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.