The new procedure uses a TransMedics system to keep hearts perfused with warm blood after the donor dies. The machine keeps the heart functional so it can be transplanted hours later and allows surgeons to evaluate the heart in a way that wasn’t possible before.
In December, a team at Durham, N.C.-based Duke University performed the nation’s first DCD heart procedure as part of a clinical trial. Boston-based Massachusetts General Hospital and University of Wisconsin-Madison are also part of the trial, reporting their first transplants last week.
Such transplants will expand the donor pool by 3,400 people, or 30 percent, Jacob Schroder, MD, a thoracic and cardiovascular surgeon on Duke’s DCD heart transplant team, told STAT.
The three centers have performed 10 DCD heart transplants since the trial began. Fifteen U.S. sites are expected to be involved in the trial, scheduled to run until 2021.
Risk arises in the time it takes to remove the organ before placing it in the machine, potentially injuring the heart. So far, though, known risks are the same as regular transplants, including organ rejection and death, Waleed Hassanein, MD, founder, president and CEO of TransMedics, told STAT.
Currently, the TransMedics system only has FDA approval for its use in lung transplants. TransMedics, the trial’s sponsor, worked with the FDA to develop protocol for the trial and hopes to apply for the agency’s approval at the end of the trial in 2021, Dr. Schroder said.
Other countries have been performing DCD heart transplants since July 2014.
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