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[Totally implantable completely electric artificial heart: "AbioCor"]
A Pavie1, Ph Léger, P Leprince
1Service de chirurgie thoracique et cardiovasculaire, Institut de cardiologie La Pitié Salpètrière, Assistance Publique des Hôpitaux de Paris, 47 boulevard de l'Hôpital, 75013 Paris. alain.pavie@psl.ap-hop-paris.fr
Archives Des Maladies Du Coeur Et Des Vaisseaux
|December 5, 2003
Summary
The AbioCor artificial heart, a fully implantable device, offers a new option for heart failure patients. Early clinical use showed promising results but also highlighted risks like embolic strokes and mortality.
Area of Science:
- Biomedical Engineering
- Cardiovascular Surgery
- Medical Devices
Context:
- The AbioCor is a fully implantable, electrohydraulic artificial heart representing a significant advancement in cardiac assistance systems.
- It received Food and Drug Administration (FDA) authorization for clinical use, marking a milestone in treating end-stage heart failure.
- The device comprises internal components (pump, battery, controller, internal coil) and external components (external coil, batteries) for energy transfer.
Purpose:
- To evaluate the initial clinical performance and safety of the fully implantable AbioCor artificial heart.
- To assess the device's efficacy in patients with severe ischemic or idiopathic dilated cardiomyopathy.
- To identify early complications and outcomes associated with the AbioCor implantation.
Summary:
- The AbioCor artificial heart features two ventricular chambers, polyurethane blood-contact surfaces, and four tri-leaflet valves, powered by an electro-hydraulic energy converter.
- It provides a stroke volume of 60-65 ml, enabling an output of 4-10 L/min.
- Seven male patients (51-70 years) with ischemic or idiopathic dilated cardiomyopathy received the device between July and November 2002.
Impact:
- The study identified significant late complications, including three severe embolic cerebrovascular accidents.
- Four late deaths occurred among the seven implanted patients, indicating critical safety concerns.
- These findings underscore the need for further research and development to mitigate risks associated with artificial heart technology.