Abstract 28: A Prospective and Randomized Trial to Compare a Left Ventricular Assist Device (Impella LP2.5) With IABP in Patients With Cardiogenic Shock by Acute Myocardial Infarction: The ISAR-SHOCK Trial
Cardiogenic shock due to left ventricular failure after myocardial infarction is associated with a high mortality and morbidity rate despite immediate PCI, positive inotropic drugs, and the use of intraaortic ballon counterpulsation (IABP). The ISAR-SHOCK trial was a randomized trial comparing the left ventricular assist device (LVAD) Impella LP2.5 with the standard care using a IABP. Impella LP2.5 (Abiomed-Europe) is a catheter-based miniaturized rotary blood pump with a maximal flow of 2.5 L/min from the left ventricle to the ascending aorta. Hemodynamic data were presented as Late-Breaking Clinical Trail at the ACC meeting 2007. In brief, 26 patients were randomized in this prospective, parallel assigned, and bicentric trial. Patients were included if clinical and hemodynamic criteria of cardiogenic shock were met within 48 hours after AMI. Primary end point was the hemodynamic improvement 20 minutes after implantation of either device. Secondary end points were additional hemodynamic changes as well as metabolic changes (BNP, Lactate) during hospital stay, mortality after 30 days, major bleeding, extent of hemolysis (fHb), and cerebrovascular events. There was no technical failure with both devices. At baseline patients did not differ in both groups. After 20 minutes of support cardiac index was significantly increased in patients with Impella P2.5 (2.20±0.64 vs. 1.71±0.45 L/min/m2 at baseline), compared to patients with IABP (1.84±0.71 vs. 1.73±0.59 L/min/m2 at baseline). Furthermore, mean arterial pressure and enddiastolic pressure were different in both groups. During the first 24 hours lactate levels were lower in patients with Impella LP2.5 compared to IABP. Whether these demonstrated hemodynamic improvements result in better clinical outcomes (mortality and morbidity) is unclear. Hemodynamic, infarct size, left ventricular function, and clinical data will be collected at 6–9 months follow-up and presented at the meeting.