The UK National Institute for Health and Care Excellence (NICE) completed a comprehensive review of the literature regarding normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death. This review comes following published and unpublished research trials using the Transmedics Organ Care System.

Heart transplantation usually involves hypothermic storage of donor heart until it is surgically implanted into the patient.  With the new Transmedics device, the donor heart is stored at normal body temperature which keeps it beating and supplied with blood and nutrients for up to 8 hours until it is implanted into the patient.

The NICE review committee was summarily advised “that normothermic extracorporeal preservation might allow more frequent use of marginal hearts, so increasing the number of hearts available for transplantation. However, the available evidence did not provide data to draw any conclusions about this potential benefit.”

Out of the five experts invited to review novel technology, two surgeons representing the Society of Cardiothoracic Surgeons of Great Britain and Ireland revealed an ongoing controversy regarding the safety of the device. Dr. John Dark commented that that two hearts were disconnected from the device and had to be discarded – as a result the hearts could not be transplanted.  This was also confirmed by Dr. Steven Tsui who added that the device could cause, “inadequate perfusion leading to donor heart ischemia. If transplanted, this can result in primary graft dysfunction or primary graft failure.  Some patients who have suffered these complications have required a period of support including inotropes, balloon pump, ECMO and/or VAD.  If donor heart function does not recover after a period of support, the recipient would either die or require re-transplantation.”

A comprehensive overview of the literature included key words such as: heart, cardiac, beating, working, normothermic, continuous perfusion, and organ preservation.

Read more about the NICE recommendations:

2015 May NICE overview IP1289

2015 Oct NICE consultation IP1289

2015 Dec NICE comments IP1289

NICE specialist questionaire IP1289