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Journal of Transplantation
Volume 2013, Article ID 163150, 11 pages
http://dx.doi.org/10.1155/2013/163150
Research Article

International Heart Valve Bank Survey: A Review of Processing Practices and Activity Outcomes

1National Cardiovascular Homograft Bank, Department of Cardiothoracic Surgery, National Heart Centre Singapore, Singapore 168752
2Sydney Heart Valve Bank, St. Vincent’s Hospital, 390 Victoria Street, Darlinghurst, NSW 2010, Australia
3Cell and Tissue Therapies WA, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000, Australia

Received 19 June 2013; Revised 13 August 2013; Accepted 13 August 2013

Academic Editor: F. H. J. Claas

Copyright © 2013 Wee Ling Heng et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A survey of 24 international heart valve banks was conducted to acquire information on heart valve processing techniques used and outcomes achieved. The objective was to provide an overview of heart valve banking activities for tissue bankers, tissue banking associations, and regulatory bodies worldwide. Despite similarities found for basic manufacturing processes, distinct differences in procedural details were also identified. The similarities included (1) use of sterile culture media for procedures, (2) antibiotic decontamination, (3) use of dimethyl sulfoxide (DMSO) as a cryoprotectant, (4) controlled rate freezing for cryopreservation, and (5) storage at ultralow temperatures of below −135°C. Differences in procedures included (1) type of sterile media used, (2) antibiotics combination, (3) temperature and duration used for bioburden reduction, (4) concentration of DMSO used for cryopreservation, and (5) storage duration for released allografts. For most banks, the primary reasons why allografts failed to meet release criteria were positive microbiological culture and abnormal morphology. On average, 85% of allografts meeting release criteria were implanted, with valve size and type being the main reasons why released allografts were not used clinically. The wide variation in percentage of allografts meeting release requirements, despite undergoing validated manufacturing procedures, justifies the need for regular review of important outcomes as cited in this paper, in order to encourage comparison and improvements in the HVBs’ processes.