Intermediate outcomes with ex-vivo allograft perfusion for heart transplantation.

BACKGROUND: The Organ Care System, an ex-vivo heart perfusion platform, represents an alternative to the current standard of cold organ storage that sustains the donor heart in a near-physiologic state. It is unknown whether using the Organ Care System influences 2-year outcomes after heart transplantation. We reviewed our institutional experience to compare 2-year outcomes for patients randomized to the Organ Care System or standard cold storage.
METHODS: Between 2011 and 2013, heart transplant candidates from a single tertiary-care medical center enrolled within the PROCEED II trial were randomized to either standard cold storage or the Organ Care System. Outcomes assessed included 2-year survival, freedom from cardiac allograft vasculopathy (CAV), non-fatal major cardiac events (NF-MACE), biopsy-proven cellular rejection (CMR) and biopsy-proven antibody-mediated rejection (AMR).
RESULTS: Thirty-eight patients were randomized to the Organ Care System (n = 19) or cold storage group (n = 19). There was no significant difference in 2-year patient survival (Organ Care System: 72.2%; cold storage: 81.6%; p = 0.38). Similarly, there were no differences in freedom from CAV, NF-MACE, CMR or AMR. The Organ Care System group had significantly longer total ischemia time (361 ± 96 minutes vs 207 ± 50 minutes; p < 0.001) and shorter cold ischemia time (134 ± 45 minutes vs 207 ± 50 minutes; p < 0.001) compared with the cold storage group.
CONCLUSION: The Organ Care System did not appear to be associated with significant differences in intermediate results compared with conventional strategies. These results suggest that this ex-vivo allograft perfusion system is a promising and valid platform for donor heart transportation. Copyright Â

RCT Entities:   Population Interventions Outcomes