- Highest bridge to human heart transplant rate of any approved heart device, 79%
- Over 1,635 implants account for nearly 560 patient years on the SynCardia Total Artificial Heart
The Sickest Patients Recover Rapidly
According to data from INTERMACS (Interagency Registry for
Mechanically Assisted Circulatory Support), 90% of patients who
receive the SynCardia temporary Total Artificial Heart
are in the two sickest categories prior to implant (see chart):
- Critical Cardiogenic Shock (Crash & Burn)
- Progressive Decline (Sliding Fast)
Gray to Pink
The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles to help vital organs recover faster.
Soon after implantation, the Total Artificial Heart’s high blood flow helps turn patients from a sickly gray to a healthier pink.
When a donor heart becomes available, these patients are in much better condition to receive their transplant than they were prior to receiving the Total Artificial Heart.
Approximately 65% of the core Total Artificial Heart patients were out of bed by the 5th day after implant.
Two weeks after implant, 60% of core patients were walking more than 100 feet.
The following statistics are from the FDA Summary of Safety and Effectiveness for the
SynCardia Total Artificial Heart:
Source: FDA Summary of Safety and Effectiveness, pages 18 & 19
Prior to implant, patients in need of the Total Artificial Heart had a baseline cardiac index of ≤ 2.0 L/min/m2 which is
considered critical cardiogenic shock. Following implantation of the Total Artificial Heart, the patient’s cardiac index immediately increased to an average of 3.0 L/min/m2.
End Organ Recovery*
Within two weeks of Total Artificial Heart implant, liver function had returned to normal and kidney function had improved significantly, trending to normal.
*Source for charts: FDA Summary of Safety and Effectiveness, page 20, 23 and 24
http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030011b.pdf ›› download