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. 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. [Review]

MedStar author(s):
Citation: Expert Review of Medical Devices. 19(1):1-10, 2022 Jan.PMID: 34894975Institution: MedStar Washington Hospital CenterDepartment: Advanced Heart Failure and Transplant Cardiology FellowshipForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Extracorporeal Membrane Oxygenation | *Heart Failure | *Heart-Assist Devices | Heart Failure/et [Etiology] | Heart Failure/su [Surgery] | Heart-Assist Devices/ae [Adverse Effects] | Humans | Intra-Aortic Balloon Pumping/ae [Adverse Effects] | Shock, Cardiogenic/su [Surgery] | Treatment OutcomeYear: 2022ISSN:
  • 1743-4440
Name of journal: Expert review of medical devicesAbstract: 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.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.All authors: Hernandez-Montfort J, Kapur NK, Kawabori M, Pahuja M, Whitehead EHOriginally published: Expert Review of Medical Devices. 2021 Dec 13Fiscal year: FY2022Digital Object Identifier: Date added to catalog: 2022-01-25
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Journal Article MedStar Authors Catalog Article 34894975 Available 34894975

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.

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.

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