Appropriate Use: Big Brother is Watching. Jason H. Rogers, MD Director, Interventional Cardiology UC Davis Medical Center

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1 Appropriate Use: Big Brother is Watching Jason H. Rogers, MD Director, Interventional Cardiology UC Davis Medical Center

2 Disclosures Consultant Boston Scientific, Medtronic, Middle Peak Medical, Millipede, St Jude Medical

3

4 Cath Lab Banter Is it tight? Looks tight Doesn t look that tight Looks tight in that view Take another view Tight-ish

5 Let s Just Stent It!!

6 Appropriateness

7

8 Appropriateness Caveats a framework for discussion many patients in clinical practice may not be represented uncertain should not be viewed as excluding the use of revascularization for such patients. it is not anticipated that all facilities will have 100% of their revascularization procedures deemed appropriate.

9

10 500,154 PCIs ACC-NCDR Registry JAMA 2011 July 2009 Sept 2010

11 4.1% 11.2% 84.6% Wall Street Journal 2011

12 Clinical Indication (ACS vs. Stable) Angina Severity (CCS Class) Extent of Ischemia Presence of High Risk Features (!EF) Medical Therapy Coronary Anatomy

13 Stress Testing HIGH MEDIUM LOW

14 Canadian Cardiovascular Society Angina Class CCS I CCS II CCS III CCS IV

15 Maximal Medical Therapy At Least 2 Classes of Therapies

16 R4Q Q3 2011

17 2012 Appropriateness Guidelines

18

19 R4Q 2011 Q3

20 icath App

21 SCAI QIT App

22 FFR

23 Fractional Flow Reserve (FFR)

24 Angiography alone cannot determine hemodynamic significance of intermediate stenoses (40-70%) Gross MC, et al. Radiology 2001;220:751.

25 Angiography: Limitations Nissen SE. Cleveland Clinic Journal of Medicine. 66(8):479-85, 1999 Sep

26 Which Coronary Factor is Constant? Pressure, Flow, or Vessel Size? Pressure (mm Hg) APEX Flow (Q) (ml/min) Diameter (mm)

27 Fractional Flow Reserve (FFR) Pa Pd FFR = Pd Pa (mean distal pressure) (mean aortic pressure) In the presence of maximal hyperemia FFR<0.80 ~ ischemia Kern MJ, et al. Circulation 2006;114:1321.

28 St. Jude Volcano PressureWire Aeris 175 and 300 cm lengths Verrata Wire 185 and 300 cm lengths RadiAnalyzer or Quantien ComboMap

29 Pressure Gradients and Hyperemia 65% stenosis Pressure Gradient (mmhg) Normal vessel Velocity (cm/sec) It is important to induce hyperemia to unmask stenosis significance Kern MJ, et al. Circulation 2006;114:1321.

30 Inducing Hyperemia Adenosine Adenosine Route IV IC Dosage 140 mcg/kg/min mcg LCA mcg RCA Time to hyperemia 1 2 min 5-10 sec Advantage Gold Standard Short action Disadvantage BP by 10-15%, Chest burning AV delay, BP

31 FFR Threshold for Ischemia Non-ischemic Range Ischemic Range Significant stenosis Pijls N., De Bruyne B. et al, N Engl J Med 1996; 334(26):

32 FFR vs. Noninvasive Testing FFR 0.75 ETT Thallium ESE Pijls, et al. NEJM 1996;334:1703

33 Non-Ischemic FFR: Generally 0.80 Normalized Wire Pd/Pa = 1.00

34 Ischemic FFR: Generally <0.75

35 FFR If It Isn t Broken, Don t Fix It

36 THE DEFER STUDY: RANDOMIZATION If FFR < 0.75 If FFR > 0.75 performance of PCI reference group (n=144) randomization followed defer PCI (n=91) perform PCI (n=90) Bech. Circulation 2001;103:2928

37 Supporting Clinical Study: DEFER 5Y Follow-Up P< % P< Cardiac Death and Acute MI Rates P= Pijls et De Bruyne, CRT 2007 DEFER PERFORM REFERENCE FFR > 0.75 FFR < 0.75

38 Case FFR mcg/kg/min

39 Case FFR mcg/kg/min

40 FAME N=496 N=509

41 FAME: Freedom from Death, MI, Revasc Fewer stents are better than more stents! FFR-Guided Angio-Guided 730 days 4.5% Pijls. JACC 2010;56.

42

43 Angiography versus FFR in the FAME study Proportions of functionally diseased coronary arteries in patients with angiographic 3 vessel disease 1-VD 34% 3-VD 14% 0-VD 9% 2-VD 43% 3 Vessel Disease P. Tonino et al ESC 2009

44 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) RandomizaBon 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

45 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Primary Outcomes Cumulative incidence (%) No. at risk MT PCI+MT Registry 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

46 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Urgent Revascularization Cumulative incidence (%) No. at risk MT PCI+MT Registry PCI+MT vs. MT: MT vs. Registry: HR 0.13 ( ); p<0.001 PCI+MT vs. Registry: HR 0.63 ( ); p=0.43 HR 4.65 ( ); p= Months after randomization

47 FAME 2 : FFR-Guided PCI versus Medical Therapy in Stable CAD Patients with urgent revascularization 21.4% Myocardial Infarction 51.8% 26.8% Unstable angina +evidence of ischemia on ECG

48 Equipoise Aug 28, 2012 Aug 28, 2012

49 2012 Key Elements of Appropriateness For Revascularization in Stable Angina Symptoms consistent with angina Document CCS Class Trial of medical therapy Ischemia documented by stress testing or FFR

50 Clarity? Every Patient is Different

51 Summary Public Reporting of Appropriateness is Here Knowledge of Appropriateness Metrics is Essential FFR is an important tool in the catheterization laboratory for lesion assessment and treatment

52 Thank You

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