Will blood-informed design signal the fourth generation of cardiac assist devices?

Autor:	Simmonds MJ; Biorheology Research Laboratory, Griffith University, Gold Coast, Australia. Electronic address: mike@thesimmonds.id.au., Thamsen B; Christian Doppler Laboratory for Mechanical Circulatory Support, Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria., Olia SE; Division of Cardiovascular Surgery, Department of Surgery, University of Pennsylvania, Philadelphia, Pennsylvania., McNamee AP; Biorheology Research Laboratory, Griffith University, Gold Coast, Australia., Granegger M; Christian Doppler Laboratory for Mechanical Circulatory Support, Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria., Wurm H; Faculty of Mechanical Engineering and Marine Technology, Institute of Turbomachinery, University of Rostock, Rostock, Germany., Rajagopal K; Division of Cardiac Surgery, Department of Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania., McGiffin DC; Cardiothoracic Surgery and Transplantation, The Alfred Hospital, Melbourne, Australia.
Jazyk:	angličtina
Zdroj:	The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation [J Heart Lung Transplant] 2024 Nov; Vol. 43 (11), pp. 1767-1770. Date of Electronic Publication: 2024 Aug 23.
DOI:	10.1016/j.healun.2024.08.011
Abstrakt:	Mechanical circulatory support devices have profoundly transformed the management of severe cardiothoracic disorders. While heart transplantation is the gold standard therapy for end-stage heart disease, long-term mechanical support devices are a viable alternative for those ineligible and/or those awaiting organ availability. Major technological advancements were made over first 5 decades of development, resulting in improved durability and survival with reduced adverse events. However, gains have tapered recently for various complications (e.g., internal bleeding, multisystem organ failure), which collectively represent a significant proportion of disability and/or mortality. Further, in light of mature ventricular assist devices failing during clinical trials or even after clinical approval (class I withdrawals), it is timely to consider: Are our preclinical assessment protocols vital in the design and development of mechanical circulatory support devices, providing a realistic and reliable profile of future clinical performance? This commentary explores this question and analyses development pathways through the lens of the various disciplines involved in the preclinical assessment of mechanical circulatory support technologies: Limitations in approaches to benchtop blood testing, computational design and simulation, and animal testing are discussed as likely contributors to some of the common hemocompatibility-related adverse events (HRAEs). While it is acknowledged that some shortcomings are pragmatic in nature, possible solutions are presented that will only be realized through truly transdisciplinary and open approaches that challenge the current nature of medical device development. We suggest that these can and must be overcome to diminish HRAEs and will potentially demarcate the fourth generation of cardiac assist devices. (Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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