Specialist commentator comments

Comments on this technology were invited from clinical experts working in the field and relevant patient organisations. The comments received are individual opinions and do not represent NICE's view.

All 4 specialist commentators were familiar with the OCS Heart system and 2 have used this technology. Two of the commentators (from the same hospital) were involved in clinical trials of the device.

Level of innovation

The specialist commentators considered the OCS Heart system to be a major variation on current clinical practice with a novel design and concept. It has the potential to improve outcomes for heart transplantation compared with cold ischaemic storage. Training is necessary and clinicians must learn how to place hearts in the OCS Heart system effectively and safely, as well as how to manage and interpret the data given before deciding whether to proceed to recipient implantation. Regular use of the device is needed to develop experience and maintain skills.

Potential patient impact

The commentators felt that the OCS Heart system is unique, in that it allows hearts to be donated from donors after circulatory death. This is a novel concept for increasing the number of hearts for transplantation, which were previously only available for donation after brainstem death. One specialist speculated that if made available across the UK, heart retrieval after circulatory death could potentially increase annual UK heart transplant activity by 30% to 40%. Increasing the number of donor hearts would reduce the average waiting time for patients. It may also reduce hospital admission rates for decompensation (functional deterioration of the heart), and waiting list mortality.

The commentator added that hearts that are considered to have extended donor criteria can be assessed by the OCS Heart system before deciding whether or not to proceed to implantation.

Heart recipients needing a complex operation to remove their own heart (for example, those with complex congenital heart disease or needing left ventricular assist device [LVAD] explant) may be more likely to need longer surgery. The OCS Heart system allows the donor heart to be moved to the recipient hospital and remain on the system until the recipient heart has been explanted, without further ischaemic time. Additionally, the OCS Heart system allows donor hearts to be transported from further away, with transport times that would be too long for standard cold storage. The specialist therefore suggested that the system could allow heart transplantation to become a planned urgent procedure rather than an emergency.

One specialist commentator stated that in their opinion the OCS Heart system offers improved outcomes through a reduction in primary graft dysfunction, although there is no published evidence to support this currently. One specialist reflected that the OCS Heart system has the potential to expand the number of suitable donors, increase the likelihood of heart transplantation, decrease waiting times and potentially reduce mortality rates of people on the waiting list.

Potential system impact

In increasing the range of donor hearts available, the OCS Heart system could increase the number of heart transplants done in the NHS. This could affect staffing and theatre time (as the OCS Heart system needs more team members present for retrieval), bed usage and post-transplant follow-up. These factors may have an impact on workforce, rotas, and costs as well as on other services which may be displaced because of the urgent nature of heart transplantation.

Two specialists suggested that if the rates of heart transplant were increased there may be a decrease in the number of LVADs used as a bridge to heart transplant, with consequent cost savings. One specialist pointed out that this would not result in a one-to-one ratio between the number of extra transplants and the avoidance of LVADs. One commentator stated that there may be a significant cost reduction for the perfusion set if it is bought in bulk.

Use of the OCS Heart system has potential for cost savings by allowing more hearts to become available and reducing overall waiting times, thus limiting prolonged and recurrent hospital admissions associated with heart failure and in-hospital waits.

General comments

One specialist highlighted that the OCS Heart system cannot be used for many paediatric patients. Two specialists stated that the technology is invaluable in special circumstances, such as heart transplantation after circulatory death. However one commentator noted that this technology is very expensive and therefore more evidence of patient benefit is needed before it could be considered for routine use.