35 Lésion du tronc coronaire gauche 213 pts Hamilos et al. Circulation 2009; 120:1505
36 Predictors of FFR: A multivariate model T β 95% CI β P Decrease LAD location Num. of diseased vessels Length, mm ACC/AHA % stenosis, % Increase Age, years Ejection fraction Other variables in the model: Center, gender, diabetes, previous MACE, symptoms, stability, non-invasive testing, proximal lesion, Reference diameter, MLD. R3F Steering Comittee: E van Belle, T Cuisset, G Rioufol, C Pouillot, P Dupouy
37 évaluation morphologique CT scan Quantitative coronary angiography 65% Diagnosis accuracy Quantitative CT angiography 67% 79 pts stable angina 89 stenosis(18% FFR 0.75, 34% FFR 0.80) Meijboom et al. JACC 2008;52:636
38 Multivessel disease and diagnosis Spect performances vs FFR Concordance 42% Sur-estimation 22% Sous-estimation 36% 67 pts 2-ou 3-vx disease Melikian et al. JACC Intv 2010;3:307
39 Dobutamine stress echography performances vs FFR accuracy 62% accuracy 77% 70 pts single vesseldisease Jung et al.eurheartj 2008;29:2536
40 Stress (adenosine) MRI performances vs FFR 37 pts 103 pts Valeur prédictive positive 97% - valeur prédictive négative 84% Costa et al. JACC 2007;50:514 Watkins et al. circulation 2009;120:2207
41 Decision making based on FFR 0.75 FFR < 0.75 ischaemia inducible: revascularization is justified. FFR > 0.75 ischaemia highly unlikely:? is it justified to DEFER revascularization, even when the lesion is angiographically serious? DEFER STUDY: 325 pat. all accepted for elective PTCA of a single lesion. Just prior to PTCA FFR was determined. Bech et al, Circulation 2001
42 DEFER study 325 patients 181 patients FFR > 0.75 => No ischaemia Randomisation 144 patients FFR < 0.75 => Ischaemia PTCA 144 patients Performance of PTCA 90 patients 2 yr follow-up Deferral of PTCA 91 patients 2 yr follow-up Bech et al, Circulation 2001
43 Pijls et al. JACC 2007
44 Cardiac Death And Acute MI After 5 Years 20 % P=0.20 P< P< DEFER PERFORM REFERENCE FFR > 0.75 FFR < 0.75
45 Compliance with FFR Non Compliance group n= 71 Clinical events Death Acute Coronary syndromes Vessel revascularization No Revasc n=34 7/34(21%) 2/34(6%) 2/34(6%) 3/34(9%) Revasc n=37 4/37(11%) 1/ 37(3%) 1/31(3%) 2/37(5)
46 Compliance with FFR Non Compliance group n= 71 Compliance group n = 336 No Revasc n=34 Revasc n=37 No Revasc n=237 Revasc n=99 Clinical events 7/34(21%) 4/37(11%) 14/237(7%) 6/99(6%) Death 2/34(6%) 1/ 37(3%) 3/237(1%) 0/99 Acute Coronary syndromes 2/34(6%) 1/31(3%) 2/237(1%) 0/99 Vessel revascularization 3/34(9%) 2/37(5) 9/237(4%) 6/99(6%)
47 FLOW CHART Patient with stenoses 50% in at least 2 of the 3 major epicardial vessels Indicate all stenoses 50% considered for stenting Randomization Angiography-guided PCI FFR-guided PCI Measure FFR in all indicated stenoses Stent all indicated stenoses Stent only those stenoses with FFR year follow-up
48 Procedural Characteristics Angio- Guided n = 496 FFR- Guided n = 509 P Value Indicated lesions / patient 2.7± ± Stents / patient 2.7 ± ± 1.3 <0.001 Procedure time (min) 70 ± ± Contrast agent used (ml) 302 ± ± 133 <0.001 Equipment cost (US $) <0.001 Length of hospital stay (days) 3.7 ± ±
49 FAME study: Event-free Survival absolute difference in MACE-free survival FFR-guided 30 days 2.9% 90 days 3.8% Angio-guided 180 days 4.9% 360 days 5.3%
50 Adverse Events at 2 Years Angio- Guided n = 496 FFR- Guided n = 509 Total no. of MACE Individual Endpoints P Value Death 19 (3.8) 13 (2.6) 0.25 Myocardial Infarction 48 (9.7) 31 (6.1) 0.03 CABG or repeat PCI 61 (12.3) 53 (10.4) 0.35 Composite Endpoints Death or Myocardial Infarction 63 (12.7) 43 (8.4) 0.03 Death, MI, CABG, or re-pci 110 (22.2) 90 (17.7) 0.07
51 1 Year Economic Evaluation Bootstrap Simulation Angio Less Costly Angio Better FFR Less Costly FFR Better QALY USD
52 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Flow Chart Stable CAD patients scheduled for 1, 2 or 3 vessel DES-PCI N = 1220 Randomized Trial FFR in all target lesions Registry At least 1 stenosis with FFR 0.80 (n=888) When all FFR > 0.80 (n=332) Randomization 1:1 PCI + MT 73% MT 27% MT 50% randomly assigned to FU Follow-up after 1, 6 months, 1, 2, 3, 4, and 5 years
53 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Primary Outcomes Cumulative incidence (%)30 No. at risk MT PCI+MT Registry 0 PCI+MT vs. MT: HR 0.32 ( ); p<0.001 PCI+MT vs. Registry: HR 1.29 ( ); p=0.61 MT vs. Registry: HR 4.32 ( ); p< Months after randomization
54 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Death from any Cause Cumulative incidence (%) PCI+MT vs. MT: HR 0.33 ( ); p=0.31 PCI+MT vs. Registry: HR 1.12 ( ); p=0.54 MT vs. Registry: HR 2.66 ( ); p= No. at risk MT PCI+MT Registry Months after randomization
55 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Myocardial Infarction Cumulative incidence (%) PCI+MT vs. MT: HR 1.05 ( ); p=0.89 PCI+MT vs. Registry: HR 1.61 ( ); p=0.41 MT vs. Registry: HR 1.65 ( ); p=0.41 No. at risk MT PCI+MT Registry Months after randomization
56 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Urgent Revascularization Cumulative incidence (%) PCI+MT vs. MT: HR 0.13 ( ); p<0.001 PCI+MT vs. Registry: HR 0.63 ( ); p=0.43 MT vs. Registry: HR 4.65 ( ); p=0.009 No. at risk MT PCI+MT Registry Months after randomization
57 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Kaplan-Meier plots of Landmark Analysis of Death or MI Cumulative incidence (%) Cumulative incidence (%) days: HR 7.99 ( ); p=0.038 > 8 days: HR 0.42 ( ); p=0.053 p-interaction: p= Days after randomization >8 days PCI plus MT MT alone 7 days 07days Months after randomization MT alone PCI plus MT
58 FFR and the change of strategy Revascularization A Global view strategy 100% 80% 60% 40% 20% P=0.02 CABG PCI Conservative 0% A priori Final
59 FFR: Change of strategy in 47% of individuals 100% 80% 60% 40% 20% 0% A priori Final P= Modified CABG PCI Conservative R3F registry Steering Comittee: E van Belle, T Cuisset, G Rioufol, C Pouillot, P Dupouy
60 Change of Revascularization strategy according to the «a priori» strategy group 100% 80% 60% 40% 20% 0% Conserv. PCI CABG n=491 n=350 n=104 «A priori» strategy Final strategy CABG PCI Conservative R3F registry Steering Comittee: E van Belle, T Cuisset, G Rioufol, C Pouillot, P Dupouy
61 FFR result and impact on the revascularization strategy FFR 1 0,9 0,8 Conservative PCI CABG 0,7 0,6 Conserv. PCI CABG n=491 n=350 n=104 «A priori» strategy R3F registry Steering Comittee: E van Belle, T Cuisset, G Rioufol, C Pouillot, P Dupouy
62 procédure -Heparine UI IV -Aspirine 250 mg IV -1 mg risordan IC -Egalisation des pressions -Franchissement de la sténose -Stimulus hyper-hémique Adénosine - ATP- Papavérine / IC - IV Krénosin 1 amp/500 ml NaCl 9% = 12 µg/ml -Mesure en continu du ratio Pd/Pa
63 Guide wire straight or J tip pressure sensor - 3 cm proximal to the end of the wire
64 Pressure sensor Tip
65 blood pressure distal to the lesion being assessed - Pressure distal (Pd) conventional pressure transducer - measures arterial/aortic pressure - Pressure arterial (Pa)
66 Pa Pd
67 mean pressures of Pd and Pa are used assuming there is no lesion present = no difference in pressure The difference between these two pressures taken at rest determines if there is a resting gradient across a lesion Gradient calculation = Pd/Pa.
68 no lesion, the pressures will be the same and therefore the gradient value will be 1 E.g. Pa = 150 mmhg Pd = 150mmHg Then Pd/Pa = 1
69 Fractional Flow Reserve The Fractional Flow Reserve (FFR) is a ratio which is measured in a state of Hyperemia
70 Hyperemia Hyperemia state of myocardial vasculature dilatation Myocardial bed - pharmacologically dilated with an agent Adenosine occurs naturally in the body in small quantities and is produced during exercise to assist in the dilatation of the myocardial bed.
71 Dilation of micro-vasculature increases oxygen demand a flow limiting lesion will cause the blood pressure distal to the lesion to fall FFR will fall The extent of this reduction gives an indication as to the degree of flow limitation and hence degree of severity of stenosis
72 Adenosine Pa Decreased Pd Decrease FFR
73 Legalery et al. Am J Cardiol 2003
74 8% 6 dogs 30sec occ. 40 µg ado vs 140 µg IV 15% 26% Rioufol Eurointerv 2005 Lopez-Palop Heart 2004 Jeremias circulation 2000 Jeremias Am Heart J 2000
75 IVA, FFR 1 = 0.75 IVA, FFR 2 = 0.68
76 PAM (mmhg) FFR mmhg 0 mmhg FFR=0.81 FFR=0.75 FFR=0.73 FFR=0.77
77 FFR1 FFR Χ = 0.005± Χ = 0.049± %des FFR>0.80 deviennent 0.80 intubé extubé FFR1 FFR F ou 6F - ostium 3.5 mm
78 Dref2.0 mm MLD 1.5 mm %S 27%
79 Adenosine IV-PSE pull-back FFR = 0.73
80 procédure -Heparine UI IV -Aspirine 250 mg IV -1 mg risordan IC - guiding au choix -Egalisation des pressions -Franchissement de la sténose - hémodynamique stable -Stimulus hyper-hémique Adénosine - ATP- Papavérine / IC - IV Krénosin 1 amp/500 ml NaCl 9% = 12 µg/ml 100 µg IC (12-15 cc) ou 140 µg/kg/min PSE - catheter extubé -Mesure en continu du ratio Pd/Pa - éliminer toute dérive Verifier en fin de procédure
Chun & McGee Am J Med 2004;117:334
Chun & McGee Am J Med 2004;117:334 Tests non invasifs et vie réelle 398.978 patients Pas d ATCD coronaire non invasive test before 83.9% Sténose >70% = 37.6% multivessel disease 53% Un test non invasif
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