The results of the nine-year study of the CardioWest Total Artificial Heart have concluded that the device prevents death in critically ill patients suffering from irreversible failure of both sides of the heart who are candidates for heart transplantation.
The heart was developed at Arizona University Medical Center by a team led by Dr. Jack G. Copeland. The results of the study are published in the Aug. 26 issue of the New England Journal of Medicine.
Of the patients involved in the study, those who received the CardioWest device had a one-year survival rate of 70 percent, compared with 31 percent for patients who did not receive the artificial heart, the study reported.
Dr. Copeland, the study's lead author, is a professor of surgery and a co-director of the Sarver Heart Center at the University of Arizona College of Medicine. Dr. Copeland is a world leader in cardiac transplantation, as well as in the development of artificial heart devices.
"This study represents the culmination of nine years of research and data, and we were thrilled that the device was recommended for approval, with conditions, by the FDA Circulatory Systems Devices Advisory Panel in March," said Dr. Marvin J. Slepian. Dr. Slepian is a clinical professor of medicine at the University of Arizona College of Medicine and a member of the UA Sarver Heart Center. He also is president and CEO of SynCardia Systems Inc., the company that owns the CardioWest technology.
"This is a significant milestone not only for the company and for patients and their families, but also a huge step in medical history," he said.
The purpose of the study was to establish the safety and efficacy of the CardioWest in transplant-eligible patients at risk of imminent death from irreversible biventricular cardiac failure. The results conclusively showed that the device reduced mortality and afforded clinical stabilization for these patients.
The centers in the study included University Medical Center in Tucson; Loyola Medical Center in Chicago; LDS Hospital in Salt Lake City; Saint Luke's Medical Center in Milwaukee; and University of Pittsburgh Medical Center. The study was initiated in 1993 and concluded in 2002.
In addition to Drs. Copeland and Slepian, the study's other authors (all from the University of Arizona) were: Richard G. Smith, director of UMC's Marshall Foundation Artificial Heart Program; Dr. Francisco A. Arabía, associate professor of surgery; Paul E. Nolan, professor of pharmaceutical sciences and professor of pharmacy practice and science; Gulshan K. Sethi, professor of surgery; Dr. Pei H. Tsau, assistant professor of clinical surgery; and Douglas McClellan, an engineer with the Artificial Heart Program.
Founded in 2001, Tucson, Ariz.-based SynCardia Systems develops biomechanical cardiac replacement and assist devices.