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The Use of Impella for CGS Patients Does It Save Lives?

Published byΤιτάνια Κορνάρος Modified over 6 years ago

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Presentation on theme: "The Use of Impella for CGS Patients Does It Save Lives?"— Presentation transcript:

1 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

2 Howard A. Cohen, MD Stocks, Stock Options, other ownership interest:
CardioAssist, Inc. Off-Label: Infarct size reduction in AMI with LV assist

3 DISCLOSURE Medical Director CardiacAssist, Inc
Stock options CardiacAssist, Inc

4 CARDIOGENIC SHOCK Etiology AMI Ischemic cardiomyopathy
Non-ischemic cardiomyopathy Myocarditis Acute valvular disease Chronic valvular disease Post cardiopulmonary bypass Toxic Metabolic

5

6 CGS AND ACUTE MI SHOCK TRIAL P=0.027 P=0.11
Hochman JS, et al. The New Engl J of Med:341; 1999:

7 Thirty-Year Trends in CGS in Patients with AMI
CGS Incidence in AMI Trends in CFR in AMI Goldberg et al. Circulation 2009;119:

8 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

9 Percutaneous MSC in Cardiogenic Shock
Device Ease of Insertion Duration of use Flow L/min MVF Cost Available LV Unloading IABP ++++ Days to weeks $ ECMO ++ Hours to Days 6.0 NA $$$ Impella 2.5 +++ Hours to days + LA-FA Bypass 5.0

10 Unloading of the ventricle
WHEN SHOULD WE USE MCS? Advantages Risks Unloading of the ventricle End-organ Perfusion Bleeding Embolism Infection Leg ischemia Deconditioning Timing Patient Selection

11 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

12 Catheter Mounted Micro Axial Flow Pump

13 Catheter Mounted Miniature Axial Flow Pump
6.4 mm device (21F via surgical cutdown ) results in L/min output (33,000 RPM) 4.0 mm device (13F percutaneous) results in 2.5 L/min output (25,000 RPM)

14 Seyfarth, M. et al. J Am Coll Cardiol 2008;52:1584-1588
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:

15 IMPELLA 2.5 Time Course of CPI Serum Lactate, and Hemolysis
Cardiac Power Index Plasma Free Hgb Seyfarth, M. et al. J Am Coll Cardiol 2008;52:

16 Organ Dysfunction Scores and Survival Curve
IMPELLA 2.5 Organ Dysfunction Scores and Survival Curve Seyfarth, M. et al. J Am Coll Cardiol 2008;52: MSOF Score SROFA Score Survival Probability

17 Retrospective multicenter registry 120 CGS AMI
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 ( ) 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

18 Overall Survival Survival and Lactate Level

19 Survival and Antecedent CPR

20 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 Renal failure 38 (31.7) Renal failure requiring dialysis 28 (23.8) MSOF 37 (30.8)

21 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)

22 Multivariate Analysis of Predictors of Mortality
Variable Odds Ratio(95% CI) p Age > 65yo 5.245 ( ) 0.011 Lactate > 3.38 mmol

23 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% When to use: This animal study is introducing the Impella 5.0 as a potential device to reduce infarct size Positioning: Impella may have the ability to reduce infarct size of AMI, proven in animals and being studied in patients in Europe The Data: Impella LP5.0 used with animal groups (5 animals in each of four groups). Study Tested the optimal time to initiate support and optimal flows. Full support relates to unloading the ventricle at the highest flow of 5.0 liters per minute, partial support is 50% to model the Area at risk remained constant to ensure size of infarct is comparable in it each study group Customer: Surgeons and Interventional cardiologists 0% No Support Partial Support (2.5 l) After Reperfusion Full Support (5.0 l) After Reperfusion Full Support (5.0 l) After Ischemia & Reperfusion Meyns, B. et al. J Am Coll Cardiol 2003;41: 23 23

24 Pressure Volume Loops in Animal Model

25 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)

26 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

27 BRIDGE TO DECISION Acute refractory CGS Medical therapy, IABP
Temporary VAD support Revascularization MSOF Neurologic deficit Recovery assessment Palliative care Bridge to Bridge long –term MCS MCS explant Rehabilitation Destination therapy Bridge to recovery Bridge to transplant Gregoric and Bermudez

28 THANK YOU

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