Recombinant activated factor VII for refractory bleeding after cardiac surgery—A retrospective analysis of safety and efficacy

Heymann, Christian von; Redlich, U.; Jain, Uday; Kastrup, Marc; Schroeder, Tobias; Sander, Michael; Grosse, Joachim; Ziemer, Sabine; Koscielny, J.; Konertz, Wolfgang; Wernecke, Klaus‐Dieter; Spies, Claudia

doi:10.1097/01.ccm.0000181527.47749.57

Cited by 86 publications

(65 citation statements)

References 21 publications

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“…3,5,7 Further, as with these studies 3,5,7 we found significant mortality and morbidity (Table IV), and were unable to distinguish possible side effects of rFVIIa from patient comorbidities and complications of the procedures. Unlike these studies, 3,5,7 however, we had a policy of using rFVIIa in the operating room with the chest open rather than in the ICU, 7 or both the operating room and the ICU. 3,5 The Australian drug regulator has yet to approve rFVIIa for bleeding in patients without hemophilia.…”

Section: Discussionmentioning

confidence: 67%

“…This policy aims to avoid the use of rFVIIa when bleeding is associated with inadequate surgical hemostasis. In other reported series, rFVIIa was administered as rescue therapy in the intensive care unit (ICU) after surgery, 7 or in the ICU and (less frequently) in the operating room. [3][4][5][6] In the only randomized trial in cardiac surgery, a small pilot study, rFVIIa was administered in the operating room as prophylaxis.…”

mentioning

confidence: 99%

“…1,2 Because of its mechanism of action there has been a rapidly expanding interest in using rFVIIa to manage other types of acquired bleeding in major surgery including cardiac surgery. 2 Fewer than 200 cases of rFVIIa utilization in cardiac surgery have been reported in the peer-reviewed literature [2][3][4][5][6][7][8] up to January 2006. The policy at our hospital has been to use rFVIIa in the operating room only when bleeding has prevented closure of the chest despite adequate conventional treatment, both at primary surgery and re-exploration.…”

mentioning

confidence: 99%

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

McCall

Story

Karapillai

2006

Can J Anesth/J Can Anesth

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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

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Section: Discussionmentioning

confidence: 67%

mentioning

confidence: 99%

mentioning

confidence: 99%

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

McCall

Story

Karapillai

2006

Can J Anesth/J Can Anesth

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“…Lacking control groups, however, these studies could not determine if this relationship was causal, nor could they determine if the observed adverse event rates were greater than the expected rates in this high-risk patient population. The case-control studies, [41][42][43][44][45] which are better able to address the latter issue, found no excess risk associated with rFVIIa, although their sample sizes were not large enough to detect small but clinically important differences in the rates of these complications. A general pattern seemed to emerge from these studies: when rFVIIa was used as a last resort, after many hours had elapsed from completion of CPB and after massive amounts of blood products were transfused, there were indications that it was less effective and associated with greater harm than when it was used early in the course of refractory blood loss.…”

Section: Rationalementioning

confidence: 99%

“…[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. These studies, however, have consistently found a strong, temporal relationship between rFVIIa administration and reduced hemorrhage in patients with refractory blood loss.…”

Section: Rationalementioning

confidence: 99%

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

Karkouti

Beattie

Crowther

et al. 2007

Can J Anesth/J Can Anesth

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Purpose: Recombinant activated factor VII (rFVIIa) is currently not approved by Health Canada or the Food and Drug Administration for treating excessive blood loss in nonhemophiliac patients undergoing on-pump cardiac surgery, but is increasingly being used "off-label" for this indication. A Canadian Consensus Conference was convened to generate recommendations for rFVIIa use in on-pump cardiac surgery. Methods: The panel undertook a literature review of the use of rFVIIa in both cardiac and non-cardiac surgery. Appropriateness, timing, and dosage considerations were addressed for three cardiac surgery indications: prophylactic, routine, and rescue uses. Recommendations were based on evidence from the literature and derived by consensus following recognized grading procedures. Results: The panel recommended against prophylactic or routine use of rFVIIa, as there is no evidence at this time that the benefits of rFVIIa outweigh its potential risks compared with standard hemostatic therapies. On the other hand, the panel made a weak recommendation (grade 2C) for the use of rFVIIa (one to two doses of 35-70 µg·kg -1 ) as rescue therapy for blood loss that is refractory to standard hemostatic therapies, despite the lack of randomized controlled trial data for this indication. Conclusions: In cardiac surgery, the risks and benefits of rFVIIa are unclear, but current evidence suggests that its benefits may outweigh its risks for rescue therapy in selected patients. Methodologically rigorous studies are needed to clarify its riskbenefit profile in cardiac surgery patients. 200 Elizabeth Street, Toronto, Ontario M5G 2C4,; E-mail: keyvan.karkouti@uhn.on.ca Disclosure statement: Novo Nordisk (Mississauga, Ontario, Canada), the makers of rFVIIa, funded this project through an unrestricted educational grant. Novo Nordisk was not involved in the selection of the members of the consensus panel, nor were they involved in the panel's review process, deliberations, conclusions, or manuscript preparation. The panel's chair selected the panel members, with the objective of achieving relevant multi-disciplinary expertise (i.e., anesthesiology, cardiac surgery, hematology, intensive care, and clinical epidemiology). The manuscript was primarily written by the panel chair (Keyvan Karkouti) and was approved by all of the panel members. All of the authors received an honorarium for attending the consensus conference.

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Efficacy and Safety of Recombinant Activated Factor VII in Major Surgical Procedures

et al. 2008

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Recombinant activated factor VII for refractory bleeding after cardiac surgery—A retrospective analysis of safety and efficacy

Abstract: When used as a last resort, rFVIIa was safe but not incrementally efficacious over conventional hemostatic therapy.

Cited by 86 publications

References 21 publications

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

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

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

Efficacy and Safety of Recombinant Activated Factor VII in Major Surgical Procedures

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