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Advantages and challenges in processing and quality control of decellularized heart valves

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Abstract

More than 1000 donated aortic and pulmonary valves from predominantly European tissue banks were centrally decellularized and delivered to hospitals in Europe and Japan. Here, we report on the processing and quality controls before, during and after the decellularization of these allografts. Our experiences show that all tissue establishments, which provide native cardiovascular allografts for decellularization, meet comparably high-quality standards, regardless of their national origin. A total of 84% of all received allografts could be released as cell-free allografts. By far the most frequent reasons for rejection were non-release of the donor by the tissue establishment or severe contaminations of the native tissue donation. Only in 2% of all cases the specification for freedom from cells was not fulfilled, indicating that decellularization of human heart valves is a safe process with a very low discard ratio. In clinical use, cell-free cardiovascular allografts have been shown to be advantageous over conventional heart valve replacements, at least in young adults. These results open the discussion on the future gold standard and funding of this innovative therapeutic option for heart valve replacement.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The authors recognize the significant invaluable contribution that organ and tissue donors provide to the community. We also thank (i) the tissue establishments and their staff, in particular the Deutsche Gesellschaft für Gewebetransplantation gGmbH, Hannover, (ii) Dr. Delventhal (Synlab, Hannover) and Dr. Sarikouch (Hannover Medical School) for medical advice and (iii) Fenlab Hamburg and the Institute of Virology of Hannover Medical School for expert analyses, and (iv) our staff for their tireless and diligent work.

Funding

The ESPOIR study received funding from the European Union’s Seventh Framework Program for Research, Technological Development and Demonstration (GA #278453). The ARISE study received funding from the European Union’s HORIZON 2020 Program (GA #643597).

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Authors and Affiliations

  1. Corlife oHG, Feodor-Lynen-Str. 23, 30625, Hannover, Germany

    Marco Lux, Ralf Haller, Bettina Giere, Bianca Lindner & Michael Harder

  2. Cliniques Universitaires Saint-Luc, European Homograft Bank, Brussels, Belgium

    Stefano Mastrobuoni & Ramadan Jashari

Authors
  1. Marco Lux
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  2. Ralf Haller
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  3. Bettina Giere
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  4. Bianca Lindner
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  5. Michael Harder
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  6. Stefano Mastrobuoni
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  7. Ramadan Jashari
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Correspondence to Marco Lux.

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Conflict of interest

M. Harder is head and partner of corlife. M. Lux, R. Haller, B. Giere and B. Lindner are employees of corlife. S. Mastrobuoni is head and R. Jashari has headed the European Homograft Bank.

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Lux, M., Haller, R., Giere, B. et al. Advantages and challenges in processing and quality control of decellularized heart valves. Cell Tissue Bank 25, 43–53 (2024). https://doi.org/10.1007/s10561-023-10092-2

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  • DOI: https://doi.org/10.1007/s10561-023-10092-2

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