Banking of cryopreserved heart valves in Europe: assessment of a 10-year operation in the European Homograft Bank (EHB).

BACKGROUND AND AIM OF THE STUDY: The preparation, banking and distribution of cryopreserved heart valves has been carried out at the European Homograft Bank (EHB) in Brussels without interruption since January 1989. We present an assessment of the Bank's activities during this 10-year period.
METHODS: Heart valve donors aged <62 years form three categories: multiorgan donors with non-transplantable hearts; recipients of cardiac transplantation; and non-beating heart cadavers with a warm ischemia time of less than 6 h. Past history and biology are checked for transmissible diseases. Dissection, incubation in antibiotics and cryopreservation in 10% dimethylsulfoxide with storage in liquid nitrogen vapors (about -150 degrees C), and quality control are according to the standards of the Belgian Ministry of Health. Cryopreserved valves are shipped to the implantation centers in a dry shipper at about -150 degrees C.
RESULTS: Between January 30th 1989 and December 31st 1998, 1,817 non-transplantable hearts and 12 excised semilunar valves were obtained. In total, 2,077 valves (1,032 pulmonary, 931 aortic and 13 mitral) were decontaminated, cryopreserved and stored in liquid nitrogen vapor (six more valves were refrigerated). In total, 1,515 valves were discarded at different stages of the protocol, the main causes of rejection being significant macroscopic lesions (68.2% aortic and 26.67% pulmonary). Inadequate excision at procurement (10.37% pulmonary), persistent contamination after antibiotics (5.6%) and positive serology for hepatitis B and C and Q fever (5.4%) were other frequent causes for rejection. Among the 2,117 accepted valves, 1,398 were graded first and 719 second choice, mainly on the basis of morphology. In total, 2,090 cryopreserved valves and one refrigerated valve were implanted in 39 institutions between May 1989 and December 1998. Of requests, 10.02% could not be satisfied. In total, 967 pulmonary valves were implanted in the right ventricular outflow tract (RVOT); 424 during a Ross procedure, and 76 in the left ventricular outflow tract (LVOT). Of the aortic valves, 732 were implanted in the LVOT and 266 in the RVOT. Mitral homografts were used for tricuspid valve replacement in two cases, and in the mitral position in seven. Complications at distribution and thawing included 10 bag ruptures and 16 transversal conduit wall fractures. Of the valves shipped, 317 (13.16%) were not used and were returned safely in the dry shipper. Comparison of distribution rates in the first 5.5 and last 4.5 years of EHB activity shows: (i) a significant increase in pulmonary valve implantations in the RVOT (from 71.95% to 81.95%); and (ii) a marked increase (265%) in pulmonary homograft implantations as part of a Ross operation, and a significant decrease (28%) in aortic homograft implantation in the LVOT.
CONCLUSION: While macroscopic lesions of procured aortic valves remain the most frequent and unavoidable cause of homograft rejection during quality control, the high percentage of inadequate surgical heart valve excision should be corrected. The rates of bacterial contamination and positive serology seem acceptable. Storage and shipping of cryopreserved homografts in liquid nitrogen vapor permits them to be spared very efficiently. The increasing use of pulmonary valves for RVOT reconstruction either in congenital heart disease or as part of the Ross procedure compensates for the limited availability of good quality aortic valves.