Protected PCI

Clinical Evidence

Safety and Efficacy

  • Extensive data, including randomized controlled trial data and FDA-reviewed studies, support Impella® safety and efficacy.1,2,7
  • Impella 2.5® and Impella CP® maintain patient hemodynamics which may allow for more complete revascularization and reduction in major adverse coronary and cerebrovascular events (MACCE).8
  • Impella heart pumps are associated with reduction of kidney injury during high-risk PCI.3
  • PROTECT III, the most contemporary data, continues to show a reduction in MACCE with Impella2

All MACCE to 90 Days

Complete Revascularization Associated with Improved Outcomes

Benefits in high-risk acute coronary syndrome (ACS) patients at 1 year4

  • 71% risk reduction in all-cause death
  • 27% risk reduction in major adverse cardiovascular events (MACE)
  • 41% risk reduction in myocardial infarction (MI)

 

Benefits in high-risk STEMI patients at 3 years4

  • 26% risk reduction in cardiovascular (CV) Death/MI
  • 47% risk reduction in CV Death/MI/Revascularization

 

Meta-analysis of benefits in 11 high-risk STEMI studies6

  • 29% risk reduction in CV Death/MI

Protected PCI Improves Quality of Life

Clinical data demonstrate that Protected PCI improves quality of life by increasing ejection fraction, reducing NYHA class, reducing adverse events, and reducing acute kidney injury requiring dialysis.3,7,8

“PROTECT III clearly demonstrates how the evolution and adoption of Impella best practices can lead to an improvement in safety and MACCE.”

- William O’Neill, MD, Principal Investigator for PROTECT II and PROTECT III

Resources from the Education Library

Clinical Dossier: Protected PCI with Impella

Features current clinical experience with Impella, clinical need for Impella in high-risk PCI, clinical evidence of safety and effectiveness of Impella Protected PCI, and more.

 

RESTORE EF Study: Impact on EF at 60-180 Days After High-risk PCI

Jason Wollmuth, MD, and Thom Dahle, MD, two of the principal investigators, discuss the impact on EF at 60-180 days after high-risk PCI with Impella support.

 

PROTECT III Study: Contemporary Practices of HR-PCI With Percutaneous MCS

Jeffrey Moses, MD, discusses results from the PROTECT III Study.

The Procedure

Learn more about single-access techniques, weaning considerations and other best practices during a Protected PCI procedure.

References

  1. Dixon, S.R., et al. (2009). JACC Cardiovasc Interv, 2(2), 91-96.
  2. Moses, et al. (2020). Presented at TCT Connect 2020.
  3. Flaherty, M.P., et al. (2017). Circ Res, 120(4), 692-700.
  4. Généreux, et al. (2012). J Am Coll Cardiol, 59(24). 
  5. Mehta, et al. (2019). N Engl J Med, 381(15):, 411-1421.
  6. Bainey, et al., (2020) JAMA Cardiol. 
  7. O’Neill, W.W., et al. (2012). Circulation, 126(14), 1717-1727.
  8. Dangas, G.D., et al. (2014). Am J Cardiol, 113(2), 222-228.

NPS-1181