Device profile of the Impella 5.0 and 5.5 system for mechanical circulatory support for patients with cardiogenic shock: overview of its safety and efficacy

ABSTRACT

Introduction

Trans-valvular micro-axial flow pumps such as Impella are increasingly utilized in patients with cardiogenic shock [CS]. A number of different Impella devices are now available providing a wide range of cardiac output. Among these, the Impella 5.0 and recently introduced Impella 5.5 pumps can provides 5.55 L/min of flow, enabling complete left ventricular support with more favorable hemodynamic effects on myocardial oxygen consumption and left ventricular unloading. These devices require placement of a surgical conduit graft for endovascular delivery, but are increasingly being used in patients with CS due to acutely decompensated heart failure [ADHF], acute myocardial infarction [AMI] and after cardiac surgery as a bridge to transplant or durable ventricular assist device surgery or myocardial recovery.

Areas Covered

This review focuses on the device profile and use of the Impella 5.0 and 5.5 systems in patients with CS. Specifically; we reviewed the published literature for Impella 5.0 device to summarize data regarding safety and efficacy.

Expert Opinion

The Impella 5.0 and 5.5 are trans-valvular micro-axial flow pumps for which the current data suggest excellent safety and efficacy profiles as approaches to provide circulatory support, myocardial unloading, and axillary placement enabling patient mobilization and rehabilitation.

Abbreviations

pMCS, Percutaneous mechanical circulatory support devices; CS, Cardiogenic shock; ADHF, Acute decompensated heart failure; AMI, Acute myocardial infarction; LVAD, Left ventricular assist deviceI; ABP, Intra-aortic balloon pump; VA-ECLS, Veno-arterial extracorporeal life support

KEYWORDS:

• Cardiogenic shock
• mechanical circulatory support devices
• impella
• trans-valvular micro-axial flow pumps

Article highlights

1. Impella 5.0 and 5.5 are trans-valvular micro-axial flow pumps used for the treatment of cardiogenic shock and can provide up to 6.2 L of peak blood flow.

2. These devices result in complete circulatory support with more complete left ventricular unloading, which promotes cardiac recovery and serves as a more durable inpatient bridge to other advanced therapies.

3. These pumps are commonly inserted through a surgical conduit on the axillary artery, which provides patients the advantage that they can mobilize with continuous left ventricular support.

4. These highly innovative technologies continue to drive us toward a future where novel sensor and software technologies will enable tailored patient management and may result in the development of novel trans-valvular pumps with closed loop communication.

Declaration of Interest

NK Kapur reports: Consulting/Speaker Honoraria and Research Grants from Abbott, Abiomed, Boston Scientific, LivaNova, Medtronic, Maquet, and MD Start. M Kawabori reports: Surgical consulting for Abiomed Impella. J Hernandez-Montfort reports: Research and education grants from Abiomed Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.