Titanium Device as a Permanent Replacement for a Human Heart  

Use of “BiVACOR Total Artificial Heart”, a titanium metal device has enabled the longest successful bridge to heart transplant lasting over three months. The patient was discharged from the hospital with the artificial heart still implanted. He received a donor heart transplant 100 days after implantation of the artificial device and is now recovering well. The patient thus survived for 100 days on the metal device that replaced his native heart. The device is based on a rotary centrifugal pump, uses a magnetically levitated impeller, has a single moving part, has no valves, and has a no-contact suspension system. It was developed as a bridge to heart transplantation but has the potential to serve as a permanent replacement for a human heart. If so, it would be a boon to heart failure patients unfit for heart transplantation as well as to many in the long queue of heart failure patients awaiting donor heart transplantation.  

A heart failure patient awaiting heart transplantation was implanted “BiVACOR Total Artificial Heart” as a bridge before a donor heart becomes available. This procedure for implantation of device was successfully performed by the clinical team of St Vincents Hospital in Sydney in late 2024. In early 2025, the patient was discharged from the hospital making him the first person in the world to leave a hospital with the “BiVACOR Total Artificial Heart”. After more than 100 days, which is the longest period for a patient with this implant, he successfully received a donor heart transplant in early March 2025. The patient is now recovering well.  

The patient with severe heart failure thus survived on the implanted metal device for 100 days that performed the function of his native heart for the bridging period before a donor heart was transplanted.    

BiVACOR Total Artificial Heart is an implantable rotary biventricular blood pump. It uses a magnetically levitated impeller which is the only moving part. Changing the speed of the impeller generates “beats”. The device is not pulsatile and has no valves and has a no-contact suspension system. It only requires a battery pack to run.  

The BiVACOR TAH System replaces the function of diseased heart in the heart failure patients. It is intended to bridge the time to heart transplant. In the recent breakthrough, the device demonstrated a bridging period of over three months which suggests that it may have potential to serve as a permanent replacement for a human heart. If so, it would be a boon to heart failure patients unfit for heart transplantation as well as to many in the long queue of heart failure patients awaiting donor heart transplantation.  

Heart failure (also known as Congestive heart failure or Congestive cardiac failure CCF) is a condition when heart fails to pump adequate blood as required. It is a serious condition requiring intervention and may be caused due to many reasons including coronary heart disease, heart inflammation, high blood pressure, cardiomyopathy, etc. Over 60 million people are affected by this condition worldwide. Many require heart transplantation however there is a long waiting queue due to limited availability of donor heart. An implantable effective device as a permanent replacement of human heart is very much need of the hour for heart failure patients.  

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References:  

1. The Texas Heart Institute. News – First Implanted by The Texas Heart Institute, BiVACOR TAH Keeps Australian Man Alive for 100 Days. Published 14 March 2025. Available at https://www.texasheart.org/bivacors-total-artificial-heart-first-implanted-at-the-texas-heart-institute-at-baylor-college-of-medicine-goes-100-days-while-australian-man-awaits-donor-heart/ 

2. St Vincent’s Hospital. News – St Vincent’s Makes History with Australia’s First Total Artificial Heart Implant. Posted 12 March 2025. Available at https://www.svhs.org.au/newsroom/news/australia-first-total-artificial-heart-implant  

3. Duke University Health System. Duke Implants Second-in-Human Total Artificial Heart. Published 5 November 2024. Available at https://physicians.dukehealth.org/articles/duke-implants-second-human-total-artificial-heart 

4. Shah A.M., 2024. First successful implant of BiVACOR’s Total Artificial Heart. Artificial Organs. Published: 09 August 2024. DOI: https://doi.org/10.1111/aor.14844 

5. BiVACOR. REPLACING HEARTS.RESTORING LIVES. Available at https://bivacor.com/  

6. BiVACOR® Total Artificial Heart Early Feasibility Study https://clinicaltrials.gov/study/NCT06174103  

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