What is the real-world evidence that supports the benefit of placing Impella pre-PCI?

June 19, 2019
  • 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.
  • Physicians are strongly encouraged to place Impella 2.5 or Impella CP prior to performing a PCI on patients in cardiogenic shock.

A critical mass of scientific research from five studies demonstrates that early implantation of Impella® leads to the best outcomes. The real-world data is summarized in figure 1.

How has this real-world evidence been validated?

Placing Impella prior to revascularization is a best practice identified through analyses of data in the IQ Database, validated in the cVAD study, and further validated by investigators leading the National Cardiogenic Shock Initiative.

What does placing Impella pre-PCI allow for?

Placement of Impella pre-PCI may allow for:

  • Reperfusion of end organs prior to revascularization
  • Hemodynamic support to the heart during revascularization
  • The halting of progression of cardiogenic shock

Placement of Impella pre-PCI is included in multiple clinical protocols that demonstrate survival benefits, including the National Cardiogenic Shock Initiative, which demonstrates that when best practices are followed, including placement of Impella pre-PCI, cardiogenic shock survival increases from ~50% to 77%.

Physicians are strongly advised to place Impella 2.5 or Impella CP prior to revascularization.

References:

  1. O’Neill, et al. Am Heart J. 2018
  2. O’Neill, et al. J Int Cardiol, 2014
  3. Basir, et al. Am J Cardiol. 2017
  4. Meraj, et al. J Int Cardiol. 2017
  5. Schroeter, et al. J Inv Cardiol. 2016
  6. O’neill, et al. TCT 2018 presentation
  7. Analysis of outcomes for 15,259 US patients with acute myocardial infarction cardiogenic shock (AMICS) supported with the Impella device.; O’Neill WW, Grines C, Schreiber T, Moses J, Maini B, Dixon SR, Ohman EM. Am Heart J. 2018 Apr 7;202:33-38. doi: 10.1016/j.ahj.2018.03.024.

 
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