Similar results with heart donation after circulatory death versus brain death

Key points to remember:

• The results were similar for donor heart transplants after circulatory death compared to donor heart transplants after brain death.
• There was no difference between the groups for serious adverse events at 30 days.

The data show that 6-month survival after transplantation with a donor heart resuscitated with non-ischemic extracorporeal perfusion after circulatory death was similar to 6-month survival after transplantation with a donor heart after brain death.

The method, known as donation after circulatory death (DCD), could potentially expand the pool of available donor hearts by 30%, according to projections Adam D. DeVore, MD, Associate Professor of Medicine at Duke University School of Medicine and Fellow of the Duke Clinical Research Institute. Currently, the need for heart transplants far exceeds the availability of suitable donor allografts; the use of DCD hearts has been evaluated based on clinical outcomes at single centers in Australia and the UK.

“There are a lot of patients whose families want to be able to donate their hearts, but the patient doesn’t meet the formal criteria for brain death,” DeVore told Healio. “These are hearts that are still healthy and families that are still interested in donating for heart transplantation. DCD gives us a way to do that, and the study provides strong, high-quality evidence that it is safe. Here we see results at least as good as with traditional transplantation.

Adam D. DeVore

In a randomized non-inferiority trial, DeVore and colleagues analyzed data from 180 adult heart transplant candidates who were assigned to a heart after donor circulatory death or to a donor heart after brain death whether that heart was available first (circulatory death group; n=90) or only a heart that had been preserved using traditional cold storage after the donor brain died (brain death group; n=90 ).

“It’s important to recognize how rare it is to conduct randomized clinical trials in heart transplantation,” DeVore said in an interview. “This was a strategic trial where patients were randomized at enrollment to access either DCD donors or the traditional route. If a patient participated and was randomized to the usual care arm, that means they would only be allowed to accept transplants from deceased brain-dead donors. If they were randomized to the procedure, they could receive donor hearts from either channel, depending on which becomes available most quickly.

The primary endpoint was risk-adjusted survival at 6 months in the as-treated circulatory death group compared to the brain death group. The primary safety endpoint was serious adverse events associated with heart transplantation 30 days after transplantation.

The findings were published in The New England Journal of Medicine.

Within the cohort, 166 transplant recipients were included in the primary as-treated analysis, including 80 who received a circulatory dead donor heart and 86 who received a circulatory dead donor heart. state of brain death.

The risk-adjusted 6-month survival in the untreated population was 94% (95% CI, 88-99) in recipients of a circulatory deceased donor heart and 90% (CI 95%, 84-97) in recipients of a heart from a brain-dead donor, for a least-squares mean difference of 3 percentage points, exceeding the non-inferiority margin by 20 percentage points (90% CI, 10 to 3; P .001 for non-inferiority).

There was no difference between the groups in the mean number per patient of serious adverse events associated with heart transplantation 30 days after transplantation.

“The data even seem to favor DCD for transplantation; subsequent tracking data and our own experience here at Duke show these recipients are doing very well,” DeVore said.

DeVore said the ability to transplant hearts via DCD could also improve transplant timing, meaning patients needing a transplant receive a heart earlier in the course of their disease, making it easier to recover after heart disease. graft.

“We talk a lot about innovations in transplantation and some of them require a lot of scientific advancements and changes to our existing healthcare structures,” DeVore told Healio. “These are donor hearts that are already available today. Now we are able to use them. It is a very big step forward to be able to expand the donor pool so quickly, with an already existing donor pool, within the current system.

For more information:

Adam D. DeVore, MD, can be attached to [email protected].