A newly developed transaortic axial flow ventricular assist device: Early clinical experience

The Impella 5.0 (Abiomed, Danvers, MA), a transaortic axial flow device, is an established and approved short-term device for patients with left ventricular (LV) failure in need of complete left ventricular circulatory support. 1 Lima B Kale P Gonzalez-Stawinski GV et al. Effectiveness and safety of the impella 5.0 as a bridge to cardiac transplantation or durable left ventricular assist device. Am J Cardiol. 2016; 117: 1622-1628 Abstract Full Text Full Text PDF PubMed Scopus (90) Google Scholar However, it is currently approved for only a maximum of 6 days of support (10 in CE countries). 2 Gaudard P Mourad M Eliet J et al. Management and outcome of patients supported with Impella 5.0 for refractory cardiogenic shock. Crit Care. 2015; 19: 363 Crossref PubMed Scopus (74) Google Scholar Often, a longer duration of support is required in critically ill patients. 3 Mastroianni C Bouabdallaoui N Leprince P et al. Short-term mechanical circulatory support with the Impella 5.0 device for cardiogenic shock at La Pitié-Salpêtrière. Eur Heart J Acute Cardiovasc Care. 2017; 6: 87-92 Crossref PubMed Scopus (29) Google Scholar , 4 Schibilsky D Lausberg H Haller C et al. Impella 5.0 support in INTERMACS II cardiogenic shock patients using right and left axillary artery access. Artif Organs. 2015; 39: 660-663 Crossref PubMed Scopus (28) Google Scholar , 5 Castillo-Sang MA Prasad SM Singh J et al. Thirty-five day Impella 5.0 support via right axillary side graft cannulation for acute cardiogenic shock. Innov Technol Tech Cardiothorac Vasc Surg. 2013; 8: 307-309 Google Scholar To address this need, the Impella 5.5 was developed. Currently, this device has CE approval for 30 days of support. The Impella 5.5 is an incremental modification of the Impella 5.0, and a 30-day pre-clinical animal study has demonstrated the longer term technical safety profile of this new device. This safety data combined with positive long-term real-world data in patients supported with the Impella 5.0 for up to 51 days led to the 30-day CE approval. 6 Perry P David E Atkins B et al. Novel application of a percutaneous left ventricular assist device as a bridge to transplant in a paediatric patient with severe heart failure due to viral myocarditis. Interact Cardiovasc Thorac Surg. 2017; 24: 474-476 PubMed Google Scholar