Normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death

Death was reported in 14% (4 of 29) of patients in the normothermic extracorporeal preservation group in a non‑randomised comparative study of 159 patients who received donor hearts stored by normothermic extracorporeal preservation (n=29) or standard cold ischaemic storage (n=130). Deaths were caused by severe multi‑organ failure (n=2), graft failure (n=1) and graft vasculopathy (n=1). Authors did not report the death rate in the standard cold ischaemic storage group. Death because of bowel ischaemia was reported in 1 patient, 44 days after transplantation, in a case series of 30 patients.

A haemorrhagic stroke was reported in 1 patient in a case series of 20 patients. No further details were provided.

Severe rejection was reported in 18% (11 of 62) of patients in the normothermic extracorporeal preservation group and 14% (9 of 66) of patients in the standard cold ischaemic storage group in a randomised non‑inferiority trial of 128 patients (not significant).

Graft failure was reported in 1 patient in the normothermic extracorporeal preservation group (n=62) and in no patients in the standard cold ischaemic storage group (n=66) in the randomised non‑inferiority trial of 128 patients (not significant). Primary graft failure was reported in 7% (2 of 29) of patients in the normothermic extracorporeal preservation group and 15% (20 of 130) of patients in the standard cold ischaemic storage group in the non‑randomised comparative study of 159 patients (not significant).

Left ventricular dysfunction was reported in 8% (5 of 62) of patients in the normothermic extracorporeal preservation group and 6% (4 of 66) of patients in the standard cold ischaemic storage group in the randomised non‑inferiority trial of 128 patients (not significant). In the same study, right ventricular dysfunction was reported in 3% (2 of 62) of patients in the normothermic extracorporeal preservation group and 9% (6 of 66) of patients in the standard cold ischaemic storage group (not significant).

Moderate right ventricular failure was reported in 19% (5 of 26) of patients in the case series of 30 patients.

A need for haemodialysis was reported in 10% (3 of 29) of patients in the normothermic extracorporeal preservation group and 25% (33 of 130) of patients in the standard cold ischaemic storage group in the non‑randomised comparative study of 159 patients (p=0.05).

In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse events: inadequate perfusion leading to ischaemic damage and the need for inotropes, extracorporeal membrane oxygenation or ventricular assist device support; clotting of the circuit during perfusion; and loss of the donor heart because of detachment from the perfusion system. They considered that the following were theoretical adverse events: 'over‑perfusion' of the donor heart leading to myocardial oedema and loss of the donor heart because of mechanical failure of the perfusion system during transportation.