10-Year Pivotal Study as Reported in the New England Journal of Medicine
Data from “Cardiac Replacement with a Total Artificial Heart as a Bridge to Transplantation.” Copeland JG, Smith RG, Arabia FA, Nolan PE, Sethi GK, Tsau PH, McClellan D, and Slepian MJ. N Engl J Med 2004; 351:859-67.
Eighty-one patients received the artificial-heart device. The rate of survival to transplantation was 79 percent (95 percent confidence interval, 68 to 87 percent).
Of the 35 control patients who met the same entry criteria but did not receive the artificial heart, 46 percent survived to transplantation (P<0.001).
Overall, the one-year survival rate among the patients who received the artificial heart was 70 percent, as compared with 31 percent among the controls (P<0.001). One-year and five-year survival rates after transplantation among patients who had received a total artificial heart as a bridge to transplantation were 86 and 64 percent.
The mean time from implant to transplantation or death for Total Artificial Heart patients was 79.1 days. For control patients who did not get the Total Artificial Heart, the mean time from study entry to transplantation or death was 8.5 days (P<0.001).