Paediatric Intensive Care Unit, The Children's Hospital at Westmead, Sydney, Australia.
Cardiothoracic Surgery Department, The Children's Hospital at Westmead, Sydney, Australia.
Eur J Cardiothorac Surg. 2019 May 1;55(5):817-822. doi: 10.1093/ejcts/ezy483.
The aim of this study is to determine whether recombinant activated factor VII (rVIIa) was associated with thrombus formation in neonates undergoing cardiac surgery.
This is a retrospective study of neonates undergoing surgical repair of congenital cardiac lesions during a 9-year period.
In our study, 416 cardiac operations requiring cardiopulmonary bypass (CPB) were performed on 414 neonates. The overall intravascular thrombus (thrombus) frequency for all operations was 45 of 416 (11%). A thrombus developed in 17 of 287 (6%) operations when rVIIa was not given. rVIIa was administered in 129 of 416 (31%) operations. Thrombus formation occurred in 28 of 129 (22%) operations when rVIIa was administered. There was an association between rVIIa use and thrombus formation [odds ratio (OR) 4.4, 95% confidence interval (CI) 2.3-8.4; P < 0.0001]. Patients with thrombus formation had an increased length of stay compared to those without thrombus. Neonates who underwent the Norwood procedures and received rVIIa and developed thrombus were more likely to be supported with extracorporeal membrane oxygenation (ECMO) and had a higher mortality compared to Norwood patients without thrombus. Logistic analysis adjusted for the paediatric index of mortality 2 score, the risk adjustment for congenital heart surgery and the use of ECMO demonstrated a strong association between rVIIa administration and thrombus formation (OR 3.5, 95% CI 1.7-6.9; P = 0.0004). However, there was no effect of the risk adjustment for congenital heart surgery-1 category or the paediatric index of mortality 2 score on thrombus formation.
In neonates who underwent CPB surgery, administration of rVIIa was associated with an increased occurrence of intravascular thrombus formation compared to neonates not given rVIIa. In the Norwood population, thrombus formation was associated with a higher mortality.
本研究旨在确定接受心脏手术的新生儿中，重组活化因子 VII（rVIIa）是否与血栓形成有关。
这是一项回顾性研究，纳入了 9 年内接受先天性心脏病变手术修复的新生儿。
在我们的研究中，414 名新生儿共进行了 416 次需要体外循环（CPB）的心脏手术。所有手术的总血管内血栓（血栓）发生率为 416 例中的 45 例（11%）。在未给予 rVIIa 的 287 例手术中，有 17 例（6%）发生血栓。在 416 例手术中，有 129 例（31%）给予了 rVIIa。给予 rVIIa 后，血栓形成发生在 129 例手术中的 28 例（22%）。rVIIa 的使用与血栓形成之间存在关联[比值比（OR）4.4，95%置信区间（CI）2.3-8.4；P<0.0001]。与无血栓形成的患者相比，发生血栓形成的患者住院时间更长。接受 Norwood 手术并接受 rVIIa 治疗且发生血栓的新生儿更有可能需要体外膜肺氧合（ECMO）支持，并且与无血栓形成的 Norwood 患者相比，死亡率更高。调整儿科死亡率 2 评分、先天性心脏病手术风险调整和 ECMO 使用的逻辑分析显示，rVIIa 给药与血栓形成之间存在强烈关联（OR 3.5，95%CI 1.7-6.9；P=0.0004）。然而，先天性心脏病手术风险调整 1 类或儿科死亡率 2 评分对血栓形成没有影响。
在接受 CPB 手术的新生儿中，与未给予 rVIIa 的新生儿相比，rVIIa 的给药与血管内血栓形成的发生率增加有关。在 Norwood 人群中，血栓形成与更高的死亡率相关。
