Outcomes similar with heart donation after circulatory death vs. brain death
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Key takeaways:
- Outcomes were similar for transplants of donor hearts after circulatory death vs. transplants of donor hearts after brain death.
- There were no differences between the groups in serious adverse events at 30 days.
Data show 6-month survival after transplantation with a donor heart reanimated with extracorporeal nonischemic perfusion after circulatory death was similar to 6-month survival after transplantation of 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 a projected 30%, according to Adam D. DeVore, MD, associate professor of medicine at Duke University School of Medicine and member in the Duke Clinical Research Institute. Currently, the need for heart transplants far exceeds the availability of suitable donor allografts; the use of hearts from DCD has been evaluated on the basis of clinical outcomes at single centers in Australia and the United Kingdom.
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“There are many patients whose families want to be able to donate their hearts, but the patient does not meet the formal criteria for brain death,” DeVore told Healio. “These are still-healthy hearts and families who are still interested in donation for heart transplantation. DCD gives us a means to do that, and the study provides robust, high-quality evidence that it is safe. We see outcomes here that are at least as good as with traditional transplantation.”
In a randomized noninferiority trial, DeVore and colleagues analyzed data from 180 adult candidates for heart transplant who were assigned to a heart after the circulatory death of the donor or a heart from a donor after brain death if that heart was available first (circulatory-death group; n = 90) or to only a heart that had been preserved with the use of traditional cold storage after the brain death of the donor (brain-death group; n = 90).
“It is important to recognize how rare it is to conduct randomized clinical trials in heart transplant,” DeVore said in an interview. “It was a strategy trial where patients were randomized at the time of listing to either access to DCD donors or the traditional pathway. If a patient participated and they were randomized to the usual care arm, that means they would only be allowed to accept transplants from donors who died from brain death. If randomized to the intervention, they could receive donor hearts from either means, whichever became available faster.”
The primary endpoint was risk-adjusted survival at 6 months in the as-treated circulatory-death group compared with the brain-death group. The primary safety endpoint was serious adverse events associated with the heart graft at 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 as-treated primary analysis, including 80 who received a heart from a circulatory-death donor and 86 who received a heart from a brain-death donor.
The risk-adjusted 6-month survival in the as-treated population was 94% (95% CI, 88-99) among recipients of a heart from a circulatory-death donor and 90% (95% CI, 84-97) among recipients of a heart from a brain-death donor, for a least-squares mean difference of 3 percentage points, beating the noninferiority margin of 20 percentage points (90% CI, 10 to 3; P < .001 for noninferiority).
There were no between-group differences in the mean per-patient number of serious adverse events associated with heart graft at 30 days after transplant.
“The data seem to even favor DCD for transplantation; the subsequent follow-up data and our own experience here at Duke is that these recipients do really well,” DeVore said.
DeVore said the potential to transplant hearts via DCD could also improve transplant timing, meaning patients in need of a transplant receive a heart earlier in their disease course, which would aid recovery after the transplant.
“We talk a lot about innovations in transplantation and some of them are things that require a lot of advancement in science and changes to our existing health structures,” DeVore told Healio. “This involves donor hearts that are already available, today. Now, we are able to use them. It is a really big leap to be able to expand the donor pool that fast, with an already existing donor pool, within the current system.”
For more information:
Adam D. DeVore, MD, can be reached at adam.devore@duke.edu.
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