Analysis of Outcomes Using Low-Dose and Early Administration of Recombinant Activated Factor VII in Cardiac Surgery

Brase, Jason; Finger, Brooke; He, Jia; Wirtz, Katy; Stun, Lucy; McMillen, Randy; Flynn, Brigid C.

doi:10.1016/j.athoracsur.2016.01.004

Cited by 23 publications

(23 citation statements)

References 26 publications

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“…136 Importantly, low dose activated factor VII regimens (≤ 40 µg/kg) and very low dose regimens (≤ 20 µg/kg) may be effective in intractable bleeding without exposing patients to an increased risk of adverse events. 128,137,138 A single dose should generally not be higher than 90 µg/kg, although doses as high as 120 µg/kg have been used in other clinical circumstances, such as in patients with hemophilia A or B with factor inhibitors. 139 While conventional laboratory tests such as the PT and aPTT typically shorten after administration of rFVIIa, therapeutic efficacy should be judged by the resolution of clinical bleeding.…”

Section: Thrombin Generationmentioning

confidence: 99%

“…Therapeutic success of rFVIIa may particularly depend on adequate fibrinogen levels, especially with dilutional coagulopathy 136 . Importantly, low dose activated factor VII regimens (≤ 40 µg/kg) and very low dose regimens (≤ 20 µg/kg) may be effective in intractable bleeding without exposing patients to an increased risk of adverse events 128,137,138 . A single dose should generally not be higher than 90 µg/kg, although doses as high as 120 µg/kg have been used in other clinical circumstances, such as in patients with hemophilia A or B with factor inhibitors 139 .…”

Section: Special Considerations In Refractory Bleedingmentioning

confidence: 99%

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Managing the coagulopathy associated with cardiopulmonary bypass

Bartoszko

Karkouti

2021

Journal of Thrombosis and Haemostasis

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Cardiopulmonary bypass (CPB) has allowed for significant surgical advancements, but accompanying risks can be significant and must be expertly managed. One of the foremost risks is coagulopathic bleeding. Increasing levels of bleeding in cardiac surgical patients at the time of separation from CPB are associated with poor outcomes and mortality. CPB‐associated coagulopathy is typically multifactorial and rarely due to inadequate reversal of systemic heparin alone. The components of the bypass circuit induce systemic inflammation and multiple disturbances of the coagulation and fibrinolytic systems. Anticipating coagulopathy is the first step in managing it, and specific patient and procedural risk factors have been identified as predictors of excessive bleeding. Medication management pre‐procedure is critical, as patients undergoing cardiac surgery are commonly on anticoagulants or antiplatelet agents. Important adjuncts to avoid transfusion include antifibrinolytics, and perfusion practices such as red cell salvage, sequestration, and retrograde autologous priming of the bypass circuit have varying degrees of evidence supporting their use. Understanding the patient's coagulation status helps target product replacement and avoid larger volume transfusion. There is increasing recognition of the role of point‐of‐care viscoelastic and functional platelet testing. Common pitfalls in the management of post‐CPB coagulopathy include overdosing protamine for heparin reversal, imperfect laboratory measures of thrombin generation that result in normal or near‐normal laboratory results in the presence of continued bleeding, and delayed recognition of surgical bleeding. While challenging, the effective management of CPB‐associated coagulopathy can significantly improve patient outcomes.

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Section: Thrombin Generationmentioning

confidence: 99%

Section: Special Considerations In Refractory Bleedingmentioning

confidence: 99%

Managing the coagulopathy associated with cardiopulmonary bypass

Bartoszko

Karkouti

2021

Journal of Thrombosis and Haemostasis

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“…The reverse hypothesis could be that procoagulants reduce false lumen patency. Fibrinogen and recombinant factor VII have proved to reduce the need for transfusion in cardiac surgery [ 22 , 23 ] but neither the use ( p = 0.19, OR 2.48, CI95% 0.65–9.49) nor the administrated dose ( p = 0.46, OR 1.09, CI95% 0.87–1.38) of recombinant factor VII had a significant impact on the false lumen status.…”

Section: Discussionmentioning

confidence: 99%

The effect of postoperative anticoagulation on false lumen patency after surgery for acute type A aortic dissection

Larsson

Božović

Sjögren

et al. 2021

J Cardiothorac Surg

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Background Patent false lumen has been shown to have a negative impact on prognosis after surgery for acute type A aortic dissection (ATAAD). We aimed to assess the effect of postoperative anticoagulation on false lumen patency and clinical outcomes in relation to false lumen status. Methods Postoperative computed tomographies of 156 patients undergoing ATAAD DeBakey type I surgery were retrospectively evaluated for false lumen patency. The patients were divided into groups determined by anticoagulation treatment at discharge. Uni- and multivariable logistic regression was used for analysing the effect of anticoagulation on the false lumen, and Kaplan–Meier estimates were used to assess the association of a patent false lumen with the incidence of reoperation and long-term survival. Results A patent false lumen was present in 81% of the patients. Postoperative anticoagulants were not associated with a patent false lumen (p = 0.48) in univariable analysis. In multivariable analysis, both hemiarch replacement (OR 0.15, CI95% 0.05–0.49, p = 0.001) and the use of betablockers had a protective effect (OR 0.29, CI95% 0.10–0.85, p = 0.023). The Kaplan–Meier estimates for survival and the composite endpoint of survival and freedom from distal reintervention indicated no difference in outcome between patients in regard to anticoagulation treatment (survival p = 0.43, composite p = 0.82) or false lumen status (survival p = 0.21, composite p = 0.09). Conclusion This study could not show negative effects from the postoperative use of anticoagulants on false lumen status, nor that false lumen patency was associated with poorer prognosis. A hemiarch procedure was shown to be associated with reduced risk of false lumen patency.

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“…Other studies and case reports supported the contention that doses of rFVIIa <90 μg/kg provided satisfactory hemostasis in cardiac surgery patients. [18192021222324] For example, Andersen et al . showed that an initial rFVIIa dose of 32 μg/kg (median value) caused a 50% reduction in postoperative transfusion requirements and eliminated the need for surgical reexploration without affecting the incidence of thromboembolic complications compared with placebo.…”

Section: Discussionmentioning

confidence: 99%

Adequacy of hemostatic resuscitation improves therapeutic efficacy of recombinant activated factor VII and reduces reexploration rate for bleeding in postoperative cardiac surgery patients with refractory hemorrhage

et al. 2019

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Background:Excessive bleeding and surgical reexploration are common complications that increase the risk of multi-organ failure and prolonged hospitalization after cardiac surgery. Off-label use of recombinant activated factor VII (rFVIIa) is a recommended treatment for refractory bleeding.Objective:The objective of the study is to determine if the adequacy of hemostatic resuscitation enhances the efficacy of rFVIIa.Methods:This retrospective, observational, cohort study included patients who received rFVIIa for refractory postoperative bleeding after cardiac surgery. Patients were divided into two groups based on the presence or absence of adequate coagulation resuscitation before rFVIIa administration, defined as international ratio (INR) ≤1.5, platelet count ≥100 K/mL, and fibrinogen ≥200 mg/dL. The failure of rFVIIa treatment was defined as surgical reexploration within 24 h, thoracostomy drainage >400 mL/h within 6 h or transfusion of additional blood products or another rFVIIa dose within 6 h after initial rFVIIa dose.Results:Of the 3833 patients, screened who underwent cardiothoracic surgery procedures, 58 patients received rFVIIa for refractory postoperative bleeding. Successful hemostasis with rFVIIa was more likely in patients who were adequately resuscitated compared with those who were not (20 [71.4%] vs. 10 [33.3%], respectively; P = 0.0046). Multiple logistic regression analysis indicated that patients who were adequately resuscitated before rFVIIa were less likely to fail treatment (odds ratio, 0.16; 95% confidence interval [0.04–0.62]; P = 0.007).Conclusions:The therapeutic efficacy of rFVIIa is dependent on the adequacy of hemostatic resuscitation; restoration of normal serum fibrinogen, INR, and platelet counts >100 K/mL may provide an adequate substrate for rFVIIa to be effective in managing refractory postoperative cardiac surgical bleeding.

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Analysis of Outcomes Using Low-Dose and Early Administration of Recombinant Activated Factor VII in Cardiac Surgery

Cited by 23 publications

References 26 publications

Managing the coagulopathy associated with cardiopulmonary bypass

Managing the coagulopathy associated with cardiopulmonary bypass

The effect of postoperative anticoagulation on false lumen patency after surgery for acute type A aortic dissection

Adequacy of hemostatic resuscitation improves therapeutic efficacy of recombinant activated factor VII and reduces reexploration rate for bleeding in postoperative cardiac surgery patients with refractory hemorrhage

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