Original clinical scienceHigh Incidence of Thromboembolic Events in Left Ventricular Assist Device Patients Treated With Recombinant Activated Factor VII
Section snippets
Methods
We retrospectively reviewed the records of LVAD patients who received rFVIIa for off-label use indications at St. Luke's Episcopal Hospital between January 2004 and November 2006. During this period, 188 patients underwent procedures involving one of the following LVADs: the Levitronix (n = 46), the HeartMate II (n = 41), the HeartMate I (n = 38), the AB 5000 (n = 31), the Jarvik 2000 (n = 20), the Thoratec VAD (n = 7), the Novacor LVAS (n = 3), the BVS 5000 (n = 1) or the MicroMed DeBakey VAD (
Results
Of the LVAD-related procedures performed on the 62 patients (51 men, 11 women; mean age 51 years [range 15 to 78 years]) (Table 1), 45 (72.6%) were device placements, 8 (12.9%) were biventricular assist device (BiVAD) placements, 7 (11.3%) were pump exchanges, and 2 (3.2%) were pump-pocket revisions. Twenty-four of the 62 procedures (38.7%) were “redo” operations, signifying increased surgical risk. Of all 62 patients, 41 (66.1%) received rFVIIa while in the operating room, 11 (17.7%) while in
Discussion
The mechanism by which rFVIIa arrests hemorrhage is thought to involve generating thrombin by initially binding to tissue factor and subsequently activating factors IX and X, which leads to accelerated prothrombin activation and localized thrombin formation. The end result is a stabilized thrombin plug and tight fibrin structure that is resistant to lysis. Recombinant activated factor VII is hypothesized to have other mechanisms of action that we do not fully understand today. In addition to
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