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Eur J Cardiothorac Surg. 2015 Jan;47(1):80-6. doi: 10.1093/ejcts/ezu321. Epub 2014 Sep 18.

System overview of the fully implantable destination therapy--ReinHeart-total artificial heart.

Author information

1
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH-Aachen University, Aachen, Germany pelletier@hia.rwth-aachen.de.
2
Department for the Surgical Therapy of end-stage Heart Failure and Mechanical Circulatory Support, Heart- and Vascular Center Duisburg, Duisburg, Germany.
3
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH-Aachen University, Aachen, Germany.

Abstract

OBJECTIVES:

Owing to the lack of suitable allografts, the demand for long-term mechanical circulatory support in patients with biventricular end-stage heart failure is rising. Currently available Total Artificial Heart (TAH) systems consist of pump units with only limited durability, percutaneous tubes and bulky external equipment that limit the quality of life. Therefore we are focusing on the development of a fully implantable, highly durable destination therapy total artificial heart.

METHODS:

The ReinHeart-TAH system consists of a passively filling pump unit driven by a low-wear linear drive between two artificial ventricles, an implantable control unit and a compliance chamber. The TAH is powered by a transcutaneous energy transmission system. The flow distribution inside the ventricles was analysed by fluid structure interaction simulation and particle image velocimetry measurements. Along with durability tests, the hydrodynamic performance and flow balance capability were evaluated in a mock circulation loop. Animal trials are ongoing.

RESULTS:

Based on fluid structure interaction simulation and particle image velocimetry, blood stagnation areas have been significantly reduced. In the mock circulation loop the ReinHeart-TAH generated a cardiac output of 5 l/min at an operating frequency of 120 bpm and an aortic pressure of 120/80 mmHg. The highly effective preload sensitivity of the passively filling ventricles allowed the sensorless integration of the Frank Starling mechanism. The ReinHeart-TAH effectively replaced the native heart's function in animals for up to 2 days.

CONCLUSIONS:

In vitro and in vivo testing showed a safe and effective function of the ReinHeart-TAH system. This has the potential to become an alternative to transplantation. However, before a first-in-man implant, chronic animal trials still have to be completed.

KEYWORDS:

Fully implantable; Heart failure; Quality of life; Total Artificial Heart TAH

PMID:
25234093
DOI:
10.1093/ejcts/ezu321
[Indexed for MEDLINE]

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