Prophylactic Activated Recombinant Factor VII in Liver Resection and Liver Transplantation: Systematic Review and Meta-Analysis

Abstract

Background and AimIntraoperative blood loss is a frequent complication of hepatic resection and orthotopic liver transplantation. Recombinant activated coagulation factor VII (rFVIIa) is a coagulation protein that induces hemostasis by directly activating factor X. There is no clear information about the prophylactic value of rFVIIa in hepatobiliary surgery, specifically in liver resection and orthotopic liver transplantation. The aim of this study was to assess the effect of rFVIIa prophylaxis to prevent mortality and bleeding resulting from hepatobiliary surgery.MethodsRelevant randomized trials were identified by searching The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index. Randomized clinical trials comparing different rFVIIa prophylactic schemas against placebo or no intervention to prevent bleeding in hepatobiliary surgery were included. Adults undergoing liver resection, partial hepatectomy, or orthotopic liver transplantation were included. Dichotomous data were analyzed calculating odds ratios (ORs) and 95% confidence intervals (CIs). Continuous data were analyzed calculating mean differences (MD) and 95% CIs.ResultsFour randomized controlled trials were included. There were no significant differences between rFVIIa and placebo for mortality (OR 0.96; 95% CI 0.35–2.62), red blood cell units (MD 0.32; 95% CI −0.08–0.72) or adverse events (OR 1.55; 95% CI 0.97–2.49).ConclusionsThe available information is limited, precluding the ability to draw conclusions regarding bleeding prophylaxis in hepatobiliary surgery using rFVIIa. Although an apparent lack of effect was observed in all outcomes studied, further research is needed.

The efficiency and safety of recombinant factor VIIa for bleeding in patients without haemophilia: a meta-analysis of 12 randomized controlled trials

“…Similar from the previous studies [26][27][28], our meta-analysis suggested that rFVIIa didn't increase mortality (RR=1.00, 95%CI=0.82-1.21, P=0.98) and total thromboembolic events (RR=1.13, 95%CI=0.94-1.36, P=0.20) compared with placebo group. Arterial events were significantly higher in rFVIIa group (RR=1.38, 95%CI=1.08-1.77, P=0.01).…”

Transfusion strategies in patients with cirrhosis

“…Although initially promising, more recent randomized controlled trials have found no benefit in terms of perioperative transfusion requirements with rVFIIa . Similarly, the results of two systematic reviews and meta‐analyses as well as a Cochrane review have found no differences in mortality or transfusion requirements between patients receiving rFVIIa or placebo prior to liver transplantation. Lastly, enthusiasm for rVFIIa has waned since it is introduction in 2005 as prothrombin complex concentrates (PCC) with factor VII became available.…”

Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference

“…In patients with and without liver diseases, administration of rFVIIa shortened the abnormal PT value [119][120][121][122][123][124]. However, in randomized clinical trials rFVIIa administration to patients with cirrhosis proved ineffective in controlling bleeding from varices or bleeding during surgery [24,120,[125][126][127].…”