Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock (ISAR-SHOCK)

German Heart Center Munich

Status and phase

Completed

Phase 4

Conditions

Myocardial Infarction

Shock, Cardiogenic

Treatments

Device: Left Ventricular Assist Device Impella LP 2.5

Device: Intraaortic Balloon Pump

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00417378

Impella M22

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of a left ventricular assist device in comparison to a standard treatment with an intraaortic balloon pump (IABP) in patients with cardiogenic shock due to left ventricular failure following an acute coronary syndrome (myocardial infarction).

Full description

Cardiogenic shock due to a left ventricular failure after myocardial infarction (MI) is associated with a mortality rate of 50-70 % despite all efforts such as immediate PCI of the occluded vessel, positive inotropic drugs, and the use of intraaortic balloon counterpulsation (IABP). While urgent heart transplantation or the surgical implantation of high-volume left ventricular assist devices are possible treatment options, a widespread use of these techniques for this common complication of myocardial infarction is limited. Because of the easy, percutaneous use of an intraaortic balloon pump, IABP is the method of choice for mechanical assistance in these patients. Despite a lack of randomized data, the ACC/AHA guidelines recommend the use of an intraaortic balloon counterpulsation (Level of evidence IB) in patients with a cardiogenic shock after myocardial infarction. However, improvement of the hemodynamic state by the use of an IABP is limited and the lack of an active cardiac support remains the major limitation of this treatment. Percutaneous left ventricular assist devices may both overcome the limitation of a surgical approach and offer the potential benefit of an active cardiac support during recovery of the failing left ventricle after PCI.

Previous studies have demonstrated a significant improvement of hemodynamic parameters by the use of a catheter-based miniaturized rotary blood pump (Impella LP2.5, Abiomed-Impella CardioSystems GmbH, Aachen, Germany), that is placed retrogradely through the aortic valve. The microaxial pump aspirates blood from the left ventricle and expels it to the ascending aorta with a maximal flow of 2.5 L/min. Randomized data comparing the LVAD with IABP are missing. Therefore, this trial will primarily compare the hemodynamic improvement of the LVAD (Impella LP2.5) with the hemodynamic improvement of an intraaortic balloon counterpulsation (IABP), while secondarily feasibility, safety and mortality will be compared.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute coronary syndrome (ACS/AMI) < 48h and cardiogenic shock defined as:
- Clinical criteria: Hypotension (syst.BP < 90 mmHg and HR > 90/min or an AV- Block II-III) or the need for positive inotropic drugs to maintain BB > 90mm Hg)and end-organ hypoperfusion
- Hemodynamic criteria: CI < 2.2 L/min/qm and a PCWP > 15 mmHg or an EF of LV < 30% and LVEDP > 20 mmHg.
Written informed consent of the patient or his/hers relatives

Exclusion criteria

Age < 18 years
Prolonged Resuscitation (> 30min)
Hypertrophic Obstructive Cardiomyopathy
Thrombus in left ventricle
Treatment with IABP
Severe valvular disease or mechanical heart valve
Cardiogenic Shock due to mechanical complications of myocardial infarction such as VSD, acute mitral regurgitation >II°, rupture of the ventricle
Failure of the right ventricle defined as the need for a RV Assist Device
Septic condition
Cerebral Disease
Bleeding with a need for surgical intervention
Pulmonary embolism
Allergy to Heparin or any known coagulopathy
Aortic regurgitation >II°
Pregnancy
Inclusion in another study or trial