At last year’s ISHLT congress, in April 2025, the one-year results from the European multicenter heart trial, NIHP2019, were presented. The results have now been published in the European Heart Journal[1].
As previously communicated, the long-term analysis of the NIHP2019 trial evaluated patient outcomes 12 months post-transplantation. The findings revealed that severe complications occurred in only 33 percent of patients who received donor hearts preserved using XVIVO Heart Assist Transport, compared to 47 percent in the control group, where donor hearts were preserved on ice — representing a 38 percent risk reduction. Additionally, the 12-month survival rate was higher among patients in the XVIVO Heart Assist Transport group, at 92 percent, versus 86 percent in the control group. The XVIVO trial is the first randomized controlled heart trial to demonstrate a direct relationship between perfusion and survival. Primary graft dysfunction (PGD) is the leading cause of early mortality following heart transplantation.
“I am very pleased that the trial results have been published in the European Heart Journal, which is one of the leading journals in cardiovascular medicine. The results demonstrate that the use of XVIVO Heart Assist Transport with the HOPE method is associated with improved clinical outcomes and reduced postoperative complications at 12 months after transplantation, while also indicating potential to improve hospital efficiency and resource allocation. We are now looking forward to the presentation of the preliminary one-year clinical data from the US single-arm PRESERVE trial at this year’s ISHLT Annual Meeting in Toronto, evaluating the same heart technology, but now for extended criteria donor hearts (ECD)”, says Christoffer Rosenblad, CEO XVIVO.
The NIHP2019 trial is a randomized, controlled, open label, multicenter clinical investigation of XVIVO Heart Assist Transport to collect the safety and performance data needed in order to obtain a European CE marking. Between November 2020 and May 2023, the NIHP2019 trial enrolled 204 patients across 15 institutions in 8 European countries.
[1] https://academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehag264/8654637
April 16, 2026
Gothenburg
Christoffer Rosenblad, CEO
XVIVO Perfusion AB (publ)