
Abstract
The Aeson total artificial heart provides right- and left-sided heart replacement for biventricular failure with notable improvements from prior generations. These include enhanced hemocompatibility and autoregulation enabling increased output in response to higher filling pressures. We report the first clinical implantation in the United States as part of an early feasibility study. The patient was successfully bridged to transplant after 5 months of support on the device and has made a full recovery.
There is a significant cohort of patients with biventricular failure who fail to establish adequate circulation with left ventricular assist device support alone. The Aeson (CARMAT SA) is the newest generation total artificial heart (TAH) that provides right- and left-sided heart replacement. This report describes the first clinical implantation in the United States as part of an early feasibility study. The inclusion criterion was severe biventricular dysfunction/failure assessed by echocardiographic and hemodynamic measurements. Patients with inadequate chest dimensions or advanced end-organ dysfunction are ineligible (https://clinicaltrials.gov/ct2/show/NCT04117295). The Aeson device has unique features relative to earlier TAH devices (Figure 1).
Its blood-contacting surface consists of bovine pericardium, and it uses 4 bioprosthetic, bovine pericardial valves; this enhances hemocompatibility, reducing the need for anticoagulation.
The device also features an electrohydraulically driven, pulsatile flow mechanism that mimics native ventricular contraction and seeks to reduce shear force applied to blood elements (Video). In addition, pump outputs are autoregulated on the basis of preload pressure changes measured inside the device.
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