Updates from the National Cardiogenic Shock Initiative

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Support:The development of this supplement was funded by Abiomed.

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Dr O’Neill began by introducing the National Cardiogenic Shock Initiative (NCSI), a group established in April 2016 to address mechanical support management of patients with acute MI (AMI) with cardiogenic shock (CS). No protocols for mechanical support management existed at the time of NCSI inception, with great disparity in device use in the context of angioplasty. Survival after angioplasty supported with an intra-aortic balloon pump (IABP) has remained at 50% for the past 30 years. Dr O’Neill formed the Detroit Cardiogenic Shock Initiative with cardiologists in the Detroit metro area with the goal of establishing a single mechanical support protocol that would increase AMI CS survival to >70%.

NCSI is a prospective, non-randomised, single-arm, multicentre nationwide study assessing the impact of early mechanical circulatory support (MCS) in AMI CS patients treated with percutaneous coronary intervention (PCI). Partial funding is provided by Chiesi and Abiomed, but neither company had direct involvement in the study design or data analysis. More than half of the 70 sites currently participating in NCSI include non-academic, teaching or community hospitals, ensuring broad protocol applicability to AMI CS patients.

The NCSI treatment protocol consists of rapid identification of CS, catheterisation lab activation, femoral access, AMI CS confirmation and implantation of an Impella CP transvalvular support device prior to PCI within a target door-to-support time of less than 90 minutes. Angioplasty is then performed, followed by an assessment of the patient’s status by right heart catheter (RHC) monitoring of cardiac power output (CPO) to assess left heart performance and pulmonary artery pulsatilty index (PAPI) or a right atrial pressure-to-wedge pressure ratio to assess right heart performance. Higher numbers for both values indicate normal heart performance. If CPO is ≥0.6 and PAPI is >0.9, left and right heart performance are doing well, and the patient can be down-titrated off of inotropes or vasopressors and the Impella device removed within 48 hours. If CPO is <0.6, the patient is still in shock and requires further left or right heart support. If PAPI is >0.9 and CPO is <0.6, the right ventricle (RV) is considered normal and increased left ventricular (LV) support should be strongly considered. If CPO is <0.6 and PAPI is <0.9, then RV failure is possible and increased RV support should be considered.

Preliminary data of 300 AMI CS patients enrolled at 57 centres demonstrated a 70% survival rate and >90% native heart recovery using the NCSI protocol.1,2 Implantation of IABP prior to referral, no AMI or anoxic brain injury were the primary reasons for patient exclusion. Comparing the NSCI result with those of five other major AMI trials and studies revealed that the NCSI survival rate of 70% is the highest reported of any modern trial or registry conducted in the US or Europe (Figure 1). Taken together, these data suggest MCS with Impella prior to PCI greatly improves patient outcomes.

Variable Comparison Between Acute MI Cardiogenic Shock Studies and Clinical Trials

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The NCSI protocol improves patient survival by early identification of shock and initiation of mechanical support with Impella prior to PCI. A golden hour of care exists for AMI CS patients with a treatment delay of every 10 minutes associated with a 3.31% increase in mortality in PCI-treated patients.3 Ineffective support for AMI CS, such as primary use of IABP, can cause further treatment delays.5,6 Mechanical unloading of the heart by Impella CP pre-PCI is associated with improved AMI CS survival, and should be considered as a support option.4,7–14

Inotrope usage greatly increases mortality in AMI CS patients, with use of more than two inotropes being associated with a near doubling of the mortality rate.4,15 Increased inotrope use also correlates with poor mortality outcomes, predicted by CPO levels of <0.8.16,17 The NCSI protocol includes down-titration of inotropes to further improve survival in AMI CS patients.

Dr O’Neill concluded that improvements in mechanical support protocols, such as those implemented in the NCSI study, improve survival and native heart recovery. Best practice protocols include early identification and support of patients with cardiogenic shock, aggressive down-titration of inotropes, identification of inadequate LV support and escalation, identification and support of RV dysfunction and the systematic use of RHC to guide therapy.2,17–19 RHC provides the data critical for the optimisation of treatment. The NCSI dataset has also demonstrated functional application to the Society of Cardiovascular Angiography and Interventions shock staging system and multivessel versus culprit vessel PCI.20,21 Future studies include a large-scale randomised clinical trial of optimal MSC compared with standard of care in AMI CS.


  1. Basir MB, Schreiber T, Dixon S, et al. Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: the Detroit cardiogenic shock initiative. Catheter Cardiovasc Interv 2018;91:454–461.
    Crossref | PubMed
  2. Basir MB, Kapur NK, Patel K, et al. Improved outcomes associated with the use of shock protocols: updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv 2019;93:1173–83.
    Crossref | PubMed
  3. Scholz KH, Maier SKG, Maier LS, et al. Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial. Eur Heart J 2018;39:1065–1074.
    Crossref | PubMed
  4. Basir MB, Schreiber TL, Grines CL, et al. Effect of early initiation of mechanical circulatory support on survival in cardiogenic shock. Am J Cardiol 2017;119:845–51.
    Crossref | PubMed
  5. Thiele H, Zeymer U, Neumann FJ, et al. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial. Lancet 2013;382:1638–45.
    Crossref | PubMed
  6. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J 2019;40:87–165.
    Crossref | PubMed
  7. Ouweneel DM, Eriksen E, Sjauw KD, et al. Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. J Am Coll Cardiol 2017;69:278–87.
    Crossref | PubMed
  8. Schäfer A, Werner N, Burkhoff D, et al. Influence of timing and predicted risk on mortality in impella-treated infarct-related cardiogenic shock patients. Front Cardiovasc Med 2020;7:74.
    Crossref | PubMed
  9. Helgestad OKL, Josiassen J, Hassager C, et al. Contemporary trends in use of mechanical circulatory support in patients with acute MI and cardiogenic shock. Open Heart 2020;7:e001214.
    Crossref | PubMed
  10. Meraj PM, Doshi R, Schreiber T, et al. Impella 2.5 initiated prior to unprotected left main PCI in acute myocardial infarction complicated by cardiogenic shock improves early survival. J Interv Cardiol 2017;30:256–63.
    Crossref | PubMed
  11. Hemradj VV, Karami M, Sjauw KD, et al. Pre-PCI versus immediate post-PCI Impella initiation in acute myocardial infarction complicated by cardiogenic shock. PLoS One 2020;15:e0235762.
    Crossref | PubMed
  12. O’Neill WW, Grimes C, Schreiber T, et al. Analysis of outcomes for 15,259 US patients with acute myocardial infarction cardiogenic shock (AMICS) supported with the Impella device. Am Heart J 2018;202:33–8.
    Crossref | PubMed
  13. O’Neill WW, Schreiber T, Wohns DHW, et al. The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry. J Interv Cardiol 2014;27:1–11.
    Crossref | PubMed
  14. Schroeter MR, Köhler H, Wachter A, et al. Use of the Impella device for acute coronary syndrome complicated by cardiogenic shock – experience from a single heart center with analysis of long-term mortality. J Inv Cardiol 2016;28:467–72.
  15. Samuels LE, Kaufman MS, Thomas MP, et al. Pharmacological criteria for ventricular assist device insertion following postcardiotomy shock: experience with the Abiomed BVS system.
    J Card Surg 1999;14:288–93.
    Crossref | PubMed
  16. Fincke R, Hochman JS, Lowe AM, et al. Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry. J Am Coll Cardiol 2004;44:340–8.
    Crossref | PubMed
  17. O’Neill WW. Achieving >70% AMI-CS survival: insight from National Cardiogenic Shock Initiative. Presented at TCT Connect, 18 October 2020.
  18. Tehrani BN, Truesdell AG, Sherwood MW, et al. Standardized team-based care for cardiogenic shock. J Am Coll Cardiol 2019;73:1658–9.
    Crossref | PubMed
  19. Sawa Y. Efficacy and safety analysis of initial Impella experience in Japan. A novel percutaneous hemodynamic support device: report from J-PVAD registry. Presented at: 84th Annual Scientific Meeting of the Japanese Circulation Society, 30 July 2020.
  20. Hanson ID, Tagami T, Mando R, et al. SCAI shock classification in acute myocardial infarction: insights from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv 2020;96:1137–42.
    Crossref | PubMed
  21. Lemor A, Basir MB, Patel K, et al. Multivessel versus culprit-vessel percutaneous coronary intervention in cardiogenic shock. JACC Cardiovasc Interv 2020;13;1171–8.
    Crossref | PubMed