An Australian man has made medical history, reportedly becoming the first person worldwide discharged from the hospital with a durable titanium artificial heart implant. The patient, an unidentified man in his 40s who was experiencing severe heart failure, volunteered as the first Australian recipient of a BiVACOR Total Artificial Heart—living for 105 days with the implant while he awaited a donor transplant.
Melbourne’s Monash University, who led the study as part of their Artificial Heart Frontiers Program, says the man received the artificial heart during surgery in November 2024 at Sydney Hospital St. Vincent’s. He stayed in the ICU for a few weeks, followed by a period of observation in the ward, and was discharged in early February before receiving his donor heart transplant on March 6. He's now "recovering well."
BiVACOR Total Artificial Heart attached to Mock Circulation Loop for Pump Hydraulics Performance Testing with Daniel Timms, PhDPhoto credit: BiVACOR
“It’s a complete game-changer,” said Dr. Paul Jansz, the cardiothoracic and transplant surgeon who led the six-hour procedure. “It’s a device that solves a lot of the problems that we have with mechanical circulatory support. This device is very easy to implant, very straightforward to run, and works exceptionally well.”
The BiVACOR is still in the trial stage and not cleared for widespread use. However, this recent success offers hope for a long-term treatment against heart failure, potentially even replacing the need for human heart donors altogether.
Professor Chris Hayward, a cardiologist at St. Vincent’s, believes the Artificial Heart will usher in "a whole new ball game for heart transplants," both in Australia and throughout the world. "Within the next decade," he said, "we will see the artificial heart becoming the alternative for patients who are unable to wait for a donor heart or when a donor heart is simply not available."
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Dr. Daniel Timms, who founded BiVACOR and invented the device, praised the patient for his "bravery," saying "countless more patients [will] receive this lifesaving technology." He added that it’s "exhilarating to see decades of work come to fruition."
A description on the BiVACOR website highlights the TAH's simple construction: "One motor and a single magnetically levitated rotor that simultaneously pumps blood to both the body and the lungs." The company claims the device is small but powerful, "suitable in size for most men and women."
According to the U.S. Health Resources & Services Administration, nearly 3,500 patients were on the waiting list for a donor heart as of September 2024, while over 4,500 received heart transplants in 2023. "A quarter of the people waiting for a transplant [used to] die," Dr. Jansz told the Australian Broadcast Corporation. "[T]hat’s changed now with devices like this."
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The TAH had previously been tested in the U.S. through the Food and Drug Administration’s Early Feasibility Study. Five patients successfully received the implant between July and November 2024, then received a heart transplant and were discharged from the hospital. Following this news, the FDA greenlit the EFS to include an additional 15 patients.
According to the CDC, heart disease is the leading cause of death for "men, women, and people of most racial and ethnic groups" in the U.S., leading to 702,880 deaths in 2022.
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