Total Artificial Heart Facts
- The SynCardia temporary Total Artificial Heart (TAH-t) is the first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart in the world.
- Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the source of end-stage biventricular heart failure.
- Unlike a donor heart, the Total Artificial Heart is available when needed at SynCardia Certified Centers.
- The SynCardia Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
- The longest a patient has been supported by the SynCardia Total Artificial Heart prior to receiving a successful donor heart transplant is just over 4 years.
- During more than 32 years of use, the valves in the SynCardia Total Artificial Heart have never failed. The diaphragm, which is responsible for pumping blood in and out of the ventricles, has a success rate of more than 99.99%.
- There have been more than 1,600 implants of the Total Artificial Heart, accounting for more than 550 patient years of support.
- Since 2012, there have been more than 500 SynCardia Total Artificial Hearts implanted.
Implanting the SynCardia Total Artificial Heart:
- Eliminates arrhythmias that could require the use of a pacemaker and/or defibrillator. In 2009, 397,000 patients underwent pacemaker-related surgeries and 116,000 underwent surgery for an implantable defibrillator.
- Eliminates failing heart ventricles that could require the use of medication, a left ventricular assist device (LVAD) or a right ventricular assist device (RVAD).
- Eliminates malfunctioning heart valves that could require surgery to correct or replace. In 2009, 139,000 patients underwent valve surgeries. (Source: American Heart Association 2012)
According to data published in the New England Journal of Medicine (N Engl J Med 2004;351:859-67) from the 10-year pivotal clinical study which led to FDA approval, 79% of patients who received the Total Artificial Heart were bridged to transplant. This is the highest bridge-to-transplant rate for any approved heart device in the world.
During the pivotal clinical study:
- 1 week after implant: 75% of all Total Artificial Heart patients were out of bed.
- 2 weeks after implant: 60% of all patients were walking more than 100 feet.
- 2 weeks after implant: Liver function had returned to normal and kidney function had improved significantly, trending to normal.
Both ventricles of the heart are failing to pump enough blood to sustain the body (end-stage biventricular failure)
The left and right failing ventricles are removed
The four native heart valves are removed
The atria, aorta and pulmonary artery remain intact
Quick connects are sewn into the atria, aorta and pulmonary artery
The Total Artificial Heart is implanted and attached via four quick connects
The donor heart is transplanted