Mechanical support devices

Mechanical support devices
Marco Barzallo MD, FACC

Temporary devices Intraaortic balloon pump Impella (2.5, CP,5.0, RP)
Tadem Heart ECMO

Indications High risk PCI (coronary intervention ) Cardiogenic shock
VT ablations (Impella) Balloon valvuloplasty

From: Percutaneous Circulatory Assist Devices for High-Risk Coronary Intervention
J Am Coll Cardiol Intv. 2015;8(2): doi: /j.jcin Figure Legend: A comparison of the intra-aortic balloon pump versus the Impella (Abiomed Inc., Danvers, Massachusetts) versus the TandemHeart (CardiacAssist, Inc., Pittsburgh, Pennsylvania) devices. Date of download: 10/30/2016 Copyright © The American College of Cardiology. All rights reserved.

From: Percutaneous Circulatory Assist Devices for High-Risk Coronary Intervention
J Am Coll Cardiol Intv. 2015;8(2): doi: /j.jcin Figure Legend: Venoarterial extracorporeal membrane oxygenation provides continuous, nonpulsatile cardiac output. Devices have become more portable so they can now be implanted percutaneously. Date of download: 10/30/2016 Copyright © The American College of Cardiology. All rights reserved.

From: A Prospective Feasibility Trial Investigating the Use of the Impella 2.5 System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (The PROTECT I Trial): Initial U.S. Experience J Am Coll Cardiol Intv. 2009;2(2): doi: /j.jcin Figure Legend: Photograph of the Impella 2.5 catheter positioned across the aortic valve. Date of download: 10/30/2016 Copyright © The American College of Cardiology. All rights reserved.

Hemodynamic Effects of Impella® Support
Outflow (aortic root) Inflow (ventricle) aortic valve Cardiac Power Output Flow End Organ Perfusion MAP Coronary Perfusion Microvascular Resistance LVEDP and LVEDV O2 Demand Unloading to Myocardial Recovery O2 Supply Mechanical Work Wall Tension Est. In-Hospital Mortality Cardiac Power Output (Watts) Cardiac Power Output (MAP x Cardiac Output x ) Fincke, et. al. JACC, 2009 SHOCK TRIAL (n=189) The principles of the Impella heart pump design allow for direct unloading of the left ventricle from the inflow, and increased MAP and flow in the aorta from the outflow of the device. The ability to unload the left ventricle by reducing your Left ventricular end diastolic pressures and volumes reduce wall tension, microvascular resistance, and increasing coronary perfusion. This results in overall improvement in oxygen supply while simultaneously reducing oxygen demand. Fincke J, et al. Am Coll Cardiol 2004 den Uil CA, et al. Eur Heart J 2010 Mendoza DD, et al. AMJ 2007 Torgersen C, et al. Crit Care 2009 Torre-Amione G, et al. J Card Fail 2009 Suga H. et al. Am J Physiol 1979 Suga H, et al. Am J Physiol 1981 Burkhoff D. et al. Am J Physiol Heart Circ 2005 Burkhoff D. et al. Mechanical Properties Of The Heart And Its Interaction With The Vascular System. (White Paper) 2011 Sauren LDC, et al. Artif Organs 2007 Meyns B, et al. J Am Coll Cardiol 2003 Remmelink M, et al. atheter.Cardiovasc Interv 2007 Aqel RA, et al. J Nucl Cardiol 2009 Lam K,. et al. Clin Res Cardiol 2009 Reesink KD, et al. Chest 2004 Valgimigli M, et al.Catheter Cardiovasc Interv 2005 Remmelink M. et al. Catheter Cardiovasc Interv 2010 Naidu S. et al. Novel Circulation.2011 Weber DM, et al. Cardiac Interventions Today Supplement Aug/Sep 2009 HCS-PMA-PP rA

High risk coronary intervention (PCI)
Protected PCI

A Growing Population Appropriate for PCI
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL 5/13/2018 A Growing Population Appropriate for PCI Patient Comorbidities Heart failure, diabetes, advanced age, peripheral vascular disease, complex lesions, history of angina, prior surgery Complex Coronary Artery Disease Multi-vessel disease, Left Main disease Protected PCI Patients Protected PCI Now found Safe & Effective by FDA for High Risk PCI in hemodynamically stable patients Hemodynamic Compromise Stable but depressed ejection fraction (LVEF<35%) The “shield” in the center represents the convergence of high-risk factors identifying hemodynamically stable patients most appropriate for Protected PCI. Complex coronary artery disease, such as left main disease or multi-vessel disease also is an indicator of increased risk to the patient. Depressed Left Ventricular ejection fraction below 35% is the third risk factor in this triumvirate of high-risk patient characteristics. There are patient comorbidities that increase the risk of a PCI procedure. Some common comorbidities include heart failure, diabetes, advancing age, PVD, complex lesions, prior surgeries and a history of angina.

Patient Characteristics of High Risk
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL 5/13/2018 Patient Characteristics of High Risk REVASCULARIZATION STUDY SYNTAX1 Stent vs. CABG (n=903) HIGH RISK PCI STUDY PROTECT II2,3 Impella 2.5 vs. IABP (n=427) LVEF ≤ 35% (%) ~2 100 CHF (%) 4 87 Unstable Angina 29 40 Diabetes (%) 26 51 Prior MI (%) 32 68 Prior PCI Prior CABG 34 Age (Mean±SD) 65±10 67±11 Not Surgical Candidates (%) 64 * And if they are definitely appropriate for revascularization treatment, should it be CABG or PCI? This should be the decision of an Institution’s Heart Team. This question can be addressed, however, in part, by comparing the patient characteristics of protected PCI patients with patients that are typically enrolled in PCI vs CABG revascularization studies such as the SYNTAX trial. This slide contrasts the PROTECT II trial patient characteristics with the SYNTAX trial patient characteristics. Although the SYNTAX trial is sometimes viewed as addressing a “high risk” patient group, the PROTECT II patients were higher risk in most categories resulting in the majority of them (64%) being not candidates for surgical revascularization, and the remaining determined inoperable by the treating physician. * 64% of patients determined inoperable by surgical consult or refused surgery. Remaining 36% determined not surgical candidate by treating physician. Serruys PW et al., N Engi J Med. 2009;360: Dangas et al., Am. Journ of Cardiol. 2014: 113(2):222-8 Pershad, et al., Am J Cardiol Sep 1;114(5):657-64

Revascularization Strategy by Risk Category
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Revascularization Strategy by Risk Category 5/13/2018 Surgical Risk Low Medium High PCI CABG or PCI PCI or CABG Support & PCI CABG Often inoperable SYNTAX Study Protected PCI FDA Indicated Safe & Effective ACC/AHA PCI Guidelines1,2 Anatomic Risk Furthering the considerations of PCI vs CABG, the Institution’s Heart Team will address the question based on the procedural risk considerations consistent with current ACC/AHA Guidelines. The vertical axis shows degrees of anatomic risk and the horizontal axis shows degree of patient surgical risk. Using this presentation of the risk stratification, the SYNTAX Study patients are all located in the far left column corresponding to lower surgical risk, since all were eligible for cardiac surgery. The lower right hand column is where the Protected PCI patients are found. In patients with medium to high anatomic complexity and high surgical risk, Impella 2.5 is FDA indicated to be safe and effective during a Protected PCI procedure. 1. Levine GN, et al. J Am Coll Cardiol, 2011 Dec 6;58(24):e44-122, 2 Amsterdam EA, et al. Circulation Dec 23; 130(25):e

Patients Most Appropriate for Revascularization
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Patients Most Appropriate for Revascularization 5/13/2018 Coronary Revascularization Appropriateness Guidelines ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT1 Heart Failure Angina High Risk Findings on Noninvasive Study Symptoms Med. Rx Class III or IV Max Rx A Class I or II Max Rx Asymptomatic Max Rx U Class III or IV No/min Rx Class I or II No/min Rx Asymptomatic No/min Rx Coronary Anatomy CTO of 1 vz.; no other disease 1-2 vz. disease; no Prox. LAD 1 vz. disease of Prox. LAD 2 vz. disease with Prox. LAD 3 vz. disease; no Left Main CCS Class III or IV Angina Stress Test Med. Rx High Risk Max Rx A High Risk No/min Rx Int. Risk Max Rx Int. Risk No/min Rx U Low Risk Max Rx Low Risk No/min Rx I Coronary Anatomy CTO of 1-vz; no other disease 1-2-vz. disease; no prox. LAD 1-vz. disease of prox. LAD 2-vz. disease with prox. LAD 3-vz. disease; no left main Protected PCI Patients = More Heart Failure More Angina More Complex More likely to be appropriate Symptoms Symptoms This slide addresses the question of whether or not these highest risk patients should be treated or revascularized in the first place. The revascularization Appropriate Use Criteria, or AUC, help you identify patients most appropriate for a revascularization procedure. In these tables, “A” refers to appropriate to revascularize. The left table stratifies patients based on their heart failure symptoms and anatomic coronary disease complexity and the right table stratifies patients based on their angina symptoms vs anatomic complexity. The yellow outlined box in both tables identifies the Protected PCI patient group which all correspond to “appropriate” for revascularization treatment – so these patients should be treated. A = Appropriate, U = Uncertain, I= Inappropriate A = Appropriate, U = Uncertain, I= Inappropriate Complexity Complexity 1. Patel MR, et al, J AM Coll Cardiol. 2012;59(9);

Impella ® Support Increases Arterial Pressure
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Impella ® Support Increases Arterial Pressure 5/13/2018 U.S. Impella Registry Data1 N=148 Systolic Pressure Diastolic Pressure Mean Pressure p<0.0001 p<0.0001 p<0.0001 139±27 101±20 81±19 119±25 17% 83±18 22% 64±15 These next two slides validate the hemodynamic concepts simulated on the previous slide using data from the Impella registry and PROTECT II. The previous slide demonstrated the concept that when Impella is initially turned on, the arterial pressures increases. That simulated demonstration validated this data from the US Impella Registry showing that when Impella is turned on it moderately increases systolic pressure, more significantly increases diastolic pressure, and overall increases mean arterial pressure. And all of these increases in pressure are statistically significant. This is one aspect of how Impella protects hemodynamics during a case. 26% Pre- Impella On Impella Pre- Impella On Impella Pre- Impella On Impella 1. Maini et al,.Catheter Cardiovasc Interv Nov 1;80(5):717-25

HCS-PMA-PP00915 rB_Protected PCI with Impella 2
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL 5/13/2018 Impella® Maintains Patient Hemodynamics Allowing For More Complete Revascularization Procedural Decrease in Arterial Pressure from Baseline Baseline Protected PCI IABP Impella N = 325 The other aspect of how Impella protects hemodynamics during a case (as seen in the simulated case) is that it maintains arterial pressure after coronary balloon inflation even if the heart’s contractility is lost. This concept is validated in the data from the PROTECT II study. This slide looks at the maximum decrease in mean arterial pressure as you treat differing numbers of coronary vessels. The yellow bars are the Impella-protected patients, and you can see that these patients had smaller decreases in mean arterial pressure across all subsets of patients treated which enable operators to perform a more extensive or complete revascularization. In fact, Impella protected patients experienced the least drop in Arterial Pressure relative to the IABP when 3 vessels were treated. p <0.001 p =0.007 p =0.026 FDA Approved Randomized Controlled Trial Protect II Kovacic, et al. J Interv Cardiol Feb;28(1):32-40

Protect II Trial Design
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL 5/13/2018 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% R 1:1 IABP + PCI IMPELLA 2.5 + PCI Primary Endpoint = 30-day Composite MAE* rate Protect II trial design including the composite endpoint. 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 O’Neill et al, Circulation. 2012;126(14):

Protect II Procedural Characteristics
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Protect II Procedural Characteristics 5/13/2018 Procedural Characteristics IABP (N=211) Impella (N=216) p-value Use of Heparin 82.4% 93.5% <0.001 IIb/IIIa Inhibitors 26.5% 13.4% Total Contrast Media (cc) 241±115 267±141 0.035 Rotational Atherectomy (RA) 9.0% 14.2% 0.083 Median # of RA Passes/lesion (IQ range) 1 (1-2) 3 (2-5) 0.001 Median # of RA passes/pt (IQ range) 2.0 ( ) 5.0 ( ) 0.003 Median RA time/lesion (IQ range sec) 40 (20-47) 60 (40-97) 0.004 RA of Left Main Artery 3.1% 8.0% 0.024 Total Support Time (hours) 8.23±21.0 1.86±2.7 Discharge from Cath Lab on device 37.7% 5.6% The Protect II procedural characteristics demonstrated more frequent and more aggressive use of atherectomy in the Impella arm shorter support time and fewer patients discharged from the cath lab on support compared to the IABP. The protocol called for support to be discontinued in the cath lab after the PCI unless the patient was hemodynamically unstable at that time. O’Neill et al, Circulation. 2012;126(14):

Impella ® Reduces Peri & Post Procedural MACCE
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Impella ® Reduces Peri & Post Procedural MACCE 5/13/2018 MACCE MACCE = Death, Stroke, MI, Repeat revasc. 10 15 20 25 30 29% reduction In MACCE IABP N=211 MACCE (%) Impella N=216 This slide shows the overall MACCE Kaplan-Meyer curves from the PROTECT II study. Use of Impella during the PROTECT II trial resulted in a 29%, overall reduction in MACCE events as compared to use of the IABP at 90 days. p=0.042 10 20 30 40 50 60 70 80 90 Time Post Procedure (day) FDA Approved Randomized Controlled Trial Protect II Dangas et al, Am. Journ of Cardiol. 2014: 113(2):222-8

Major Adverse Events Per Protocol (N=427) 22% 30 Day MAE 90 Day MAE
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Major Adverse Events 5/13/2018 Per Protocol (N=427) 30 Day MAE 90 Day MAE 20 25 30 35 40 45 50 IABP p=0.092 N=216 N=211 N=215 N=210 22% reduction p=0.023 Major Adverse Events Rate (%) Impella The Protect II trial composite endpoint of 10 Major Adverse Events (MAE) is shown at 30 days with a trend towards lower MAE in the Impella arm, and a significant reduction in the Impella arm at 90 days on the left, and as a Kaplan Meier curve on the right. Log rank test, p=0.048 IABP Impella IABP Impella 10 20 30 40 50 60 70 80 90 Time post index procedure (days) MAE= Major Adverse Event Rate O’Neill et al, Circulation. 2012;126(14):

Pre-Specified Sub-group Analysis
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Pre-Specified Sub-group Analysis 5/13/2018 90 day MAE Relative Risk [95% CI] Group p-value Interaction 0.79 [0.64, 0.97] 0.023 0.70 [0.55, 0.89] 0.003 1.19 [0.75, 1.91] 0.444 0.82 [0.53, 1.25] 0.351 0.78 [0.61, 0.99] 0.039 1.14 [0.75, 1.71] 0.540 0.71 [0.56, 0.91] 0.006 0.92 [0.62, 1.38] 0.697 0.74 [0.58, 0.95] 0.016 Overall – Per Protocol (n=425) Impella better IABP better 0.0 0.5 1.0 1.5 2.0 PCI Procedure Without Atherectomy (n=373) 0.087 With Atherectomy (n=52) Anatomy ULM / Last conduit (n=101) 0.845 3VD (n=324) STS Mortality Score STS ≥ 10 (n=71) Pre-specified sub-group analysis was conducted in the Protect II randomized controlled trial. In all subgroups, Impella demonstrated statistically significant reductions in the composite 90-day MAE rate compared to IABP. 0.092 STS < 10 (n=354) Roll in subject 1st Impella/IABP Pt per site (n=116) 0.348 After 1st Impella/IABP Pt (n=309) Per Protocol O’Neill et al, Circulation. 2012;126(14):

HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Major Adverse Events 5/13/2018 Pre-specified High Risk PCI Without Atherectomy Group (N=375) 30 Day MAE 90 Day MAE Time from index procedure (days) 10 20 30 40 50 60 70 80 90 Major Adverse Events Rate (%) 25 35 45 Log rank test, p=0.005 Impella IABP 29% reduction p=0.003 N=184 N=191 p=0.01 N=184 N=191 Rotational atherectomy was conducted in 12% patients enrolled in Protect II. It was also observed more often, and was done more aggressively, in the Impella arm. The remaining 88% of patients enrolled in the study experienced a lower rate of MAE in the 30 day/90 day end points, and Kaplan Meier curve of MAE over 90 days. IABP Impella IABP Impella MAE= Major Adverse Event Rate Cohen et al, Catheter Cardiovasc Interv Jun 1;83(7):

More Complete Revascularization Leads to Reduced Adverse Events
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL More Complete Revascularization Leads to Reduced Adverse Events 5/13/2018 MACCE at 90 Days Protect II, Both IABP and Impella Arms, All Patients p=0.019 And extensive revascularization is important since multiple studies have shown that it correlates with improved patient outcomes (Rosner G et al. Circulation 2012, Farooq et al, JACC 2013, Hannan EL et al. JACC Intv 2009;2:17-25, Généreux et al. J Am Coll Cardiol Jun 12;59(24): ). A similar result was observed in the PROTECT II study, where more extensive revascularization led to lower MACCE. N=157 N=215 N=53 FDA Approved Randomized Controlled Trial Protect II O'Neill, PROTECT II Abstract, Presented at Transcatheter Cardiovascular Therapeutics 2013

Additional Impella ® Safety Endpoints1
HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL Additional Impella ® Safety Endpoints1 5/13/2018 IABP Control Arm (n=210) Impella Protected PCI (n=215) p-value Aortic Valve Damage NA Vascular Complications2 1.9% 1.4% 0.680 Acute Renal Dysfunction 4.8% 4.2% 0.774 (Total Contrast media) 3 (241 mL) (267 mL) (0.036) Low reported incidence of adverse events such as aortic valve damage, vascular complications, and acute renal dysfunction demonstrates the strong safety profile of Impella. Also, the total contrast used during a procedure was higher in the Impella-protected arm of PROTECT II, with numerically less acute renal dysfunction (protective role for kidneys during revascularization). O’Neill WW et al. Circulation Oct 2:126(14): Vascular complications from Protect II RCT = Cardiac, thoracic, or abdominal operation, or vascular operation for limb ischemia. Acute renal dysfunction was numerically lower even with additional contrast media in the Protected PCI with Impella arm of Protect II RCT

HCS-PMA-PP00915 rB_Protected PCI with Impella 2.5 Educational Material_FINAL 5/13/2018 Conclusions Candidates are hemodynamically stable, higher risk patients that have depressed LVEF, complex CAD, and with co-morbidities Higher risk patients are appropriate for revascularization according to AUC criteria; a heart team should determine PCI or CABG Impella is a hemodynamic percutaneous support device proven safe and effective in elective and urgent High Risk PCI patients Benefits from a Protected PCI may include: More complete revascularization with reduction in MACCE Reduction in symptoms and class of heart failure Improvement in LVEF post procedure Reduction in days in the hospital Reduction in readmissions due to fewer repeat procedures Clinical guidelines and the FDA approval support the use of Impella 2.5 for Protected PCI in this higher risk patient population

Cardiogenic shock

Incidence of Cardiogenic Shock Growing
Cardiogenic Shock in STEMI Increasing 1 STEMI Cardiogenic Shock in Medicare Age Increasing 2 56,508 36,969 53% A recent increase in the incidence of cardiogenic shock in both the overall STEMI population and the Medicare patient population emphasizes the importance of focusing on this critical patient population. While some believe this is partially driven by better documentation, the result is a rate approximately 50% higher than that documented in previous literature (10-12% vs 5-7%). 2010 2014 Age >65 only, excludes non-Medicare population 1. Dhaval Kolte et al. J Am Heart Assoc NATIONWIDE INPATIENT SAMPLE 2. Centers for Medicare and Medicaid database, MEDPAR FY14 HCS-PMA-PP rA

Cardiogenic Shock Remains Leading Cause of Mortality in Acute Myocardial Infarction
5/13/2018 High In-Hospital Mortality During AMI Cardiogenic Shock1 … and Ongoing Hazard Post Discharge after AMI Cardiogenic Shock2 N = 23,696 N = 112,668 % 2000 2001 2002 2003 2004 2005 2006 10 20 30 40 50 60 70 80 Death Rate, % 90 100 Mortality % Post Discharge Even more concerning is that in-hospital mortality remains high at over 50% for more than a decade. It also remains an ongoing hazard after a patient survives their hospital experience, with an additional 10% mortality in just the first 60 days after they are discharged. 1. Jeger, et al. Ann Intern Med. 2008 2. Shah, et al. JACC 2016 NCDR Registry HCS-PMA-PP rA

Mortality in PCI with Cardiogenic Shock Remains a Clinical Challenge
In-Hospital Mortality AMI Cardiogenic Shock with PCI1 N = 32,598 31% 28% p<0.0001 11% When more specifically at outcomes in the Cath Lab for AMI cardiogenic shock with PCI, cardiogenic shock remains the leading cause of mortality in the stemi setting. An increase in mortality in recent years, with a similar increase in morbidity and complexity of the patient population, emphasize the need to relook at current clinical practice and role of hemodynamic support. AMI Cardiogenic Shock with PCI only; Overall mortality >50% Wayangankar, et al. JACC Int 2016 CATH-PCI Registry HCS-PMA-PP rA

Reverse the Cardiogenic Shock Spiral
5/13/2018 Reverse the Cardiogenic Shock Spiral Myocardial Recovery Patients Reverse Spiral Cardiac Output MAP Death Spiral of Cardiogenic Shock Cardiogenic Shock Identifiers (Protocol elements) SBP <90 mmHg or on Inotropes/Pressors Cold, clammy, tachycardia Lactate elevated >2 mmoI/L Cardiogenic etiology evaluation EKG (STEMI / NSTEMI) Echocardiography If available, PA catheter, Cardiac Output, CPO, CI, PCWP, SvO2 Cardiac Power Output End Organ Perfusion The goal in the setting of cardiogenic shock is to break and reverse the downward spiral. Impella provides hemodynamic stability, and can reverse the cycle by increasing 1) coronary flow 2) end organ perfusion, 3) cardiac output and 4) decrease LVEDP. With the goal of myocardial recovery, it is critical to identify cardiogenic shock early, initiate early support with Impella, accomplish complete revascularization, and evaluate for recovery or the need to escalate for a higher level left side support and ambulation, or right side/combined biventricular support Ischemia End Organ Failure Progressive Myocardial Dysfunction Impella Now FDA Approved for Cardiogenic Shock Therapy HCS-PMA-PP rA

The Global cVAD Registry™
Reported Usage at Registry Sites N=2704 Characteristics of AMI/CS Patients N= 485* HRPCI Elective & Urgent 47% (n=1275) Cardiogenic Shock 40% (n=1090) Other 13% (n=339) The global CVAD registry is now the largest active registry evaluating hemodynamic support in various clinical settings. It is also the source for multiple FDA PMA approvals and post market surveillance, and a source for clinical best practices for improved outcomes. The catheter based VAD Registry is a worldwide, multicenter, IRB approved, monitored clinical registry of all patients at participating sites; registry data is used for FDA PMA submissions * cVAD Registry Data of Patients Undergoing PCI for Acute Myocardial Infarction Complicated by Cardiogenic Shock as of September 2015 cVAD Registry HCS-PMA-PP rB

Samuels LE et al , J Card Surg. 1999
High dose Vasopressors/inotropes Associated With Increased In-Hospital mortality Mortality Risk N = 3462 Three High Dose 2% 3% 7.5% 21% 42% 80% No Inotrope Low Moderate One High Two High Conventional therapy is largely driven by the use of inotropes and vasopressors, which have long been known to be associated with high mortality rates as both dosage and number is increased. Samuels LE et al , J Card Surg. 1999 HCS-PMA-PP rA

IABP in AMI Cardiogenic Shock: No Hemodynamic or Survival Benefit
5/13/2018 IABP in AMI Cardiogenic Shock: No Hemodynamic or Survival Benefit IABP SHOCK I Randomized Controlled Trial1 N = 40 IABP-SHOCK II Randomized Controlled Trial2 N = 600 IABP (n=301) Medical Therapy (n=299) IABP (n=19) Medical Therapy (n=21) 41.3% 39.7% Recent randomized controlled trials have challenged the benefit of IABP in the setting in AMI cardiogenic shock . Even basic hemodynamic benefit was not observed because IABP is only augmenting the native heart function, which is low or nonexistent in this population. Large randomized controlled trials have also shown no mortality benefit. Meta-analysis of IABP and the PAMI-II trial showed an increased hazard risk for stroke leading to a class 3, harm/no benefit, level of evidence A, in 2014 ESC guideline updates CPO = MAP x Cardiac Output x log-rank, p=0.92 IABP Increased hazard risk of stroke, downgraded to Class III (harm), Level of Evidence A, ESC STEMI Guidelines 2014 1- Prondzinsky R. et al. Jn Critical Care Medicine IABP SHOCK I 2010 – Clinicaltrial.gov # NCT 2- Thiele H et al. NEJM Clinicaltrial.gov # NCT HCS-PMA-PP rA

Hemodynamic Stability & LV Unloading with Impella ®
Improvement in Cardiac Index ISAR SHOCK Randomized Controlled Trial Hemodynamic Stability & LV Unloading with Impella ® (L/min/m2) Seyfarth et al., JACC, 2008 Augmented CI Ventricular Unloading Impella 2.5 Native Heart Pre-Support On Impella 1.71±0.45 2.20±0.64 1.73±0.59 1.84±0.71 On IABP N.S. P= 0.02 Native CI N=26 The same hemodynamic improvements can be seen in a randomized controlled trial called ISAR SHOCK with the Impella Improvement in cardiac index while simultaneously unloading the left ventricle with statistical improvement over results observed with the IABP. HCS-PMA-PP rA

Hemodynamic Improvement Impella - cVAD Registry™
HCS-PMA-PP01224 rA_Physician Heart Recovery and Cardiogenic Shock External_FINAL 5/13/2018 MAP Cardiac Output 94.4±23.1 5.3±1.7 62.7±19.2 3.4±1.3 p<0.0001 p<0.0001 51% 56% (n=143) (n=23) Pre-Support On Support Pre-Support On Support Cardiac Power Output (MAP x CO x ) PCWP 31.9±11.1 Improvement in cardiac power output, as well as mean arterial pressure and wedge pressure, were seen with the Impella 2.5 in the largest ongoing registry for hemodynamic support in cardiogenic shock 1.06±0.48 19.2±9.7 p<0.0001 40% 0.48±0.17 120% p<0.0001 (n=23) (n=25) Pre-Support On Support Pre-Support On Support The catheter based VAD Registry is a worldwide, multicenter, IRB approved, monitored clinical registry of all patients at participating sites; registry data is used for FDA PMA submissions O’Neill, et. al. J Interven Cardiol, 2013 cVAD Registry HCS-PMA-PP rC

Clinical Outcomes By Support Strategy
5/13/2018 Support Strategy (N=154) No support Pre-PCI (N=38) IABP Pre-PCI (N=53) Impella Pre-PCI (N=63) PCI PCI PCI Impella Post PCI Impella Post PCI Continue Impella P=0.016 N=38 N=53 N=63 Survival to discharge cVAD Registry O’Neill, et. al, J Interven Cardiol, 2014 HCS-PMA-PP rD

Impella® Best Practices in AMI Cardiogenic Shock
5/13/2018 Cardiogenic etiology evaluation SBP <90 mmHg or on Inotropes/Pressors Cold, clammy, tachycardia Lactate elevated >2 mmoI/L Identify (Protocols) EKG (STEMI / NSTEMI) Echocardiography If available, PA catheter, Cardiac Output, CPO, CI, PCWP, SvO2 Stabilize Early Impella Support pre-PCI Reduce Inotropes/Pressors Complete Revascularization PCI Guidelines based in Cardiogenic Shock ↑Cardiac Output ↑Cardiac Power Output ↑ Urine Output ↓ Lactate ↓ Inotropes Assess for Myocardial Recovery (Weaning and Transfer Protocols) Best practices for improving outcomes and cardiogenic shock include: early identification with the documentation of protocols for the emergency department, intensivists, ICU nurses, and in the Cath Lab. Stabilizing early with Impella support pre-PCI and reduction of inotropes in vasopressors The ability to provide a complete Revascularization per the PCI guidelines. Establish a weaning protocol is to assess for myocardial recovery and the ability to escalate and ambulate as needed, or transfer to other hospital as needed Myocardial Recovery No Recovery Escalate & Ambulate Ongoing Left heart failure Assess for Right heart failure HCS-PMA-PP rA

5/13/2018 Population Studies Show Reduced Mortality with pVAD in AMI Cardiogenic Shock Mortality AMI Cardiogenic Shock Pre/Post PVAD Era Mortality In AMI Cardiogenic Shock ECMO/eLVAD vs. PVAD p=0.012 p<0.001 N=1188 Co-morbidity Matching N=11,887 In large population-based studies evaluating the outcomes of pVADs in cardiogenic shock, mortality improved when looking at clinical practice with the availability of pVADs as compared to prior. Interestingly, IABP was associated with higher mortality and higher cost in the same setting. Mortality benefit was also seen in a comorbidity paired study comparing Pvad with surgical MCS (85% ECMO). No PVAD PVAD Era Surgical MCS PVAD Stretch, et. al JACC 2014 National Inpatient Sample Maini, et. al. CCI, 2014 and SCAI/ACC/STS /HFSA Expert Consensus Document HCS-PMA-PP rA

Clinical Society Guidelines for Impella Therapy
5/13/2018 Clinical Society Guidelines for Impella Therapy Clinical Society Guideline Populations (SCAI, ACCF, HFSA, STS, ISHLT, HRS) Class Latest Update Impella FDA Approval PCI in Cardiogenic Shock I 2013 2016 Multi-organ failure, Cardiogenic Shock PCI in Low Ejection Fraction, Complex CAD IIb 2011* 2015 Bridge to Recovery or Decision, Cardiogenic Shock IIa STEMI and Cardiogenic Shock STEMI and Urgent CABG Acutely Decompensated Heart Failure 2012 TBD Consensus Document on Hemodynamic Support N/A 2015/16 ** Categories referencing Impella include Percutaneous LVAD, PVAD, Non-durable MCS, TCS and percutaneous MCSD * Excludes Protect II Randomized Controlled Trial, and FDA PMA approval studies due to timing of available data in 2011 HCS-PMA-PP rA

Shock is an spectrum rather than a single syndrome
No single device fits all scenarios Lack of strong clinical evidence and or randomized control trials to support a unified strategy

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