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Clinical Trial
. 2024 Mar;12(3):438-447.
doi: 10.1016/j.jchf.2023.11.015. Epub 2024 Jan 24.

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

Jacob N Schroder  1 , Chetan B Patel  2 , Adam D DeVore  2 , Sarah Casalinova  2 , Kevin J Koomalsingh  3 , Ashish S Shah  4 , Anelechi C Anyanwu  5 , David A D'Alessandro  6 , Karol Mudy  7 , Benjamin Sun  7 , Martin Strueber  8 , Asghar Khaghani  9 , Yasuhiro Shudo  10 , Fardad Esmailian  11 , Kenneth Liao  12 , Francis D Pagani  13 , Scott Silvestry  14 , I-Wen Wang  15 , Christopher T Salerno  16 , Tarek S Absi  4 , Joren C Madsen  6 , Donna Mancini  5 , Amy G Fiedler  17 , Carmelo A Milano  2 , Jason W Smith  17
Affiliations
Free article
Clinical Trial

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

Jacob N Schroder et al. JACC Heart Fail. 2024 Mar.
Free article

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. (International EXPAND Heart Pivotal Trial [EXPANDHeart]; NCT02323321; Heart EXPAND Continued Access Protocol; NCT03835754).

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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Conflict of interest statement

Funding Support and Author Disclosures The study was funded by TransMedics Inc. Dr Schroder has received research funding paid to his institution from TransMedics. Dr DeVore has received research funding through his institution from the American Heart Association; Biofourmis; Bodyport; Cytokinetics; American Regent Inc; The National Heart, Lung, and Blood Institute; Novartis; and Story Health; consulting fees and/or honoraria from Abiomed, AstraZeneca, Cardionomic, InnaMed, LivaNova, Natera, Novartis, Procyrion, Story Health, Vifor, and Zoll; and nonfinancial support from Abbott for educational and research activities. Dr Silvestry has received research funding from Abbott, Abiomed, and Medtronic. Dr Milano has received research funding from TransMedics. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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