A young Graham, N.C., father became the second person in the world to receive a BiVACOR Total Artificial Heart (TAH) as a bridge to transplant, living with the device for 10 days before undergoing a heart transplant at Duke University Hospital.
The device completely replaces a patient’s heart muscle, providing the essential mechanics to circulate blood throughout the body. For patients with biventricular heart failure awaiting a heart transplant, the device provides blood circulation until a donor heart becomes available.
The use of the device at Duke was part of a first-in-human clinical study aiming to evaluate the safety and performance of the BiVACOR TAH. The device provides an option for eligible patients with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended.
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“While there are many ways to bridge patients with end-stage heart failure as they await heart transplant, all conventional strategies were unsuccessful for our patient, who had dysfunction of both the right and left side of the heart,” said Duke transplant surgeon Carmelo Milano, M.D., chief of the Division of Cardiothoracic Surgery. “The BiVACOR TAH effectively replaced his entire heart and restored normal circulation. He was able to be successfully transplanted 10 days later.”
The Duke patient is a 34-year-old education consultant expecting his fourth child. Donavon Harbison, a recreational runner and former N.C. Central University football player, began feeling poorly in late 2023 and thought he had pneumonia.
To his surprise, he was diagnosed with heart failure.
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“It was shocking,” said his wife, Lindsey Harbison. Hoping to manage the condition with medications along with diet and lifestyle changes, Harbison learned earlier this spring his condition was genetic and likely the cause of his father’s early death.
After further tests, his doctors at Cone Health in Greensboro, Daniel R. Bensimhon, M.D., and Aditya Sabharwal, D.O., found that he had end-stage biventricular heart failure and referred him to Duke for a heart transplant.
“We can offer our patients VADs, ECMO and other technologies, but the ability to offer our patients the very highest level of care, such as heart and dual-organ transplant, as well as access to advanced devices such as the BiVACOR TAH — that does not happen unless you’re aligned with a partner like Duke Health,” Bensimhon said. “It allows us to get our patients super high-level therapies, fairly close to home, that they would not have access to otherwise.”
With his condition deteriorating quickly, Harbison received a ventricular assist device, but it could not provide the level of assistance needed. After ruling out other technologies, Harbison and his Duke team opted to move forward with the artificial heart.
“There was definitely a feeling of the fear of the unknown,” Donavon Harbison said, “but at that point, I had resolved to take the leap of faith and do everything I could do to increase the success of what would happen.”
“Now, I’m looking forward to getting back to making memories with my family, my kids, my wife, just doing the things you often do and take for granted, like putting my kids to bed at night.”
Harbison received the BiVACOR device in early August—the second in the world after the first implantation occurred in Texas a few weeks earlier. The device provided strong blood circulation, and within 10 days, Harbison gained enough strength to receive a donated heart.
“Many end-stage heart disease patients are actually too sick to qualify for heart transplants,” said heart surgeon Jacob Schroder, M.D., surgical director of Advanced Heart Failure at Duke and member of the transplant team. “Current technologies are effective for some patients, but still leave others without options. Having another way to bridge a path to transplant would fill a tremendous void and truly be a lifesaver.”
The BiVACOR TAH utilizes an electro-mechanical rotary blood pump that is a simpler construction than other investigational devices. It has no valves, and a motor drives a single magnetically levitated rotor that simultaneously pumps blood to both the body and the lungs.
“It was a remarkable opportunity for our team to witness the recovery and subsequent bridge to transplant of our second courageous BiVACOR TAH patient at Duke,” said Daniel Timms, Ph.D., founder and chief technology officer of BiVACOR. “He and his family embraced a positive attitude toward this new technology, which not only helped extend their lives together, but their experience will provide hope for many others with end stage heart failure.”
The BiVACOR device is the second total artificial heart implanted via clinical trial at Duke. In 2021, the heart transplant team became the first in the world to successfully implant a different technology, manufactured by CARMAT.
The Duke heart transplant team has been a world leader in pioneering new technologies that make heart transplantation accessible to more patients,” said Adam DeVore, M.D., medical director of the Duke Heart Transplant program. “With long waiting lists for the limited numbers of donor hearts, it’s imperative that we continue to find innovative ways to maximize scarce resources.”
