Remote Monitoring of Heart Transplant Recipients during the COVID-19 Pandemic

PURPOSE: The COVID-19 pandemic created significant challenges in monitoring heart transplant (HT) recipients for rejection due to efforts to minimize contact with the hospital setting. The aim of this study was to evaluate the safety and efficacy of transitioning HT patients to home phlebotomy and a monitoring protocol based on gene expression profiling (GEP) and donor derived cell free DNA (ddcfDNA). METHODS: A single-center cohort study that prospectively enrolled consecutive HT patients who were transitioned to a remote monitoring protocol employing home phlebotomy and non-invasive surveillance for rejection. Patients were enrolled starting at 2 months post-HT. Positive GEP values were defined as ≥32 (up to 6 months post-HT) and ≥34 (> 6 months post-HT). A positive ddcfDNA score was defined as >0.12%. A positive biopsy was defined as grade ≥1B/1R RESULTS: 246 HT patients were enrolled and followed for a minimum of 3 months. Mean age was 56±14, 71.5% were male, and median time from transplant was 2.7 years. The average distance of patients from the hospital was 25.6 miles. 359 blood tests were drawn for detection of GEP and ddcfDNA and 102 biopsies performed (Figure). Among 32 patients who had negative results on both tests and had a biopsy, 0 had a positive biopsy. Of 25 patients who had positive results on both tests and had a biopsy, 3 (12%) had a positive biopsy. The biopsy positivity rate in patients who were GEP+/ddcfDNA- was 6% and in patients who were GEP-/ddcfDNA+ was 8%. None of the positive biopsies were associated with hemodynamic compromise. 15 (6%) of patients were admitted due to allograft rejection during the study period. There were no deaths. CONCLUSION: Using a remote monitoring protocol with home phlebotomy and noninvasive rejection surveillance was feasible and safe in HT recipients. In this cohort, the combination of negative GEP and ddcfDNA scores was accurate at predicting a lack of allograft rejection.