Who is the high risk patient?

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2 Who is the high risk patient? High risk of periprocedural death or other major complications (hemodynamic compromise, MI, stroke, dialysis) Contributors of Risk Lesion/Procedure Governed by 1. Patient presentation (shock, STEMI, cardiac arrest) Patient Presentation Patient Substrate 2. Patient substrate (elderly, low EF, renal failure, frailty) 3. Lesion risk (unprotected left main, high risk bifurcation, calcification, CTO)

3 The Emerging High Risk Patient High Lesion Risk with Poor Patient Substrate in the Non- STEMI or Elective Setting - Less acute presentations - Low EF, heart failure - Declined for surgery Contributors of Risk - Elderly, diabetic, kidney dz Lesion/Proce - Calcified vessels, CTOs, last remaining vessel, degenerated vein graft - High readmission rates. Lesion/Proce dure Patient Presentation Patient Substrate

4 Grading Risk for LM or MV disease SYNTAX score STS SYNTAX II 4

5 SYNTAX 5 Year outcomes Equipoise in the low SYNTAX Score group 5 Mohr et al. Lancet 2013.

6 Left Main subgroup Differences less in the LM Group 6

7 Surgical Turndowns SYNTAX Registry MGH/BWH Surgical Turndown Registry 7 Waldo, et al. Circulation fold increase in IH mortality compared to eligible pts, after adjustment

8 Complete vs. Incomplete Revasc Association between complete revasc and outcomes as been studies in > 35 studies, > 80,000 patients. Complete revasc associated with lower mortality and MI. 30% reduction in mortality. 22% reduction in MI. Observed for both CABG and PCI. 8 Garcia et al. JACC 2013.

9 CTO PCI CTO PCI is infrequent Associated with 2x MACE rate as non- CTO PCI Success ~60% 70 % of total PCI Procedural success MACE % Operator volume associated with higher success rate, decreased MACE of 1,387 sites (17%) never performed CTO PCI Brilakis et al, JACC Cardiovasc Intv 2015.

10 IABP for Low EF, High Risk PCI BCIS pts with EF < 30, High myocardium at risk No shock or acute MI within 48 hrs IABP vs. no IABP HR 0.66 ( , p=0.039) 10

11 PROTECT II Trial Design Patients Requiring Prophylactic Hemodynamic Support During Non-Emergent High Risk PCI on Unprotected LM/Last Patent Conduit and LVEF 35% OR 3 Vessel Disease and LVEF 30% IABP + PCI R 1:1 IMPELLA PCI Primary Endpoint = 30-day Composite MAE* rate Follow-up of the Composite MAE* rate at 90 days *Major Adverse Events (MAE) : Death, MI (>3xULN CK-MB or Troponin), Stroke/TIA, Repeat Revasc, Cardiac or Vascular Operation or Vasc. Operation for limb ischemia, Acute Renal Dysfunction, Increase in Aortic insufficiency, Severe Hypotension, CPR/VT, Angio Failure

12 High Risk is a Relative Perception Risk Increases from SYNTAX, to BCIS to PROTECT II SYNTAX PCI arm (n=903) BCIS (n=301) PROTECT II (n=448) Age (Mean±SD) 65±10 71±10 67±11 Male (%) DM (%) Prior Stroke Prior MI (%) CHF (%) 4-87 Prior PCI Prior CABG LVEF 30% (%) Euroscore (Mean±SD) 4±3-18±18 In-hospital Mortality (%) ~ ~3 month Mortality (%)

13 Hemodynamic Compromise Based on Extent of Revascularization Decrease in MAP During Procedure (in % from baseline) 1 Vessel IABP Impella 2 Vessels 3 Vessels -3.4% -8.4% -14.4% p <0.001 PROTECT II Study -8.6% -15.6% p = % p =0.004

14 Impella for Low EF, High Risk PCI PROTECT pts with 3VD or LM, depressed EF randomized to IABP vs. Impella 2.5. Primary endpoint in- hospital or 30-day death, MI, stroke, TIA, repeat revasc, CV operation, AKI, procedural hypotension, VT, CPR, AI, PCI failure day: IABP 40.1 vs. Impella 35.1, P = 0.277

15 40% IABP p = % 32.5% Impella p = % 30% 20% 15.9% 10% 0% 1 Vessel 2 or 3 Vessels Extent of Revascularization PROTECT II Study

16 16 LVEF Improvement Post PCI p< % ± 11 22% 27 % ± 9 Baseline 90 days LVEF (%) N=304 patients with LVEF measurements available at baseline and 90 days

17 17 NYHA Improvement Post PCI p<0.001 Class IV 17% 58% reduction 8% 18% in Class III,IV Class III 45% 30% Class II 31% 44% Class I 7% Baseline NYHA Class Distribution N=223 patients with NHYA assessment available at baseline and 90 days 90 days

18 Gray Area of PPCI 3-vessel CAD with EF < 30%* ULM EF < 35%* ULM that is L dominant ULM with occluded RCA LRA with EF < 35%* Retrograde via LRA MV Atherectomy ULM Atherectomy EF < 35% PCWP > 20 > 2 Criteria Recommend PPCI MVO2 < 55 Severe MR Severe Pulmonary HTN High risk for Hemodynamic Collapse

19 Henriques et al, Am Heart J. 2014;0:1-9.e5

20 Study Device Learning Curve Effect 20 Per Protocol Population 90day Outcome (N=423) IABP IMPELLA N=82 N=82 MAE= Major Adverse Event Rate N=63 N=63 N=65 N=68

21 Cohen et al, Catheter Cardiovasc Interv. 2014:83:

22 High Risk Revasc Guidelines - ACC/AHA/SCAI PCI Guidelines

23 AUC on Multivessel CAD PCI Appropriate Use Criteria,

24 O ld very old Frail very frail L otsofcoo-m orbidities P riorca BG (poorl V function) CKD S evereco P D P VD ChronicA F Cancerinrem ission..but still enjoying life.!

25 Conclusion Supported PCI Improves Outcomes In High Risk Patients Coronary Artery Disease is Changing Learn Hemodynamics Right Heart Cath Large unmet need for revascularization in high risk patients Tools Know how to use them BEFORE you need them Develop Protocol For Your Hospital

26 Skill Sets Hemodynamics Interventional volume Atherectomy Laser, Rotablator, Orbital Atherectomy Imaging Treatment Plan Right heart cath Large Bore Devices Peripheral Skills 26

27 Techniques and Tools Guide Extension Inchworm or BAT Wires Know a Few Well Impella Insertion and Management Trapping Balloon Trapliner Trapper CTO strategies Retrograde CART Crossboss and Stingray Twinpass Covered Stents Closure Devices

28 Study Device Learning Curve Effect Per Protocol Population 90day Outcome (N=423) IABP IMPELLA N=82 N=82 N=63 N=63 N=65 N=68 MAE= Major Adverse Event Rate 28

29 IABP for STEMI/Shock Thiele, et al. NEJM

30 Impella for MI and Shock No randomized data USPella registry 154 pts Insertion pre-pci vs. post-pci in AMI with shock More complete revascularization with pre-pci insertion O Neill et al. J Interv Cardiol 2014.

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32 With Further Investigations* and Innovations Percutaneous Biventricular Support Impella CP (LV support) Impella RP (RV support) Impella Right Side Support Trial ClinicalTrials.gov Identifier:NCT

33 J Interv Cardiol. 2011

34 34 Martinez et al CCI 2012

35 35 Martinez C et al ACC 2011

36 Catheter Cardiovasc Interv Dec 1;80(7):1201-9

37 37 ECMO IABP CPS Hemopump TandemHeart 70 s 80 s 90 s 00 s Impella

38 Outflow (aortic root) Flow Inflow (ventricle) AOP EDV, EDP Wall Tension Mechanical Work Microvascular Resistance Coronary Flow Cardiac Power Output Hemodynamic Protection O2 Supply O2 Demand Unloading to Recovery

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46 High-Risk PCI Harjai and O neill. J Interv Cardiol. 2010

47 Ischemic Cardiomyopathy STICH Trial CABG trial with many limitations, but still our best evidence. Inducible myocardial ischemia and viability did not alter the benefit/risk of CABG vs. medical therapy Bonow et al. NEJM, 2011; Panza JACC, et al Velasquez NEJM

48 Wide variation in success Operators with > 10 CTOs Institutions with > 30 CTOs This represents an enormous opportunity to improve care 48

49 Hemodynamic Support 2011 ACC/AHA/SCAI Guidelines: Class II b: elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in carefully selected high-risk patients ESC Guidelines: Class II b: Short-term mech support in ACS patients with cardiogenic shock may be considered.

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51 51 Martinez C et al.submitted

52 Hemodynamic Support Effectiveness Cardiac Power Output Maximal Decrease in CPO on device Support from Baseline (in x0.01 Watts) IABP Impella N=138 N= ± 24 p= ± 27 CPO data available only for 279 patients (N=138 IABP and N=141 Impella Impella)) CPO= Cardiac Power Output = Cardiac Output x Mean Arterial Pressure x (Fincke ( Fincke R, Hochman J et al JACC 2004; 44: ) 52

53 Long-Term Follow-up of Elective CTO PCI: Evidence for Mortality Benefit? 14,439 CTO PCIs between in England and Wales. Successful CTO PCI and Complete revasc associated with improved survival Causation vs. Confounding? George et al, JACC

54 IMPELLA RP Flow: Access: 4.0 l/mn Outflow in PA Femoral vein Diameter pump: 21F Length cannula: mm Diameter cannula: 7.0mm Placement: Sensor: monorail guide wire afterload sensitive Flow monitoring: pressure sensor Inflow in IVC