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

70cc 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

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