The Impella device is a 13 F microaxial blood pump allowing femoral vascular access. It provides nonpulsatile blood flow of up to 2.4 l/min.
To assess the safety, feasibility and efficacy of the Impella device in patients with cardiogenic shock or patients undergoing high-risk surgery or PCI.
A triple-centre, prospective, nonrandomised two-arm study.
The patient population was: Arm 1, cardiogenic shock patients with low cardiac output defined as a cardiac index < 2.0 l/min/m2 and pulmonary capillary wedge pressure (PCW) > 18 mmHg, or patients with PCW > 18 mmHg and a systolic blood pressure (BP) < 90 mmHg or in need of inotropes to keep systolic BP > 90 mmHg; and Arm 2: high-risk CABG or high-risk PCI following the Euroscore criteria. Sample size: 20/45 patients are included. Hemodynamics included the assessment of cardiac output (CO), PCW, arteria pulmonalis (AP), arterial BP and intracardiac pump parameters. Biochemistry included free hemoglobin at baseline, each hour during the pump run and 6 hours after removal of the pump.
These preliminary data indicate the feasibility of the Impella pump for patients in cardiogenic shock, high-risk CABG and PCI. More data will be available in March 2004.