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心脏移植术中抗血栓药物的停用:来自国际安全及时抗血栓药物停用(STAR)登记处的病例系列

Intraoperative antithrombotic drug removal during heart transplantation: A case series from the International Safe and Timely Antithrombotic Removal (STAR) registry.

作者信息

Schmitto Jan, De Somer Filip, Thielmann Matthias, Marczin Nandor, Ruhparwar Arjang, Meyer Anna L, Hagl Christian, Matejic-Spasic Marijana, Wendt Daniel, Fan Weihong, Deliargyris Efthymios N, Storey Robert F, Schmoeckel Michael

机构信息

Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany.

Heart Centre, Ghent University Hospital, Ghent, Belgium.

出版信息

JHLT Open. 2025 Aug 20;10:100369. doi: 10.1016/j.jhlto.2025.100369. eCollection 2025 Nov.

DOI:10.1016/j.jhlto.2025.100369
PMID:40933270
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12418872/
Abstract

BACKGROUND

Patients on heart transplant waiting lists are often on antithrombotic (AT) drugs. Emergency orthotopic heart transplantation (OHT) when performed on such patients without optimal washout periods increases the risk of severe perioperative bleeding. Intraoperative AT removal by hemoadsorption may mitigate excess bleeding risks.

METHODS

The international Safe and Timely Antithrombotic Removal (STAR) registry captures real-world outcomes (ClinicalTrials.gov# NCT05077124). Included patients were on ticagrelor or direct-acting oral anticoagulants (DOACs) undergoing emergent OHT. Hemoadsorption was integrated into the cardiopulmonary bypass (CPB) circuit. Bleeding was assessed with the universal definition of perioperative bleeding (UDPB) and volume of chest tube drainage (CTD).

RESULTS

Seven patients were included (3 ticagrelor, 2 apixaban, 2 dabigatran; mean age 39.1 ± 11.1 years; 4 females). Mean time from the last AT dose to surgery was 29.4 ± 13.4 hours. Mean CPB duration was 206.0 ± 56.9 minutes with a mean device flow of 340 ± 126 ml. There were no massive bleeding events (UDPB 4), surgical revisions to control bleeding, or deaths within 30 days. Severe bleeding (UDPB 3) occurred in 1/7 (14.3%). Mean 12-hour and 24-hour CTD were 385.7 ± 263.4 m and 586.1 ± 315.0 ml, respectively. No device-related adverse events were reported.

CONCLUSIONS

This case series from the ongoing STAR registry shows that intraoperative AT removal is simple and potentially effective in minimizing serious perioperative bleeding in patients on ticagrelor or DOACs undergoing OHT. Prospective, controlled studies in larger cohorts are needed to validate these promising observations.

摘要

背景

心脏移植等待名单上的患者通常在服用抗血栓(AT)药物。在此类患者未经过最佳洗脱期就进行急诊原位心脏移植(OHT)会增加围手术期严重出血的风险。通过血液吸附在术中去除AT可能会降低出血风险。

方法

国际安全及时抗血栓清除(STAR)注册研究记录了实际治疗效果(ClinicalTrials.gov编号:NCT05077124)。纳入的患者为正在服用替格瑞洛或直接口服抗凝剂(DOAC)且接受急诊OHT的患者。血液吸附被整合到体外循环(CPB)回路中。采用围手术期出血通用定义(UDPB)和胸管引流量(CTD)评估出血情况。

结果

共纳入7例患者(3例服用替格瑞洛,2例服用阿哌沙班,2例服用达比加群;平均年龄39.1±11.1岁;4例女性)。从最后一次服用AT到手术的平均时间为29.4±13.4小时。平均CPB持续时间为206.0±56.9分钟,平均设备流量为340±126毫升。未发生大出血事件(UDPB 4级)、为控制出血而进行的手术修正或30天内死亡。1/7(14.3%)的患者发生严重出血(UDPB 3级)。12小时和24小时的平均CTD分别为385.7±263.4毫升和586.1±315.0毫升。未报告与设备相关的不良事件。

结论

来自正在进行的STAR注册研究的该病例系列表明,术中去除AT操作简单,对于服用替格瑞洛或DOAC且接受OHT的患者,在最大程度减少围手术期严重出血方面可能有效。需要在更大队列中进行前瞻性对照研究以验证这些有前景的观察结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dbb/12418872/6c045548a020/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dbb/12418872/6c045548a020/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0dbb/12418872/6c045548a020/gr1.jpg

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本文引用的文献

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CytoSorb hemoadsorption of apixaban during cardio-pulmonary bypass for heart transplantation.心脏移植体外循环期间阿哌沙班的CytoSorb血液吸附
JHLT Open. 2024 Oct 11;7:100165. doi: 10.1016/j.jhlto.2024.100165. eCollection 2025 Feb.
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Early CABG with intraoperative hemoadsorption in patients on ticagrelor: Real world data from the international Safe and Timely Antithrombotic Removal (STAR) registry.替格瑞洛治疗患者早期行冠状动脉旁路移植术并术中进行血液吸附:来自国际安全及时抗栓清除(STAR)注册研究的真实世界数据。
Cardiovasc Revasc Med. 2025 Feb 28. doi: 10.1016/j.carrev.2025.02.015.
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Direct-acting oral anticoagulant removal by intraoperative hemoadsorption in CABG and/or single valve surgery: interim analysis of the International Safe and Timely Antithrombotic Removal (STAR) registry.
冠状动脉旁路移植术和/或单瓣膜手术中通过术中血液吸附清除直接作用口服抗凝剂:国际安全及时抗栓清除(STAR)注册研究的中期分析
J Cardiothorac Surg. 2025 Jan 20;20(1):74. doi: 10.1186/s13019-024-03326-1.
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Perioperative Management of Patients Taking Direct Oral Anticoagulants: A Review.直接口服抗凝剂治疗患者的围手术期管理:综述。
JAMA. 2024 Sep 10;332(10):825-834. doi: 10.1001/jama.2024.12708.
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Platelet inhibitor withdrawal and outcomes after coronary artery surgery: an individual patient data meta-analysis.血小板抑制剂停药与冠状动脉手术后结局:一项个体患者数据荟萃分析。
Eur J Cardiothorac Surg. 2024 Jul 1;66(1). doi: 10.1093/ejcts/ezae265.
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Clinical outcomes and anticoagulation therapy in elderly non-valvular atrial fibrillation and heart failure patients.老年非瓣膜性心房颤动伴心力衰竭患者的临床转归和抗凝治疗。
ESC Heart Fail. 2024 Apr;11(2):902-913. doi: 10.1002/ehf2.14550. Epub 2024 Jan 11.
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Intraoperative ticagrelor removal via hemoadsorption during on-pump coronary artery bypass grafting.体外循环冠状动脉搭桥术中通过血液吸附术去除术中替格瑞洛
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