Abstract
De novo donor-specific antibody (DSA) production has been correlated to the development of antibody-mediated rejection after heart transplantation. It is unclear whether the Cylex ImmuKnow (IK) assay - a rapid, quantitative assessment of T-cell-mediated immune function designed to monitor immunosuppression response - can be a useful tool in overall immunosuppression and identification of patients at risk for de novo DSA production. We hypothesize that, among heart transplant recipients, increased immune function activity as measured by the IK assay would correlate with de novo DSA production. We conducted a single center cohort study including all consecutive single organ heart transplant recipients from 2014 to 2018. The IK assay categorized subjects into low, moderate, or high immune response levels at 6, 12, and 24-month intervals. De novo DSA production based on human leukocyte antigen antibody testing was correlated to IK immune response levels at these time points. 122 single organ heart transplant recipients were included. High immune response levels were noted in 10%, 9%, and 12% of subjects at 6, 12, and 24-months, respectively. Compared to baseline, de novo DSA production was noted in 21%, 23%, and 25% of subjects at the respective time intervals. 6-month IK category did not correlate with DSA production at 6 (r = -0.03, p=0.9), 12 (r = -0.03, p=0.9), or 24 months (r = 0.15, p=0.3). Similar findings were noted at 12 and 24 months. Being in a high IK category at any interval was not associated with de novo DSA production at any time point (p>0.05). Univariate analysis of demographic factors, induction agents used, and co-morbidities (including EMV or CBV infection status) did not reveal significant associations with de novo DSA production. High T-cell-mediated immune response levels, a possible indicator of under-suppression, as measured by the IK assay were not associated with de novo DSA production after heart transplantation.
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