Introduction
Aprotinin is a serine protease inhibitor which is used in cardiac surgery as an anti-fibrinolytic
agent to minimise patient bleeding. It was withdrawn from the European market in 2008
due to potential increased mortality when compared to tranexamic acid. Aprotinin was
subsequently re-introduced in 2012 with narrow licencing indications, specifically
isolated coronary artery bypass graft surgery in high risk patients. Minimisation
of intra-operative blood loss plays an important role in patient outcomes, especially
in decreasing the need for transfusion which carries its own mortality risks(3,. Tranexamic
acid is utilised in the majority of cardiac surgery cases throughout Europe. We looked
to quantify and determine indications for aprotinin usage in an Irish tertiary cardiac
centre and compare findings to tranexamic acid.
Methods
Retrospective study of aprotinin usage in cardiac surgery in an Irish tertiary centre
over a 3 year period to determine number of cases and indications. Data collection
involved operative notes, patient records, pharmacy dispensing accounts. Aprotinin
dosage intra-operatively was per the full or half Hammersmith protocol. A cohort which
had undergone comparable cardiac surgery procedures with tranexamic acid as the anti-fibrinolytic
agent were also studied.
Results
From 2018-2021, 21 cardiac surgeries were carried out using aprotinin as the sole
anti-fibrinolytic agent to minimise patient bleeding in a high risk cohort. For the
same time period, to provide scale, 737 cardiac surgeries were carried out using tranexamic
acid. Each of the cases which utilised aprotinin represents an emergent, life-threatening
operation. The emergency cases comprised: repair of Stanford type A aortic dissection
(8, 38%); aortic valve replacement (7, 33.3%); mitral valve replacement (3, 14.3%);
tricuspid valve replacement (1, 4.8%); mediastinal revision for cardiac tamponade
(1, 4.8%). Valve replacements were complicated by: acute infective endocarditis, aortic
root abscess, haematoma, failure of pre-existing prosthetic valves. 1 case utilised
aprotinin as per the licenced indication: isolated CABG in patient with high bleeding
risk. An ST-elevated myocardial infarction necessitated the emergency CABG procedure
in this case.
Discussion
In summation, 95% of aprotinin usage for cardiac surgery in an Irish tertiary centre
falls outside the remit of the licenced indication. Given similar findings in a number
of European institutes(5), is it time to re-assess the existing guidelines on aprotinin
use, with view to expansion of the licenced indications?
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© 2021 Published by Elsevier Inc.