male with a BSA of 2.4 m2 may require escalation from Impella 2.5⢠to Impella CP® in order to wean inotropes or to in
CLINICAL DOSSIER
Cardiogenic Shock therapy with Impella
Contents 3 Executive Summary 4 Epidemiology of Cardiogenic Shock 5 Trends and Incidence of Cardiogenic Shock in Today's Patient Population 7 Challenges in Contemporary Therapies for Cardiogenic Shock 7 Intravenous Inotropic Drugs and/or Vasopressor Agents 9 Intra-aortic Balloon Pumps 11 Extracorporeal Membrane Oxygenation (ECMO) 12 Impella® Device Description and Hemodynamic Characteristics 12 Current Clinical Experience 13 Impella Platform/FDA Approvals 14 The Hemodynamic Benefits of Impella Therapy in Cardiogenic Shock 16 Clinical Evidence of Safety and Effectiveness for Impella in Cardiogenic Shock 16 USpella/cVAD Registry™ Results for All Impella Devices 18 Analysis of the USpella/cVAD Registry Data 20 The Need for Early Identification of Cardiogenic Shock Patients 22 Benchmark Data from the AB5000/BVS 5000 Registry 22 Prospective Randomized Trial, ISAR-SHOCK for the Impella 2.5™ heart pump 23 Literature Review 24 Best Practices in Cardiogenic Shock 25 The Key to a Good Outcome 25 Stabilize Early (STEMI & NSTEMI) 26 Complete Revascularization 27 Assess for Myocardial Recovery 28 Escalate and/or Ambulate 28 Left and Right Heart Support 29 Cost Effectiveness 30 References
Executive Summary Improving Outcomes in Cardiogenic Shock Impella 2.5™, Impella CP®, Impella 5.0™, and Impella LD™ heart pumps are now FDA indicated to provide treatment of ongoing cardiogenic shock. In this setting, the Impella heart pumps have the ability to stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs, and allow for recovery of the native heart. Impella devices have also been proven to be cost effective through reduction in length of hospital stay, readmissions, and overall costs compared with alternative treatment.1 The latest approval adds to the prior FDA indication of Impella 2.5 for elective and urgent high-risk percutaneous coronary intervention (PCI), or Protected PCI™.
Identify Cardiogenic Shock Early
Reverse the Cardiogenic Shock Spiral
Cardiac Output MAP
Cardiogenic Etiology Evaluation • EKG (STEMI/NSTEMI) • Echocardiography • If available, PA catheter, cardiac output, CPO, CI, PCWP, SVO2
Coronary Perfusion
End Organ Perfusion
• Systolic blood pressure (SBP) 2 mmoI/L
Myocardial Recovery Patients
Reverse Spiral
Ischemia Progressive Myocardial Dysfunction
End Organ Failure
Death Spiral of Cardiogenic Shock
Hemodynamic Effects of Impella Support Principles of Impella Design2-19 Outflow (aortic root)
