Focus of the Report: The focus of this Health Technology Assessment is to evaluate the safety and effectiveness of Impella devices for hemodynamic support during high-risk percutaneous coronary intervention (HRPCI).
Technology Description: The Impella 2.5, Impella CP (Cardiac Power), and Impella CP with SmartAssist devices (Abiomed Inc.) are catheter-based intravascular microaxial blood pumps indicated for temporary use during HRPCI. They are inserted percutaneously, usually through the femoral artery, and threaded into the left ventricle, where blood is pumped into the aorta at a rate of 2.5 to 4.3 liters per minute (L/min).
Controversy: Percutaneous mechanical circulatory support (MCS) devices, such as intra-aortic balloon pumps (IABPs), left ventricular assist devices, and extracorporeal membrane oxygenation (ECMO) machines, have been used to prevent or treat hemodynamic collapse during HRPCI. While available in most cardiac catheterization laboratories, IABPs have limitations dependent on the patient’s cardiac status. ECMO is more complex and requires specialized staff. Other controversies relevant to use of the Impella device in HRPCI include agreement on the definition of HRPCI and the lack of determinative risk scores for MCS during HRPCI.
Do Impella percutaneous ventricular assist devices (pVADs) (Impella 2.5, Impella CP) improve postprocedure outcomes in adults undergoing HRPCI?
How do Impella devices compare with alternative MCS devices (e.g., IABP, ECMO) for adults undergoing HRPCI?
Are Impella devices safe in adults undergoing HRPCI?
Have definitive patient selection criteria been identified for Impella devices in patients undergoing HRPCI?
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