Investigating heart transplantation procedures, comparing the two fluids used to preserve the heart during transport to see which one is better at reducing the risk of the heart being rejected.
Surgery,
Clinical trial
For a heart transplant to occur, the donor heart must be retrieved and transported. In order for this to occur safely, the heart is flushed with a preservative fluid. Currently there are two fluids in use for this purpose in the UK, however it is not known if one solution is better than the other. Custodiol-HTK is a fluid that has additives specifically designed to protect the heart during transport. St Thomas’ solution does not have these additives but protects the heart through stopping it quickly. St Thomas’ is the standard fluid used in the UK currently, in part because of its low cost. Some previous studies and data from transplants have suggested that Custodiol-HTK may preserve the heart better. However, this has never been tested in a controlled way in humans.
Dr Berman and his team aim to conduct a randomised controlled trial (RCT) – the gold standard in research – to compare the two fluids. They will observe the rate of primary graft dysfunction (PGD). PGD is when the heart fails in the first 24 hours and is the leading cause of death within 30 days of transplant and a major issue in heart transplantation. This is different to rejection, where the recipient’s immune system attacks the donor heart. In PGD the heart simply does not work properly, possibly as a result of damage during the retrieval process. The final goal for this team is to test whether using Custodiol HTK will protect the heart better and, therefore, reduce the number of hearts that develop PGD.
In order to properly test whether there is a difference, data needs to be collected from lots of patients, a process which will take a long time. Therefore, they first want to test if enough patients will consent to take part in the study to make it realistic goal to complete in a reasonable timeframe. This is called a feasibility study. For this feasibility study the team intends to randomise 50 hearts to receive either Custodiol HTK or St Thomas’ solution. This should take less than 1 year. Data will then be collected on whether the recipients develop PGD or not. The primary aim of the project is to see if more than two-thirds of eligible patients consent to take part and go on to receive a heart that has been correctly randomised.
Through this feasibility study there is the potential to prove that it is possible to conduct the RCT. By conducting the RCT, the question can be answered of which preservative fluid should be used in transplants. Ultimately, if one is shown to be better, practice change can be recommended in the UK, reducing the rate of PGD, and saving the lives of transplant recipients.
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