Transplant Trial Watch

Intermediate outcomes with ex-vivo allograft perfusion for heart transplantation.

Chan JL, Kobashigawa JA, et al.

Journal of Heart & Lung Transplantation 2017; 36(3): 258-263.


Aims
To compare 2-year outcomes in heart transplant patients using the Organ Care System, an ex-vivo heart perfusion platform versus standard cold storage.

Interventions
Participants were randomised to receive either standard cold storage or the Organ Care System.

Participants
38 adult heart transplant recipients aged ≥ 18 years from the PROCEED II study* with a mean arterial pressure >60 mmHg and a satisfactory echocardiogram.

Outcomes
The primary outcome measured was 2-year patient survival. Secondary outcomes measured included freedom from cardiac allograft vasculopathy, incidence of non-fatal major cardiac events, freedom from any-treated rejection, biopsy-proven cellular rejection and biopsy proven antibody-mediated rejection, total ischemia time and cold ischemia time.

Follow-up
2 years

CET Conclusions
This paper reports results from a single centre in the PROCEED II trial at 2 years after transplantation. Therefore the numbers included are limited and data analysis is retrospective. The authors acknowledge that this paper has only 4.7% power to detect a difference in patient survival with these numbers. The patient survival difference between the two groups (72.2% normothermic perfusion and 81.6% cold storage) is therefore not statistically significant. Similarly, there was no difference in freedom from non-fatal cardiac events or cardiac allograft vasculopathy. What is needed now is a combined long-term follow up across all centres in the PROCEED II trial.

Jadad score
2

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Quality notes
Previously assessed as *Ardehali A, et al. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. Lancet 2015; 385: 2577-2584.

Trial registration
None

Funding source
Not reported