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Published January 02, 2021
“People die waiting for a heart – and people are suffering with symptoms while they wait,” said Muhammad Anwer, MD, cardiac surgeon, Yale New Haven Hospital (YNHH) Heart and Vascular Center.
For this reason, the Heart and Vascular Center at Yale New Haven Hospital is participating in a clinical trial evaluating outcomes for donation after circulatory death (DCD), a method of heart transplantation new to the United States. This method allows surgeons to restart a heart after it has stopped beating and assess if the organ is appropriate for transplant, expanding the amount of viable donor hearts.
“This method is one of the most exciting developments in heart transplantation, said Arnar Geirsson, MD, chief of cardiac surgery, Yale New Haven Hospital Heart and Vascular Center. “It saves hearts that would previously not be viable for donation and extends the organ’s out-of-body life span. These types of trials push the envelope in heart transplants and are a step forward in expanding the donor pool.”
The clinical trial completed enrollment in September of 2020. In December 2020, the U.S. Food and Drug Administration (FDA) granted YNHH approval to use the method under Continued Access, a pathway for treatment outside of the clinical trial.
A heart transplant is sometimes the only hope of survival for those with severe heart failure, which affects more than 250,000 people in the United States.
There remains a gap between people who need a heart transplant and people who receive one on time. A patient in need of a new heart typically waits more than six months for a donor organ to become available, and often much longer. Over the last five years, an average of 318 people died annually while on the heart transplant waitlist.
“The most recent organ allocation restructuring in 2018 was designed to decrease waitlist deaths by prioritizing patients with the most severe illness,” said Christopher Maulion, MD, advanced heart failure and transplant cardiologist, YNHH Heart and Vascular Center. “There is still a discrepancy between how many hearts are required versus available. The changes that were made cannot circumvent supply and demand.”
Traditionally, hearts for transplant have been donated after brain death. This means a donor has no brain activity, but the heart is still beating via life support. This allows transplant specialists to perform a functional assessment of the organ before transplant. The heart is then packed in cold storage and must be transplanted within four hours. This method restricts how far the heart can travel and excludes potentially viable hearts because there was no opportunity for assessment since they were not beating inside the donor.