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.
From February 1995 to February 2005, 30 patients underwent the Ross procedure with the root replacement technique. There were 20 males (66.7%) and 10 females (33.3%), aged 13 to 49 years. The diagnosis was aortic stenosis in 12 patients (40%), aortic regurgitation in 10 (33%), mixed stenosis and regurgitation in 6 (20%), prosthetic endocarditis with an aortic root abscess in 1 (3.3%), and a perivalvular leak in 1 (3.3%). There was no early or late death. Six patients (20%) suffered 7 significant operative complications. Over a median follow-up of 65 months (range, 4-114 months), there were 3 re-operations for autograft failure and 2 for homograft failure. No patient experienced a cerebrovascular accident, and all but one were free from endocarditis. Freedom from autograft failure was 94.1% +/- 5.7% at 5 years and 79.5% +/- 10.7% at 8 years, while freedom from homograft failure was 96.6% +/- 3.4% at 5 years and 88.5% +/- 8.3% at 8 years. Our midterm results show that good early and late survival can be obtained in young patients with aortic valve disease. Re-exploration for bleeding and late autograft failure are the main concerns of this challenging operation, especially early in the surgeon's learning-curve.
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