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肝素涂层与未涂层的微创体外循环用于孤立性冠状动脉搭桥手术的出血及炎症相关可比结局——一项双盲随机对照试验

Comparable bleeding and inflammation outcomes between heparin-coated and uncoated minimal invasive extracorporeal circuits in isolated coronary artery bypass surgery - A double-blinded randomized control trial.

作者信息

Jenni Hansjoerg, Kovacic Benjamin, Mihalj Maks, Huber Markus, Rieben Robert, Carrel Thierry, Siepe Matthias, Kadner Alexander, Erdoes Gabor

机构信息

Department of Cardiac Surgery, University of Bern, University Hospital Bern, Bern, Switzerland.

Department of BioMedical Research, University of Bern, Bern, Switzerland.

出版信息

Perfusion. 2025 Jul;40(5):1248-1257. doi: 10.1177/02676591241290924. Epub 2024 Oct 7.

Abstract

ObjectiveMinimally invasive extracorporeal circulation has been shown to be non-inferior or even superior to conventional cardiopulmonary bypass circuits in isolated coronary artery bypass grafting, but there is little evidence whether the addition of a heparin-coated circuit can further reduce the inflammatory response and amount of bleeding in these patients.MethodsA single-center randomized control trial enrolled 49 adult patients scheduled to undergo isolated coronary artery bypass grafting with minimally invasive extracorporeal circulation (MiECC) between January 2015 and December 2018. Patients were randomized 1:1 to either the heparin-coated circuit group, or the uncoated (control) circuit group. The primary outcome was chest tube output 18 h after weaning from MiECC, and secondary outcomes included inflammatory (TNF-α, IL-6, IL-8, IL-10) and complement (C3a, C4d, C5a, sC5b-9) biomarkers, platelet count and function (D2D, TAT, SDC1, PF4), number of transfused blood products, and 30-day survival.ResultsPatients were randomized to undergo myocardial revascularization using heparin-coated circuits ( = 25), and to the uncoated MiECC circuit ( = 24), with comparable baseline demographics. No significant difference was observed in chest tube output and for all secondary outcomes. IL-6 and IL-8 were increased from baseline at 18 h after weaning (effect size 0.29 and 0.05, respectively) and sC5b-9 was lower (effect size 0.11) in the heparin-coated than in the uncoated MiECC, although not significantly different.ConclusionsCompared with an uncoated MiECC circuit, heparin-coated MiECC circuit was not associated with a reduction in postoperative bleeding, transfusion, inflammation, complement activation, and platelet biomarkers, following isolated coronary artery bypass grafting.

摘要

目的

在单纯冠状动脉搭桥术中,微创体外循环已被证明不劣于甚至优于传统心肺转流回路,但几乎没有证据表明添加肝素涂层回路是否能进一步降低这些患者的炎症反应和出血量。

方法

一项单中心随机对照试验纳入了49例计划在2015年1月至2018年12月期间接受微创体外循环(MiECC)下单纯冠状动脉搭桥术的成年患者。患者按1:1随机分为肝素涂层回路组或未涂层(对照)回路组。主要结局是MiECC撤机后18小时的胸管引流量,次要结局包括炎症(TNF-α、IL-6、IL-8、IL-10)和补体(C3a、C4d、C5a、sC5b-9)生物标志物、血小板计数和功能(D2D、TAT、SDC1、PF4)、输注血液制品的数量以及30天生存率。

结果

患者被随机分配接受使用肝素涂层回路(n = 25)和未涂层MiECC回路(n = 24)进行心肌血运重建,基线人口统计学特征具有可比性。在胸管引流量和所有次要结局方面未观察到显著差异。肝素涂层MiECC组中,IL-6和IL-8在撤机后18小时较基线升高(效应量分别为0.29和0.05),sC5b-9较低(效应量为0.11),但差异均无统计学意义。

结论

与未涂层的MiECC回路相比,肝素涂层的MiECC回路在单纯冠状动脉搭桥术后与术后出血、输血、炎症、补体激活和血小板生物标志物的减少无关。

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