The AbioCor Totally Implantable Replacement Heart

The AbioCor artificial heart (Abiomed, Inc., Danvers, MA) represents the latest technologic advancement in the quest for a total heart replacement system. The AbioCor is an electric heart with fully implantable components. The Food and Drug Administration approved a clinical trial in January 2001. The clinical trial was designed as an initial feasibility study to determine the safety and efficacy of this first generation system. The study criteria include end-stage adult heart failure patients who are not transplant candidates. These patients have biventricular failure with a predicted 30-day life expectancy of less than 30%. On July 2, 2001 the first AbioCor device was implanted. Six other patients have undergone implantation to date. Four of the seven have been successful as defined by the study parameters of 60-day survival with improved quality of life. Two patients were discharged from the hospital. Outpatient activities were possible in four patients. There have been no device malfunctions and no device-related infections. The trial is active and enrollment is ongoing.