Health Problem: Patients undergoing percutaneous coronary intervention (PCI) may be considered high risk based on a variety of factors, including advanced age, comorbidities, and lesion-specific characteristics. Patients undergoing high-risk PCI (HRPCI) may require mechanical circulatory support (MCS) during the PCI procedure to prevent adverse events and improve clinical outcomes.

Technology Description: The Impella 2.5 is an intravascular, nonpulsatile axial blood pump indicated for temporary use during HRPCI. It is inserted percutaneously, usually through the femoral artery, and threaded into the left ventricle, where it pumps blood into the aorta at a rate of up to 2.5 liters per minute.

Controversy: Controversies revolve around agreement on the definition of HRPCI and the lack of determinative risk scores for MCS support during HRPCI.

Key Questions: 

  • For adults undergoing HRPCI, is the Impella 2.5 MCS efficacious in improving post-procedure outcomes?
  • How does the Impella 2.5 MCS compare with other clinical alternatives (e.g., medical management, IABP, and other MCS) for adults undergoing HRPCI?
  • Is the Impella 2.5 MCS safe in adults undergoing HRPCI?
  • Have definitive patient selection criteria been identified for the Impella 2.5 MCS in patients undergoing HRPCI? 

If you have a Hayes login, click here to view the full report on the Knowledge Center.