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Ex-Vivo Donor Organ Perfusion or Cold Storage for Harvested Hearts in Orthotopic Heart Transplantation | Journal Scan
Study Questions:
What are clinical outcomes of the ex-vivo organ perfusion compared with standard cold storage of human donor hearts for transplantation?
Methods:
The study was a prospective, open-label, multicenter, randomized noninferiority trial evaluating the ex-vivo perfusion utilizing the Organ Care System. The Organ Care System is the only clinical ex-vivo heart perfusion platform that can maintain the donor heart in a warm, beating, near-physiological state ex vivo for transplantation. The study was conducted between June 29, 2010, and Sept 16, 2013. Recipients of heart transplants (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the ex-vivo perfusion by Organ Care System (n = 67) or standard cold storage (n = 63; the intention-to-treat population). The primary endpoint was patient and graft survival at the end of 30 days (with a 10% noninferiority margin). Secondary endpoints were cardiac-related serious adverse events, severe rejection rates (ISHLT biopsy-proven grade 2R or 3R rejection), and median length of stay in the intensive care unit. The investigators performed analyses in the intention-to-treat, as-treated, and per-protocol populations.
Results:
The investigators found that in the intention-to-treat population, the 30-day patient and graft survival rates were 94% (n = 63) in the ex-vivo organ perfusion group and 97% (n = 61) in the standard cold storage group (difference 2.8%, one-sided 95% upper confidence bound 8.8; p = 0.45). Patient and graft survival rates were similar because no redo heart transplant surgeries were done. 13% (n = 8) of patients in the ex-vivo organ perfusion group and 14% (n = 9) of patients in the standard cold storage group had cardiac-related serious adverse events. Mean total out-of-body time was significantly longer in the ex-vivo organ perfusion group than in the standard cold storage group (324 minutes [standard deviation (SD) 79] vs. 195 minutes [65]; p < 0.0001). However, mean total cold ischemia time was significantly shorter in the ex-vivo organ perfusion group than in the standard cold storage group (113 minutes [27] vs. 195 minutes [65]; p < 0.0001).
Conclusions:
The study authors concluded that clinical outcomes of donor hearts adequately preserved with ex-vivo perfusion are noninferior to the outcomes of those preserved with standard cold storage.
Perspective:
This is an important study because it suggests that ex-vivo perfusion is a satisfactory method to harvest hearts for orthotopic heart transplantation. If indeed the outcomes with ex-vivo perfusion are comparable for 1 year after transplantation, then the next step would be to determine whether it is effective for long-distance procurements. Ex-vivo perfusion may allow HLA typing, and therefore, this may minimize the incidence of future rejection. As the authors point capability of this technology to assess cardiovascular metabolics (including cardiac biomarkers) may be helpful in determining which organs to accept and which to reject.
Keywords: Biomarkers, Biopsy, Cold Ischemia, Cryopreservation, Graft Survival, Heart Failure, Heart Transplantation, Intensive Care Units, Intention to Treat Analysis, Length of Stay, Preservation, Biological, Prospective Studies
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