A nonrandomized open-label phase 2 trial of nonischemic heart preservation for human heart transplantation.
Adult
Aged
Cryopreservation
/ methods
Female
Graft Rejection
Heart Transplantation
/ instrumentation
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Non-Randomized Controlled Trials as Topic
Organ Preservation
/ methods
Outcome Assessment, Health Care
/ methods
Perfusion
Prospective Studies
Time Factors
Tissue Donors
Waiting Lists
Journal
Nature communications
ISSN: 2041-1723
Titre abrégé: Nat Commun
Pays: England
ID NLM: 101528555
Informations de publication
Date de publication:
12 06 2020
12 06 2020
Historique:
received:
02
12
2019
accepted:
20
05
2020
entrez:
14
6
2020
pubmed:
14
6
2020
medline:
25
8
2020
Statut:
epublish
Résumé
Pre-clinical heart transplantation studies have shown that ex vivo non-ischemic heart preservation (NIHP) can be safely used for 24 h. Here we perform a prospective, open-label, non-randomized phase II study comparing NIHP to static cold preservation (SCS), the current standard for adult heart transplantation. All adult recipients on waiting lists for heart transplantation were included in the study, unless they met any exclusion criteria. The same standard acceptance criteria for donor hearts were used in both study arms. NIHP was scheduled in advance based on availability of device and trained team members. The primary endpoint was a composite of survival free of severe primary graft dysfunction, free of ECMO use within 7 days, and free of acute cellular rejection ≥2R within 180 days. Secondary endpoints were I/R-tissue injury, immediate graft function, and adverse events. Of the 31 eligible patients, six were assigned to NIHP and 25 to SCS. The median preservation time was 223 min (IQR, 202-263) for NIHP and 194 min (IQR, 164-223) for SCS. Over the first six months, all of the patients assigned to NIHP achieved event-free survival, compared with 18 of those assigned to SCS (Kaplan-Meier estimate of event free survival 72.0% [95% CI 50.0-86.0%]). CK-MB assessed 6 ± 2 h after ending perfusion was 76 (IQR, 50-101) ng/mL for NIHP compared with 138 (IQR, 72-198) ng/mL for SCS. Four deaths within six months after transplantation and three cardiac-related adverse events were reported in the SCS group compared with no deaths or cardiac-related adverse events in the NIHP group. This first-in-human study shows the feasibility and safety of NIHP for clinical use in heart transplantation. ClinicalTrial.gov, number NCT03150147.
Identifiants
pubmed: 32532991
doi: 10.1038/s41467-020-16782-9
pii: 10.1038/s41467-020-16782-9
pmc: PMC7293246
doi:
Banques de données
ClinicalTrials.gov
['NCT03150147']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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