4 Efficacy
This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1
In a randomised non‑inferiority trial of 128 patients who received donor hearts stored by normothermic extracorporeal preservation (n=62) or standard cold ischaemic storage (n=66), the mean out‑of‑body times (the duration from the time the donor heart was stopped to the time of reperfusion after transplantation) were 324±79 minutes and 195±165 minutes respectively (p<0.001). The 30‑day survival rate was 94% (58 of 62) in the normothermic extracorporeal preservation group and 97% (64 of 66) in the cold ischaemic storage group (not significant).
4.2
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), the mean hospital length of stay was 26 days in the normothermic extracorporeal preservation group and 28 days in the standard cold ischaemic storage group (not significant). Cumulative survival rates were 96% and 95% respectively at 30‑day follow-up (not significant).
4.3
In a case series of 30 patients, biventricular allograft function was well preserved in 92% (24 of 25) of patients at mean follow‑up of 257 days; the mean left ventricular ejection fraction was 66%, the mean fractional shortening was 37%, and the mean longitudinal right ventricular systolic function was 13.6 mm.
4.4
In the non‑randomised controlled study of 159 patients who received donor hearts stored by normothermic extracorporeal preservation (n=29) or standard cold ischaemic storage (n=130), the cumulative survival rates were 89% and 81% respectively at 1‑year follow-up (not significant). At 2‑year follow-up, the cumulative survival rates were 89% and 79% respectively (not significant).
4.5
Specialist advisers listed the following as key efficacy outcomes: an increase in preservation times; a decrease in ischaemia times, the need for organ reconditioning, length of stay in an intensive care unit, primary graft function, and 30‑day survival or mortality rates; and an increase in the number of hearts available for transplantation.