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a Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
b Monash University Department of Epidemiology and Preventive Medicine, Melbourne, Victoria, Australia
c The Austin Hospital, Melbourne, Victoria, Australia
d Royal North Shore Hospital, Sydney, New South Wales, Australia
e Prince of Wales Hospital, Sydney, New South Wales, Australia
f Novo Nordisk Pharmaceuticals Pty Ltd, Baulkham Hills, New South Wales, Australia
g Emergency and Trauma Centre, The Alfred Hospital, Melbourne, Victoria, Australia
Accepted for publication June 26, 2007.
* Address correspondence to Dr Phillips, Monash University, Epidemiology and Preventive Medicine, Haemostasis Registry, Alfred Hospital, Melbourne, Victoria 3004, Australia (Email: louise.phillips{at}med.monash.edu.au).
Background: Data from the Australian and New Zealand Haemostasis Registry (ANZHR) were used to report on the efficacy, mortality, and outcomes of a cohort of cardiac surgical cases receiving recombinant activated factor VII (rFVIIa).
Methods: The ANZHR collects retrospective and contemporaneous data on the use of rFVIIa in patients with critical bleeding from hospitals throughout Australia and New Zealand. Participating centers commit to the collection of data on all patients without hemophilia treated with rFVIIa, which limits bias and prevents the reporting of only positive or anecdotal experiences.
Results: At September 2006, the cardiac surgical cohort comprised 304 patients (43%) of a total of 695 cases reported to the ANZHR from 46 hospitals. The 304 cases date from January 2001. The median patient age was 66 years (interquartile range [IQR], 53 to 75 years), and 73% were men. After administration of rFVIIa, all blood product usage was significantly reduced. Patients received a median dose of 93 µg/kg (IQR, 82 to 102), and 85% of patients received a single dose. The documented response rate to a single dose of rFVIIa was 84%, of which 23% reported cessation of bleeding and 61% reported a reduction in bleeding. Patients received a median volume of 6 U of red blood cells before rFVIIa treatment. The median reduction in red blood cells after the rFVIIa dose compared with before was 4 U. Response was reduced in patients with a lower baseline hemoglobin, coagulopathy (determined by international normalized ratio, fibrinogen, and platelets), the number of red blood cell units transfused before rFVIIa, advanced age, more complex operations, hypothermia, and acidosis. Responders had a significantly reduced mortality (p < 0.001). The percentage of patients alive at 28 days was 95% if bleeding ceased after rFVIIa, 86% if bleeding reduced, and 60% for nonresponders. A 7% adverse event rate attributed as "probably" or "possibly" associated with rFVIIa was reported with a 4% reported thromboembolic event rate.
Conclusions: Recombinant FVIIa is a potential rescue therapy in severe uncontrollable critical bleeding after cardiac operations. The observed response rate was high, and response was associated with improved mortality. There was an observed reduction in blood product usage after rFVIIa. The adverse event rate reported was similar to documented adverse event rates in complex cardiac surgical patients. In the absence of randomized controlled trials, this registry provides a basis for understanding current clinical practice with rFVIIa in cardiac surgical procedures.
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