Clinical Research & Data, AMI Cardiogenic Shock

TCT 2021: Real World Evidence Leading to RECOVER IV


William O’Neill, MD, addresses the question “Where are we with the use of mechanical support in acute myocardial infarction cardiogenic shock (AMICS)?” He discusses how best practices have evolved in managing AMICS and led to the RECOVER IV randomized controlled trial (RCT). Dr. O’Neill, who is one of the co-principal investigators of RECOVER IV, gave this presentation at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference.

Dr. O’Neill describes how observational data led to best practices for improving survival in AMICS. These practices became the foundation of the National Cardiogenic Shock Initiative (NCSI) algorithm. This algorithm, he explains, “can be widely applied in hospitals that have the resources to be able to do acute MI shock with Impella® support.”

Key aspects of the NCSI algorithm are identifying cardiogenic shock early, using Impella prior to performing the PCI (pre-PCI) and using right heart catheterization (RHC). Dr. O’Neill explains the importance of recognizing that balloon pumps are ineffective in these patients. “What we understand now is that intra-aortic balloon pumps just really supply insufficient incremental cardiac power output for improving the outcome for these patients… The reason that this is so important is because you have to have adequate forward cardiac power to perfuse the extremities. And we know now that in order to understand that you have to use a right heart cath… So early therapy and use of the right heart cath is very important.”

In addition, Dr. O’Neill states that Impella pre-PCI “just makes intuitive sense… If you put them on support, then it’s much safer to do the interventions. So, there are two things you’re accomplishing. You’re making it safer to do that cath and the intervention. And secondly, you’re offloading the patients quicker so that they can get out of shock as soon as possible.”

Another best practice comes from the understanding that vasopressors are independently associated with worse outcomes. Dr. O’Neill emphasizes, “really try to decrease the use of inotropes and provide mechanical support so you can de-escalate the amount and duration of inotropic therapy which will decrease infarct size and enhance survival.” He also discusses how right ventricular (RV) failure is associated with worse outcomes and the importance of identifying RV dysfunction with RHC data and aggressively treating these patients to improve survival.

To demonstrate the benefits of following these best practices, Dr. O’Neill highlights survival data from the INOVA health system showing that survival in patients with AMICS went from 44% to 82% within two years with systematic use of these practices. Similarly, he describes how a nationwide Japanese registry rigorously following these practices saw survival rise from 30% to 77% in AMICS patients.

Dr. O’Neill concludes his presentation with an overview of the RECOVER IV trial design. RECOVER IV is designed to be a head-to-head study of AMI shock management with patients randomized to either Impella pre-PCI, hemodynamic monitoring, and weaning of pressors and inotropes, or the control arm, which is standard of care with or without IABP, but no Impella devices.

“I’m very optimistic that once this study is done that this will really lead the way,” Dr. O’Neill emphasizes. In the meantime, he states, using mechanical support and the best practices described here will likely produce dramatic improvement in outcomes for patients with AMI cardiogenic shock.

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