1. RCT, multicentre A randomized clinical to Included N = 26 patients presenting with 2008, November evaluate the safety and efficacy of a cardiogenic shock from myocardial percutaneous left ventricular assist infarction, randomised to either IABP or device versus intra-aortic balloon Impella® 2.5. pumping for treatment of Impella® was associated with superior cardiogenic shock caused by augmentation of cardiac index and mean myocardial infarction arterial pressure with lower serum lactate Seyfarth et al 2008 (8) levels. However, there were no differences ISAR-SHOCK in 30-day mortality or complications. NCT00417378 2. Prospective, single The RECOVER I: A multicenter Haemodynamics improved immediately 2012, January arm prospective study of Impella 5.0/LD after initiation of 16 patients with for postcardiotomy circulatory mechanical support (1.65 vs. 2.7 l/min/m2 support (p=0.0001). For the primary efficacy endpoint, recovery of native heart function Griffith et al 2013 (9) was achieved in 93% of patients RECOVER I discharged, with bridge to other therapy in NCT00596726 7%. Survival at 30 days, 6 months and 1 year was 94%, 81% and 75%, respectively. 3. Retrospective The Impella Device for Acute Of the 47 patients 38 (80%) received 2016, July review Mechanical Circulatory Support in Impella® 5.0 and rest received Impella® Patients in Cardiogenic Shock 2.5. Ventricular function recovered in 34 of 47 patients (72%), and the device was Lemaire et al 2014 (10) removed, with 4 patients (8%) transitioned to long term VADs. The 30-day mortality was 25%. Right heart failure
1. RCT, multicentre A randomized clinical to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction Seyfarth et al 2008 (8) ISAR-SHOCK NCT00417378 Included N = 26 patients presenting with cardiogenic shock from myocardial infarction, randomised to either IABP or Impella® 2.5. Impella® was associated with superior augmentation of cardiac index and mean arterial pressure with lower serum lactate levels. However, there were no differences in 30-day mortality or complications. 2008, November 2. Prospective, single arm The RECOVER I: A multicenter prospective study of Impella 5.0/LD for postcardiotomy circulatory support Griffith et al 2013 (9) RECOVER I NCT00596726 Haemodynamics improved immediately after initiation of 16 patients with mechanical support (1.65 vs. 2.7 l/min/m2 (p=0.0001). For the primary efficacy endpoint, recovery of native heart function was achieved in 93% of patients discharged, with bridge to other therapy in 7%. Survival at 30 days, 6 months and 1 year was 94%, 81% and 75%, respectively. 2012, January 3. Retrospective review The Impella Device for Acute Mechanical Circulatory Support in Patients in Cardiogenic Shock Lemaire et al 2014 (10) Of the 47 patients 38 (80%) received Impella® 5.0 and rest received Impella® 2.5. Ventricular function recovered in 34 of 47 patients (72%), and the device was removed, with 4 patients (8%) transitioned to long term VADs. The 30-day mortality was 25%. 2016, July Right heart failure
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