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 six studies demonstrates that early implantation of Impella® leads to the best outcomes. The real-world data is summarized in figure 1.

Figure 1: Unloading Pre-PCI Associated with Improved AMI-CS Outcome1-6

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.

Figure 2: Historical Advancements in the Treatment of Cardiogenic Shock7

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%.

Figure 3: Predictors of Survival to Explant8

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

References:

  1. Meraj PM., et al., (2017) J Interven Cardiol; 9999:1–8.
  2. Zeymer U., et al., (2018). Culprit Shock Data Analysis. Unpublished raw data.
  3. Ouweneel DM., et al., (2017) JACC; 69(3): 278-287.
  4. Schäfer A., et al., (2020) Front Cardiovasc Med; https://doi.org/10.3389/fcvm.2020.00074
  5. Helgestad OKL., et al., (2020) Open Heart;7:e001214.
  6. Hemradj VV., et al., (2020). PLoS ONE; 15(7):e0235762.
  7. Basir, MB., et al. (2019). Catheterization and Cardiovascular Interventions, 93(7): 1173–1183.
  8. O'Neill WW., et al., (2018). Am Heart J;202:33-38

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