The use of FEIBA for refractory bleeding in cardiac surgery - a systematic review

ABSTRACT

Introduction

Significant blood loss during cardiac surgery is associated with a dramatic increase in morbidity and mortality. Factor Eight Inhibitor Bypassing Activity (FEIBA), a hemostatic bypassing agent mainly used in hemophiliac patients, has also been used for intractable bleeding during cardiac surgical procedures in non-hemophiliac patients. However, concerns exist that its use may be linked to increased incidence of perioperative adverse effects including thrombotic complications.

Areas covered

A systematic literature search was performed on MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases for all studies that reported the administration of FEIBA for treatment of bleeding during adult cardiac surgery in non-hemophiliac patients. After selecting the title and abstracts, two authors assessed the methodological quality of the full-text articles prior to final inclusion in the manuscript.

Expert opinion

The safety profile of FEIBA was determined through an aggregate count of adverse events. Major complications included renal failure, re-operation for unresolved bleeding, postoperative mortality, and thromboembolic events. Overall, there is insufficient robust evidence to make a definitive conclusion about the safety or efficacy of using of FEIBA as a hemostatic agent in the setting of cardiac surgery.

KEYWORDS:

• Bypassing agents
• cardiac surgery
• blood loss
• activated prothrombin complex concentrate
• thrombotic risk

Abbreviations

FEIBA: Factor Eight Inhibitor Bypassing Activity; rFVIIa: Recombinant factor VIIa; POC: point-of-care; PCC: prothrombin complex concentrate

Article highlights

• FEIBA is a hemostatic bypassing agent that has been used for intractable bleeding during cardiac surgical procedures in non-hemophiliac patients

• There are concerns that its use may be linked to an increased incidence of perioperative adverse effects including thrombotic complications

• This systematic review includes five studies that documented the use of FEIBA in cardiac surgery encompassing a total of 430 adult patients

• There is an overall paucity of robust evidence relating to the use of FEIBA in cardiac surgery and therefore an aggregate conclusion regarding the optimal dose, efficacy, and safety cannot be definitively made

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplemental data

Supplemental data for this article can be accessed here.

Additional information

Funding

This paper was not funded.