Non ischemic heart preservation (NIHP)

Purpose and goal

The purpose of this project was to compare a new preservation method with the standard preservation method of donor hearts in adult heart transplants. Initially, six patients was transplanted using this new method. The results of these patients were compared with contemporary transplants where the heart is preserved according to the standard method. Subsequently, the goal was to randomize 28 patients in a controlled clinical trial. The primary outcome measure was survival free from early graft dysfunction or retransplantation, rejection grade 2R or more, or the need for ecmo.

Expected results and effects

The results of the project have met the expectations we had. The method has proven to be feasible and could be used safely. During the first six months, all patients treated with the new method achieved an event-free survival, compared with 72% of those treated with the standard method. We also saw a lower rate of ischemic injury in the patients treated with the new method, although the ischemia time was longer. The proportion of complications did not differ between the groups. In the randomized part of the study, 13 of the 28 patients has been included.

Planned approach and implementation

The design of the study has worked well. The rate of inclusion has been limited in waiting times for decisions by authorities. The study has resulted in the patent being sold to a Swedish medical technology company that started the production of a commercial product consisting of a heart box with preservation solution. An international multicenter CE marking study haas been initiated. >12 international heart transplant centers from Europe, the USA and Australia will be included in future clinical studies to be used for (CE marking and FDA approval).