1. Management of Cardiogenic Shock in AMI
Ramesh Daggubati, MD FACC FSCAI
Director of the Cardiac Catheterization Laboratories
Vidant Medical Center
Co-Director of the Structural Heart Disease Service Line
Director of the Interventional Cardiology Fellowship Program
Brody School of Medicine
East Carolina Heart Institute

2. Conflict Of Interest
Consultant: Cardiac Assist, Abiomed, Abbott Vascular,
Speaker’s Bureau: Astra Zeneca, Gilead, Medtronic

3. Cardiogenic Shock: United States
AMI
PCCS
ADHF
Admissions / Surgeries , , million
Shock Incidence % % %
Refr IABP / Inotropes % % %
Relative Incidence : : : 60
Device Candidates ~18, ~4, ~16,000
AHA Heart Disease and Stroke Statistics-2011 Update

4. Cardiogenic Shock is a Spectrum
Pre-Shock
Shock
Profound Shock
No Hemodynamic
Support
Needs Partial
Hemodynamic Support
Needs Full Hemodynamic Support
Three High
Dose 2% 3%
7.5%
21%
42%
80%
No Inotrope
Low
Moderate
One High
Two High
Mortality Risk with Inotrope Dosing
Adapted from Samuels LE et al , J Card Surg Jul-Aug;14(4):288-93

5. Therapeutic Goal AMI Shock
Stabilize the Patient
Reperfuse
Minimize Stunning
- Stop myocardial injury
- Restore normal myocardial metabolism
- Prevent reperfusion injury
- Enhance myocyte recovery

6. Current evidence from RCT in Cardiogenic Shock in the Era of PCI
Small samples
Different devices
Not powered studies
Thiele H et al. Eur Heart J 2010;31:

7. Current Pharmacology & Devices
Inotropes
IABP
ECMO
Tandem-Heart
Impella
Surgical VAD
Advantages
Flow (L/min.)
Coronary Perfusion
LVEDP
<0.5 ↑
0.5 ↑↑ ↓ 4 -
↑↑↑↑
3.5 ↓↓
↓↓↓
6.0
↓↓↓↓
Limitations
Arrhythmia
Stroke
Limb ischemia
Bleeding
Cost
+++
N.A $ ++ +
++++
$$$
+ / ++
$$$$$

8. Inotropes: Energetic Data in AMI Shock
Positive inotropic agent
Energy-starved myocardium
Theory
Reality
Alternative
Positive inotropic agent
on Ventricular Dysfunction
Circulatory Support + Cardiac Function
Drugs that increase systolic function typically increase energetic demand and result in adverse chronic outcomes
What is the energetic cost of Circulatory Support Device?
This cartoon explains a little bit the concept and rationale for inotropes usage…. In theory, if the slope represents the work load, you ll expect that giving stimuli to the muscle will improve the function…. Well in reality, that doesn’t help that much in case of ventricular dysfunction…. Unloading the heart with a circulatory support device will help provide enough output at NO energetic cost for the viable but suffering myocardium.
Adapted from Katz AM. Cellular mechanisms in congestive heart failure. Am J Cardiol ;62:8A.

9. Paradigm Shift in The Near Future:
Percutaneous Cardiac Assist Devices Have Been Integrated in
the 2011 PCI Guidelines
Adapted from
Percutaneous Cardiac Assist Device
The purpose of this meeting is to make sure that you take full advantage of all
of the services that are offered under the Partnership in Healthcare support
Program. Some of the goals that I would like to achieve today is finding out
Key contacts for each element so that when information is new or updated
From this day forward….we would be able to contact you with that update. I
Would also like to spend some time talking about the Six Sigma Performance
Improvement Service that is part of this program.

10. Most Commonly Used Mechanical Devices in the CathLab
IABP
Impella
TandemHeart

11. No Survival Benefit With IABP in AMI Cardiogenic Shock

12. IABP vs TandemHeart Cardiac Index 30-day Mortality Transfusion
Post
p=0.005 10 30 50 20 40 60
30-day Mortality (%)
1.4
1.8
2.2
1.6
2.0
2.4
Cardiac Index
(l/min/m2)
Pre
p=0.4
p=0.8
2.3
45%
43%
1.7
1.7
1.5
9/20
9/21
n=20
n=21
IABP
Tandem
IABP
Tandem
IABP
Tandem 40 60 80 50 70 90
Required Transfusion (%)
100
Transfusion
Limb Ischemia 10 30 50 20 40 60
Limb Ischemia (%)
90%
p=0.002
p=0.009
33% 0%
40%
From hemodynamic point of view, a comapred to IABP, the tandem heart improves the CI, reduces significantly Wedge pressure, Central venous pressure and has a significant better impact on the perfusion of the tissues.
19/21
0/20
7/21
8/20
IABP
Tandem
IABP
Tandem
Thiele and al. Eur. Heart Journal 2005 Jul;26(13):

13. Tandem Heart for LV and RV support

14. AMI, AS, Left main and Cardiogenic shock patient

15. ISAR-SHOCK RANDOMIZED TRIAL:
IMPELLA 2.5 vs. IABP in AMI Cardiogenic Shock
Primary Endpoint:
Increase in Cardiac Index From Baseline
(measured after 20 min of support)
0.75
1.50
P<0.01
P<0.01
0.60
1.25
0.45
0.75
1.10
Cardiac Index Increase (L/min/m2)
0.53
Cardiac Output (L/min)
0.30
0.50
0.15
0.25
0.11
0.20
Impella
IABP
Impella
IABP
Seyfarth et al. JACC 2007

16. Study Not Powered for Mortality
30 day - Survival %
100
Impella
(n=13) 80 60
IABP
(n=13)
54 % 40
Study Not Powered for Mortality 20
Log-rank P = 0.97 5 10 15 20 25 30
Days After Randomization
Seyfarth et al. JACC 2007

17. Managing Right Side Failure
IMPELLA RP
Flow: 4.0 l/mn
Access: Femoral vein
Diameter pump: 21F
Length cannula: mm
Diameter cannula: 7.0mm
Placement: monorail guide wire
Sensor: afterload sensitive
Flow monitoring: pressure sensor
Outflow in PA
Inflow in IVC
IMPELLA RP is Not an FDA approved device

18. Percutaneous VA ECMO: Advantages
Rapid deployment (no need for Cath Lab or OR suit
Acceptable pump flow (3-6 l/min)
RV support
Pulmonary support
Permits cooling
Allows for inter-hospital transfer
Provides time to achieve organ recovery and assess patient
Inexpensive and available
Of those patients affected 5-15% have advanced heart failure and it’s difficult to determine when patients will progress to the advanced heart failure classification

19. Problems LV Unloading, pulmonary edema and Clot formation
Arterial/venous laceration/dissection
LV Unloading, pulmonary edema and Clot formation
Stroke
Ischemic limb
Air embolism
Cannula dislodgement
Thromboembolism
Infection
Atrial perforation

20. LV Decompression on VA ECMO
IABP
Atrial Septostomy and or TH
Impella
Left atrial cannulation
PA Cannulation
Of those patients affected 5-15% have advanced heart failure and it’s difficult to determine when patients will progress to the advanced heart failure classification

21. Support With ECMO: Lacks Evidence
Poor outcomes with high complication rates in Adult Cardiac Patients even with last generation ECMO
100% bleeding, high rate of hemolysis, low survival rate in Shock

22. Of those patients affected 5-15% have advanced heart failure and it’s difficult to determine when patients will progress to the advanced heart failure classification

23. When Support Should Be Initiated?

24. When Support Should Be Initiated?

25. Impact of IABP-Timing in CS
Design
Total mortality
DESIGN: Single center observational study in 102 patients (Jan Dez. 2010).
OBJECTIVE: To evaluate the impact of IABP timing (before or after PCI) in STEMI complicated by cardiogenic shock.
ENDPOINTS: Total mortality, MACCE, renal failure
Schwarz et al. (submitted for publication)

26. Peri-PCI Support Strategy vs. Outcomes
Emergent Support Strategy
(N=154)
IABP Pre-PCI
(N=53)
No support Pre-PCI
(N=38)
Impella Pre-PCI
(N=63)
P=0.01
PCI
Survival to discharge
N=49
N=29
N=44
Impella
Post PCI
Continue
O’Neill et al. Euro PCR 2012 (updated)

27. ECHI Shock Protocol

29. Predictor of Cardiogenic shock
Finke et al JACC 2004; 44:340
Finke et al JACC 2004; 44:340
Finke et al JACC 2004; 44:340
Finke et al JACC 2004; 44:340
Finke et al JACC 2004; 44:340

30. ECHI CS protocol reduces mortality

31. RECENT DATA
Out of 124 patients, 30 patients treated without a device had 50% mortality.
55/78 patients with IABP for CS from 1/12 to 6/13, 68% survival.
22 patients in refractory shock had 50% mortality.

32. 2013 ACC/AHA STEMI Guidelines: Treatment of Cardiogenic Shock
IIa
IIb
III B
The use of intra-aortic balloon pump counterpulsation can be useful for patients with cardiogenic shock after STEMI who do not quickly stabilize with pharmacological. I
IIa
IIb
III
Alternative LV assist devices for circulatory support may be considered in patients with refractory cardiogenic shock.
O’Gara PT, et al. Circulation 2013

33. Conclusions
Management of Cardiogenic shock remains a challenge despite the progress made in reperfusion techniques and pharmacotherapy
Without clear supporting evidence, hemodynamic support with IABP remains controversial and is being challenged
The newly developed percutaneous left ventricular assist devices provide better hemodynamic support compared IABP
As the technology continues to evolve and the experience matures, paradigm shifts and new protocol will emerge for the management of cardiogenic shock with circulatory support
Stronger clinical evidence is required to define the selection criteria to identify the patients who would benefit the most from these new technologies