Treatment of Cardiogenic Shock – in the Community Setting - PowerPoint Presentation

1. Treatment of Cardiogenic Shock – in the Community SettingFarhan J. Khawaja MD, FACC, FSCAI, RPVI

2. OUTLINEDefinition of Cardiogenic ShockEpidemiology- A Call to ActionTreatment of Cardiogenic Shock Advances in the Treatment of Cardiogenic Shock

3. Cardiogenic ShockAtkinson (J Am Coll Cardiol Intv 2016;9:871–83)

4. 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 rACardiogenic Shock (%)

5. Cardiogenic Shock Remains Leading Cause of Mortality in Acute Myocardial Infarction200020012002200320042005200601020304050607080 Death Rate, %901001. Jeger, et al. Ann Intern Med. 2008 2. Shah, et al. JACC 2016 NCDR RegistryHigh In-Hospital MortalityDuring AMI Cardiogenic Shock1… and Ongoing Hazard Post Discharge after AMI Cardiogenic Shock2Mortality % Post DischargeN = 112,668N = 23,696 %HCS-PMA-PP01224-006 rA

6. Mortality in PCI with Cardiogenic Shock Remains a Clinical ChallengeIn-Hospital MortalityAMI Cardiogenic Shock with PCI1N = 32,598Wayangankar, et al. JACC Int 2016 CATH-PCI Registryp<0.00012005-20062011-201328%31%11%AMI Cardiogenic Shock with PCI only; Overall mortality >50%HCS-PMA-PP01224-007 rA

7. AMI Shock Often Treated in Community Hospitals90%Private/Community10%AMI Cardiogenic Shock with PCI N = 56,4972005-062011-13>500PCI<500PCI>500PCI<500PCIWayangankar et al. JACC Interventions 2016 CATH-PCI REGISTRYAcademic/Gov’tHCS-PMA-PP01224-008 rA

8. Treatment of Cardiogenic ShockRevascularization

9. The 2011 Guideline for PCILevine GN, et al. J Am Coll Cardiol 2011;58:e44-122.Class IPPCI should be performed within 12 hoursof onset of STEMI (LOE = A)PPCI should be performed in patients withSTEMI who develop severe heart failure or cardiogenic shock and are suitable candidates irrespective of the time delay (LOE = B) Class IPPCI is recommended in patients with acute MI who develop cardiogenic shock and are suitable candidates (LOE = B)

10. ESC Guidelines2017 ESC Guidelines for the Management of Acute Myocardial Infarction in Patients Presenting With ST-Segment Elevation: The Task Force for the Management of Acute Myocardial Infarction in Patients Presenting With ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J 2017;Aug 26:

11. Culprit lesion only PCIImmediate multivessel PCI344219207198192189184341199172162156153152Culprit lesion only PCIImmediate multivessel PCICulprit lesion only PCIImmediate multivessel PCIRelative risk 0.83; 95% confidence interval 0.71-0.96; P=0.01All-cause mortality or renal replacement therapy (%) 344219207198192189184341199172162156153152Number at risk:All-cause mortality or renal replacement therapy (%) Immediate multivessel PCIPrimary Study EndpointAll-Cause Mortality or Renal Replacement Therapy55.4%Number at risk:55.4%45.9%

12. Mechanical Circulatory SupportAtkinson (J Am Coll Cardiol Intv 2016;9:871–83)

13. IABP in AMI Cardiogenic Shock: No Hemodynamic or Survival Benefit 1- Prondzinsky R. et al. Jn Critical Care Medicine IABP SHOCK I 2010 – Clinicaltrial.gov # NCT004692482- Thiele H et al. NEJM 2012 - Clinicaltrial.gov # NCT00491036IABP-SHOCK II Randomized Controlled Trial2N = 600IABP SHOCK IRandomized Controlled Trial1N = 40IABP Increased hazard risk of stroke, downgraded to Class III (harm), Level of Evidence A, ESC STEMI Guidelines 2014 IABP (n=19)Medical Therapy (n=21)IABP (n=301)Medical Therapy (n=299)log-rank, p=0.92 41.3%39.7%CPO = MAP x Cardiac Output x 0.0022HCS-PMA-PP01224-010 rA

14. New Cardiogenic Shock Indicated Therapy: ImpellaHCS-PMA-PP01224-011 rA

15. FDA IndicationThe 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

16. Data Supporting FDA IndicationsScientific Evidence Total # of Patients# of Impella PatientsRecover I FDA Study1717ISAR Shock RCT 2613U.S. Impella Registry401401Literature review2,537692Total2,9811,123Protect I FDA Study2020Protect II FDA Study452225U.S. Impella Registry1,322637Literature review2,537756Total4,3311,638HCS-PMA-PP00908-014 rCProtected PCI24,000 Patients from FDA medical device reporting (MDR) databaseCardiogenic Shock

17. StudyTrial IDConditionPts Required (n)Pts Enrolled (n)Duration(months)StatusReason for Discontinuation FRENCH TRIAL (2006)NCT00314847AMI CS2001952DiscontinuedLow EnrollmentISAR-SHOCK (2006)NCT00417378AMI CS262619CompletedN/AIMPRESS (2007)NTR1079trialregister.nlSTEMI Pre-CS1301822DiscontinuedLow EnrollmentRECOVER I FDA (2008)NCT00596726PCCSUp to 201728CompletedN/ARECOVER II FDA (2009)NCT00972270AMI CS384118DiscontinuedLow EnrollmentRELIEF I (2010)NCT01185691ADHF20133DiscontinuedLow EnrollmentDANSHOCK (2012)NCT01633502AMI CS360~5040EnrollingN/ARandomization in AMI CS is Challenging Prospective Impella Trials In Emergent SettingsHCS-PMA-PP01224-026 rA

18. Population Studies Show Reduced Mortality with pVAD in AMI Cardiogenic Shock2004 - 20072008 - 2011No PVADPVADEraMortality AMI Cardiogenic Shock Pre/Post PVAD Erap=0.012N=11,887SurgicalMCSPVADp<0.001N=1188Co-morbidity MatchingMortality In AMI Cardiogenic ShockECMO/eLVAD vs. PVADStretch, et. al JACC 2014 National Inpatient SampleMaini, et. al. CCI, 2014 and SCAI/ACC/STS /HFSA Expert Consensus DocumentHCS-PMA-PP01224-022 rA

19. 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 2009HCS-PMA-PP00229-017 rH

20. Dagmar M. Ouweneel et al. JACC 2017;69:278-287IMPRESS

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22. National Variation in Impella AMI/CGS OutcomesData on file. Abiomed Impella Quality(IQ)Data, AMI/CGS Apr 2015 – Mar 2016. Danvers, MA: Abiomed.Greater than 90% of survivors were explanted with native heart recovery

23. Improvement in National OutcomesData on file. Abiomed Impella Quality(IQ)Data, AMI/CGS Apr 2016 – Sept 2017. Danvers, MA: Abiomed.525 sites supporting >6 AMICS patients, 7,483 patients total since March 2016

24. RV SUPPORTShishehbor CCJM 2017

25. STANDARDIZED APPROACHProtocolEarly Initiation of Hemodynamic SupportHemodynamic Monitoring

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27. IMPELLA PRE

28. HEMODYNAMIC MONITORING

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30. DETROIT CSI INITIATIVE

31. Orlando Health Cardiogenic Shock Protocol

32. Orlando Health Cardiogenic Shock Protocol

33. Orlando Health Cardiogenic Shock Protocol

34. Orlando Health Impella Survival to Discharge (AMI/CGS)11/1911/1713/154/6

35. Registry OutcomesMuharrem Akin et al. JCIN 2018;11:1811-1820

36. Registry OutcomesMuharrem Akin et al. JCIN 2018;11:1811-1820

37. ConclusionCardiogenic Shock remains lethalEarly Revascularization improves survivalMechanical Circulatory Support is redefining the treatment paradigmProtocol Driven Approaches are promising