The time has come to extend the expiration limit of cryopreserved allograft heart valves

Burkert, Jan; Kochová, Petra; Tonar, Zbyněk; Cimrman, Robert; Blassová, Tereza; Jashari, Ramadan; Fiala, Radovan; Spaténka, J

doi:10.1007/s10561-020-09843-2

Cited by 11 publications

(12 citation statements)

References 144 publications

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“…All these changes would need to be justified within the stability plan after a risk-based analysis. A longer shelf life assigned outright to all cryopreserved ATMPs is consistent with other practices, for example, shelf life assigned to cryopreserved heart valves [50].…”

Section: Discussionsupporting

confidence: 70%

A comprehensive report of long-term stability data for a range ATMPs: A need to develop guidelines for safe and harmonized stability studies

et al. 2022

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Section: Discussionsupporting

confidence: 70%

A comprehensive report of long-term stability data for a range ATMPs: A need to develop guidelines for safe and harmonized stability studies

et al. 2022

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“…A well-preserved structure can provide a favorable environment for cell repopulation: the crosstalk between ECM and cells can also promote tissue structural organization, directing cell functions. Understanding the process underlying the crosstalk between cells and ECM will lead to the design of the remodeling process [ 27 , 28 ].…”

Section: Introductionmentioning

confidence: 99%

Tergitol Based Decellularization Protocol Improves the Prerequisites for Pulmonary Xenografts: Characterization and Biocompatibility Assessment

et al. 2023

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Right ventricle outflow tract obstruction (RVOTO) is a congenital pathological condition that contributes to about 15% of congenital heart diseases. In most cases, the replacement of the right ventricle outflow in pediatric age requires subsequent pulmonary valve replacement in adulthood. The aim of this study was to investigate the extracellular matrix scaffold obtained by decellularization of the porcine pulmonary valve using a new detergent (Tergitol) instead of Triton X-100. The decellularized scaffold was evaluated for the integrity of its extracellular matrix (ECM) structure by testing for its biochemical and mechanical properties, and the cytotoxicity/cytocompatibility of decellularized tissue was assessed using bone marrow-derived mesenchymal stem cells. We concluded that Tergitol could remove the nuclear material efficiently while preserving the structural proteins of the matrix, but without an efficient removal of the alpha-gal antigenic epitope. Therefore, Tergitol can be used as an alternative detergent to replace the Triton X-100.

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“…The median age of RHT and DBD donors was 46 and 47 years, respectively, which represents rather young population of donors. When CTB was established, the accepted upper age of donors was lower than today, and it changed in time according to the commonly accepted age limits in other cardiovascular tissue establishments (EDQM 2019 ) and the results of published studies (Grosse et al 2008 ; Burkert et al 2021 ). The younger age of our donor population is reflected in lower tissue discard rate due to morphological quality which is the discard reason strongly related to the donor’s age.…”

Section: Discussionmentioning

confidence: 99%

Cryopreserved human heart valve allografts: a ten-year single centre experience

et al. 2022

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This study provides an overview of tissue banking activities at the Croatian Cardiovascular Tissue Bank (CTB) during past ten years and presents the outcomes of cryopreserved heart valve allografts (CHAs) use in different patient groups. From June 2011 until December 2021, 75 heart donations were referred to CTB: 41 recipient of heart transplant (RHT), 32 donors after brain death (DBD) and 2 donors after circulatory death (DCD) donations. Processing resulted in 103 valves of which 65 met quality requirements for clinical use. Overall tissue discard rate was 37%. The most frequent reasons for discard were inadequate morphology (12%) in RHT donations and microbiological contamination (19%) in DBD donations. Altogether, 38 CHAs were transplanted to 36 patients. Recipients were divided in three groups; infective endocarditis (IE), non-infectious heart disease and congenital heart disease group. In the IE group, the 30-day, 1-year and 3-year survival was 71%, 53% and 47%, respectively. Freedom from re-operation due to all graft-related causes was 76% and due to structural valve deterioration 88%. There were no cases of graft reinfection. In the congenital heart disease group CHAs were predominantly (94%) used for right ventricular outflow tract reconstruction and 88% of patients recovered without graft-related complications. At present, the number of demands for CHAs at CTB considerably outweighs their availability.

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The time has come to extend the expiration limit of cryopreserved allograft heart valves

Cited by 11 publications

References 144 publications

A comprehensive report of long-term stability data for a range ATMPs: A need to develop guidelines for safe and harmonized stability studies

A comprehensive report of long-term stability data for a range ATMPs: A need to develop guidelines for safe and harmonized stability studies

Tergitol Based Decellularization Protocol Improves the Prerequisites for Pulmonary Xenografts: Characterization and Biocompatibility Assessment

Cryopreserved human heart valve allografts: a ten-year single centre experience

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