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 Unpublished raw data.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