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HVAD to HeartMate 3 left ventricular assist device exchange: Best practices recommendations.

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Citation: Journal of Thoracic & Cardiovascular Surgery. 2022 Mar 15PMID: 35341579Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): EditorialSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2022 ISSN:

0022-5223

Name of journal: The Journal of thoracic and cardiovascular surgeryAbstract: The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. Copyright © 2022 The Society of Thoracic Surgeons, The American Association for Thoracic Surgery and European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. and Oxford. All rights reserved. Published by Elsevier Inc. All rights reserved.All authors: Atluri P, Cowger J, Davis E, Feller E, Goldstein D, Hall S, Hayward C, HeartWare HVAD System to HeartMate 3 Left Ventricular Assist System Device Exchange Advisory Group, Kaczorowski D, Kilic A, Lorts A, Mokadam NA, Molina E, Pagani FD, Pham DT, Potapov E, Saeed D, Salerno CT, Schmitto J, Silvestry S, Slaughter MS, Soltesz E, Tsui S, Zimpfer DFiscal year: FY2022 Digital Object Identifier:

https://dx.doi.org/10.1016/j.jtcvs.2021.11.085

Date added to catalog: 2022-05-11

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Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	35341579	Available		35341579

The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. Copyright © 2022 The Society of Thoracic Surgeons, The American Association for Thoracic Surgery and European Association for Cardio-Thoracic Surgery. Published by Elsevier Inc. and Oxford. All rights reserved. Published by Elsevier Inc. All rights reserved.

English