A new study showed that using a reanimated donor heart following circulatory death is not inferior to using a heart obtained following brain death. The results, published in the New England Journal of Medicine, have important implications, as the demand for heart transplantations often exceeds the supply.
“Until recently, brain-dead donors were the only donors for heart transplantation because brain death permitted in situ assessment of the viability and function of the heart. Advancements with in situ and ex situ perfusion of donor hearts for transplantation and the development of broad policies to allow the use of organs from donors after circulatory death in selected geographic regions enabled the transplantation of hearts from circulatory-death donors in adults [beginning] in 2015,” the authors wrote.
In this randomized, noninferiority trial, researchers assessed 180 patients who underwent transplantation. Of those patients, 90 received a transplant from a circulatory-death donor and 90 received a transplant from a brain-death donor. An additional 166 transplant recipients were included in an as-treated primary analysis. This group comprised 80 patients who received a heart from a circulatory-death donor and 86 patients who received a heart from a brain-death donor.
The primary efficacy end point was defined as risk-adjusted survival at 6 months in the as-treated circulatory-death group compared with the brain-death group. The primary safety end point was defined as serious adverse events (AEs) associated with the heart graft at 30 days post-transplant.
Is Reanimation the Future?
The study met its efficacy end point. Results showed that risk-adjusted 6-month patient survival in the as-treated population was 94% among recipients of a circulatory-death donor heart compared with 90% of recipients of a brain-death donor heart. Risk-adjusted 6-month patient survival in the overall population was 93% in recipients of a heart from a circulatory-death donor compared with 90% in recipients of a heart from a brain-death donor.
In terms of safety, patients who received hearts from circulatory-death donors had slightly more instances of serious AEs associated with the heart graft within the first 30 days post-transplant compared with patients in the brain-death donor cohort. Despite the favorable efficacy findings, researchers cautioned that long-term data analyses are required. However, the findings are encouraging. “A lot of programs … have been waiting to see this data to make sure that there’s going to be a meaningful increase on transplant if they invest in all the infrastructure required,” said Dr. Nancy Sweitzer, director of clinical research for the Division of Cardiology at Washington University School of Medicine in St. Louis, in an interview about the study.
“Now, people will start pushing the envelope, and we’ll find out when it works and when it doesn’t, I think over the next couple of years,” she said. “I’m really excited, because I think it’s going to transform what’s happening in our field pretty rapidly.”