Effect of COVID-19 Infection on HeartCare, Data from the SHORE Multicenter Registry

PURPOSE: Transplant patients represent a cohort in which COVID-19 (C19) may stimulate an unpredictable clinical course. The aim of this study was to evaluate the impact of C19 infection on AlloMap gene expression profiling (AM) and AlloSure donor derived cell free DNA (AS) results in patients post heart transplant. METHODS: The Surveillance Using HeartCare Outcomes Registry (SHORE) is a multicenter study for post heart transplant patients followed with AM/AS for 5 years. Patients enrolled were analyzed based on C19 . AM/AS were evaluated before, at the time and following infection. 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. RESULTS: 21 patients developed C19 infection; 16 (76%) were males, median age 50 years. There was no significant difference in AM or AS in stable patients (no rejection, CAV, graft dysfunction, dnDSA) compared to the first AM/AS profile in the C19+ patients, Figure 1. Event rates in C19+ patients are described in Table 1. 12 C19+ patients had 28 biopsies, 2 of which were within 30 days of C19. 1 patient had ACR 2R and another AMR 1; all other biopsies were <ACR 2R/AMR1. Additionally, 5 patients developed dnDSA and 7 patients developed subsequent CMV viremia, a median of 67 and 158 days after C19 diagnosis, respectively. No CAV, graft dysfunction, or deaths were reported in this small group of C19+ patients. CONCLUSION: The presence of C19 infection is not associated with a significant increase in AS or AM scores, suggesting AS and AM are not confounded by C19 and can be used safely as non-invasive surveillance in this population.