Multicenter Trial Supports Transplantation of Hearts Donated After Circulatory Death

Since 2015, the U.S. has allowed the transplantation of hearts donated after circulatory death, an update to the former standard of requiring brain death before donation. Technological advancements now permit in situ and ex situ perfusion of donor hearts, and clearly written policies on ethics have been developed.

Subscribe to the latest updates from Cardiovascular Advances in Motion

Thank you for subscribing!

Error: Please enter a valid email address.

Email Address Submit

In a multicenter, randomized, controlled trial, Massachusetts General Hospital researchers observed similar outcomes in patients who received a heart that had been reanimated with portable extracorporeal nonischemic perfusion after the circulatory death of the donor and those who received a heart that had been preserved and transported with the use of traditional cold storage after the donor's brain death.

David A. D'Alessandro, MD, surgical director of the Mass General Heart Transplant Program and Ventricular Assist Devices at Mass General, Jacob N. Schroder, MD, of Duke University, and colleagues published the findings in The New England Journal of Medicine.

Methods

From December 2019 through November 2020, the team enrolled 297 adults who were awaiting heart transplantation at 15 U.S. centers. The patients were randomly assigned 3:1 to:

• The circulatory-death group (n=226)—Could receive either a heart from a circulatory-death donor or a heart from a brain-death donor, whichever was matched to them first according to the priority status assigned to them by the United Network for Organ Sharing (UNOS)
• The brain-death group (n=71)—Could receive a heart only from a brain-death donor

Hearts from circulatory-death donors were reanimated, preserved, and assessed with a portable extracorporeal perfusion and preservation system (Organ Care System Heart, TransMedics). The study was sponsored by TransMedics.

Data was pooled on all patients who underwent transplantation with a heart from a brain-death donor, regardless of group assignment. 166 patients underwent transplantation and had no protocol violations: 80 in the circulatory-death group and 86 in the brain-death group.

Primary Endpoint

The primary endpoint was patient survival six months after transplantation with adjustment for prespecified donor and recipient risk factors:

• Circulatory-death group—94%
• Brain-death group—90%

The least-squares mean difference was −3 percentage points (P<0.001 for noninferiority; margin, 20 percentage points).

Other Endpoints

The secondary endpoint was the donor-heart utilization rate, defined as the number of hearts transplanted after circulatory death divided by the total number of hearts from circulatory-death donors that were placed on the perfusion system: 90/101 (89%).

Wait time from informed consent to transplantation was 24 days in the circulatory-death group and 31 days in the brain-death group.

Safety

Notable safety observations were:

• Primary graft dysfunction—moderate or severe in 22% of patients in the circulatory-death group vs. 10% in the brain-death group; severe in 15% vs. 5%, respectively
• Primary graft failure resulting in re-transplantation—0% of patients in the circulatory-death group vs. 2.3% in the brain-death group

Commentary

The shorter wait time for patients in the circulatory-death group may be clinically important, because in general, their priority on the transplantation list was lower (21% were UNOS allocation status 1 or 2, the most urgent categories, compared with 58% of the brain-death group). That suggests this type of donor heart sourcing and perfusion technology may allow for increased organ utilization and matching.

view original journal article Subscription may be required

Learn more about Heart Transplantation at Mass General

Refer a patient to the Corrigan Minehan Heart Center