Treatment of

Cardiogenic Shock – in
the Community Setting
Farhan J. Khawaja MD, FACC,
FSCAI, RPVI
OUTLINE

• Definition of Cardiogenic Shock

• Epidemiology- A Call to Action
• Treatment of Cardiogenic Shock
• Advances in the Treatment of Cardiogenic Shock
Cardiogenic Shock

Atkinson (J Am Coll Cardiol Intv 2016;9:871–83)

 4

INCIDENCE OF CARDIOGENIC SHOCK GROWING

Cardiogenic Shock in STEMI Cardiogenic Shock in

STEMI Increasing 1
Medicare Age Increasing 2

56,508

36,969
Cardiogenic Shock (%)

53%

2010 2014

Age >65 only, excludes non-Medicare population

1. Dhaval Kolte et al. J Am Heart Assoc 2014 NATIONWIDE INPATIENT SAMPLE
2. Centers for Medicare and Medicaid database, MEDPAR FY14
 5

CARDIOGENIC SHOCK REMAINS LEADING CAUSE OF

MORTALITY IN ACUTE MYOCARDIAL INFARCTION

High In-Hospital Mortality … and Ongoing Hazard Post Discharge

During AMI Cardiogenic Shock 1
after AMI Cardiogenic Shock 2

N = 23,696 N = 112,668
%

100
90

Mortality % Post Discharge

80
70
Death Rate, %

60
50
40
30
20
10

0
2000 2001 2002 2003 2004 2005 2006

1. Jeger, et al. Ann Intern Med. 2008

2. Shah, et al. JACC 2016 NCDR Registry
 6

MORTALITY IN PCI WITH CARDIOGENIC SHOCK REMAINS

A CLINICAL CHALLENGE

In-Hospital Mortality
AMI Cardiogenic Shock with PCI 1

N = 32,598

31%

28%
p<0.0001
11%

2005-2006 2011-2013

AMI Cardiogenic Shock with PCI only; Overall mortality >50%

Wayangankar, et al. JACC Int 2016 CATH-PCI Registry

 7

AMI SHOCK OFTEN TREATED IN COMMUNITY HOSPITALS

AMI Cardiogenic Shock with PCI

N = 56,497

2005-06 2011-13

90% 69%
Private/Community
52%
48%

31%

10%
Academic/ >500 <500 >500 <500
Gov’t PCI PCI PCI PCI

Wayangankar et al. JACC Interventions 2016 CATH-PCI REGISTRY

Treatment of Cardiogenic Shock

• Revascularization
 The 2011 Guideline for PCI
Class I
• PPCI should be performed within 12 hours
of onset of STEMI (LOE = A)
• PPCI should be performed in patients with
STEMI who develop severe heart failure or
cardiogenic shock and are suitable
candidates irrespective of the time delay
(LOE = B)

Class I
• PPCI is recommended in
patients with acute MI
who develop cardiogenic
shock and are suitable
candidates (LOE = B)
Levine GN, et al. J Am Coll Cardiol 2011;58:e44-122.
ESC Guidelines

2017 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:
 Primary Study Endpoint
All-Cause Mortality or Renal Replacement Therapy

60 Immediate multivessel PCI

55.4%
50 Culprit lesion only PCI
renal replacement therapy (%)

45.9%
All-cause mortality or

40

30

20

10

Relative risk 0.83; 95% confidence interval 0.71-0.96; P=0.01

0
0 5 10 15 20 25 30

Days after randomization

Number at risk:

Culprit lesion only PCI

344 219 207 198 192 189 184
Immediate multivessel
341 199 172 162 156 153 152
PCI
Mechanical Circulatory Support

Atkinson (J Am Coll Cardiol Intv 2016;9:871–83)

 13

IABP IN AMI CARDIOGENIC SHOCK: NO HEMODYNAMIC

OR SURVIVAL BENEFIT

IABP SHOCK I IABP-SHOCK II

Randomized Controlled Trial1 Randomized Controlled Trial2
N = 40
N = 600

IABP (n=19) IABP (n=301)

Medical Therapy (n=21) Medical Therapy (n=299) 41.3%

39.7%

CPO = MAP x Cardiac Output x 0.0022

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 # NCT00469248
2- Thiele H et al. NEJM 2012 - Clinicaltrial.gov # NCT00491036
 1414

NEW CARDIOGENIC SHOCK INDICATED

THERAPY: IMPELLA
 15

FDA INDICATION

The 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 IABP
 16

DATA SUPPORTING FDA INDICATIONS

Scientific Evidence Total # of Patients # of Impella Patients

Recover I FDA Study 17 17

Cardiogenic Shock

ISAR Shock RCT 26 13

U.S. Impella Registry 401 401
Literature review 2,537 692
Total 2,981 1,123

Protect I FDA Study 20 20

Protected PCI

Protect II FDA Study 452 225

U.S. Impella Registry 1,322 637
Literature review 2,537 756
Total 4,331 1,638
24,000 Patients from FDA medical device reporting (MDR) database
 17

RANDOMIZATION IN AMI CS IS CHALLENGING

Prospective Impella Trials In Emergent Settings

Pts Pts
Duration Reason for
Study Trial ID Condition Required Enrolled Status
(months) Discontinuation
(n) (n)

FRENCH TRIAL NCT0031484

AMI CS 200 19 52 Discontinued Low Enrollment
(2006) 7
NCT0041737
ISAR-SHOCK (2006) AMI CS 26 26 19 Completed N/A
8
NTR1079 STEMI
IMPRESS (2007) 130 18 22 Discontinued Low Enrollment
trialregister.nl Pre-CS
RECOVER I FDA NCT0059672
PCCS Up to 20 17 28 Completed N/A
(2008) 6
RECOVER II FDA NCT0097227
AMI CS 384 1 18 Discontinued Low Enrollment
(2009) 0
NCT0118569
RELIEF I (2010) ADHF 20 1 33 Discontinued Low Enrollment
1
NCT0163350
DANSHOCK (2012) AMI CS 360 ~50 40 Enrolling N/A
2
 18

POPULATION STUDIES SHOW REDUCED MORTALITY WITH

PVAD IN AMI CARDIOGENIC SHOCK

Mortality AMI Cardiogenic Shock Mortality In AMI Cardiogenic Shock

Pre/Post PVAD Era ECMO/eLVAD vs. PVAD

56%
p=0.012
52% p<0.001

43% 42%

N=1188
Co-morbidity
N=11,887 Matching

2004 - 2007 2008 - 2011

No PVAD PVAD Surgical PVAD

Era MCS
Stretch, et. al JACC 2014 National Inpatient Sample
Maini, et. al. CCI, 2014 and SCAI/ACC/STS /HFSA Expert Consensus Document
 19

HEMODYNAMIC EFFECTS OF IMPELLA SUPPORT ®

Outflow Inflow
(aortic root) (ventricle)

aortic
valve

Flow MAP LVEDP and LVEDV

Wall Mechanical
Tension Work

Microvascular
Resistance

Coronary
Perfusion

Cardiac Power
Output O2 Supply O2 Demand
End Organ Perfusion Unloading to Myocardial Recovery

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
IMPRESS

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

 National Variation in Impella AMI/CGS Outcomes

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

1. Data on file. Abiomed Impella Quality(IQ)Data, AMI/CGS Apr 2016 – Sept 2017. Danvers, MA: Abiomed.
2. 525 sites supporting >6 AMICS patients, 7,483 patients total since March 2016
RV SUPPORT

Shishehbor CCJM 2017

STANDARDIZED APPROACH

• Protocol
• Early Initiation of Hemodynamic Support
• Hemodynamic Monitoring
IMPELLA PRE
HEMODYNAMIC MONITORING
DETROIT CSI INITIATIVE
Orlando Health Cardiogenic Shock
Protocol
Orlando Health Cardiogenic Shock
Protocol
Orlando Health Cardiogenic Shock
Protocol
Orlando Health Impella Survival to
Discharge (AMI/CGS)
100%

90% 87%

80%

70% 65% 67%

60% 58%

50%

40%

30% 11/19 11/17 13/15 4/6

20%

10%

0%
ORMC HC DPH SLK
Registry Outcomes

Muharrem Akin et al. JCIN 2018;11:1811-1820

 Registry Outcomes

Muharrem Akin et al. JCIN 2018;11:1811-1820

Conclusion

• Cardiogenic Shock remains lethal

• Early Revascularization improves survival
• Mechanical Circulatory Support is redefining the
treatment paradigm
• Protocol Driven Approaches are promising