Australia's first implant of a BiVACOR Total Artificial Heart has been announced as an unmitigated clinical success, with the patient becoming the first in the world to be discharged from hospital.
The implant took place on 22 November 2024 at St Vincent's Hospital Sydney in a six-hour procedure led by renowned St Vincent's cardiothoracic and transplant surgeon, Dr Paul Jansz.
After a few weeks in the ICU, followed by observation in the ward by St Vincent's clinicians, led by heart failure and transplant cardiologist Professor Chris Hayward, the patient - a man in his forties from NSW who has declined to be identified - became the first patient in the world to be discharged from hospital with the BiVACOR Total Artificial Heart in early February 2025.
The implant - the first in a series of procedures planned in Australia as part of the Monash University-led Artificial Heart Frontiers Program, and which benefited from a $50 million grant from the Australian Government's Medical Research Future Fund - is designed as a bridge to keep patients alive until a donor heart transplant becomes available.
The patient received their donor heart transplant on Thursday, 6 March and is recovering well. At 105 days, it is the longest period in the world for a BiVACOR Total Artificial Heart patient between obtaining their implant and then receiving their donor heart transplant.
The long-term ambition is for implant recipients to be able to live with their device without needing a heart transplant.
The world's first BiVACOR Total Artificial Heart implant occurred on 9 July 2024 at the Texas Heart Institute at Baylor St Luke's Medical Center in the Texas Medical Center. Since that operation, four more implants have taken place in the US. The successful Australian implant of the TAH is the first to take place outside the US and is the sixth in the world.
The patient, who was experiencing severe heart failure, volunteered to become the first Australian recipient of a total artificial heart.
Dr Daniel Timms, the Queensland-born inventor of the world's first durable total artificial heart and BiVACOR's founder and Chief Technical Officer, said he was proud to see the technology progress in Australia.
"Being able to bring Australia along this journey and be part of the first clinical trials is immensely important to me and something that I set out to do from the very beginning," says Dr Timms.
"It is incredibly rewarding to see our device deliver extended support to the first Australian patient. The unique design and features of the BiVACOR Total Artificial Heart translate into an unmatched safety profile, and it's exhilarating to see decades of work come to fruition.
"The entire BiVACOR team is deeply grateful to the patient and his family for placing their trust in our Total Artificial Heart. Their bravery will pave the way for countless more patients to receive this lifesaving technology.
St Vincent's Hospital Sydney's Dr Paul Jansz said it was a privilege to be part of such an historic and pioneering Australian medical event.
"Heart failure kills almost 5,000 Australians every year. We've worked towards this moment for years and we're enormously proud to have been the first team in Australia to carry out this procedure," said Dr Jansz.
"As Australia's leading heart and lung transplant centre, St Vincent's was the natural first choice as the venue for the first total artificial heart implant. St Vincent's was the location for Australia's first heart transplant in 1968, the establishment of the National Heart Transplant Program by Dr Victor Chang in 1984, and the development of 'heart in a box' technology in 2014.
"We're all privileged to have added to that history with the first total artificial heart implant."
St Vincent's Hospital Sydney cardiologist, Professor Chris Hayward, said the BiVACOR Total Artificial Heart would transform heart failure treatment internationally.
"The BiVACOR Total Artificial Heart ushers in a whole new ball game for heart transplants, both in Australia and internationally. Within the next decade 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."
Monash University's Vice Chancellor and President, Professor Sharon Pickering, said the Artificial Heart Frontiers Program is a shining example of the transformative innovation our nation can achieve when universities, industry and government come together.
"The Artificial Heart Frontiers Program underlines Monash's commitment to purpose-driven research and innovation to deliver tangible and significant benefits to so many individuals, families and communities, both in Australia and globally," said Professor Pickering.
"This revolutionary milestone in Australian medical history is a triumph of science and a source of hope for patients and families. In my own family and for so many others this is a poignant reminder of the critical importance of medical research - made possible by the great relationships between universities, hospitals and industry - to improving and saving the lives of millions of Australians.
"Over the next three years and beyond, the AHFP Consortium's expert engineers, clinicians and researchers will accelerate this Australian-grown world leading research and development program to further develop the TAH and related game-changing mechanical circulatory support devices that will deliver substantial global health and economic benefits through urgently needed solutions for advanced forms of heart failure, for which there are limited or no available treatments.
"Monash's world-leading cardiac and engineering research, and our commitment to working with partners to address global challenges has been central to the opportunity now before us of developing an Australian-based cardiac device industry."
About the Artificial Heart Frontiers Program
The Artificial Heart Frontiers Program, led by Monash University is a consortium of expert engineers, clinicians and researchers from Monash University, industry partner BiVACOR (both BiVACOR entities - BiVACOR Australia Pty Ltd and the US based BiVACOR Inc), the research institutions of University of NSW, University of Queensland, Griffith University, Queensland University of Technology, and the Baker Heart and Diabetes Institution, and our clinical collaborators, Alfred Health and St Vincent's Hospital Sydney.
The Monash University-led Artificial Heart Frontiers Program is developing and commercialising three key devices to treat the most common forms of heart failure. Together the highly durable devices could halve deaths from heart failure and establish Australia as a world leader in the clinical trial, development and local manufacture of cardiac medical technology.
The devices comprise:
- a wholly new miniature device, the Mini-Pump, that is implanted inside the hearts of patients who currently have no other option for treating their heart failure symptoms
- a new type of Left Ventricle Assist Device (LVAD) that is implanted next to a natural heart to help it pump
- the Australia-US based BiVACOR 's Total Artificial Heart (TAH) that fully replaces a natural heart.
All three devices use game-changing technologies that will allow them to mimic a natural heart by automatically responding to the body's physical demands - for the first-time offering heart failure patients a treatment that doesn't just keep them alive but helps them lead an active life.
The Artificial Heart Frontiers Program is developing and commercialising three key devices to treat the most common forms of heart failure. Together the highly durable devices could halve deaths from heart failure and establish Australia as a world leader in the clinical trial, development and local manufacture of cardiac medical technology.
By 2036, the program is expected to have generated a $1.8 billion benefit to Australia and Australian society, including savings to the healthcare system, an expansion in local industry in research and manufacturing, the creation of more than 2000 jobs, and providing Australians early access to clinical trials and emerging life-saving technologies.
