Objectives: 

Heparin is the universal anticoagulant for patients receiving extracorporeal membrane oxygenation support. However, heparin has many disadvantages, especially in young children, who develop heparin resistance. Recently our center has used bivalirudin, a direct thrombin inhibitor, for systemic anticoagulation in pediatric extracorporeal life support. Bivalirudin binds directly to thrombin with no need for antithrombin III and it inhibits both circulating and clot-bound thrombin. In this study, we sought to evaluate our experience with bivalirudin in pediatric extracorporeal life support.

Design: 

Retrospective chart review study of patients receiving extracorporeal membrane oxygenation support between October 2014 and May 2018.

Setting: 

Tertiary, academic PICU.

Patients: 

Sixteen patients receiving heparin and 16 patients receiving bivalirudin on extracorporeal life support were included in the study.

Interventions: 

None.

Measurements and Main Results: 

Patients in the bivalirudin group had a median age of 31 months versus 59 months in the heparin group (p = 0.41). Recovery and extracorporeal membrane oxygenation decannulation were similar in both groups (56% in the heparin group and 62% in the bivalirudin group; p = 0.62). Time to reach goal therapeutic anticoagulation level was shorter in the bivalirudin group (11 vs 29 hr; p = 0.01). Bleeding events were fewer in the bivalirudin group, and there was no difference in the rate of thrombotic events between the two groups. Comprehensive cost analysis that includes anticoagulant, laboratories, and antithrombin III cost, showed that heparin anticoagulation therapy total cost was significantly higher than bivalirudin (1,184 dollars per day in heparin group vs 494 dollars per day in bivalirudin group; p = 0.03). Bivalirudin dose required to maintain target anticoagulation will increase over time, and this is associated with an increase in creatinine clearance and an increase in fibrinogen serum levels.

Conclusions: 

This study showed that the use of bivalirudin in pediatric extracorporeal membrane oxygenation support is feasible, safe, reliable, and cost-effective in comparison to heparin. Further prospective randomized clinical trials are necessary to confirm our observations.

中文翻译：

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评价比伐卢定作为肝素的替代品在小儿体外膜氧合中的全身抗凝作用。

目标： 

肝素是接受体外膜氧合支持的患者的通用抗凝剂。但是，肝素有许多缺点，尤其是对肝素耐药性的幼儿。最近，我们的中心使用了比伐卢定（一种直接的凝血酶抑制剂）在小儿体外生命支持中进行全身性抗凝治疗。比伐卢定无需抗凝血酶III即可直接与凝血酶结合，并且既抑制循环凝血酶，又抑制结合血凝块的凝血酶。在这项研究中，我们试图评估比伐卢定在儿科体外生命支持中的经验。

设计： 

回顾性图表审查研究了2014年10月至2018年5月间接受体外膜氧合支持的患者。

设置： 

大专，学术PICU。

耐心： 

该研究包括16位接受肝素的患者和16位接受比伐卢定的体外生命支持患者。

干预措施： 

没有。

测量和主要结果： 

比伐卢定组的患者中位年龄为31个月，肝素组为59个月（p = 0.41）。两组的恢复和体外膜氧合脱氧作用相似（肝素组为56％，比伐卢定组为62％；p = 0.62）。比伐卢定组达到抗凝治疗目标的时间较短（11 vs 29 hr；p = 0.01）。比伐卢定中出血事件较少两组之间的血栓事件发生率没有差异。包括抗凝剂，实验室和抗凝血酶III成本在内的综合成本分析表明，肝素抗凝治疗的总成本显着高于比伐卢定（肝素组每天1,184美元，比伐卢定组每天494美元；p = 0.03）。维持目标抗凝所需的比伐卢定剂量会随着时间的推移而增加，这与肌酐清除率的增加和血纤蛋白原血清水平的增加有关。

结论： 

这项研究表明，与肝素相比，将比伐卢定用于小儿 体外膜充氧支持是可行，安全，可靠且具有成本效益的。需要进一步的前瞻性随机临床试验来证实我们的观察结果。