The Association Between Antifibrinolytic Agent and Recombinant Factor VIIa (rVIIa) on the Incidence of Perioperative Morbidity and Mortality in Cardiac Surgery Using a Retrospective Study Cohort. Public
Sniecinski, Roman (Spring 2018)
Abstract
Bleeding is a common problem following complex cardiac surgery utilizing cardiopulmonary bypass (CPB). Recombinant activated Factor VII (rVIIa) is often used as a rescue agent when coagulopathy is resistance to conventional treatment with hemostatic blood products. In this retrospective cohort study, we examined the association of rVIIa administration with perioperative mortality, major adverse cardiac events (MACE), and venous thromboembolic events (VTE). We also examined the association of two different types of antifibrinolytic agents on perioperative mortality in those patients administered rVIIa.
From 1/1/2005 thru 12/31/2012, 4569 patients underwent complex cardiac surgery using CPB at Emory University Hospital and Emory University Hospital Midtown and of these patients, 2,371 experienced severe bleeding. Of the bleeding patients, 610 (25.7%) were administered rVIIa as rescue therapy. Using multivariable logistic regression to control for known confounders, administration of rVIIa was associated with an increased incidence of perioperative mortality compared to bleeding patients not administered rVIIa (OR 1.875, 95% CI 1.390, 2.530). There was no association detected with rVIIa administration and MACE or VTE. When hemophiliac dosing regimens were considered, patients administered doses >90 mcg/kg (i.e. more than a “full dose”) had a higher incidence of perioperative mortality compared to patients given a “half dose of ≤45 mcg/kg (OR 3.389 95% CI 1.494, 7.691). Patients who were prophylactically treated with the antifibrinolytic aprotinin had a greater incidence of perioperative death when administered rVIIa than patients given tranexamic acid for an antifibrinolytic (OR 1.880, 95% CI 1.067, 3.313).
Our results confirm that administration of rVIIa to severely bleeding complex cardiac surgical patients is associated with increased perioperative mortality, although the mechanism by which this occurs is not clear. If rVIIa must be used in a rescue situation, then clinicians should start with doses ≤45 mcg/kg and avoid exceeding 90 mcg/kg. Other concomitantly administered medications can have an effect of rVIIa risks and should be considered in future research in this area.
Table of Contents
Introduction………………………………………………………
1
Background…………………………………………………………
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Methods…………………………………………………………….
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Results……………………………………………………………...
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Discussion…………………………………………………………...
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References…………………………………………………………...
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Figure 1: Study cohort……………………………………………….
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Table 1: Baseline demographics……………………………………...
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Table 2: Unadjusted outcomes………………………………………
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Figure 2: Unadjusted mortality percentage by year…………………...
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Figure 3: Primary causes of death……………………………………
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Table 3: Odds ratios for outcomes based on full model……………...
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Table 4: Model fit statistics…………………………………………..
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Figure 4: Logistic plot for perioperative death by rVIIa dose………...
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Table 5: Dose of rVIIa in cohort and by antifibrinolytic agent………
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Figure 6: Boxplot of rVIIa dose by antifibrinolytic agent……………
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Table 6: Odds ratio of primary outcome according to rVIIa dose…...
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