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.
Résumé
Objectif
Un nombre croissant d’articles et d’essais isolés traitent du facteur VII recombinant activé (rFVIIa) utilisé contre les saignements chirurgicaux. Peu d’articles mentionnent le rFVIIa pendant la chirurgie cardiaque. Nous présentons son utilisation en salle d’opération pour contrer les saignements qui entravent la fermeture du thorax malgré le traitement approprié habituel suivant une opération cardiaque complexe.
Méthode
Une revue rétrospective a été faite des dossiers des patients de chirurgie cardiaque, d’un hôpital universitaire australien et d’un hôpital privé associé, qui ont reçu une dose habituelle de 90 μg·kg-1 de rFVIIa. L’usage du rFVIIa visait à contrer les saignements qui surviennent malgré les produits sanguins et la protamine administrés et des tentatives chirurgicales pour assurer l’hémostase.
Résultats
Le rFVIIa a été administré à 55 reprises chez 53 patients qui ont subi, en majorité, une opération aortique ou valvulaire complexe avec une CEC d’une durée moyenne de 266 min. Les patients ont d’abord reçu en moyenne: quatre unités de culots globulaires, 15 unités de plaquettes, huit unités de plasma frais congelé et dix unités de cryoprécipité. Après le rFVIIa, la moyennes des produits sanguins administrés jusqu’à 12 h après l’arrivée à l’unité des soins intensifs a été de: une unité de culot globulaire, aucune unité de plaquettes, de plasma frais congelé et de cryoprécipité, donc une diminution significative (P < 0,001). Un rôle possible du rFVIIa dans les taux significatifs de mortalité (19%) et de morbidité (17%) n’a pu être déterminé.
Conclusion
Le rFVIIa en chirurgie cardiaque peut être efficace, mais des études cliniques approfondies devront clarifier son rôle dans une pratique clinique sûre. Nous présentons une ligne de conduite concernant le rFVIIa, élaborée pendant la période d’évaluation.
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Funding and conflict-of-interest statement: The Austin Department of Anaesthesia Research Fund funded this audit. The Austin Department of Anaesthesia Fund has received a non-conditional educational grant from Novo Nordisk. Peter McCall is a member of a Cardiac Surgery Advisory Committee for Novo Nordisk and has presented at company sponsored educational seminars. David Story and Darshi Karapillai have no other potential conflicts-of-interest with this study.
An erratum to this article is available at http://dx.doi.org/10.1007/BF03021596.
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McCall, P., Story, D.A. & Karapillai, D. Audit of factor VIIa for bleeding resistant to conventional therapy following complex cardiac surgery. Can J Anesth 53, 926–933 (2006). https://doi.org/10.1007/BF03022836
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DOI: https://doi.org/10.1007/BF03022836