Advice

Summary

Summary

  • The technology described in this briefing is the Organ Care System (OCS) Heart. It is a portable ex-vivo organ perfusion system to monitor and preserve a donor heart.

  • The innovative aspects are that it is the only system available in clinical practice that may preserve a donor heart in a near-normothermic and beating state from retrieval until heart transplantation. Using the OCS allows hearts to be transported over longer distances than cold storage, and is the only available technology which allows donation after circulatory death. Both of these factors may result in an increased number of hearts suitable for donation.

  • The intended place in therapy would be as an alternative to heart preservation using cold ischaemic storage in people needing heart transplantation. NICE interventional procedures guidance on normothermic extracorporeal preservation of hearts for transplantation following donation after brainstem death found that the evidence for short-term safety was sufficient for the procedure to be used with normal arrangements for clinical governance and audit.

  • The key points from the evidence summarised in this briefing are from 5 studies published since December 2015 (n=158 transplants in total). Four studies were conference abstracts and therefore lacked detail on methodology. Two out of 5 studies were done outside the UK and all of the studies were single-centre, and so may not be generalisable to wider NHS populations. Overall, no adverse events were reported. Patients who received hearts donated after brainstem death and preserved using the OCS Heart system were found to have similar survival at 30 days and 2 years in comparison with cold storage preservation.

  • Key uncertainties around the evidence and technology are that there is limited evidence for using the OCS Heart system for hearts that do not meet standard donor criteria.

  • The cost of the single-use OCS Heart Perfusion Set is approximately £30,000 and the cost of the reusable Heart console is approximately £180,000. The cost of standard care using cold ischaemic storage would range from around £55 to £162.