Long-term use of a left ventricular assist device for end-stage heart failure.
BACKGROUND
Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated.


METHODS
We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure.


RESULTS
Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P=0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P=0.002), and the rates at two years were 23 percent and 8 percent (P=0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group.


CONCLUSIONS
The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.
Rose
E A
EA
College of Physicians and Surgeons, Columbia University, New York, NY, USA.
Gelijns
A C
AC
Moskowitz
A J
AJ
Heitjan
D F
DF
Stevenson
L W
LW
Dembitsky
W
W
Long
J W
JW
Ascheim
D D
DD
Tierney
A R
AR
Levitan
R G
RG
Watson
J T
JT
Meier
P
P
Ronan
N S
NS
Shapiro
P A
PA
Lazar
R M
RM
Miller
L W
LW
Gupta
L
L
Frazier
O H
OH
Desvigne-Nickens
P
P
Oz
M C
MC
Poirier
V L
VL
D000203:Activities of Daily Living; D000368:Aged; D002423:Cause of Death; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006333:Heart Failure / Q000145:classification / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012720:Severity of Illness Index; D016019:Survival Analysis