Antithrombotic therapy in pediatric ventricular assist devices: Multicenter survey of the European EXCOR Pediatric Investigator Group

Antithrombotic therapy in pediatric ventricular assist devices: Multicenter survey of the European EXCOR Pediatric Investigator Group
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DOI:
10.1177/0391398818773040
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发表时间:
2018-07-01
影响因子:
1.7
通讯作者:
Amodeo, Antonio
Amodeo, Antonio
中科院分区:
工程技术4区
文献类型:
--
作者:
Miera, Oliver;Schmitt, Katharina L.;Amodeo, Antonio

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目的:使用柏林心脏EXCOR心室辅助系统为小儿心力衰竭患者提供机械循环支持是唯一获批和确立的恢复或心脏移植桥接策略。近年来,血栓栓塞事件的负担导致了推荐的抗血栓治疗的修改。因此,我们的目的是评估修改欧洲EXCOR儿科Investigator Group members.Methods之间的抗血栓形成的做法:我们发送了一份问卷,评估七个方面的抗血栓治疗,以18个欧洲医院使用EXCOR设备的儿童。对返回的问卷进行分析,并将确定的抗血栓策略与为美国EXCOR儿科批准研究开发的“埃德蒙顿方案”建议进行比较。对收到的18份调查的分析显示,与埃德蒙顿方案存在实质性偏差,包括在50%的调查中心中,在术后6-12小时提前开始肝素治疗,使用aPTT测定监测肝素有效性,在12个月大之前给予维生素K拮抗剂。约39%的中心使用更高的国际标准化比值目标,56%的中心改变了血小板抑制作用,包括使用氯吡格雷代替双嘧达莫。从埃德蒙顿协议的多个偏差的显着的中心间变异性被发现,只有一个中心以下的埃德蒙顿protocol completely.Conclusion:目前欧洲EXCOR用户代表治疗600多名儿科患者的抗血栓形成的做法已经改变了随着时间的推移,一个更积极的治疗趋势。有必要对前瞻性研究中的抗血栓治疗实践进行系统的循证评价和协调,以修订建议。
Objectives: Mechanical circulatory support for pediatric heart failure patients with the Berlin Heart EXCOR ventricular assist system is the only approved and established bridging strategy for recovery or heart transplantation. In recent years, the burden of thromboembolic events has led to modifications of the recommended antithrombotic therapy. Therefore, we aimed to assess modifications of antithrombotic practice among the European EXCOR Pediatric Investigator Group members.Methods: We sent a questionnaire assessing seven aspects of antithrombotic therapy to 18 European hospitals using the EXCOR device for children. Returned questionnaires were analyzed and identified antithrombotic strategies were descriptively compared to "Edmonton protocol" recommendations developed for the US EXCOR pediatric approval study.Results: Analysis of 18 received surveys revealed substantial deviations from the Edmonton protocol, including earlier start of heparin therapy at 6-12 h postoperatively and in 50% of surveyed centers, monitoring of heparin effectiveness with aPTT assay, administering vitamin K antagonists before 12 months of age. About 39% of centers use higher international normalized ratio targets, and platelet inhibition is changed in 56% including the use of clopidogrel instead of dipyridamole. Significant inter-center variability with multiple deviations from the Edmonton protocol was discovered with only one center following the Edmonton protocol completely.Conclusion: Current antithrombotic practice among European EXCOR users representing the treatment of more than 600 pediatric patients has changed over time with a trend toward a more aggressive therapy. There is a need for systematic evidence-based evaluation and harmonization of developmentally adjusted antithrombotic management practices in prospective studies toward revised recommendations.