Audit of factor VIIa for bleeding resistant to conventional therapy following complex cardiac surgery

Abstract

Purpose:There are an increasing number of anecdotal reports and trials of recombinant activated factor VII (rFVIIa) for bleeding during surgery. The reports of rFVIIa during cardiac surgery are limited. We report our experience using rFVIIa, in the operating room; to treat bleeding that prevented chest closure, despite appropriate conventional treatment, following complex cardiac surgery.Methods: Retrospective chart review, at an Australian University hospital and associated private hospital, of cardiac surgery patients given rFVIIa (usual dose 90 μg·kg -1 ). We used rFVIIa for bleeding that prevented closure of the chest despite administration of blood products, protamine, and surgical attempts to secure hemostasis.Results: Recombinant activated factor VII was administered on 55 occasions to 53 patients. Most patients had complex aortic or valve surgery. Median bypass time was 266 min. Before administering rFVIIa, patients received (median): packed red cells four units; platelets 15 units; fresh frozen plasma eight units; and cryoprecipitate ten units. After administering rFVIIa the median doses of donor blood products up to 12 hr after intensive care unit admission were: packed red cells one unit; platelets zero units; fresh frozen plasma zero units; and cryoprecipitate zero units. The decrease in doses of all blood products was significant (P < 0.001). We could not determine if rFVIIa played a role in significant mortality (19%) and morbidity (17%). Conclusion:Use of rFVIIa in cardiac surgery may be effective, but definitive clinical trials are needed to clarify its role in clinical practice and safety. We present an rFVIIa guideline developed during the audit period. Objectif

Safety and Efficacy of Recombinant Activated Factor VII

“…11 In cardiac surgery, mortality and complication rates of patients who have failed to respond to standard transfusion therapy and then received rFVIIa are in range of 19% to 40%. 10,14,24,25 The lack of control patients in most of these case series makes it difficult to determine whether the reported adverse events are related to the administration of rFVIIa or the critical unstable condition of patients when they received rFVIIa. When rFVIIa was used on a compassionate basis to reduce uncontrolled bleeding in 51 patients after cardiac surgery, propensity matching techniques to adjust for baseline risks demonstrated that the rates of cSAEs were equivalent.…”

“…The committee's advice was based on the data within the expanding cardiac literature in which doses of rFVIIa were in the range of 60 g/kg. 6,9,10,15 Patients were randomized through an interactive voice response system and were always assigned to the lowest available randomization number. After randomization, freeze-dried powdered (4.8 mg) rFVIIa or placebo was reconstituted with 8.5 mL sterile water and administered as a bolus injection.…”

“…9,10,13,15,23,25,28 This is illustrated by an increase in the off-label use of rFVIIa from 300 doses in 1999 to 4500 doses in 2004 11 and numerous case reports and case series reporting its efficacy in reducing bleeding and transfusion requirements. Recombinant FVIIa also has been shown to significantly reduce transfusion in a small randomized pilot study of patients undergoing major cardiac reconstructive surgery.…”

The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

“…The evidence on rFVIIa in refractory bleeding associated with cardiac surgery is currently limited to observational studies consisting of case reports (not referenced), case series, [27][28][29][30][31][32][33][34][35][36][37][38][39][40] and case-control studies. [41][42][43][44][45] These observational studies have important limitations such as reporting bias in favour of the intervention and inability to fully adjust for the effects of confounding variables.…”

A Single Dose of Recombinant Activated Factor VII (NovoSeven®) Did Not Impair the Function of the Coronary Artery Bypass Grafts – Successful Treatment of Critical Bleeding after Cardiac Surgery in Two Cases

“…However, these methods gave only indirect evidence of the graft patency; a postoperative intracardiac catheterization was not performed. The usefulness of rFVIIa in inherited or acquired bleeding disorders had been published on cardiac surgical patients [5][6][7][8]. Al-Douri et al [9] evaluated the role of rFVIIa in 5 patients (1 child, aged 2.5 years, and 4 adults) who underwent different surgical procedures.…”