The Syncardia total artificial heart: In vivo, in vitro, and computational modeling studies

Marvin J Slepian, Yared Alemu, João Silva Soares, Richard G. Smith, Shmuel Einav, Danny Bluestein

Research output: Contribution to journalArticle

39 Citations (Scopus)

Abstract

The SynCardia total artificial heart (TAH) is the only FDA-approved TAH in the world. The SynCardia TAH is a pneumatically driven, pulsatile system capable of flows of >9L/min. The TAH is indicated for use as a bridge to transplantation (BTT) in patients at imminent risk of death from non-reversible bi-ventricular failure. In the Pivotal US approval trial the TAH achieved a BTT rate of 79%. Recently a multi-center, post-market approval study similarly demonstrated a comparable BTT rate. A major milestone was recently achieved for the TAH, with over 1100 TAHs having been implanted to date, with the bulk of implantation occurring at an ever increasing rate in the past few years.The TAH is most commonly utilized to save the lives of patients dying from end-stage bi-ventricular heart failure associated with ischemic or non-ischemic dilated cardiomyopathy. Beyond progressive chronic heart failure, the TAH has demonstrated great efficacy in supporting patients with acute irreversible heart failure associated with massive acute myocardial infarction. In recent years several diverse clinical scenarios have also proven to be well served by the TAH including severe heart failure associated with advanced congenital heart disease. failed or burned-out transplants, infiltrative and restrictive cardiomyopathies and failed ventricular assist devices.Looking to the future a major unmet need remains in providing total heart support for children and small adults. As such, the present TAH design must be scaled to fit the smaller patient, while providing equivalent, if not superior flow characteristics, shear profiles and overall device thrombogenicity. To aid in the development of a new "pediatric," TAH an engineering methodology known as "Device Thrombogenicity Emulation (DTE)", that we have recently developed and described, is being employed.Recently, to further our engineering understanding of the TAH, as steps towards next generation designs we have: (1) assessed of the degree of platelet reactivity induced by the present clinical 70. cc TAH using a closed loop platelet activity state assay, (2) modeled the motion of the TAH pulsatile mobile diaphragm, and (3) performed fluid-structure interactions and assessment of the flow behavior through inflow and outflow regions of the TAH fitted with modern bi-leaflet heart valves. Developing a range of TAH devices will afford biventricular replacement therapy to a wide range of patients, for both short and long-term therapy.

Original languageEnglish (US)
Pages (from-to)266-275
Number of pages10
JournalJournal of Biomechanics
Volume46
Issue number2
DOIs
StatePublished - Jan 18 2013

Fingerprint

Artificial heart
Artificial Heart
Heart Failure
In Vitro Techniques
Transplantation
Platelets
Equipment and Supplies
Blood Platelets
Restrictive Cardiomyopathy
Transplants
Pediatrics
Heart-Assist Devices
Fluid structure interaction
Heart Valves
Dilated Cardiomyopathy

Keywords

  • Artificial heart
  • Computational fluid dynamics
  • Heart failure
  • Mechanical circulatory support
  • Platelet reactivity

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Rehabilitation
  • Biophysics
  • Biomedical Engineering

Cite this

The Syncardia total artificial heart : In vivo, in vitro, and computational modeling studies. / Slepian, Marvin J; Alemu, Yared; Soares, João Silva; G. Smith, Richard; Einav, Shmuel; Bluestein, Danny.

In: Journal of Biomechanics, Vol. 46, No. 2, 18.01.2013, p. 266-275.

Research output: Contribution to journalArticle

Slepian, Marvin J ; Alemu, Yared ; Soares, João Silva ; G. Smith, Richard ; Einav, Shmuel ; Bluestein, Danny. / The Syncardia total artificial heart : In vivo, in vitro, and computational modeling studies. In: Journal of Biomechanics. 2013 ; Vol. 46, No. 2. pp. 266-275.
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