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Implantation of left ventricular assist devices (LVAD)is associated with HLA antibody sensitization. The objective of this study was to determine the specificity of antibodies produced by LVAD recipients using a combination of ELISA, Luminex and microcytotoxicity assays. Fifty-one LVAD patients were studied, from 44 to 838 days post-implantation. No patient developed HLA antibodies, although 24 produced IgG antibodies detectable in both ELISA and Luminex assays. These antibodies manifest as positive reactions with class I and class II wells of the ELISA and also blank wells. In Luminex assays, they produce high MFI readings with the negative control beads. Antibodies were detected 18 to 228 days after implantation. This reactivity was found to be directed against bovine serum albumin (BSA), commonly used to block non-specific binding in ELISA and Luminex assays; absorption of sera with BSA-coated beads completely abrogated reactivity in all solid phase assays, but did not eliminate anti-HLA antibodies in control sera. Ten of the 24 patients have proceeded to transplantation, with a 1-year graft survival of 69%. In conclusion, it appears that implantation of LVADS disrupts immunoregulatory pathways leading to production of anti-albumin antibodies. These can be misinterpreted as anti-HLA antibodies in solid phase assays.

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Results:Of the studied 183 LVAD recipients, 44 pts died. The majority (82%) of deaths occurred prior to hospital discharge. The DTRS correlated significantly with 90-days in-hospital mortality (pϽ.001) and 6-months survival (pϽ.001), Table 1. By multivariate analysis, DTRS was an independent predictor of 90-days in-hospital mortality (pϽ.001), whereas the type of device (HeartMate I vs. II) and indication (BTT vs. DT) showed no significant correlation. The discrimination and calibration of the DTRS model is shown in Figure 1. Conclusions: In our experience, the DTRS appeared to be a helpful tool in candidate selection as it correlated with the operative risk of LVAD, irrespective of the indication or type of implanted device.