Extended mechanical circulatory support with a continuous-flow rotary left ventricular assist device.
OBJECTIVE
This study sought to evaluate the use of a continuous-flow rotary left ventricular assist device (LVAD) as a bridge to heart transplantation.


BACKGROUND
LVAD therapy is an established treatment modality for patients with advanced heart failure. Pulsatile LVADs have limitations in design precluding their use for extended support. Continuous-flow rotary LVADs represent an innovative design with potential for small size and greater reliability by simplification of the pumping mechanism.


METHODS
In a prospective, multicenter study, 281 patients urgently listed (United Network of Organ Sharing status 1A or 1B) for heart transplantation underwent implantation of a continuous-flow LVAD. Survival and transplantation rates were assessed at 18 months. Patients were assessed for adverse events throughout the study and for quality of life, functional status, and organ function for 6 months.


RESULTS
Of 281 patients, 222 (79%) underwent transplantation, LVAD removal for cardiac recovery, or had ongoing LVAD support at 18-month follow-up. Actuarial survival on support was 72% (95% confidence interval: 65% to 79%) at 18 months. At 6 months, there were significant improvements in functional status and 6-min walk test (from 0% to 83% of patients in New York Heart Association functional class I or II and from 13% to 89% of patients completing a 6-min walk test) and in quality of life (mean values improved 41% with Minnesota Living With Heart Failure and 75% with Kansas City Cardiomyopathy questionnaires). Major adverse events included bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in 4 patients.


CONCLUSIONS
A continuous-flow LVAD provides effective hemodynamic support for at least 18 months in patients awaiting transplantation, with improved functional status and quality of life. (Thoratec HeartMate II Left Ventricular Assist System [LVAS] for Bridge to Cardiac Transplantation; NCT00121472).
Pagani
Francis D
FD
University of Michigan, Ann Arbor, Michigan 48109, USA. fpagani@umich.edu
Miller
Leslie W
LW
Russell
Stuart D
SD
Aaronson
Keith D
KD
John
Ranjit
R
Boyle
Andrew J
AJ
Conte
John V
JV
Bogaev
Roberta C
RC
MacGillivray
Thomas E
TE
Naka
Yoshifumi
Y
Mancini
Donna
D
Massey
H Todd
HT
Chen
Leway
L
Klodell
Charles T
CT
Aranda
Juan M
JM
Moazami
Nader
N
Ewald
Gregory A
GA
Farrar
David J
DJ
Frazier
O Howard
OH
D000328:Adult; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D016027:Heart Transplantation; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome