The Aeson Total Artificial Heart (TAH) is a bioprosthetic, autoregulated cardiac replacement device, designed to treat patients with end-stage biventricular heart failure awaiting heart transplantation. In clinical trials and real-world experience, the Aeson TAH has demonstrated that the combination of hemocompatible blood contact surfaces and normal physiological blood flow dynamics results in a reduced incidence of coagulopathies. This allows for a low-dose anticoagulation management regime with the associated reduced risk for strokes and bleeding-related adverse events. In addition, the sophisticated functional autoregulation mode (Auto-Mode) mimics normal physiological responses to changing patient needs. Auto-Mode has also demonstrated a much-reduced need for operator adjustments and consequently a reduced requirement for readmissions. Although not yet demonstrated, it is anticipated that Auto-Mode will facilitate a good exercise response. In addition, patients bridged to transplant with Aeson have shown limited device adhesions and a near normal cardiac explant space combined with reduced device-mediated sensitization following transplantation. Clinical experience is still limited, but two ongoing studies (NCT04475393, NCT04117295) are expected to confirm the early positive clinical experience and provide further data on reliability and durability of this physiological heart replacement device.

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The Aeson Bioprosthetic Total Artificial Heart

  • Yuriy Pya,
  • Piet Jansen

摘要

The Aeson Total Artificial Heart (TAH) is a bioprosthetic, autoregulated cardiac replacement device, designed to treat patients with end-stage biventricular heart failure awaiting heart transplantation. In clinical trials and real-world experience, the Aeson TAH has demonstrated that the combination of hemocompatible blood contact surfaces and normal physiological blood flow dynamics results in a reduced incidence of coagulopathies. This allows for a low-dose anticoagulation management regime with the associated reduced risk for strokes and bleeding-related adverse events. In addition, the sophisticated functional autoregulation mode (Auto-Mode) mimics normal physiological responses to changing patient needs. Auto-Mode has also demonstrated a much-reduced need for operator adjustments and consequently a reduced requirement for readmissions. Although not yet demonstrated, it is anticipated that Auto-Mode will facilitate a good exercise response. In addition, patients bridged to transplant with Aeson have shown limited device adhesions and a near normal cardiac explant space combined with reduced device-mediated sensitization following transplantation. Clinical experience is still limited, but two ongoing studies (NCT04475393, NCT04117295) are expected to confirm the early positive clinical experience and provide further data on reliability and durability of this physiological heart replacement device.