Patient Selection

Patients with these conditions should be considered for the SynCardia TAH 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

1. FDA Summary of Safety and Effectiveness


2. Feldman 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.


3. Shah 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.


4. Cook JA, Shah KB, Quader MA, et al. The total artificial heart. J Thorac Dis. 2015;7(12):2172–80.

SynCardia TAH patient demographics*

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

50cc 

  • 61% female
  • 39% male
  • Age range: 11 to 72 years old

70cc 

  • 89% male
  • 11% female
  • Age range: 9 to 80 years old

Fit assessment

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

Example A

T10: 13.7 cm

Example B

T10: 8.3 cm

Bridge To Transplant

BTT APPROVED INDICATION

  • At risk of imminent death from biventricular heart failure
  • Transplant-eligible

Most common pre-implant etiologies*

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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SynCardia Systems, LLC

1992 E. Silverlake Rd. Tucson, AZ 85713
+1 520-545-1234 | info@syncardia.com
www.SynCardia.com

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SynCardia Systems, LLC – a Picard Medical Company

The SynCardia Total Artificial Heart is a treatment option for cardiac transplant-eligible patients at risk of imminent death from biventricular failure.

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