Left Main PCI. Integrated Use of IVUS and FFR. Seung-Jung Park, MD, PhD

Transcription

1 Left Main PCI Integrated Use of IVUS and FFR Seung-Jung Park, MD, PhD Professor of Medicine, University of Ulsan College of Medicine, Heart Institute, Asan Medical Center, Seoul, Korea

2 Efficacy of Left Main PCI

3 Major Studies PCI vs CABG in Left Main Disease MAIN-COMPARE Registry, 3 year F/U SYNTAX RCT, subgroup LM, 4 year F/U MAIN-COMPARE Registry, 5 year F/U PRECOMBAT RCT, 2 year F/U META-ANAYLSIS of 4 RCTs Seung KB, Park DW, Park SJ, NEJM 2008;358: Parick W.Serruys, et al. TCT 2011 presentation Park DW, et al. JACC 2010;56: Park SJ et al, NEJM 2011; May 5;364(18): Capodanno D etal, JACC 2011;58;

4 PCI vs. CABG for Left Main Disease 1-Year Outcomes PCI (n = 809) CABG (n = 802) OR (95% CI) No Difference in Death or MI 14.5% 11.8% 1.28 ptvr is Higher in PCI group. ( ) 3.0% 4.1% 0.74 Stoke is Higher in CABG group. Primary Endpoint Death ( ) MI 28% 2.8% 29% 2.9% ( ) Stroke 0.1% 1.7% 0.15 ( ) TVR 11.4% 5.4% 2.25 ( ) P Value < Meta-Analysis; Capodanno D etal, JACC 2011;58;

5 Joint 2010 ESC-EACTS Guidelines for unprotected LMCA PCI Subset of CAD by anatomy CABG PCI Left Main (Isolated or 1 VD, ostium/shaft) Left Main (Isolated or 1 VD, distal bifurcation) Left Main + 2VD or 3 VD, SYNTAX score <32 Left Main + 2VD or 3 VD, SYNTAX score >33 IA IA IA IA IIa, B IIb, B IIb, B III, B

6 Current Issue is, How To Do? Functional Angioplasty ; Integrated Use of IVUS and FFR

7 Is Angiography Enough for Diagnosis of Clinical i l Ischemia?

8 Visual Functional Mismatch Visual : 80% IVUS MLA : mm 2 FFR : 0.82 Treadmill test : Negative Thallium spect : Normal Stress Echo : Negative

9 Reverse Mismatch Visual Estimation : 30% FFR : 0.70 IVUS MLA: 4.5 mm2 Treadmill test: + stage 2 Thallium spect : + large LAD

10 Mismatches ; Significant Stenosis (>50%) with Negative FFR Reverse Mismatches ; Insignificant Stenosis (<50%) with Positive FFR

11 How Many Mismatches?

12 Mismatch in intermediate LM Disease 12% 6% 23% 59% Hamilos M, Circulation 2009; 120:

13 Mismatch in Isolated intermediate LM Disease (n=55) FFR 9% 26% DS % (QCA)

14 Why Relatively Higher Reverse Mismatches in LM disease?

15 LM supplied Large Myocardium DS=50% Large Myocardium FFR=0.70 DS=85% FFR=0.90 Acute Onic Injury Scar and/or Chronic Scar Small Myocardium

16 Univariable Analysis to Predict FFR <0.8 Variables C-OR 95%CI p-value MLA within LM <0.001 Plaque burden Lesion length Rupture Angiographic DS Lesion location Male Age Diabetes melitus Hypertension Smoker Hyperlipidemia p Stable presentation

17 Multivariable Analysis to Predict FFR Independent predictors for FFR as continuous variable MLA (β=0.58, %CI CI= , 04 p<0.001) 001) Plaque rupture (β=-0.24, 95% CI= , p=0.036) Kang SJ et al, JACC. Cardiovascular Interventions Nov;4(11):

18 Presence of Plaque Rupture 70% FFR : % % % 0.58 Steady-state 3D Computed Simulation under Hyperemic Condition, AMC data

19 FFR theory FFR is more sensitive and integrated summation of physiological and anatomical aspects (total morphology) of a stenosis rather than 2-dimensional i angiographic g diameter stenosis.

20 Why FFR? 1. Angiography is not always enough! 2. FFR is the only matched index with objective ischemia even in the Left main disease.

21 IVUS MLA vs. FFR

22 IVUS MLA < 6.0 mm 2 is matched with FFR < mm 5.9mm 2 67% 50% Jasti V et al. Circulation 2004;110:2831-6

23 New Comparison AMC prospective cohort registry (n=55 lesions), 2011 FFR vs. IVUS MLA JACC Cardiovasc Interv, 2011 (in press)

24 New IVUS MLA 4.1 mm mm 2 Kang SJ, Park SJ et al, JACC. Cardiovascular Interventions Nov;4(11):

25 New IVUS MLA Matched with FFR <0.80 in LM Disease 4.8 mm 2 Kang SJ, Park SJ et al, JACC. Cardiovascular Interventions Nov;4(11):

26 Jasti s s dataa FF FR 0.8 Large Vessels, 75% Negative FFR Not normal distribution MLA (mm 2 )

27 Kang s data,amc Jasti s s dataa FF FR More Positive FFR Normal Distribution 0.5 Large Vessels, 75% Negative FFR Not normal distribution MLA (mm 2 )

28 Ethnic Difference?

29 Reference Vessel Size of Left Main Coronary Artery by QCA 2309 USA/EU Patients in 17 Studies mm m mm

30 FFR > Sensitivity 89% Specificity 83% NPV 89% PPV 82% 0.9 NPV 89% Accuracy 86% Don t Use Anymore the IVUS 0.8 MLA of 6 mm 2 for LM PCI. It s too Big! 0.7 FFR <0.8 PPV 82% PPV 53% 0.6 MLA mm MLA 6.0 mm 2 MLA 4.8 mm 2

31 Why IVUS?

32 IVUS guidance saves lives in LM PCI ortali ity(%) ive M mulat Cum Angiography-guidance IVUS-guidance P= % 44% 4.4% Park SJ et al, Circulation. Cardiovasc Interv Jun;2(3):

33 Why IVUS guidance The IVUS-guidance will reduce 3-year mortality from MAIN COMPARE registry data. (Park SJ, et al. Circulation Cardiovasc Interv Jun;2(3):167-77) Treat or not treat decision could be made by IVUS MLA 4.8 mm 2 (PPV:82%). IVUS guidance have more understanding about the inside of the vessel (negative remodeling, true reference vessel size and ostial lesion assessment). We can decide the treatment strategy based on IVUS guidance.

34 Ostial and Shaft LM PCI How to Do?

35 Ostial and Shaft LM PCI Functional Assessment (FFR) is Crucial. FFR works LAD LCX Courtesy of Akiko Maehara, MD

36 Ostial and Shaft LM PCI Functional Assessment (FFR) is Crucial. IVUS MLA (4.8 mm 2 ) can predict functional significance of stenosis of LM disease. Just Stent t it! It takes just 5 minutes! We have more than 5-10 year long-term data. No difference of death and MI compared with surgery (even better). Long-term clinical i l outcomes should be comparable to 100% of arterial grafts.

37 Distal Bifurcation LM PCI How to Do?

38 Problem of FFR for LMCA Lesions Possible False Negative Possible False Positive Conceptual Problem! LAD LCX Courtesy of Akiko Maehara, MD

39 In Reality,

40 Plaque Distribution by IVUS (n=140) 1/1,1,1 LMCA (1/1) 1/0,1,1 LMCA (1/0) 1/0,1,0 LMCA (1/0) LAD (1) LCX (1) LAD (1) LCX (1) LAD (1) LCX (0) 62% 14% 14% 0/111 0/1,1,1 0/010 0/0,1,0 0/011 0/0,1,1 0/101 0/1,0,1 LMCA (0/1) LMCA (0/0) LMCA (0/0) LMCA (0/1) LAD (1) LCX (1) LAD (1) LCX (0) LAD (1) LCX (1) LAD (0) LCX (1) 4% 3% 2% 1% In 90% plaque extends from LMCA-LAD Oviedo C et al. Circ Cardiovasc Interv 2010;3:

41 Plaque Distribution by IVUS (n=82 82) In all cases, the LM disease extended into LAD and LCX continuously. Kang et al, Catheterization and Cardiovascular Interventions Jul 29.

42 Placed Transducer Beyond Bifurcation inbothladandlcx LCX FFR still works. Single Unit of Disease LCX LAD

43 Distal LM Bifurcation PCI Single Stent Cross Over 2 Stents Procedures

44 When, 1 vs. 2 stents Single stent Normal ostial LCX with MEDINA or Small LCX with < 2.5 mm in diameter Diminutive LCX Normal or focal disease in distal LCX Two stent Diseased LCX with MEDINA , , or stent Large LCX with 2.5 mm in diameter Diseased left dominant coronary system Concomitant diffuse disease in distal LCX Park SJ, Kim YH. Colombo A, Issam D. Moussa et al. Textbook of Bifurcation Stenting

45 Cu umulative in ncidence (% %) (%) incidence Cumulative MI Nondistal vs Simple p=0.32 Nondistal vs Complex p<0.001 Simple vs Complex p= P< TVR Complex 2 stents Non-distal (Ostial and Shaft) Simple (single stent cross over) In LM bifurcation lesions Single Stent Cross Over yrs MACE is Clearly l better! Nondistal vs Simple p=0.43 Nondistal vs Simple p= Nondistal vs Complex p<0.001 Nondistal vs Complex p<0.001 Simple vs Complex p=0.014 Simple vs Complex p< P<0.001 Cumulative incidence e (%) yrs P< yrs Kim WJ, et al. Catheter Cardiovasc Interv May 1;77(6):775-82

46 Stent t Cross Over for LM Bifurcation Lesions

47 LM Bifurcation Lesion with minimal-disease of LCX 72/M, Unstable angina,

48 IVUS LAD Ostium LCX Ostium Minimal-disease MLA 5.4 mm 2

49 Single Stent Cross-Over with minimal-disease i at LCX OS LM-LAD cross over Cypher mm Additional high pressure Inflation with 4.0 mm non-compliant balloon

50 Final Results after Single Stent t Cross-Over Immediate after the procedure, there was no significant p, g compromise of LCX ostium.

51 FFR of LCX is 0.94 Pre-adenosine Post-adenosine

52 Single Stent Cross-Over IVUS Guided Stent Cross over depending on LCX disease status t by IVUS, stent t size selection, stent optimization. FFR Guided decision making for further treatment about the compromised side branch (LCX).

53 2 stent techniques in LM true bifurcation lesions

54 2 stent Techniques T-stent, modified T-stent or TAP Mini-crush (or step crush) Culotte V-stent Y-stent (SKS-simultaneous kissing stents)

55 When to Choose Different 2 stent Techniques Technique T, modified d T, TAP: Culotte: Mini-crush (or step crush): V-stent: SKS: When to choose angled LCX Y bif with matched LAD/LCX dia. Y bif with LAD/LCX dia mismatch. Medina 0,1,1 (true LMEQ ds) Short LM, unstable pt End with a FKB inflation with all 2-stent techniques Gregg W. Stone, Complex PCI: Left Main and CTO Summit, NY, 2012

56 Whatever you choose 2 stent techniques, You have to consider IVUS guided Stent Optimization!

57 IVUS Stent Area and its Impact for restenosis in 403 Patients with Unprotected Left Main Disease All patients treated with SES 100% Post-stent IVUS, 100% Angiography F/U at 9 months and 2 years clinical F/U Kang SJ, et al. Circulation. Cardiovascular Interventions Dec 1;4(6):562-9.

58 Restenosis at 2 year % 30 Ostial and Shaft Bifurcation PCI /67 14/222 29/114 Single stent Any Two stent

59 IVUS Measurement for LM Bifurcation Stents LCX carina LCX Ostium LM Ostium *POC LAD Ostium 3 mm 3 mm *POC : Polygon Of Confluence LAD carina

60 Minimal Stent Area (mm 2 ) to predict ISR LCX _ LAD Sens sitivity mm 2 Sensitivity 78% specificity 78% AUC= % CI= _ POC Sensitivity 73% specificity 85% AUC= % CI= LM Sensitivity 100% specificity 78% AUC= % CI= Specificity Sensitivity 80% specificity 81% AUC= % CI=

61 IVUS Stent Optimization (Stent Cross-sectionalsectional Area) 8 mm 2 LM ,6,7,8 mm 2 of fstent tcsac Can Make a Good 7 Clinical mm 2 Outcomes in 2 stents POC technique 6 mm 2 in LM bifurcation PCI. 5 mm (Restenosis Rate <5% dtlr<2%) 2 LAD and LCX Kang SJ et al. Circulation. Cardiovascular Interventions Dec 1;4(6):562-9.

62 Whatever you choose 2 stent t techniques, IVUS Final stent CSA (5,6,7,8 mm 2 ) is the most important criteria for the good clinical i l outcomes!

63 Distal LM Bifurcation Treatment For the intermediate LM bifurcation disease, FFR still works. IVUS guidance give us more understanding about the inside of vessel. And also MLA of LM <4.8 mm 2 can predict functional significance of stenosis (PPV 83%). When we used single stent cross over, FFR guided side branch optimization is reasonable approach. When we used 2 stents technique, IVUS guided optimization of stent (IVUS stent CSA 5,6,7,8 mm 2 ) can make a good clinical outcomes.

64 Functional Angioplasty Integrated Use of FFR and IVUS Avoid unnecessary PCI Avoid unnecessary Surgery Minimize MACE Maximize clinical outcomes Save money Save lives