The Duke University Health System was responsible for the second-ever utilization of a technology that acts as a complete artificial heart to extend the lives of patients waiting for a transplant.
The BiVACOR Total Artificial Heart, a device currently undergoing clinical trials, was used in August to keep Donavan Harbison, a resident of Graham, N.C., alive for 10 days while he awaited a heart transplant at Duke University Hospital. The device was first used in July at Baylor St. Luke’s Medical Center in Texas.
“We just weren't able to find a heart fast enough and … the rest of his heart was failing,” said Adam DeVore, medical director of the Duke Heart Transplant program and associate professor of medicine at the School of Medicine. “… That's where a total artificial heart can come in.”
Total Artificial Hearts (TAHs) are devices that can pump blood through the body in the event of heart failure. While the standard treatment, temporary ventricular assist devices (VADs), work for many patients, they may not be suitable in cases of severe biventricular heart failure or univentricular heart failure. In these cases, TAHs can be used to replace the functioning of the heart entirely while the patient waits for a real transplant.
This was the scenario for Harbison, who began feeling poorly in late 2023. A former North Carolina Central University football player and father who is currently expecting his fourth child, Harbison initially thought he had pneumonia and was shocked when doctors diagnosed him with end-stage biventricular heart failure.
As his condition continued to worsen, doctors feared he would soon be too sick for a heart transplant. They needed to act fast — but human hearts are in short supply.
“He's a former right tackle. He's a big guy, and a lot of times, the bigger you are, the longer your wait time,” DeVore said. “… The big problem we have is that there are more patients that need a heart transplant than there are transplants available.”
Harbison initially received a VAD, but it wasn’t enough to support him as he waited for a transplant. So, he and his team of doctors decided to move forward with the BiVACOR TAH, something Harbison described to Duke Today as a “leap of faith.”
For Harbison and his medical team, the leap paid off. The TAH functioned as his heart for 10 days, allowing him to regain enough strength to undergo a complete transplant once a human heart became available.
While the first TAHs — developed by SynCardia — received FDA approval in 2004, many new versions of the technology have been entering clinical trials over the past few years. Duke Hospital has played a vital role in helping pioneer these technologies, being the first U.S. hospital to implant a similar artificial heart device developed by Aeson in 2021.
“We're the world's largest advanced heart failure program,” DeVore said. “If you look at volume by transplants and LVADs — durable left ventricular assist devices — that people go home with, we're far and away the largest program in the world.”
The BiVACOR device was a profound success for Harbison. Since his TAH replacement, the BiVACOR artificial heart model has been successfully used twice more.
DeVore said that the BiVACOR TAH shows particular promise thanks to its unique design. It has very few moving parts and uses magnetic levitation technology, which could potentially make it more durable than other iterations of the device. The hope for these devices is that, in the future, they could be used for more than just temporary amounts of time.
“Someday, you can imagine that it would be a replacement to be used instead of a transplant,” DeVore explained.
For now, Duke Hospital doctors like DeVore said they are grateful that they have access to groundbreaking technology like this to give more patients a second chance.
“I saw [Harbison] in the clinic the other day, and he looks like he never had a heart transplant. He looks fantastic,” he said. “… He’s going to get to see his next child born, so it’s pretty amazing stuff we get to do.”
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