U MICHIGAN EPERIENCE 1983-1985

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Cardiogenic Shock Complicating Acute Myocardial Infarction

6

1. Dhaval Kolte et al. J Am Heart Assoc 2014 NATIONWIDE INPATIENT SAMPLE2. Centers for Medicare and Medicaid database, MEDPAR FY14

INCIDENCE OF CARDIOGENIC SHOCK GROWING

STEMI Cardiogenic Shock inMedicare Age Increasing 2

Cardiogenic Shock inS

2010 2014

Age >65 only, excludes non-Medicare population

8

LIMITATIONS OF CONVENTIONAL THERAPY

1- Samuels LE et al , J Card Surg. 19992- Thiele H et al. NEJM 2012 - Clinicaltrial.gov # NCT00491036

IABP-SHOCK IIRandomized Controlled Trial2

N = 600

Mortality Risk withInotropes/Vasopressors1

N = 40

Inotrope Harm in Cardiogenic Shock

1. Marked increase in MVO2 at a time of oxygen starvation.

2. Tachycardia increases MVO2 and decreases diastolicinterval.

3. Marked increase in LVEDP causes further decrease indiastolic perfusion pressure and increased wall tension.

4. Tachycardia mediated apoptosis may decrease myocardialrecovery.

10

HEMODYNAMIC EFFECTS OF IMPELLA SUPPORT

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 ItsInteraction 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

tal

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IMPELLA REDUCES NEED FOR INOTROPES/PRESSORS

RECOVER I FDA IDE Study2

(N=16)ISAR-SHOCK RCT1

N=25

Impella 2.5Reduction in Inotropes/Pressors

in 24 Hours

Impella 5.0Reduction in Inotropes/Pressors

Over days

1- Seyfarth et al. JACC 20082- Griffith et a. J Thorac Cardiovasc Surg 2012

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The catheter based VAD Registry is a worldwide observational clinical registry designed to monitor patientsafety and real-world outcomes of patients supported with Impella 2.5/CP/5.0/LD/RP

THE CVAD REGISTRY: A GLOBAL INITIATIVE

Impella 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, SaudiArabia, Kuwait

Impella Approved and cVAD Registry Active: USA, Canada, Spain, France, Italy, Switzerland, Germany, Netherland, UK, Denmark

Basir, O’Neill, et al. TCTAbstract 121 (2016)

Basir, O’Neill, et al. TCTAbstract 121 (2016)

Basir, O’Neill, et al. TCTAbstract 121 (2016)

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DETROIT CARDIOGENIC SHOCK INITIATIVE DETROITCSI

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0

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0.4

0.6

0.8

1

1.2

Pre-Impella Post-Impella

DETROITCSI Observations

1. MCScan be initiated in a majority of patientswithin 60 minutesifarrival.

2. Door to support may become a quality marker for shockmanagement.

3. Most patientshave inotropicsupport eliminated or markedlyreduced before cath lab discharge.

4. Cardiacpower output >0.6 wattscan be achieved in all patientsprior to cath lab discharge.

5. Promising trends in coronary perfusion and survival ( 80 %hospital survival) exist.

CARDIOGENIC SHOCKA CHANGE IN PARADIGM

DOOR TO BALLOON DOOR TO SUPPORT

CARDIOGENIC SHOCK OUTCOME EUROPEAN EECMOExperience

EuroIntervention 2016