Advanced heart failure treated with continuous-flow left ventricular assist device.
BACKGROUND
Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices.


METHODS
In this randomized trial, we enrolled patients with advanced heart failure who were ineligible for transplantation, in a 2:1 ratio, to undergo implantation of a continuous-flow device (134 patients) or the currently approved pulsatile-flow device (66 patients). The primary composite end point was, at 2 years, survival free from disabling stroke and reoperation to repair or replace the device. Secondary end points included survival, frequency of adverse events, the quality of life, and functional capacity.


RESULTS
Preoperative characteristics were similar in the two treatment groups, with a median age of 64 years (range, 26 to 81), a mean left ventricular ejection fraction of 17%, and nearly 80% of patients receiving intravenous inotropic agents. The primary composite end point was achieved in more patients with continuous-flow devices than with pulsatile-flow devices (62 of 134 [46%] vs. 7 of 66 [11%]; P<0.001; hazard ratio, 0.38; 95% confidence interval, 0.27 to 0.54; P<0.001), and patients with continuous-flow devices had superior actuarial survival rates at 2 years (58% vs. 24%, P=0.008). Adverse events and device replacements were less frequent in patients with the continuous-flow device. The quality of life and functional capacity improved significantly in both groups.


CONCLUSIONS
Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device. Both devices significantly improved the quality of life and functional capacity. (ClinicalTrials.gov number, NCT00121485.)
Slaughter
Mark S
MS
Advocate Christ Medical Center, Oak Lawn, IL, USA. mark.slaughter@louisville.edu
Rogers
Joseph G
JG
Milano
Carmelo A
CA
Russell
Stuart D
SD
Conte
John V
JV
Feldman
David
D
Sun
Benjamin
B
Tatooles
Antone J
AJ
Delgado
Reynolds M
RM
Long
James W
JW
Wozniak
Thomas C
TC
Ghumman
Waqas
W
Farrar
David J
DJ
Frazier
O Howard
OH
D000206:Actuarial Analysis; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002423:Cause of Death; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011788:Quality of Life; D020521:Stroke / Q000209:etiology / Q000401:mortality; D013318:Stroke Volume