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Patient Selection

Help Your Patients Live Longer, Live Better

The SynCardia temporary 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. The TAH increases their chances of survival, allows them to enjoy a good quality of life at home and prepares them for transplant by increasing cardiac output and optimizing organ function.

Two sizes to Fit most Patients

70CC TAH

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 Trials

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

*posterior sternum to anterior spine measurement at T10

50CC TAH

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 Trials

  • 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.

TAH PATIENT DEMOGRAPHICS

70cc TAH

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

50cc TAH

  • 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 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.

Example A

  • T10: 13.7 cm
  • BSA: 1.36m2

Example B

  • T10: 8.3 cm
  • BSA: 1.47m2

Bridge to Transplant (BTT) or Destination Therapy (DT)?

BTT (APPROVED INDICATION)

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

DT (INVESTIGATIONAL INDICATION)

  • Life-threatening, irreversible biventricular heart failure (INTERMACS Profile 1-4)
  • Ineligible for transplant and unlikely to become eligible in the future (e.g., contraindication to immunosuppression, cancer, elevated PRAs)

Most Common Pre-Implant Etiologies*

1,700+ Implants Worldwide

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.

*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

Time Is of the Essence

  • Since 2016, more than 1,400 patients1,2 in the U.S. and Europe have been removed from the heart transplant waiting list because of death or deterioration.
  • Optimal patient outcomes with the TAH depend on timely decision-making.

When patients have been on ECMO for less than 4 days, the chance of a good outcome with the TAH as BTT can be as high as 80% or better. However, once patients surpass 7 days, their chances can drop to 50%

Dr. Francisco Arabia, TAH surgical leader and proctor involved in more than 200 TAH cases

1Removal Reasons by Year, Organ Procurement and Transplantation Network National Data

2Heart waiting list removals, by year, by country, by reason, Eurotransplant

We’re Ready to Help

The sooner you contact us about potential patients, the better prepared we can be to assist you. In addition, if you have a new team member or your personnel need a refresher on TAH implantation and patient management best practices, our Clinical Support Team is ready to provide the necessary training to ensure that your team is confident and prepared to meet every patient’s needs. Contact your SynCardia Clinical Support or Sales representative today, or fill out the form below.

Please note that due to new privacy and data protection regulations, the information you are providing on this form cannot be submitted unless you give SynCardia consent to process this information.

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CAUTION – In the United States, the use of the SynCardia 70cc TAH for destination therapy is investigational.

CAUTION – In the United States, the SynCardia 50cc TAH is an investigational device, limited by federal law to investigational use.