The SynCardia temporary Total Artificial Heart (TAH) is a clinically proven life-saving treatment option for cardiac transplant-eligible patients at risk of imminent death from biventricular failure. The TAH increases their chances of survival, allows them to enjoy a good quality of life at home and prepares them for transplant by increasing cardiac output and optimizing organ function.
Device Selection Criteria
Patients with a T10 measurement* ≥ 10 cm. Patients supported by the 70cc TAH typically have a body surface area (BSA) ≥ 1.7m2.
Approvals & Clinical Trials
*posterior sternum to anterior spine measurement at T10
Device Selection Criteria
Patients with adequate T10 measurement* or adequate room in the chest as determined by 3D imaging assessment or by other standard clinical assessments. The 50cc TAH is intended to support patients with a BSA ≤ 1.85m2.
Approvals & Clinical Trials
*posterior sternum to anterior spine measurement at T10
1FDA Summary of Safety and Effectiveness
2Feldman D, Pamboukian SV, Teuteberg JJ, et al. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant. 2013;32:157-87.
3Shah KB, Thanavaro KL, Tang DG, et al. Impact of INTERMACS profile on clinical outcomes for patients supported with the total artificial heart. J Card Fail 2016;22(11):913-919.
4Cook JA, Shah KB, Quader MA, et al. The total artificial heart. J Thorac Dis. 2015;7(12):2172–80.
70cc TAH
50cc TAH
Source: As reported on SynCardia Implant Forms as of 9 Oct 2017. Not all Implant Forms have complete information.
The most useful determinant of whether the 70cc or 50cc TAH will fit in a patient’s chest is the T10 measurement. Commonly assessed via CT scan, the T10 measurement is the anteroposterior distance between the sternum and the 10 thoracic vertebra (T10). Patients with a T10 measurement ≥ 10 cm should be considered for the 70cc TAH.
Example A
Example B
BTT (APPROVED INDICATION)
DT (INVESTIGATIONAL INDICATION)
Source: SynCardia Implant Forms and published scientific papers as of 15 Dec 2017. Not all Implant Forms have complete information.
*Note: Some patients have multiple pre-implant etiologies and are counted as a case under more than one category. Call us to discuss these etiologies further or to discuss other etiologies not listed here
When patients have been on ECMO for less than 4 days, the chance of a good outcome with the TAH as BTT can be as high as 80% or better. However, once patients surpass 7 days, their chances can drop to 50%
Dr. Francisco Arabia, TAH surgical leader and proctor involved in more than 200 TAH cases
1Removal Reasons by Year, Organ Procurement and Transplantation Network National Data
2Heart waiting list removals, by year, by country, by reason, Eurotransplant
The sooner you contact us about potential patients, the better prepared we can be to assist you. In addition, if you have a new team member or your personnel need a refresher on TAH implantation and patient management best practices, our Clinical Support Team is ready to provide the necessary training to ensure that your team is confident and prepared to meet every patient’s needs. Contact your SynCardia Clinical Support or Sales representative today, or fill out the form below.