Rationale for Prophylactic Support During Percutaneous Coronary Intervention

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1 Rationale for Prophylactic Support During Percutaneous Coronary Intervention Navin K. Kapur, MD, FACC, FSCAI Assistant Director, Interventional Cardiology Director, Interventional Research Laboratories Boston, MA

2 Relevant Disclosures: Research Support: Cardiac Assist, Abiomed, Maquet, Heartware Consultant/Speaker: Cardiac Assist, Abiomed, Maquet, Thoratec We will be discussing off label uses and investigational devices.

3 Defining Risk during PCI Risk: an exposure to the possibility of loss or injury caused by an action or inaction. To mitigate risk in PCI, ask three questions in advance: 1) Can I achieve angiographic success? 2) Can I do this without causing a complication? 3) Will successful PCI clinically benefit my patient?

4 Defining Risk during PCI Patient Advanced Age Female Diabetics Prior MI Multivessel disease Renal dysfunction Periph. Vasc. disease Depressed LV function Technical ACC/AHA Classification SCAI Classification Large myocardium at risk (Jeopardy Score) Sole-remaining vessel Unprotected LM Bifurcation lesions Chronic total occlusions Saphenous vein graft Clinical Any ACS (Active Ischemia) Cardiogenic Shock

5 Defining Risk during PCI CABG Risk Calculators 1 Euroscore 2 STS Score 3 Mass-Dac CABG 4 Hannan-CABG 5 Euroscore/Parsonnet 6 CCMRP Coronary Risk Calculators 1 Mayo Clinic 2 Wu-PCI 3 Mass-Dac PCI 4 SYNTAX Score Risk calculators for the use of circulatory support during PCI do not exist. Existing risk calculators do not account for deranged hemodynamic conditions.

6 When is Circulatory Support Rational? Patient Advanced Age Female Diabetics Prior MI Multi-vessel disease Renal dysfunction Periph. Vasc. disease Depressed LV function Technical ACC/AHA Classification SCAI Classification Large myocardium at risk (Jeopardy Score) Sole-remaining vessel Unprotected LM Bifurcation lesions Chronic total occlusions Saphenous vein graft Clinical Any ACS (Active Ischemia) Cardiogenic Shock

7 Physiology of High Risk PCI Arterial and Venous Features Govern Myocardial Perfusion 1. Mean arterial pressure 2. Complex coronary lesion 3. Microvascular obstruction 1. LV pressure overload 2. Systemic venous congestion 3. Coronary sinus congestion What is the hemodynamic condition of your patient? Physiol Rev 86: , 2006

8 Goals of Circulatory Support during PCI A B 1. Stabilize systemic perfusion and improve multi organ function. 2. Reduce myocardial oxygen demand by limiting LV wall stress. C 3. Augment coronary perfusion. 4. Create a window in time for: Complete revascularization Comprehensive evaluation (Neuro, Surgical, or Adv HF)

9 How does Circulatory Support Work? Arterial Elastance (Ea) Ea = ESP SV End-Systolic Elastance (Ees) Contractility Afterload = Wall Stress = ESP x EDV Pressure Stroke Volume Stroke Work (PV Area) Potential Energy Volume

10 How does Circulatory Support Work? LV EDV LV ESP LV Work LV EDP Reduced Myocardial O 2 Demand Pressure Volume

11 How does IABP Support Work? MEGA IABP Hemodynamic Effect: Systolic Unloading: mmhg Diastolic Augmentation: mmhg Proximal Aorta Unassisted Systolic Pressure: 98 mmhg Augmented Diastolic Pressure: 122 mmhg Assisted Systolic Pressure: 75 mmhg Unassisted Diastolic Pressure: 58 mmhg

12 How does Rotodynamic Support Work? Baseline Tandem 6500 rpm 6500 rpm + LAD PTCA 93/57, 69 97/75, 81 73/67, 69 Systemic and coronary perfusion maintained. LV EDV LV ESP LV Work LV EDP Reduced Myocardial O 2 Demand

13 Does Circulatory Support Work in Elective HR PCI? (Prophylactic) (Provisional) Prophylactic IABP reduces acute complications, but no change in mortality during PCI in patients with low LVEF. Am Heart J 2003;145:700-7

14 Does Circulatory Support Work in Elective HR PCI? Prophylactic, not rescue, IABP improves clinical outcomes during high risk PCI in patients with hemodynamic instability. Am J Cardiol 2006;98:608-12

15 Does Circulatory Support Work in Elective HR PCI? BCIS 1 Study HR PCI Definition: 1. LVEF<30% 2. High Jeopardy Score No 6-month mortality benefit to elective IABP insertion. JAMA. 2010;304(8):

16 Does Circulatory Support Work in Elective HR PCI?

17 Does Circulatory Support Work in Elective HR PCI? No clear difference between IABP and Impella 2.5 LP in HR-PCI. Follow up analyses have been informative: 1. Trends towards benefit with ITT analysis favoring Impella 2. Rotational atherectomy is an extreme high risk substrate 3. Learning curve support devices improves outcomes 4. Multi-vessel revascularization may be beneficial Circulation 2012

18 Does Circulatory Support Work in Acute MI? CRISP-AMI: Pre-reperfusion IABP in Anterior MI JAMA 2011

19 Does Circulatory Support Work in Cardiogenic Shock? SHOCK-II: IABP in AMI+Cardiogenic Shock STEMI and Non-STEMI 45% Anterior infarct CGS: hypotension / poor perfusion IABP use pre- or post-pci Median LVEF : 35% No PA catheter indices Thiele H et al. NEJM 2012

20 Does Circulatory Support Work in Cardiogenic Shock? Medscape: A Hard Look at Cardiogenic Shock. 2012

21 Does Circulatory Support Work in Cardiogenic Shock? Impella 2.5 and Tandem devices provide better hemodynamic support in cardiogenic shock compared to IABP alone Eur H J 2009

22 Does Circulatory Support Work in Cardiogenic Shock? No change in 30 day mortality with Impella 2.5 or TandemHeart devices in cardiogenic shock compared to an IABP alone. Eur H J 2009

23 Why the disconnect between hemodynamic effect and clinical outcomes? 1. Patient selection No hemodynamic criteria used to characterize patients. 2. Device selection No hemodynamic evaluation of device effect. Are all patients responders to device therapy? 3. No exit strategy in cardiogenic shock. Salvaging the unsalvageable? 4. Incomplete support with a uni ventricular strategy? No assessment of RV function in shock.

24 High Risk PCI I IIa IIb III Elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in carefully selected high risk patients. Treatment of Cardiogenic Shock I IIa IIb III I IIa IIb III The use of intra aortic balloon pump counterpulsation can be useful for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological. Alternative LV assist devices for circulatory support may be considered in patients with refractory cardiogenic shock.

25 Tufts Medical Center: pvad Program Elective High Risk PCI Complex CAD Reduced LVEF Jeopardy Score NYHA Class I / II Compensated Hemodynamics NYHA Class III / IV Decompensated Hemodynamics Optimize hemodynamics No Support Pre PCI IABP Optimize hemodynamics Pre PCI IABP Pre PCI Impella CP Pre PCI TH LVSD Do NOT use mechanical support as a bailout strategy in HR PCI. Rarely, if ever, use device support in HR PCI with normal LVEF.

26 Tufts Medical Center: pvad Program Impella Stepwise escalation CP 5.0 Surgical Availability for 5.0 Axillary Option (Ambulation) Long term LV support BiV support IABP Refractory Cardiogenic Shock TH plvad Trans septal required LV Thrombus Aortic Regurgitation VSD or Acute MR VA ECMO Cardio respiratory Failure VF Arrest Unstable for transport

27 Key Points: High risk PCI is a relative term that is being performed with increasing frequency. There is limited clinical data for circulatory support during high risk PCI. Let the hemodynamics guide your approach: 1. A careful assessment of pre procedural hemodynamics 2. Anticipated need for intra procedural support 3. Close monitoring of post procedural hemodynamc indices during device weaning and removal.

28 Thank you.

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