Increasing Utilization of Extended Criteria Donor Hearts for Transplantation: The OCS Heart EXPAND Trial

Jacob N. Schroder, Chetan B. Patel, Adam D. DeVore, Sarah Casalinova, Kevin J. Koomalsingh, Ashish S. Shah, Anelechi C. Anyanwu, David A. D'Alessandro, Karol Mudy, Benjamin Sun, Martin Strueber, Asghar Khaghani, Yasuhiro Shudo, Fardad Esmailian, Kenneth Liao, Francis D. Pagani, Scott Silvestry, I. wen Wang, Christopher T. Salerno, Tarek S. AbsiJoren C. Madsen, Donna Mancini, Amy G. Fiedler, Carmelo A. Milano, Jason W. Smith

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)438-447
Number of pages10
JournalJACC: Heart Failure
Volume12
Issue number3
DOIs
StatePublished - Mar 2024

Keywords

  • Organ Care System
  • clinical outcomes
  • ex situ donor heart perfusion
  • extended criteria donor hearts
  • heart transplantation
  • ischemia reperfusion injury
  • normothermic heart perfusion
  • organ shortage

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