2. Randomised controlled (RCT) A prospective, randomized clinical of hemodynamic support with Impella® 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study O’Neill et al 2012 (4) PROTECT II NCT00562016 Patients were randomly assigned to IABP (n = 226) or Impella®2.5 (n = 226). Impella®provided superior hemodynamic support in comparison with IABP (maximal decrease in CPO from baseline of W vs -0.14±0.27 W for IABP (P=0.001). The 30-day incidence of major AEs was not statistically different (P=0.277). The 90-day incidence of major AEs was statistically different in Impella® patients compared with IABP: 40.0% vs. 51% in PP population, respectively. 2012, October 3. Retrospective, comparative, single-arm study Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. et al 2015 (5) USPella registry and PROTECT II trial data NCT00562016 Compared outcomes from patients in multicentre registry (who would have met trial enrolment criteria for PROTECT II trial; n = 339) with patients in Impella® arm of PROTECT II (n = 216). Registry patients had higher risk (older, but clinical outcomes appeared to be favourable and consistent with the RCT. 2015, November supported
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
Identify yet to be published research that may have results available in the near future that could be relevant in the consideration of your application by MSAC (limiting these to the English language only). Please do not attach full text articles, this is just intended to be a summary. Type of design Title of research (including any trial identifier if relevant) Short description of research (max 50 words) Website link to research (if available) Date High-risk PCI (including protected PCI) 1. RCT, open label Coronary interventions in patients using a novel percutaneous leaft ventricular support device (SHIELD II) NCT02468778 Currently recruiting patients to evaluate the use of HeartMate PHP with Impella® 2.5 as the active comparator, for both the elective and urgent indications Suspended 2. Prospective, single-arm study PROTECTED PCI A Prospective Clinical For Patients Undergoing Protected Percutaneous Coronary Intervention With IMPELLA® 2.5 System NCT02831881 Observational study measuring the composite rate of following and post-procedural major adverse events at 90 days post index procedure. Currently recruiting. Estimated primary completion - November 2020. Cardiogenic shock 1. RCT, interventional, parallel assignment, Phase 3 Danish Cardiogenic Shock Trial (DanShock) NCT01633502 Seeks to compare Impella® with conventional circulatory support for cardiogenic shock following ST-elevation myocardial infarct (MI). The trial has been expanded to include German sites and aims to recruit 360 patients by 2021 with all cause mortality at 6 months as the primary outcome measure. Currently recruiting. Expected to complete in 2021 risk