Novoseven Use To Reduce Peri-Operative Bleeding Following HeartMate II Implant

Abstract

Purpose Peri-operative bleeding is a significant complication of left ventricular assist device (LVAD) implantation. Excessive bleeding requiring substantial blood product adminstration can contribute to sustained systemic inflammatory response syndrome (SIRS), tissue edema, pulmonary dysfunction, prolonged ventilator requirement, and even right heart heart failure. We describe the use use of recombinant human activated caogulation factor VII (Novoseven, Novo-Norsk) to reduce peri-operative bleeding. Methods and Materials In this single center, retrospective, non-randomized review, we analysed our use of Novoseven in the operating room (OR) or intensive care unit (ICU) to manage bleeding following implantation of the HeartMate II. 133 patients were implanted from Jan 1, 2012 through Nov 1, 2012, with 65 of those receiving Novoseven. Total chest tube drainage (CTD), ICU stay, hospital length of stay (LOS), thromboembolic (TE) events, and bleeding events were compared between the 2 groups using Stastica (Statsoft). Results 65 patients received an average of 5.8 mg of Novoseven. 27 received Novoseven in the OR, 10 in the ICU, and 28 in both locations. There was no significant difference in surviavl at 1, 3, or 6 months. CTD was higher in patients who did not receive Novoseven by an average of 120 mL, but there was no significant differnce in ICU stay (4.7 vs. 5.2 days, p=N.S.) or average LOS (22.4 vs. 21.3, p=N.S.). There was also no statistical differnce in TE rate, but patients receiving Novoseven were 1.8 times more likely to experience a GIB (p Conclusions Novoseven was used in 65 of 133 HeartMate II recipients with no apparent adverse effects. An increased risk of GIB observed in patients receiving Novoseven may reflect a population at higher risk for bleeding. Further study to identify those at highest risk for bleeding could improve the use of Novoseven to ameliorate peri-operative bleeding associated with LVAD implantation.