Abstract 16765: Clinical Outcomes and Thromboembolic Complications Related to Recombinant Factor VII Activated Use for Refractory Medical Bleeding After Pediatric Cardiac Surgery
Introduction: Resolution of refractory bleeding after cardiac surgery with Recombinant Factor VII activated (rFVIIa) has been demonstrated. Increased use for this indication and resultant thromboembolic complications (TCs) have been described.
Hypothesis: rFVIIa use after pediatric cardiac surgery reduces postoperative bleeding without increasing the risk of TCs or death.
Methodology: A matched case-control analysis of pediatric inpatients from 2004-2009 was performed. Cases received rFVIIa intraoperatively or in the intensive care unit after cardiac surgery. Cases were matched 1:1 to controls by age and operation. Demographic and perioperative clinical variables were collected. Primary outcomes of interest were death or TCs; secondary outcomes were blood product utilization, chest tube drainage, duration of ventilation and length of stay. TCs were defined as intravascular thrombosis (venous, arterial, intracardiac), cardioembolic stroke or pulmonary embolism confirmed by radiologic methods, surgery, catheterization or autopsy performed at any point after the index operation.
Results: 50 cases were reviewed; cases had median weight at operation of 6 kg. Index operations for which rFVIIa was given included single ventricle palliations(26%) and heart transplantation(24%). Cases had longer cardiopulmonary bypass (157 vs 124 minutes, p=0.003) time with greater postoperative red blood cell (13 vs 10 ml/kg; p=0.008) and platelet (29 vs 6 ml/kg; p=0.008) transfusion requirements. The median rFVIIa dose was 150 mcg/kg with thirty-six (72%) patients receiving it intraoperatively; bleeding reduced significantly after rFVIIa administration (10.5 vs 2.0 mL/kg/h; p=0.001). Cases had a longer duration of postoperative ventilation (4 vs 1.5 days, p=0.02) and hospital stay (19 vs 9 days, p=0.03). After rFVIIa use, rate of TCs (32 vs 26%, p=0.66) and mortality (32 vs 20%, p=0.25) were comparable to controls.
Conclusions: rFVIIa dramatically reduces refractory bleeding after pediatric cardiac surgery; these patients still have increased blood product requirements and length of stay. There does not appear to be an incremental risk of TCs after rFVIIa administration. This may be reflective of the high burden of TCs in this population.
- © 2011 by American Heart Association, Inc.