Dhruva et al. is a retrospective, observational analysis of patients with acute myocardial infarction (AMI) complicated by cardiogenic shock undergoing percutaneous coronary intervention (PCI) between October 1, 2015 and December 31, 2017.
Data from the PROTECT II randomized controlled trial show that patients treated with Impella had numerically lower rates of vascular complications compared with patients treated with intra-aortic balloon pump (1.4% for Impella versus 1.9% for IABP).1
The pivotal trial will build on the promising results of the successful STEMI DTU safety and feasibility trial, or STEMI DTU pilot trial, which met its goal by demonstrating it is safe and feasible to conduct
A preponderance of evidence from the FDA cVAD Study, Impella Quality Assurance Database and physician-initiated National Cardiogenic Shock Initiative support the recommendation that placing Impella 2.5 or Impella CP pre-PCI improves outcomes.
The NCSI Study is based on adopting the best practices algorithm focused on identifying shock early and unloading using Impella devices before PCI, reducing use of inotropes, and the use of invasive hemodynamic monitoring to aid in escalation and weaning.