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

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 world...

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Main Authors: Wee Ling Heng, Helmi Albrecht, Paul Chiappini, Yeong Phang Lim, Linda Manning
Format: Article
Language:English
Published: Wiley 2013-01-01
Series:Journal of Transplantation
Online Access:http://dx.doi.org/10.1155/2013/163150
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author Wee Ling Heng
Helmi Albrecht
Paul Chiappini
Yeong Phang Lim
Linda Manning
author_facet Wee Ling Heng
Helmi Albrecht
Paul Chiappini
Yeong Phang Lim
Linda Manning
author_sort Wee Ling Heng
collection DOAJ
description 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.
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spelling doaj-art-c7e7cf9f9dc546c49fe2893a1fc463e62025-02-03T01:02:34ZengWileyJournal of Transplantation2090-00072090-00152013-01-01201310.1155/2013/163150163150International Heart Valve Bank Survey: A Review of Processing Practices and Activity OutcomesWee Ling Heng0Helmi Albrecht1Paul Chiappini2Yeong Phang Lim3Linda Manning4National Cardiovascular Homograft Bank, Department of Cardiothoracic Surgery, National Heart Centre Singapore, 168752, SingaporeSydney Heart Valve Bank, St. Vincent’s Hospital, 390 Victoria Street, Darlinghurst, NSW 2010, AustraliaCell and Tissue Therapies WA, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000, AustraliaNational Cardiovascular Homograft Bank, Department of Cardiothoracic Surgery, National Heart Centre Singapore, 168752, SingaporeCell and Tissue Therapies WA, Royal Perth Hospital, 197 Wellington Street, Perth, WA 6000, AustraliaA 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.http://dx.doi.org/10.1155/2013/163150
spellingShingle Wee Ling Heng
Helmi Albrecht
Paul Chiappini
Yeong Phang Lim
Linda Manning
International Heart Valve Bank Survey: A Review of Processing Practices and Activity Outcomes
Journal of Transplantation
title International Heart Valve Bank Survey: A Review of Processing Practices and Activity Outcomes
title_full International Heart Valve Bank Survey: A Review of Processing Practices and Activity Outcomes
title_fullStr International Heart Valve Bank Survey: A Review of Processing Practices and Activity Outcomes
title_full_unstemmed International Heart Valve Bank Survey: A Review of Processing Practices and Activity Outcomes
title_short International Heart Valve Bank Survey: A Review of Processing Practices and Activity Outcomes
title_sort international heart valve bank survey a review of processing practices and activity outcomes
url http://dx.doi.org/10.1155/2013/163150
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AT paulchiappini internationalheartvalvebanksurveyareviewofprocessingpracticesandactivityoutcomes
AT yeongphanglim internationalheartvalvebanksurveyareviewofprocessingpracticesandactivityoutcomes
AT lindamanning internationalheartvalvebanksurveyareviewofprocessingpracticesandactivityoutcomes