PATIENT SELECTION

PATIENTS WITH THESE CONDITIONS SHOULD BE CONSIDERED FOR THE TAH-t 1,2,3,4

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.

TAH-t PATIENT DEMOGRAPHICS

70cc TAH-t

  • 89% male
  • 11% female
  • Age range: 9 to 80 years old
  • Largest BSA: 2.96m2

50cc TAH-t

  • 61% female
  • 39% male
  • Age range: 11 to 72 years old
  • Smallest BSA: 1.16m2

Source: As reported on SynCardia Implant Forms as of 9 Oct 2017. Not all Implant Forms have complete information.

FIT ASSESSMENT

The most useful determinant of whether the 70cc or 50cc TAH-t 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-t.

Example A

Example A

T10: 13.7 cm
BSA: 1.36m2
Example B

Example B

T10: 8.3 cm
BSA: 1.47m2

BRIDGE TO TRANSPLANT (BTT)

BTT (APPROVED INDICATION)

MOST COMMON PRE-IMPLANT ETIOLOGIES*

Idiopathic Dilated Cardiomyopathy

Ischemic
Cardiomyopathy

Congenital and Genetic Conditions

Post-Heart Transplant Graft Failure

Valvular
Cardiomyopathy

Restrictive
Cardiomyopathy

LVAD Failures (Device Malfunction or RV Failure)

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