SynCardia temporary Total Artificial Heart

Help Your Patients Live Longer, Live Better

The SynCardia 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.

WHAT IS THE TOTAL ARTIFICIAL HEART?

The TAH is a pneumatically driven pulsatile system used for orthotopic replacement of the native ventricles and four valves in cases of end-stage biventricular heart failure.

Steps for Implanting the TAH

Step 1

Cut the circumferential 1 cm distal-to-AV groove

Step 2

Expose mitral valves

Step 3

Cut ends of pulmonary artery and aorta

Step 4

Oversew coronary sinus

Step 5

Invert inflow connectors, running suture around inflow cuffs, then evert inflow connectors

Step 6

Pressure test suture lines

Step 7

End-to-end anastomosis of aorta and pulmonary artery

Step 8

Pressure test suture lines

Step 9

Connect ventricles to quick connects

Step 10

Process is complete. Illustration represents implanted Total Artificial Heart prior to GORE-TEX® wrap

To learn more about managing a patient with the TAH, click here.

TWO SIZES TO FIT MOST PATIENTS

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 Studies

  • Bridge to Transplant
    • Approved in the U.S. (2004), Europe (1999), Canada (2005)

*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 Studies

  • Bridge to Transplant
    • Approved in Europe (2014) and Canada (2016)
    • Undergoing an FDA clinical trial in the U.S.

*posterior sternum to anterior spine measurement at T10

Patients with These Conditions Should Be Considered for the TAH1,2,3,4

  • 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.

For more information, visit our Patient Selection Page or download our Patient Selection Guide

Most Common Pre-Implant Etiologies

Idiopathic Dilated Cardiomyopathy

560+

Cases

Ischemic
Cardiomyopathy

470+

Cases

Congenital and Genetic Conditions

125+

Cases

Post-Heart Transplant Graft Failure

110

Cases

Valvular
Cardiomyopathy

85+

Cases

Restrictive
Cardiomyopathy

85+

Cases

LVAD Failures (Device Malfunction or RV Failure)

75+

Cases

Source: SynCardia Implant Forms and published scientific papers as of 15 Dec 2017. Not all Implant Forms have complete information.

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