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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