Abstract

<h3>Purpose</h3> CMV infection post-heart transplantation presents complex challenges affecting changes in immunosuppression and antiviral therapy that have both short- and long-term consequences. AlloMap gene expression profiling (AM), a non-invasive method to detect acute cellular rejection was affected by the presence of CMV infection. The aim of this study was to evaluate the impact of CMV infection on donor derived cell free DNA (AS) in patients post heart transplantation (HT). <h3>Methods</h3> The Surveillance Using HeartCare Outcomes Registry (SHORE) is a multicenter study for post-heart transplant patients followed with AM/AS for 5 years following heart transplantation. Patients enrolled in the SHORE registry were analyzed based on CMV infection. AM/AS were evaluated before, at the time, and following the viremic episodes. Both individual trends and the differences between the median AS and AS levels were studied. Nonparametric tests were used to assess categorical and longitudinal variables. <h3>Results</h3> 1702 patients were included, 1245 (73%) male, median age 57, 1156 (68%) white. CMV infection was diagnosed in 360 (21%) patients occurring at a mean time of 229 days after HT. CMV(-) patients had similar demographics to those patients CMV(+ve), but CMV(+) were older (p=0.025). CMV(+ve) patients had an increase in both AS (0.07% v. 0.05%, p<0.001) and AM (34 v. 30, p<0.001) compared to those without CMV [Figure 1a]. Levels returned to baseline within 5 weeks following the infection [Figure 1b]. The threshold to discriminate CMV infection with a NPV of 95% with GEP is 34 and dd-cfDNA is 0.12% . <h3>Conclusion</h3> AS does not seem to be confounded by CMV, but the presence of CMV infection may be associated with an elevated AS if there is allograft injury. Recovery from CMV infection was associated with normalization of AS and AM. This study points to the need to evaluate CMV in the presence of an increased AS, with further work to compare PCR titers and AS levels planned.

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