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

Nilsson J, Jernryd V, Qin G, Paskevicius A, Metzsch C, Sjöberg T and Steen D.

This Swedish pilot study was a prospective, open-label, non-randomized study comparing hypothermic oxygenated preservation (HOPE) to static cold preservation (SCS). Six patients were assigned to HOPE[1] and 25 to SCS. The same standard acceptance criteria for donor hearts were used in both study arms. During the first six months, all patients assigned to HOPE met the primary composite endpoint of 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%]). Creatine kinase-myocardial band (CK-MB) assessed 6 ± 2 h after ending perfusion was 76 (IQR, 50–101) ng/mL for HOPE compared with 138 (IQR, 72–198) ng/mL for SCS. Four deaths (16%) within six months after transplantation and three (12%) cardiac-related adverse events were reported in the SCS group compared with no deaths or cardiac-related adverse events in the HOPE group.

“The potential benefits with NIHP system [i.e. XVIVO Heart Assist Transport System] are an improved postoperative course and reduced total cost of the transplantation.”

Nilsson et al 2020

Nat Commun / 2020 / doi:10.1038/s41467-020-16782-9

1. Assignment to the HOPE-group was dependent on the availability of the device and trained personnel.


The XVIVO Heart Technology is not regulatory approved on any market and its safety and efficacy has not been established.
The XVIVO Heart Technology is not commercially available.

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