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Introduction
Since 2019, at our Universitary Hospital, an unusual rate of patients had hemostasis
abnormalities in immediate postoperative period of cardiac surgery. There was no change
in practices explaining these anomalies. In order to assess our professional practices,
we conducted a prospective study during one month with complete careful hemostasis
monitoring: aPTT, AntiXa activity, Activited Clotting Time (ACT) by Hemostasis Management
System (HMS) Plus and Quantra if relevant in the operating room after heparin neutralization.
Our analyses frequently showed a defect of heparin antagonization. Indeed, several
weeks later, a pharmacovigilance alert indicated a 30% under-dosage of the protamine
batches. Therefore, we could evaluate the validity of these monitoring devices with
incomplete heparin neutralization.
Methods
The analysis of coagulation in the operating room was recorded on a collection form.
Heparin-induced anticoagulation level and calculation for dose of protamine was tested
by the HMS Plus (Medtronic,Minneapolis, MN, USA) device, for all consecutive patients
undergoing cardiac surgery. From the same blood sample 15 minutes after the end of
protamine infusion, an assay of ACT, aPPT and anti Xa weas performed. In case of unusual
clinical bleeding, an additional analysis by Quantra was performed. The study protocol
has been submitted and approved by the Ethics Committee of the French Society of Anesthesia
and intensive care.
Results
During the study period, 33 procedures were included, consisting in 26 surgeries with
cardiopulmonary bypass and 7 Off-pump coronary artery bypass grafting. Considering
a 30% underdosing for protamine, the initial protamine / initial heparin ratio was
0.56 [0.48-0.64]. ACT, APPT and CTR (Quantra) correlated all well with AntiXa activity(Fig).
Spearman coefficients were 0.85 [CI: 0.69-0.93] (p<0.0001), 0.80 [CI: 0.6-0.9] (p<0.0001)
and 0.95 (p= 0.0012) respectively. However, aPTT was not relevant for AntiXa activity>
0.5 UI. To detect anti-Xa activity> 0.2, HMS detected residual heparinemia with a
sensitivity of 62% [45-78%], a specificity of 94%[50-100%], a positive predictive
value of 88% and a negative predictive value of 75%. For ACT, a threshold of 150 sec
had a sensitivity of 85% [58-97] and a specificity of 85% [58-97%] for the detection
of an antiXa>0.2 UI and a sensitivity of 100% [72-100] and a specificity of 81% [61-93]
for the detection of aPTT>100. A threshold of 1.4 CTR had a sensitivity of 67% [30-94]
and a specificity of 100% [18-100] for the detection of antiXa activity>0.2 and a
sensitivity of 100% [56-100] and a specificity of 100% [61-100] for the detection
of aPTT>100.
Discussion
Despite a limited number of assays, we found that both Quantra and HMS were efficient
to detect residual heparinemia in the operating room.
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© 2021 Published by Elsevier Inc.
