William W ONeill MD Henry Ford Health System Medical Director Center for Structural Heart Disease Detroit MI Diffuse Multivessel Disease Border Zone Dysfunction Central Zone Dyskinesis ID: 1014662
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1. Cardiogenic ShockWhere Do We Go After The SHOCK TrialWilliam W. O’Neill, MDHenry Ford Health SystemMedical DirectorCenter for Structural Heart DiseaseDetroit, MI
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4. Diffuse MultivesselDiseaseBorder ZoneDysfunctionCentral ZoneDyskinesisPROFOUND FORWARDPUMP FAILURESystemicHypotensionAcidosisCoronaryHypoperfusionDiffuse MultivesselDiseaseLack of CompensatoryHyperkinesisPathogenesis of Myocardial Dysfunction During Cardiogenic Shock
5. Probability of Survival BasedOn Arterial Blood Lactate10075502500246810Probability of Survival (%)Lactate mM
6. U MICHIGAN EPERIENCE 1983-1985Cardiogenic Shock Complicating Acute Myocardial InfarctionLee et al Circulation 1987
7. SHOCK Trial1-Year Survivalp=0.025p=0.01
8. HypotensionSBP <= 90 *SBP <= 80 * systolic blood pressure in mmHgMortality Based on Admission Blood Pressure in Thrombolytic Trials
9. 1. Dhaval Kolte et al. J Am Heart Assoc 2014 NATIONWIDE INPATIENT SAMPLE2. Centers for Medicare and Medicaid database, MEDPAR FY14Incidence of Cardiogenic Shock GrowingSTEMI Cardiogenic Shock in Medicare Age Increasing 2Cardiogenic Shock in STEMI Increasing 12010201436,96956,50853%Age >65 only, excludes non-Medicare populationHCS-PMA-PP01224-005 rA
10. Limitations of Conventional Therapy1- Samuels LE et al , J Card Surg. 19992- Thiele H et al. NEJM 2012 - Clinicaltrial.gov # NCT00491036IABP-SHOCK II Randomized Controlled Trial2N = 600Mortality Risk with Inotropes/Vasopressors1N = 40IABP (n=301)Medical Therapy (n=299)41.3%39.7%HCS-PMA-PP01224-033 rA
11. Inotrope Harm in Cardiogenic ShockMarked increase in MVO2 at a time of oxygen starvation.Tachycardia increases MVO2 and decreases diastolic interval.Marked increase in LVEDP causes further decrease in diastolic perfusion pressure and increased wall tension. Tachycardia mediated apoptosis may decrease myocardial recovery.
12. New FDA Indication For Cardiogenic ShockThe Impella 2.5™, Impella CP®, Impella 5.0 ™ and Impella LD ™ catheters, in conjunction with the Automated Impella Controller console, are intended for short-term use (<4 days for the Impella 2.5 and Impella CP and <6 days for the Impella 5.0 and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction (AMI) or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump. The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.* Optimal medical management and conventional treatment measures include volume loading and use of pressors and inotropes, with or without IABPHCS-PMA-PP01224-002 rA
13. Hemodynamic Effects of Impella® SupportInflow(ventricle)Outflow(aortic root)aorticvalve Coronary Perfusion Microvascular ResistanceLVEDP and LVEDV O2 DemandUnloading to Myocardial Recovery O2 Supply Mechanical Work Wall Tension Cardiac Power Output FlowEnd Organ Perfusion MAPFincke J, et al. Am Coll Cardiol 2004den Uil CA, et al. Eur Heart J 2010Mendoza DD, et al. AMJ 2007Torgersen C, et al. Crit Care 2009Torre-Amione G, et al. J Card Fail 2009Suga H. et al. Am J Physiol 1979Suga H, et al. Am J Physiol 1981Burkhoff D. et al. Am J Physiol Heart Circ 2005Burkhoff D. et al. Mechanical Properties Of The Heart And Its Interaction With The Vascular System. (White Paper) 2011Sauren LDC, et al. Artif Organs 2007Meyns B, et al. J Am Coll Cardiol 2003 Remmelink M, et al. atheter.Cardiovasc Interv 2007Aqel RA, et al. J Nucl Cardiol 2009Lam K,. et al. Clin Res Cardiol 2009Reesink KD, et al. Chest 2004Valgimigli M, et al.Catheter Cardiovasc Interv 2005Remmelink M. et al. Catheter Cardiovasc Interv 2010 Naidu S. et al. Novel Circulation.2011Weber DM, et al. Cardiac Interventions Today Supplement Aug/Sep 2009Est. In-Hospital MortalityCardiac Power Output (Watts)Cardiac Power Output (MAP x Cardiac Output x 0.0022)Fincke, et. al. JACC, 2009 SHOCK TRIAL(n=189)HCS-PMA-PP01224-032 rA
14. Improvement in Cardiac IndexISAR SHOCK Randomized Controlled TrialHemodynamic Stability & LV Unloading with Impella ®(L/min/m2)Seyfarth et al., JACC, 2008Augmented CIVentricular UnloadingImpella 2.5NativeHeartPre-SupportOn Impella1.71±0.452.20±0.641.73±0.591.84±0.71Pre-SupportOn IABPN.S.P= 0.02Native CIN=26Impella 2.5IABPHCS-PMA-PP01224-014 rA
15. Impella® Reduces Need for Inotropes/Pressors RECOVER I FDA IDE Study2(N=16)ISAR-SHOCK RCT1N=25Impella 2.5 Reduction in Inotropes/Pressorsin 24 HoursImpella 5.0 Reduction in Inotropes/PressorsOver days1- Seyfarth et al. JACC 20082- Griffith et a. J Thorac Cardiovasc Surg 2012HCS-PMA-PP01224-030 rA
16. Decrease in Inotropes/Pressors in Right Heart FailureTO UPDATECohort ACohort BAverage time of Impella RP supportPump ImplantAnderson MB. et al., J Ht Lg Transplant. 2015HCS-PMA-PP01224-031 rA
17. The catheter based VAD Registry is a worldwide observational clinical registry designed to monitor patient safety and real-world outcomes of patients supported with Impella 2.5/CP/5.0/LD/RP The cVAD Registry: A Global InitiativeImpella Approved: USA, Canada, Panama, Colombia, Venezuela, Brazil, Portugal, Spain, France, Italy, Greece, Switzerland, Austria, Germany, Belgium, Luxemburg, Netherland, Ireland, UK, Denmark, Norway, Sweden, Finland, Russia, China, Saudi Arabia, KuwaitImpella Approved and cVAD Registry Active: USA, Canada, Spain, France, Italy, Switzerland, Germany, Netherland, UK, Denmark
18. Global cVAD Registry Overview (as of March 2016)~3,000 existing patients (legacy)74 Sites (932 Impella users) and growing10 Countries5 sub-specialties (Interventional cardiology, Cardiac Surgery, Heart Failure, Electrophysiology, Structural Heart)Representative of real world settingWell established operating mechanisms and operationsBaseline, procedural, hemodynamic, imaging, outcome and adverse events data with up to 1 year follow-up
19. Mortality Based on the Number of Inotropes Used Before Impella Supportp<0.001, (N=287)Number of InotropesEarly Initiation of Impella Support Is Associated with Improved Outcomes in AMICS
20. Mortality Based on Duration of Cardiogenic Shock Before Impella Supportp=0.01, (N=140)Early Initiation of Impella Support Is Associated with Improved Outcomes in AMICS [0.1 - 1.3 hrs[[1.3 - 4.8 hrs[[4.8 - 243 hrs]Duration of Cardiogenic Shock Distribution
21. Log-rank test, p=0.004Early Initiation of Impella Support Is Associated with Improved Outcomes in AMICS
22. Distribution of Survival to Explant at Impella Sites(379 sites supported >4 AMICS patients)N=68N=147N=277N=488N=777N=465N=425N=331N=99N=62SurvivalTotal # of PatientsSG Use Associated with Improved OutcomesAbiomed Internal Clinical Quality DataAMI/CGS April 2015 – March 2016
23. Significant Increase in Survival with Use of Swan p<.00001N=1894N=1612Abiomed Internal Clinical Quality DataAMI/CGS April 2015 – March 2016
24. Detroit Cardiogenic Shock Initiative
25. CARDIOGENIC SHOCK A CHANGE IN PARADIGM DOOR TO BALLOON DOOR TO SUPPORT
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