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Related Experiment Videos

Reliable long-term non-pulsatile circulatory support without anticoagulation.

S Saito1, S Westaby, D Piggott

  • 1Oxford Heart Centre, John Radcliffe Hospital, Headley Way, Headington, OX3 9DU, Oxford, UK.

European Journal of Cardio-Thoracic Surgery : Official Journal of the European Association for Cardio-Thoracic Surgery
|May 10, 2001
PubMed
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The Terumo implantable left ventricular assist system (T-ILVAS) demonstrated successful in-vivo support in sheep for 210 days. This continuous flow device showed good biocompatibility and mechanical reliability without anticoagulation.

Area of Science:

  • Cardiovascular Engineering
  • Biomedical Devices
  • Implantable Pumps

Background:

  • The Terumo implantable left ventricular assist system (T-ILVAS) is a titanium centrifugal pump with a magnetically suspended impeller, designed for continuous non-pulsatile flow.
  • The device features a heparin-coated interior and lacks a purge system, necessitating evaluation of its biocompatibility and hemocompatibility in vivo.

Purpose of the Study:

  • To assess the in-vivo hemodynamic function of the T-ILVAS in a large animal model.
  • To evaluate the mechanical reliability and biocompatibility of the T-ILVAS over an extended period.
  • To determine the impact of continuous non-pulsatile flow on organ function and hematological parameters.

Main Methods:

  • The T-ILVAS was surgically implanted in six sheep without cardiopulmonary bypass.

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  • Animals received no post-operative anticoagulation therapy.
  • Hemodynamic parameters, pump function, and hematological/biochemical indices were monitored for up to 210 days.
  • Explanted devices and organs underwent macroscopic and histological examination.

    • Main Results:

    • All sheep tolerated the T-ILVAS well, with no major complications such as pump failure, thromboembolism, or hemorrhage.
    • The device consistently delivered up to 8 L/min of flow, supporting systemic circulation.
    • Hematological and biochemical markers for liver and renal function, as well as hemolysis, remained within normal limits.
    • Explanted pumps were mechanically sound and free of thrombus; one minor embolic event was noted in a kidney section.

    Conclusions:

    • The T-ILVAS successfully supported systemic circulation in sheep for up to 210 days without anticoagulation.
    • The study demonstrated the mechanical reliability and biocompatibility of the T-ILVAS.
    • Continuous non-pulsatile flow from the T-ILVAS maintained normal organ function throughout the study period.