Key result
Noninvasive rejection surveillance with GEP and dd-cfDNA in heart transplant recipients allowed immunosuppression reduction in 42% of cases and yielded 90% patient satisfaction.
Why the study?
The COVID-19 pandemic reduced access to endomyocardial biopsy rejection surveillance in heart transplant recipients, leaving the role of noninvasive surveillance in personalizing immunosuppression titration and patient satisfaction unstudied in Canada.
Does noninvasive rejection surveillance with GEP and dd-cfDNA improve patient satisfaction and allow immunosuppression titration in adult heart transplant recipients?
Cohort (n=31)
Does noninvasive rejection surveillance with GEP and dd-cfDNA improve patient satisfaction and allow immunosuppression titration in adult heart transplant recipients?
Noninvasive rejection surveillance using GEP and dd-cfDNA in heart transplant recipients allows for safe reduction of immunosuppression and yields high patient satisfaction.
May support noninvasive surveillance for titration in heart transplant recipients; hypothesis-generating and requires randomized validation before practice change.
Background The COVID-19 pandemic has reduced access to endomyocardial biopsy (EMB) rejection surveillance in heart transplant (HT) recipients. This study is the first in Canada to assess the role for noninvasive rejection surveillance in personalizing titration of immunosuppression and patient satisfaction post-HT. Methods In this mixed-methods prospective cohort study, adult HT recipients more than 6 months from HT had their routine EMBs replaced by noninvasive rejection surveillance with gene expression profiling (GEP) and donor-derived cell-free DNA (dd-cfDNA) testing. Demographics, outcomes of noninvasive surveillance score, hospital admissions, patient satisfaction, and health status on the medical outcomes study 12-item short-form health survey (SF-12) were collected and analyzed, using t tests and χ 2 tests. Thematic qualitative analysis was performed for open-ended responses. Results Among 90 patients, 31 (33%) were enrolled. A total of 36 combined GEP/dd-cfDNA tests were performed; 22 (61%) had negative results for both, 10 (27%) had positive GEP/negative dd-cfDNA results, 4 (11%) had negative GEP/positive dd-cfDNA results, and 0 were positive on both. All patients with a positive dd-cfDNA result (range: 0.19%-0.81%) underwent EMB with no significant cellular or antibody-mediated rejection. A total of 15 cases (42%) had immunosuppression reduction, and this increased to 55% in patients with negative concordant testing. Overall, patients' reported satisfaction was 90%, and on thematic analysis they were more satisfied, with less anxiety, during the noninvasive testing experience. Conclusions Noninvasive rejection surveillance was associated with the ability to lower immunosuppression, increase satisfaction, and reduce anxiety in HT recipients, minimizing exposure for patients and providers during a global pandemic.
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Amadio et al. (2022) conducted a cohort in Heart transplant (n=31). Noninvasive rejection surveillance with gene expression profiling (GEP) and donor-derived cell-free DNA (dd-cfDNA) vs. Routine endomyocardial biopsy (historical/implied) was evaluated on Immunosuppression reduction. Noninvasive rejection surveillance with GEP and dd-cfDNA in heart transplant recipients allowed immunosuppression reduction in 42% of cases and yielded 90% patient satisfaction.
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