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Updated: Jul 4, 2025
A High-Fidelity Porcine Model of Orthotopic Heart Transplantation Following Donation after Circulatory Death
Published on: June 6, 2025
Increasing Utilization of Extended Criteria Donor Hearts for Transplantation: The OCS Heart EXPAND Trial
Jacob N Schroder1, Chetan B Patel1, Adam D DeVore1
1Duke University Hospital, Durham, North Carolina, USA.
Insights
Extended criteria donor (ECD) hearts are now more accessible for transplantation. An extracorporeal perfusion system enabled 87% of these hearts to be transplanted, showing excellent patient survival and low graft dysfunction rates.
Area of Science:
- Cardiology
- Transplantation Medicine
- Medical Devices
Background:
- Extended criteria donor (ECD) hearts from donation after brain death (DBD) are underutilized for transplantation.
- Cold storage limitations restrict the use of these valuable donor hearts.
Purpose of the Study:
- To evaluate the use of an extracorporeal perfusion system for donor heart utilization.
- To assess post-transplant outcomes in recipients of ECD DBD hearts using this system.
Main Methods:
- A prospective, single-arm, multicenter study involved adult heart transplant recipients.
- ECD hearts meeting study criteria were preserved and transported using an extracorporeal perfusion system.
- Primary outcome: composite of 30-day survival and absence of severe primary graft dysfunction (PGD).
Main Results:
- 173 ECD DBD hearts were perfused, with 150 (87%) successfully transplanted.
- 30-day outcomes: 92% survival with no severe PGD; 97% 30-day survival overall; 6.7% incidence of severe PGD.
- Mean graft-related serious adverse events within 30 days was 0.17. Patient survival reached 86% at 2 years.
Conclusions:
- Extracorporeal perfusion successfully transplanted 87% of ECD DBD hearts.
- This method demonstrated excellent 2-year patient survival and low severe PGD rates.
- Increased utilization of ECD DBD hearts can expand heart transplant access.
Background:
Extended criteria donor (ECD) hearts available with donation after brain death (DBD) are underutilized for transplantation due to limitations of cold storage.
Objectives:
This study evaluated use of an extracorporeal perfusion system on donor heart utilization and post-transplant outcomes in ECD DBD hearts.
Methods:
In this prospective, single-arm, multicenter study, adult heart transplant recipients received ECD hearts using an extracorporeal perfusion system if hearts met study criteria. The primary outcome was a composite of 30-day survival and absence of severe primary graft dysfunction (PGD). Secondary outcomes were donor heart utilization rate, 30-day survival, and incidence of severe PGD. The safety outcome was the mean number of heart graft-related serious adverse events within 30 days. Additional outcomes included survival through 2 years benchmarked to concurrent nonrandomized control subjects.
Results:
A total of 173 ECD DBD hearts were perfused; 150 (87%) were successfully transplanted; 23 (13%) did not meet study transplantation criteria. At 30 days, 92% of patients had survived and had no severe PGD. The 30-day survival was 97%, and the incidence of severe PGD was 6.7%. The mean number of heart graft-related serious adverse events within 30 days was 0.17 (95% CI: 0.11-0.23). Patient survival was 93%, 89%, and 86% at 6, 12, and 24 months, respectively, and was comparable with concurrent nonrandomized control subjects.
Conclusions:
Use of an extracorporeal perfusion system resulted in successfully transplanting 87% of donor hearts with excellent patient survival to 2 years post-transplant and low rates of severe PGD. The ability to safely use ECD DBD hearts could substantially increase the number of heart transplants and expand access to patients in need. (International EXPAND Heart Pivotal Trial [EXPANDHeart]; NCT02323321; Heart EXPAND Continued Access Protocol; NCT03835754).
