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阿哌沙班作为HeartMate 3左心室辅助装置患者主要抗凝剂的长期疗效。

Long-term outcomes of apixaban as main anticoagulant in patients with HeartMate 3 left ventricular assist devices.

作者信息

Jdaidani Jennifer, Shadi Mahmoud, Asogwa Nnedi, Winik Jennifer, Rossi Dora, Saikus Christina, Avila Maria D, Rojas-Marte Geurys R

机构信息

Department of Internal Medicine, Staten Island University Hospital, Northwell Health, New Hyde Park, New York, USA.

Cardiovascular Institute, Staten Island University Hospital, Northwell Health, New Hyde Park, New York, USA.

出版信息

ESC Heart Fail. 2025 Jun;12(3):1714-1718. doi: 10.1002/ehf2.15182. Epub 2024 Dec 9.

Abstract

AIMS

HeartMate 3 (HM3) left ventricular assist devices (LVADs) offer improved haemocompatibility-related outcomes for end-stage heart failure patients, facilitating the exploration of alternative anticoagulation therapies beyond warfarin. This study presents a long-term evaluation of thrombotic and bleeding outcomes in HM3 LVAD patients transitioned from warfarin to apixaban.

METHODS

We retrospectively identified HM3 LVAD patients at our single centre who transitioned from warfarin to apixaban. Baseline characteristics were described at discharge from implant hospitalization and at the last follow-up on each anticoagulation regimen. We reported survival, thrombo-embolic events (including LVAD pump thrombosis, stroke, arterial thrombo-embolic events and pump exchange) and bleeding events on both warfarin and apixaban.

RESULTS

Eight patients were identified between May 2018 and June 2022 who transitioned from warfarin to apixaban 5 mg twice daily. Patients were followed for a mean of 1233 days after LVAD implantation and 789 days after transition to apixaban. All patients were transitioned due to difficulty maintaining a therapeutic international normalized ratio (INR), including five patients who experienced bleeding complications on warfarin. No patients encountered LVAD pump thrombosis, stroke events, arterial thrombo-embolic event, pump exchange or death. While on warfarin, five patients had eight bleeding events: one major [requiring 2 units of packed red blood cells (pRBCs)] and seven minors (five gastrointestinal bleeds, one episode of haematuria and one episode of haemoptysis). After switching to apixaban, one patient with angioectasia had a major gastrointestinal bleed requiring two pRBCs and endoscopic clipping.

CONCLUSIONS

Apixaban demonstrated safe and favourable long-term outcomes in a cohort of HM3 LVAD patients over a mean follow-up of more than 2 years. To our knowledge, our report provides the longest follow-up duration for this patient population to date. Larger prospective studies are needed before this can be adopted as the standard of care.

摘要

目的

HeartMate 3(HM3)左心室辅助装置(LVAD)为终末期心力衰竭患者提供了与血液相容性相关的改善结局,有助于探索华法林以外的替代抗凝治疗。本研究对从华法林转换为阿哌沙班的HM3 LVAD患者的血栓形成和出血结局进行了长期评估。

方法

我们回顾性确定了在我们单中心从华法林转换为阿哌沙班的HM3 LVAD患者。在植入住院出院时以及每种抗凝方案的最后一次随访时描述基线特征。我们报告了华法林和阿哌沙班治疗期间的生存率、血栓栓塞事件(包括LVAD泵血栓形成、中风、动脉血栓栓塞事件和泵更换)和出血事件。

结果

在2018年5月至2022年6月期间,确定了8例从华法林转换为每日两次5 mg阿哌沙班的患者。LVAD植入后患者平均随访1233天,转换为阿哌沙班后平均随访789天。所有患者因难以维持治疗性国际标准化比值(INR)而转换治疗,其中5例患者在华法林治疗期间出现出血并发症。没有患者发生LVAD泵血栓形成、中风事件、动脉血栓栓塞事件、泵更换或死亡。在使用华法林期间,5例患者发生了8次出血事件:1次大出血[需要2单位浓缩红细胞(pRBC)]和7次小出血(5次胃肠道出血、1次血尿和1次咯血)。转换为阿哌沙班后,1例患有血管扩张症的患者发生了一次大出血,需要2单位pRBC并进行内镜夹闭。

结论

在平均随访超过2年的一组HM3 LVAD患者中,阿哌沙班显示出安全且良好的长期结局。据我们所知,我们的报告提供了迄今为止该患者群体最长的随访时间。在将其作为护理标准采用之前,需要进行更大规模的前瞻性研究。

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本文引用的文献

1
Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices: The DOAC LVAD Study.
JACC Heart Fail. 2024 Sep;12(9):1540-1549. doi: 10.1016/j.jchf.2024.04.013. Epub 2024 May 7.
2
A Prospective Randomized Trial of Direct Oral Anticoagulant Therapy With a Fully Magnetically Levitated LVAD: The DOT-HM3 Study.
Circulation. 2024 Aug 6;150(6):509-511. doi: 10.1161/CIRCULATIONAHA.124.069726. Epub 2024 Apr 9.
4
Apixaban Anticoagulation in Children and Young Adults Supported With the HeartMate 3 Ventricular Assist Device.
ASAIO J. 2023 Jun 1;69(6):e267-e269. doi: 10.1097/MAT.0000000000001889. Epub 2023 Feb 10.
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Apixaban: Alternative Anticoagulation for HeartMate 3 Ventricular Assist Device.
ASAIO J. 2022 Mar 1;68(3):318-322. doi: 10.1097/MAT.0000000000001650.
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Apixaban as an alternative to warfarin for patients with a left ventricular assist device.
Am J Health Syst Pharm. 2022 May 24;79(11):826-829. doi: 10.1093/ajhp/zxac028.

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