Patients Recover Faster
According to data from INTERMACS, 90% of patients who receive the SynCardia temporary Total Artificial Heart (TAH-t) are in the two sickest categories prior to implant:
- Critical Cardiogenic Shock (Crash & Burn)
- Progressive Decline (Sliding Fast)
Artificial Heart Patients are the Sickest of the Sick
The INTERMACS data used in the chart below were released June 2, 2009. Data includes devices implanted from June 23, 2006-March 31, 2009. This was the last report in which INTERMACS publicly published bridge-to-transplant rates and patient profile status for left ventricular assist devices (LVADs), biventricular assist devices (BiVADs) and the Total Artificial Heart (TAH).
Patients Bridged-to-Transplant at 6 Months - INTERMACS
74% (1089/1476) of all INTERMACS patients were in the two sickest categories.
*90% (46/51) of all Total Artificial Heart patients were in the two sickest categories.
*73% (1043/1425) of LVAD/BiVAD patients were in the two sickest categories.
INTERMACS Official Shorthand
Gray to Pink
The SynCardia TAH-t is the only approved device in use that provides immediate, safe blood flow of up to 9.5 L/min through each ventricle to help vital organs recover faster. Soon after implantation, the SynCardia Heart’s high volume of blood flow helps turn many patients from a sickly gray to a healthier pink as the SynCardia Total Artificial Heart perfuses the body with the blood flow that their dying heart ventricles were no longer able to supply. Toes and fingertips that were cold for years become warm again as blood flow is restored to a healthy level.
- Approximately 65% of SynCardia Heart patients were out of bed by the fifth 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:
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
Pre-implant central venous pressure of 19.7 became 13.6 soon after SynCardia TAH-t implant. Within two weeks of implant, liver function had returned to normal and kidney function had improved significantly, trending to normal.