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The BiVACOR Total Artificial Heart, named for the company that created it, was implanted July 9 into a patient on the wait list for a transplant. The device was removed eight days later when a donor heart became available for the patient.

Dr. Alexis Shafii is the surgical director of heart transplantation at Baylor St. Luke's Medical Center and was the primary surgeon for the implant. The medical center is part of St. Luke's Health, a subsystem of CommonSpirit Health.

"This is an amazing advancement as the BiVACOR Total Artificial Heart may offer hope for countless patients who suffer from end-stage heart failure," Shafii said in a statement. "This device may serve as a life-saving bridge to a heart transplant; future studies may prove its potential as a long-term pump that can effectively serve as a total replacement for a patient's heart."

BiVACOR says on its website that the titanium device has only one moving part, a rotor levitated by magnets, that pumps blood "to the systemic (body) and pulmonary (lung) circulations to replace both ventricles of a failing heart."

The device is currently charged with a battery pack connected to wires that go through the skin. Its creators say it will eventually have internal batteries that can be charged through the skin, like a wirelessly charging smartphone.

"As we progress through, then that's our ultimate goal. When we find that stage, we feel like we can rival heart transplantation," Daniel Timms, the founder and chief technology officer of BiVACOR and the inventor of its artificial heart, said at a press conference July 25 in Houston.

Big potential
Dr. William "Billy" Cohn, chief medical officer of BiVACOR, pointed out at the press conference that heart failure is the No. 1 cause of death in the United States. The National Institutes of Health estimates that up to 100,000 patients could immediately benefit from mechanical circulatory support.

To date, Cohn noted, artificial hearts have had valves and other parts that wear out as they beat 144,000 times a day.

"No man-made device can do that without breaking," he said. "And that's been borne out by all these hearts. They can keep a patient alive while we're looking for a donor heart to transplant them, but they fail capriciously."

Cohn said BiVACOR's device could become the exception. "Perhaps someday, this will be used instead of a transplant because it's small, it's energy efficient, and it should never wear out," he said.

12 years in development
Shafii spent time in the lab with researchers as they tested the artificial heart and implanted it into calves. He had confidence in the device and the trust of the patient who agreed to the implant. If they didn't act, the patient would get too sick for any type of transplant, Shafii explained during an interview.

"The patient thought that he himself was tenuous, and he was agreeable, and that's how he accepted to move forward," Shafii said.

Dr. Joseph Rogers is the president and CEO of the Texas Heart Institute and the national principal investigator on the research of the BiVACOR device. He reported at the press conference that the operation was the culmination of a 12-year development program. The patient was the first of five set to have the BiVACOR heart implanted as part of a U.S. Food and Drug Administration Early Feasibility Study.

At the time of the surgery, the 57-year-old patient was in cardiogenic shock, a condition in which the heart can't pump enough blood to meet the body's needs. Three days after the nearly six-hour operation, he was removed from a ventilator and able to sit up in a chair, Rogers said.

Seven days after the operation, the patient was able to walk the halls, and Rogers said his blood flow was like that of a person with a healthy heart.

A day later, the patient underwent the donor heart transplant. He celebrated his 58th birthday later in July and continues to recover.

"First and most importantly, I'd like to acknowledge the patient and his family," Rogers said. "The courage that he displayed was remarkable. And he has a wonderful spirit ... I want to thank the clinical team. There were hundreds of people that surrounded the patient to make this happen."

Team-building moment
In an interview alongside Dr. Brad Lembcke, Baylor St. Luke's Medical Center president, Shafii emphasized the importance of innovation, research and teamwork over the years to get to the point where the BiVACOR artificial heart was ready for implantation.

Shafii said: "The science behind the development of the actual device requires an enormous amount of patience. I'm more like, oh, OK, you've made your experimental plane. OK, I'll fly it."

Added Lembcke: "Everyone had to learn how to do this. And it's just been one of those uplifting, team-building moments. And that's what you want from an organization like this. That's what our community expects out of Baylor St. Luke's."