Gibbs Neville M, Weightman William M
Department of Anaesthesia, Sir Charles Gairdner Hospital, Nedlands, Australia.
The University of Western Australia, Nedlands, Australia.
Anaesth Intensive Care. 2020 Sep;48(5):339-353. doi: 10.1177/0310057X20948868. Epub 2020 Oct 4.
Hypofibrinogenaemia during cardiac surgery may increase blood loss and bleeding complications. Viscoelastic point-of-care tests provide more rapid diagnosis than laboratory measurement, allowing earlier treatment. However, their diagnostic test accuracy for hypofibrinogenaemia has never been reviewed systematically. We aimed to systematically review their diagnostic test accuracy for the identification of hypofibrinogenaemia during cardiac surgery. Two reviewers assessed relevant articles from seven electronic databases, extracted data from eligible articles and assessed quality. The primary outcomes were sensitivity, specificity and positive and negative predictive values. A total of 576 articles were screened and 81 full texts were assessed, most of which were clinical agreement or outcome studies. Only 10 diagnostic test accuracy studies were identified and only nine were eligible (ROTEM 7; TEG5000 1; TEG6S 1, = 1820 patients) (ROTEM, TEM International GmbH, Munich, Germany; TEG, Haemonetics, Braintree, MA, USA). None had a low risk of bias. Four ROTEM studies with a fibrinogen threshold less than 1.5-1.6 g/l and FIBTEM threshold A10 less than 7.5-8 mm had point estimates for sensitivity of 0.61-0.88; specificity 0.54-0.94; positive predictive value 0.42-0.70; and negative predictive value 0.74-0.98 (i.e. false positive rate 30%-58%; false negative rate 2%-26%). Two ROTEM studies with higher thresholds for both fibrinogen (<2 g/l) and FIBTEM A10 (<9.5 mm) had similar false positive rates (25%-46%), as did the two TEG studies (15%-48%). This review demonstrates that there have been few diagnostic test accuracy studies of viscoelastic point-of-care identification of hypofibrinogenaemia in cardiac surgical patients. The studies performed so far report false positive rates of up to 58%, but low false negative rates. Further diagnostic test accuracy studies of viscoelastic point-of-care identification of hypofibrinogenaemia are required to guide their better use during cardiac surgery.
心脏手术期间的低纤维蛋白原血症可能会增加失血和出血并发症。与实验室检测相比，床旁粘弹性检测能更快做出诊断，从而实现更早治疗。然而，它们对低纤维蛋白原血症的诊断检测准确性从未得到系统评价。我们旨在系统评价其在心脏手术中识别低纤维蛋白原血症的诊断检测准确性。两名评价者从七个电子数据库中检索相关文章，从符合条件的文章中提取数据并评估质量。主要结局指标为灵敏度、特异度、阳性预测值和阴性预测值。共筛选出576篇文章，评估了81篇全文，其中大部分是临床一致性或结局研究。仅识别出10项诊断检测准确性研究，只有9项符合条件（旋转血栓弹力图（ROTEM）7项；血栓弹力图（TEG）5000 1项；TEG6S 1项，n = 1820例患者）（ROTEM，德国慕尼黑TEM国际有限公司；TEG，美国马萨诸塞州布伦特里海莫尼克斯公司）。均无低偏倚风险。四项纤维蛋白原阈值低于1.5 - 1.6 g/L且FIBTEM阈值A10低于7.5 - 8 mm的ROTEM研究，其灵敏度的点估计值为0.61 - 0.88；特异度为0.54 - 0.94；阳性预测值为0.42 - 0.70；阴性预测值为0.74 - 0.98（即假阳性率30% - 58%；假阴性率2% - 26%）。两项纤维蛋白原（<2 g/L）和FIBTEM A10（<9.5 mm）阈值均较高的ROTEM研究，其假阳性率相似（25% - 46%），两项TEG研究的假阳性率也相似（15% - 48%）。本综述表明，关于床旁粘弹性检测识别心脏手术患者低纤维蛋白原血症的诊断检测准确性研究较少。迄今为止开展的研究报告的假阳性率高达58%，但假阴性率较低。需要进一步开展关于床旁粘弹性检测识别低纤维蛋白原血症的诊断检测准确性研究，以指导其在心脏手术中的更好应用。
