Patient Selection
PATIENTS WITH THESE CONDITIONS SHOULD BE CONSIDERED FOR THE TAH-t 1,2,3,4
- Irreversible biventricular failure (RVEF <20% or CVP >18 mmHg)
- Allograft failure, rejection or heart transplant vasculopathy
- Decompensated right heart failure on LVAD support
- Failure to wean from ECMO
- Massive myocardial infarction or direct myocardial injury that affects technical insertion of a VAD
- Recurrent ventricular tachycardia/fibrillation
- Intracardiac thrombus
- Small/non-dilated ventricles (hypertrophic, infiltrative and other restrictive cardiomyopathies)
- Post-infarction VSD or Type A aortic dissection with coronary artery dissection
- End-stage congenital heart disease
- Aortic regurgitation, stenosis, prosthesis or other valve issues with left and/or right ventricular failure
- Cardiac tumor
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
- T10: 13.7 cm
- BSA: 1.36m2
Example B
- T10: 8.3 cm
- BSA: 1.47m2
BRIDGE TO TRANSPLANT (BTT)
BTT (APPROVED INDICATION)
- At risk of imminent death from biventricular heart failure
- Transplant-eligible
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