Algorithms, Clinical Research & Data, Safety & Efficacy
FAQ: What Is the Clinical Evidence That Supports the Benefit of Placing the Impella® Heart Pump Pre-PCI?
A preponderance of evidence from the FDA cVAD Study®, Impella Quality (IQ) Database and physician-initiated National Cardiogenic Shock Initiative (NSCI) study 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.
How has this real-world evidence been validated?
Placing the Impella heart pump 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 NCSI Study.
What does placing Impella pre-PCI allow for?
Placement of the Impella heart pump 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 NCSI Study, which demonstrates that when best practices are followed, including placement of Impella pre-PCI, cardiogenic shock survival increases from ~50% to >70%.
Figure 3: Predictors of Survival to Explant1
Physicians are strongly advised to place Impella 2.5 or Impella CP prior to revascularization.
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References
1. O'Neill, W.W., et al. (2018). Am Heart J, 202, 33-38.
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