A nonrandomized open-label phase 2 trial of nonischemic heart preservation for human heart transplantation.

Nature Communications
J NilssonStig Steen

Abstract

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% ...Continue Reading

References

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Citations

Nov 10, 2020·The Journal of Heart and Lung Transplantation : the Official Publication of the International Society for Heart Transplantation·Lu WangJohn H Dark
Mar 30, 2021·Current Treatment Options in Cardiovascular Medicine·Calvin K W Tong, Kiran K Khush
Apr 28, 2021·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·Matthew A WellsUNKNOWN Dead Heart Project
Jun 29, 2021·Frontiers in Immunology·Corbin E GoerlichMuhammad M Mohiuddin
Aug 21, 2021·Annals of Biomedical Engineering·Daniel J PortilloR Lyle Hood
Sep 18, 2021·Frontiers in Physiology·Junfa XueLixin Xie

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Methods Mentioned

BETA
biopsies
sedation

Clinical Trials Mentioned

NCT03150147

Software Mentioned

XVIVO
Excel
Stata MP
NIHP

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