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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.
Materials
The housings, diaphragms and connectors in the TAH are made from a highly specialized segmented polyurethane solution. The compound offers a high degree of biocompatibility, fatigue resistance and strength.
Ventricles
The TAH consists of two independent artificial ventricles and is available in two sizes — 70cc and 50cc. The 70cc ventricle has a maximum stroke volume of 70mL and is capable of generating a cardiac output of up to 9.5 L/min. The 50cc ventricle has a maximum stroke volume of 50mL and is capable of generating a flow rate of up to 7.5 L/min.
Diaphragms
Each ventricle is divided by a multi-layer flexible polyurethane diaphragm that separates the blood chamber from the air chamber.
Velcro
The polyurethane ventricles are connected by Velcro, which allows for flexible positioning inside the chest cavity.
Valves
The direction of blood flow is controlled by four SynHall (formerly Medtronic Hall) tilting disc valves that are mounted in the inflow and outflow ports of each artificial ventricle. These high-performing valves have proven to be extremely durable and dependable for long-term support.
Cannulae & Drivelines
The cannula of each artificial ventricle acts as a conduit for air from the driver to the ventricles. Each cannula is partially covered with velour fabric to promote tissue ingrowth, is tunneled through the chest wall and attaches to drivelines that connect to the external pneumatic driver.
External Driver
Both the Companion 2 Hospital Driver (for use in the hospital) and the Freedom® Portable Driver (approved for use at home) run on batteries, as well as A/C power, and produce pulses of air that travel through the drivelines and cannulae to inflate the diaphragms to fully eject the blood.
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.
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
*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
*posterior sternum to anterior spine measurement at T10
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
Source: SynCardia Implant Forms and published scientific papers as of June 30, 2019. Not all Implant Forms have complete information.
