Cardiac replacement with a total artificial heart as a bridge to transplantation.
BACKGROUND
The CardioWest Total Artificial Heart orthotopically replaces both native cardiac ventricles and all cardiac valves, thus eliminating problems commonly seen in the bridge to transplantation with left ventricular and biventricular assist devices, such as right heart failure, valvular regurgitation, cardiac arrhythmias, ventricular clots, intraventricular communications, and low blood flows.


METHODS
We conducted a nonrandomized, prospective study in five centers with the use of historical controls. The purpose was to assess the safety and efficacy of the CardioWest Total Artificial Heart in transplant-eligible patients at risk for imminent death from irreversible biventricular cardiac failure. The primary end points included the rates of survival to heart transplantation and of survival after transplantation.


RESULTS
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.


CONCLUSIONS
Implantation of the total artificial heart improved the rate of survival to cardiac transplantation and survival after transplantation. This device prevents death in critically ill patients who have irreversible biventricular failure and are candidates for cardiac transplantation.
Copeland
Jack G
JG
Sarver Heart Center, University of Arizona, Tucson 85724-5071, USA. jgcbriez@aol.com
Smith
Richard G
RG
Arabia
Francisco A
FA
Nolan
Paul E
PE
Sethi
Gulshan K
GK
Tsau
Pei H
PH
McClellan
Douglas
D
Slepian
Marvin J
MJ
D016638:Critical Illness; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000601:surgery*; D016027:Heart Transplantation; D006354:Heart, Artificial / Q000009:adverse effects; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality; D006801:Humans; D007239:Infections / Q000209:etiology / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011788:Quality of Life; D015996:Survival Rate