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. 2025 Nov 1;109(11):1692-1709.
doi: 10.1097/TP.0000000000005435. Epub 2025 Jun 24.

Bioartificial Hearts, Assist Devices, and Myocardium: New Developments

Patricia Castellanos Vaquero  1 , Anastasiya Rozenbaum  1 , Maria Rocchi  1 , Maziar Arfaee  1 , Paul F Gründeman  1   2 , Jolanda Kluin  1
Affiliations

Bioartificial Hearts, Assist Devices, and Myocardium: New Developments

Patricia Castellanos Vaquero et al. Transplantation. .

Abstract

The rising prevalence of heart failure, global donor heart shortages, and limitations of current assist devices have driven innovation in bioartificial hearts (BAHs) and cardiac constructs. This systematic review aims to give an overview of new developments in BAHs, engineered myocardium, and biohybrid ventricular assist devices research, evaluating their clinical readiness and outcomes while addressing strengths and limitations. Significant variability in study designs and outcomes highlights both advancements and ongoing challenges in this field. Although the development of BAHs and larger cardiac tissue constructs remains in preclinical stages, progress has been achieved in the development of cardiac patches, with 2 approved for clinical use. Several critical challenges continue to hinder the successful clinical translation of bioengineered cardiac solutions. Achieving meaningful myocardial contraction remains a complex task, as well as ensuring adequate vascularization and electrical integration. Biocompatibility limits the progression of bioengineered cardiac constructs toward clinical applications. Innovations in 3-dimensional bioprinting, shape-memory materials, adhesives, microfabrication techniques, and soft and stretchable bioelectronics are driving advancements in this field. However, outcomes regarding hemodynamic performance of BAHs or constructs are marginal at best. Cardiac patches show promising results in preclinical studies, with the paracrine effect of the patches being the most plausible explanation of these results. Importantly, from very little clinical experience thus far, we cannot conclude that cardiac patches have any beneficial effects nor that they are safe. The path toward developing a fully functional BAH or even parts of a functional myocardium appears to be long, complex, and perhaps even unattainable.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

None
Graphical abstract
FIGURE 1.
FIGURE 1.
PRISMA search results. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
FIGURE 2.
FIGURE 2.
Number of studies published annually (2014–2024) by research focus. VAD, ventricular assist device.
FIGURE 3.
FIGURE 3.
Level of clinical readiness. VAD, ventricular assist device.
FIGURE 4.
FIGURE 4.
BAH results. BAH, bioartificial heart.
FIGURE 5.
FIGURE 5.
Cardiac construct results.
FIGURE 6.
FIGURE 6.
Cardiac patch results.
See this image and copyright information in PMC

References

    1. McDonagh TA, Metra M, Adamo M, et al. ; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021;42:3599–3726. - PubMed
    1. Colvin MM, Smith JM, Ahn YS, et al. OPTN/SRTR 2021 annual data report: heart. Am J Transplant. 2023;23(2 Suppl 1):S300–S378. - PubMed
    1. Yuzefpolskaya M, Schroeder SE, Houston BA, et al. The Society of Thoracic Surgeons Intermacs 2022 annual report: focus on the 2018 heart transplant allocation system. Ann Thorac Surg. 2023;115:311–327. - PubMed
    1. Zijderhand CF, Antonides CFJ, Veen KM, et al. Left ventricular assist device-related infections and the risk of cerebrovascular accidents: a EUROMACS study. Eur J Cardiothorac Surg. 2022;62:ezac421. - PMC - PubMed
    1. Kiyatkin ME, Zuver AM, Gaudig A, et al. Carotid artery blood flow and its association with stroke during left ventricular assist device support. J Heart Lung Transplant. 2019;38(4, Supplement):S171.

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