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Heart failure & cardiomyopathiesRandomised controlled trial

Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial

LancetPublished

  • Randomised controlled trial
  • open-label
  • multicentre
  • multinational
  • superiority design
  • 15 transplant centres in 8 European countries
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Authors' conclusion

Although there was not a significant difference in the primary endpoint, the 44% risk reduction associated with HOPE was suggested to be a clinically meaningful benefit.

Study context

Population
Adult heart transplant candidates; donors aged 18–70 years, no previous sternotomy, donation after brain death204 in primary analysis
Participants
229 candidates
Comparison
HOPE vs static cold storage (SCS) of the donor heart
  • HOPEn = 101
  • SCSn = 103reference
Primary endpoint
Time to first event of composite of:
  • Cardiac-related death
  • Moderate or severe LV primary graft dysfunction (PGD)
  • RV PGD
  • Acute cellular rejection ≥2R
  • Graft failure (mechanical circulatory support or re-transplantation)
Follow-up
Within 30 days after transplantation

Primary result

As reported in the abstract

Hazard ratio

0.56

95% CI 0.32–0.99

P = 0.059

Events by treatment group

HOPE vs SCS
HR 0.56 (95% CI 0.32–0.99); P = 0.059

Secondary outcomes

OutcomeHOPESCSRR (95% CI)
PGD as primary outcome event11%28%0.39 (0.20–0.73)
Major adverse cardiac transplant events18%32%0.56 (0.34–0.92)

Donor hearts transplantable after HOPE perfusion

All donor hearts preserved with HOPE were transplantable after perfusion
100

Safety

Serious adverse events

Events HOPE 158 · SCS 222

Original publication

Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial. Lancet. Published 17 August 2024. doi:10.1016/s0140-6736(24)01078-x
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Summarised from the published abstract; every number is checked against it