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Ann Thorac Surg 2003;75:S93-S99
© 2003 The Society of Thoracic Surgeons


Supplement

The AbioCor implantable replacement heart

Robert D. Dowling, MDa*, Laman A. Gray, Jr, MDa, Steven W. Etoch, MDa, Hillel Laks, MDb, Daniel Marelli, MDb, Louis Samuels, MDc, John Entwistle, MDc, Greg Couper, MDd, Gus J. Vlahakes, MDd, O. H. Frazier, MDe

a Department of Surgery, Division of Thoracic and Cardiovascular Surgery, University of Louisville School of Medicine, Louisville, Kentucky, USA
b Division of Cardiothoracic Surgery, University of California Los Angeles School of Medicine, Los Angeles, California, USA
c Division of Cardiothoracic Surgery, MCP Hahnemann University, Philadelphia, Pennsylvania, USA
d Division of Cardiac Surgery, Massachusetts General/Brigham & Women’s Hospital, Boston, Massachusetts, USA
e Division of Cardiothoracic Surgery, Texas Heart Institute Medical Center, Houston, Texas, USA

* Address reprint requests to Dr Dowling, 201 Abraham Flexner Way, #1200, Louisville, KY, USA40202
e-mail: rddowl01{at}ahtena.louisville.edu

Presented at the Heart Failure & Circulatory Support Summit, Cleveland, OH, Aug 22–25, 2002.

Abstract

The AbioCor implantable replacement heart (IRH) is the first available totally implantable artificial heart. We recently initiated a multicenter trial of this device in patients with severe, irreversible biventricular failure. Patients who were not candidates for other therapies, including transplantation, were evaluated. All candidates were adults with inotrope-dependent biventricular failure, whose 30-day predicted mortality was higher than 70%. A three-dimensional computerized fit study predicted fit of the AbioCor thoracic unit in all recipients. At operation, the internal battery controller and transcutaneous energy transfer unit were placed. The AbioCor thoracic unit was placed in an orthotopic position after incision of the ventricals. There were 2 intraoperative deaths (due to intraoperative bleeding or aprotinin reaction). Four late deaths were recorded, 1 from multi-system organ failure and 3 cerebrovascular accidents. Autopsy revealed thrombus on the atrial struts of the 3 patients with cerebrovascular accident. Blood pumps and valves were clean on all patients. Significant morbidity was observed, primarily related to preexisting severity of illness. However, 3 patients recovered to the point of being able to take multiple trips outside of the hospital. Two patients were discharged from the hospital, with 1 patient being discharged home for more than 7 months. No significant device malfunctions or multi-system organ failure device-related infections were noted. The AbioCor IRH may be effective therapy for patients with end-stage heart failure. Many milestones have been achieved in the initial trial in humans, including the successful discharge of a patient to home and no significant device malfunctions. The occurrence of stroke is likely related to the presence of thrombus on the atrial struts and may be decreased as these atrial struts have been removed for future clinical implants.




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