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)
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
Grading Risk for LM or MV disease SYNTAX score STS SYNTAX II 4
SYNTAX 5 Year outcomes Equipoise in the low SYNTAX Score group 5 Mohr et al. Lancet 2013.
Left Main subgroup Differences less in the LM Group 6
Surgical Turndowns SYNTAX Registry MGH/BWH Surgical Turndown Registry 7 Waldo, et al. Circulation 2014. 6 fold increase in IH mortality compared to eligible pts, after adjustment
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.
CTO PCI CTO PCI is infrequent Associated with 2x MACE rate as non- CTO PCI Success ~60% 70 % of total PCI Procedural success MACE 60 50 40 % 30 20 55.5 57.1 59.2 59.8 Operator volume 10 3.2 3.5 3.8 4.2 4.8 associated with 1.9 1.6 1.7 1.4 1.3 0 higher success rate, 2009 2010 2011 2012 2013 decreased MACE. 61.9 234 of 1,387 sites (17%) never performed CTO PCI Brilakis et al, JACC Cardiovasc Intv 2015.
IABP for Low EF, High Risk PCI BCIS-1 301 pts with EF < 30, High myocardium at risk No shock or acute MI within 48 hrs IABP vs. no IABP HR 0.66 (0.44-0.98, p=0.039) 10
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 2.5 + 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
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 (%) 76 79 82 DM (%) 26 35 52 Prior Stroke - 8 15 Prior MI (%) 32 73 68 CHF (%) 4-87 Prior PCI 0 10 39 Prior CABG 0 15 33 LVEF 30% (%) 1.3 100 92 Euroscore (Mean±SD) 4±3-18±18 In-hospital Mortality (%) ~1.0 1.3 3.5 ~3 month Mortality (%) 2.5 4.9 10.3 12
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 =0.001-22.0% p =0.004
Impella for Low EF, High Risk PCI PROTECT 2 452 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 14 30-day: IABP 40.1 vs. Impella 35.1, P = 0.277
40% IABP p = 0.737 35.0% 32.5% Impella p = 0.015 28.5% 30% 20% 15.9% 10% 0% 1 Vessel 2 or 3 Vessels Extent of Revascularization PROTECT II Study
16 LVEF Improvement Post PCI p<0.001 33 % ± 11 22% 27 % ± 9 Baseline 90 days LVEF (%) N=304 patients with LVEF measurements available at baseline and 90 days
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
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
Henriques et al, Am Heart J. 2014;0:1-9.e5
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
Cohen et al, Catheter Cardiovasc Interv. 2014:83:1057 1064
High Risk Revasc Guidelines - ACC/AHA/SCAI PCI Guidelines 2011 22
AUC on Multivessel CAD PCI Appropriate Use Criteria, 2012 23
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.!
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
Skill Sets Hemodynamics Interventional volume Atherectomy Laser, Rotablator, Orbital Atherectomy Imaging Treatment Plan Right heart cath Large Bore Devices Peripheral Skills 26
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
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
IABP for STEMI/Shock Thiele, et al. NEJM. 2012.
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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With Further Investigations* and Innovations Percutaneous Biventricular Support Impella CP (LV support) Impella RP (RV support) Impella Right Side Support Trial ClinicalTrials.gov Identifier:NCT01777607
J Interv Cardiol. 2011
34 Martinez et al CCI 2012
35 Martinez C et al ACC 2011
Catheter Cardiovasc Interv. 2012 Dec 1;80(7):1201-9
37 ECMO IABP CPS Hemopump TandemHeart 70 s 80 s 90 s 00 s Impella
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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High-Risk PCI Harjai and O neill. J Interv Cardiol. 2010
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 2013. Velasquez NEJM 2011. 47
Wide variation in success Operators with > 10 CTOs Institutions with > 30 CTOs This represents an enormous opportunity to improve care 48
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. 49 2014 ESC Guidelines: Class II b: Short-term mech support in ACS patients with cardiogenic shock may be considered.
51 Martinez C et al.submitted
Hemodynamic Support Effectiveness Cardiac Power Output Maximal Decrease in CPO on device Support from Baseline (in x0.01 Watts) IABP Impella N=138 N=141-4.2 ± 24 p=0.001-14.2 ± 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 0.0022 (Fincke ( Fincke R, Hochman J et al JACC 2004; 44:340-348) 52
Long-Term Follow-up of Elective CTO PCI: Evidence for Mortality Benefit? 14,439 CTO PCIs between 2005-2009 in England and Wales. Successful CTO PCI and Complete revasc associated with improved survival Causation vs. Confounding? George et al, JACC. 2014.
IMPELLA RP Flow: Access: 4.0 l/mn Outflow in PA Femoral vein Diameter pump: 21F Length cannula: + 140.0mm Diameter cannula: 7.0mm Placement: Sensor: monorail guide wire afterload sensitive Flow monitoring: pressure sensor Inflow in IVC