Low thromboembolic risk without anticoagulation using advanced-design left ventricular assist devices.
BACKGROUND
A major limitation of cardiac assist devices has been the high incidence of thromboembolic events and their requirement for systemic anticoagulation. The Thermo Cardiosystems HeartMate 1000 IP left ventricular assist device (LVAD) employs a design that may reduce thromboembolic risk and obviate the need for systemic anticoagulation.


METHODS
Two hundred twenty-three patients with nonreversible heart failure were supported with the HeartMate LVAD as a bridge to heart transplantation. All patients were monitored prospectively for thromboembolic events. Anticoagulation regimens and occurrence of subclinical thromboembolic events, including those seen by transcranial Doppler examinations in selected patients, were also recorded.


RESULTS
Total time of LVAD support use was 531.2 patient-months. Twenty-three patients (10%) received warfarin postoperatively for 42.4 patient-months (8.2% of total support time). Six patients (2.7%) had thromboembolic events, representing 0.011 events per patient-month of device use.


CONCLUSIONS
The thromboembolic complication rate associated with this LVAD is acceptably low despite the minimal anticoagulation employed in this series, allowing consideration of long-term device use for the treatment of heart failure.
Department of Surgery, College of Physicians and Surgeons, Columbia University, New York, USA.
J P
JP
Slater
E A
EA
Rose
H R
HR
Levin
O H
OH
Frazier
J K
JK
Roberts
A D
AD
Weinberg
M C
MC
Oz
D000293:Adolescent; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000601:surgery*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D013923:Thromboembolism / Q000000981:diagnostic imaging / Q000209:etiology*; D013997:Time Factors; D017585:Ultrasonography, Doppler, Transcranial; D014850:Waiting Lists
D000925:Anticoagulants