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The Use of Impella for CGS Patients
Does It Save Lives?
Howard A. Cohen, MD, FACC, FSCAI
Professor of Medicine
Director Temple Interventional Heart & Vascular Institute
Temple University Health System
Howard A. Cohen, MD
Stocks, Stock Options, other ownership
interest:
CardioAssist, Inc.
Off-Label: Infarct size reduction in AMI
with LV assist
DISCLOSURE
• Medical Director CardiacAssist, Inc
• Stock options CardiacAssist, Inc
CARDIOGENIC SHOCK
Etiology
• AMI
• Ischemic cardiomyopathy
• Non-ischemic cardiomyopathy
• Myocarditis
• Acute valvular disease
• Chronic valvular disease
• Post cardiopulmonary bypass
• Toxic
• Metabolic
CGS AND ACUTE MI
SHOCK TRIAL
P=0.027
P=0.11
Hochman JS, et al. The New Engl J of Med:341; 1999:625-634
Thirty-Year Trends in CGS in Patients with AMI
CGS Incidence in AMI
Trends in CFR in AMI
Goldberg et al. Circulation 2009;119:1211-1219
CIRCULATORY SUPPORT DEVICES
• Intra-aortic balloon pump
• Catheter mounted miniature axial flow pump
Impella
•
•
•
•
LA-FA bypass TandemHeart
ECMO
Surgically implanted VAD
Total artificial heart
Percutaneous MSC in Cardiogenic Shock
Device
IABP
Ease of
Duration Flow
Insertion of use
L/min
MVF
Cost
Available LV
Unloading
++++
Days to
weeks
±
±
$
++++
±
ECMO
++
Hours to
Days
6.0
NA
$$$
++
++
Impella
2.5
+++
Hours to
days
2.5
+
$$$
+++
+
LA-FA
Bypass
+
Days to
weeks
5.0
+++
$$$
++
+++
WHEN SHOULD WE USE MCS?
Advantages
Risks
Bleeding
Embolism
Unloading of the ventricle
End-organ Perfusion
Infection
Leg ischemia
Deconditioning
Timing
Patient Selection
Percutaneous MCS in CGS
Ideal Percutaneous Left Ventricular Assist
 Safety and efficacy
 Freedom from thrombosis, bleeding, infection,
hemolysis, vascular compromise
 Flow rate – complete support
 Improve systemic and myocardial perfusion
 Improve LV unloading
 Improve Survival
 Ease of insertion, weaning and removal
 Cost
 Availability
Catheter Mounted Micro Axial Flow Pump
Catheter Mounted Miniature Axial Flow Pump
• 6.4 mm device (21F via surgical cutdown )
results in 4.2-5.0 L/min output (33,000 RPM)
• 4.0 mm device (13F percutaneous) results in
2.5 L/min output (25,000 RPM)
A RCT to Evaluate Safety and Efficacy of a pLVAD
vs IABP for Rx of CGS Caused by MI
• Prospective RCT to test whether the Impella 2.5
provides superior hemodynamic support
compared to IABP
• Primary EP Cardiac Power Index from baseline to
30 minutes after implantation
• Secondary EP included lactic acidosis, hemolysis
and mortality after 30 days
Seyfarth, M. et al. J Am Coll Cardiol 2008;52:1584-1588
IMPELLA 2.5
Time Course of CPI Serum Lactate, and Hemolysis
Cardiac Power Index
Serum Lactate
Plasma Free Hgb
Seyfarth, M. et al. J Am Coll Cardiol 2008;52:1584-1588
IMPELLA 2.5
Organ Dysfunction Scores and Survival Curve
Seyfarth, M. et al. J Am Coll Cardiol 2008;52:1584-1588
MSOF Score
SROFA Score
Survival Probability
Percutaneous LV Support With the
Impella-2.5–Assist Device in Acute CGS
Results of the Impella–EUROSHOCK-Registry
• Retrospective multicenter registry 120 CGS AMI
pts, 14 centers, 5 countries (2005-2010)
• Primary endpoint – 30 day mortality
• Secondary endpoints
– Change in Lactate after institution of support
– MACCE and long-term survival
Latten et al – EUROShock Registry;Circ Heart Fail 2013;6;23-30
Overall Survival
Survival and Lactate Level
Survival and Antecedent CPR
Secondary Safety Endpoints
Latten et al – EUROShock Registry;Circ Heart Fail 2013;6;23-30
Baseline (N=120)
MACCE (total)
18 (15)
Myocardial infarction
8 (6.7)
Re-PCI
13( 10.8)
CABG
3 (2.5)
Stroke
2( 1.7)
Bleeding requiring transfusion
29 (24.2)
Bleeding requiring surgery
5 (4.2)
Hemolysis
9 (7.5)
Pericardial drainage
2(1.7)
Device Malfunction
3 (2.5)
Renal failure
38 (31.7)
Renal failure requiring dialysis
28 (23.8)
Mortality at 30 Days
Latten et al – EUROShock Registry;Circ
Heart Fail 2013;6;23-30
Baseline (N=120)
Primary Endpoint
Mortality at 30 days
77 (64.2)
Death on circulatory support
50 (40.0)
Successfully weaned from support
53 (44.5)
Long-term survival (after 317±526d)
34 (28.3)
Secondary Endpoints
Successful implantation procedure
119 (99.2)
Procedure related easy or suitable
114 (95)
Multivariate Analysis of Predictors of Mortality
Variable
Odds Ratio(95% CI)
p
Age > 65yo
5.245 (1.473-18.677)
0.011
Lactate > 3.38 mmol
5.245 (1.473-18.677)
0.011
Limiting MI with LV Assist
Minimize Infarct Size =
(Early Support, Extent of Ventricle Unloading)
80%
70%
60%
Infarct size
% of total area
at risk
50%
40%
30%
20%
10%
0%
No Support
Partial Support
(2.5 l)
After Reperfusion
Full Support
(5.0 l)
After Reperfusion
Meyns, B. et al. J Am Coll Cardiol 2003;41:1087-1095
Full Support
(5.0 l)
After Ischemia &
Reperfusion
Pressure Volume Loops in Animal Model
The Use of Impella 2.5 in CGS Patients
Does It Save Lives?
• Based in the foregoing data – no, in severe shock
the device does not unload the LV sufficiently or
provide enough systemic support, or increase
MVF
• The same can be said for IABP
• Not as a bridge to recovery but as a bridge to
decision
• Decisions needs to be made rapidly and in an
environment where all therapeutic alternatives
are available (pVAD, VAD, TAH, Transplant)
SHOCK TEAM CONCEPT
•
•
•
•
•
•
Interventional Cardiology
Advanced Heart Failure Transplant
Cardiovascular/VAD Surgery
Nursing service, MSW
Patient and/or patient’s family
Short and long term goal assessed –What is the
“end-game?”
• Rapid acceleration of therapy as appropriate as
described in algorithm
BRIDGE TO DECISION
Acute refractory CGS
Medical therapy, IABP
Temporary VAD support
Revascularization
Recovery assessment
MSOF
Neurologic deficit
Bridge to Bridge
long –term MCS
Bridge to transplant
Destination therapy
Gregoric and Bermudez
Palliative care
MCS explant
Rehabilitation
Bridge to recovery
THANK YOU