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Impella CP (Abiomed) for Use in Adult Patients with Cardiogenic Shock

AT A GLANCE

Focus of Report: This health technology assessment focuses on the use of the Impella CP device for the management of cardiogenic shock (CS).

Technology Description: The Impella CP is an intravascular nonpulsatile axial blood pump designed to support the circulatory system during CS, low output syndrome, or other conditions. Typically, it is inserted percutaneously through the femoral artery and threaded into the left ventricle where it pumps blood from the left ventricle into the aorta. The Impella CP has a 14 Fr diameter and pumps at a rate of 3 to 4 liters per minute (L/min). The Impella CP is Food and Drug Administration approved for ≤ 4 days and is available in Europe for use for ≤ 5 days for the treatment of CS.

Health Problem: CS is an acute life-threatening condition resulting from inadequate blood circulation due to the inability of the heart (most often the left ventricle) to adequately meet systemic tissue demands for oxygen and nutrients. CS is most often caused by acute myocardial infarction (AMI), particularly among acute coronary syndrome (ACS) patients with ST-segment elevation myocardial infarction (STEMI). The mortality rate with CS in AMI may be as high as 50%. Morbidities of cardiac necrosis,
anoxic brain injury, renal failure, and liver dysfunction are associated with end-organ hypoperfusion. 

Pharmacological intervention with inotropes and vasopressors have been the first-line therapy for CS. Mechanical circulatory support (MCS) can augment pharmacological therapy and serve as a bridge to recovery. The intra-aortic balloon pump (IABP) device was the first broadly used cardiac MCS. The effects of the IABP include perfusion support by reducing afterload with increased cardiac output of 0.5 to 1 L/min. Additional MCS devices have been developed for CS. The Impella CP was developed to permit percutaneous insertion and provide a higher pumping capacity of up to 4 L/min.

Patient Population: The Impella CP is intended for short-term use (< 4 days) for the treatment of ongoing CS that occurs within 48 hours following AMI or open heart surgery as a result of isolated left ventricular failure that is unresponsive to optimal medical management and conventional treatment measures of pressors, inotropic agents, and IABP.

Evidence Base: The literature search identified 2 clinical studies (n=28 to 48 total patients) that evaluated the efficacy and safety of the Impella CP ventricular support device for the management of CS. One study was a randomized controlled trial (RCT) and 1 was a retrospective case series. Both studies enrolled a majority of patients in severe CS.

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