On July 9, the Texas Heart Institute of Houston performed the first-ever successful implant of a BiVacor Total Artificial Heart (TAH) on a 57-year-old man—making for a heartfelt moment.
The patient, who was not named, was critically ill and in cardiogenic shock, meaning his heart couldn’t pump the amount of blood his body needed. However, finding donor organs can be difficult, as nearly 3,500 patients are currently awaiting a heart transplant, according to the public-private Organ Procurement and Transplantation Network.
But the patient had another option: a BiVacor TAH, which is a titanium heart that uses magnetic technology to pump blood. It is designed to replace both ventricles of a failing heart.
Heart to (other) heart
The surgery was part of an FDA early feasibility study, in which new medical devices are used on a small number of patients to assess their safety and efficacy.
In the study, the TAH functioned as a placeholder rather than a long-term solution. Daniel Timms, founder and chief technology officer at BiVacor, said the team hopes to do four more similar surgeries like this to test the TAH before Q1 next year.
On post-op day three, Joseph Rogers, president and CEO of the Texas Heart Institute, said the patient in the July 9 surgery was disconnected from a ventilator and could sit up in a chair.
“The first thing he said when the breathing tube came out was: ‘I feel great,’” Rogers told Healthcare Brew.
Seven days after the survey, the patient walked about one-tenth of a mile, according to an emailed statement. While active, the titanum heart pumped 12 liters of blood flow per minute, which is similar to a human heart’s capabilities.
“The pump actually did exactly what we thought it would, and that is, pump more blood when he got up to exercise,” Rogers said.
On July 17, eight days after the implant, a donor heart became available, and the artificial heart was replaced.
Heart of metal
Achieving long-term use of the TAH is the end goal—and that played a major role in how the artificial heart was designed.
The TAH, which has been in development since 2001, pumps blood to the lungs and throughout the body using a rapidly spinning disk that is magnetically levitated and rotated, Timms said. He added that there’s “no mechanical wear,” and therefore, there’s less of a chance that the device will deteriorate or die out over time.
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Typically, artificial hearts use compression sacs to squeeze the blood out of the device and distribute it to the body, but these can fail over time, Timms said. Artificial hearts are also occasionally too big for some patients, so by not using sacs, the TAH is smaller.
Sac-based pumps, Timms added, also are not able to produce a cardiac output that can handle light or medium exercise, leaving patients “somewhat limited to resting conditions” because they have to stay connected to an external battery and driver.
In comparison to a traditional organ transplant, Timms said TAHs aren’t dependent on someone else donating a heart, and don’t require anti-rejection medications to stop the body from attacking the transplanted organ.
“Eventually the body wins, and those anti-rejection drugs lose out. And after 10 years, half the patients that have a donor heart reject [the transplant] and they pass away, or they need another donor heart,” Timms said.
But the team chose to make the BiVacor heart out of titanium, which Timms said is the “the most unique metal on the planet in regards to biocompatibility.”
“The body barely even knows it’s there; it doesn’t reject it. It just basically thinks it’s another tissue,” he said.
Ultimately, Timms said the goal is to create a device that can last longer than 10 years and “continue on for the patient’s life.”
On July 24, the patient celebrated his 58th birthday. While he was still in the hospital recovering at that time, Rogers said it’s important to “remember the courage of the patient.”
“I just have great admiration for both him and his family for really thinking critically about whether this was the right thing for him. I think as he looks back on it now, he believes he made a good decision,” Rogers said.