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.

IF 1.5 4区医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiothoracic Surgery Pub Date : 2025-01-20 DOI:10.1186/s13019-024-03326-1

Michael Schmoeckel, Matthias Thielmann, Keti Vitanova, Thomas Eberle, Nandor Marczin, Kambiz Hassan, Andreas Liebold, Sandra Lindstedt, Georg Mächler, Marijana Matejic-Spasic, Daniel Wendt, Efthymios N Deliargyris, Robert F Storey

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引用次数: 0

Abstract

Objective: Patients on direct-acting oral anticoagulants (DOACs) are at high risk of perioperative bleeding complications. Intraoperative hemoadsorption is a novel strategy to reduce perioperative bleeding in patients on DOACs undergoing non-deferable cardiac surgery. The international STAR-registry reports real-world clinical outcomes associated with this application.

Methods: The hemoadsorption device was incorporated into the cardiopulmonary bypass (CPB) circuit and active for the duration of the pump run. Patients on DOACs undergoing CABG and/or single valve surgery before completing the recommended washout were included. Outcome measurements included bleeding events according to standardized definitions and 24-hour chest-tube-drainage (CTD).

Results: A total of 62 patients were included from 7 institutions in Austria, Germany, Sweden, and the UK (mean age 69.9 ± 7.5years, 71% male). Approximately half were on apixaban and the other half was split between rivaroxaban and edoxaban with 21% of patients also on aspirin. Surgery occurred at a median time of 28.9 h since the last DOAC dose with single valve surgery accounting for 2/3 of cases. Mean CPB duration was 118.6 ± 46.4 min. Severe bleeding (UDPB ≥ 3) occurred in 4.8%, and BARC-4 bleeding occurred in 3.2% of the patients. Only one patient (1.6%) required reoperation for bleeding control. The mean 24-hour CTD was 771.3 ± 482.79mL. No device-related adverse events were reported.

Conclusions: This interim report of the ongoing STAR-registry shows that, in patients on DOAC undergoing non-deferable CABG and/or single valve surgery, the use of intraoperative hemoadsorption is associated with low rates of severe perioperative bleeding complications. Further prospective studies in larger cohorts are needed to validate the efficacy of this method.

Clinical registration number: ClinicalTrials.gov identifier: NCT05077124.

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在CABG和/或单瓣膜手术中通过术中血液吸附直接口服抗凝剂去除：国际安全及时抗血栓去除（STAR）登记的中期分析

目的：口服直接作用抗凝剂（DOACs）患者围手术期出血并发症的危险性较高。术中血液吸附是一种新的策略，以减少围术期出血的DOACs患者接受不可推迟的心脏手术。国际STAR-registry报告了与该应用相关的真实临床结果。方法：将血液吸附装置纳入体外循环回路，并在泵运行期间保持有效。DOACs患者在完成推荐冲洗前接受CABG和/或单瓣手术。结果测量包括标准化定义的出血事件和24小时胸管引流（CTD）。结果：共纳入来自奥地利、德国、瑞典和英国7家机构的62例患者，平均年龄69.9±7.5岁，男性71%。大约一半的患者服用阿哌沙班，另一半患者服用利伐沙班和依多沙班，21%的患者同时服用阿司匹林。手术发生的中位时间为最后一次DOAC给药后28.9 h，单瓣膜手术占2/3。CPB平均持续时间为118.6±46.4 min，重度出血（UDPB≥3）发生率为4.8%，BARC-4出血发生率为3.2%。只有1例（1.6%）患者需要再次手术控制出血。平均24小时CTD为771.3±482.79mL。无器械相关不良事件报告。结论：正在进行的star登记的中期报告显示，在接受不可延迟CABG和/或单瓣膜手术的DOAC患者中，术中血液吸附的使用与严重围手术期出血并发症的发生率低有关。需要在更大的队列中进行进一步的前瞻性研究来验证该方法的有效性。临床注册号：ClinicalTrials.gov标识符：NCT05077124。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Cardiothoracic Surgery 医学-心血管系统

CiteScore

2.50

自引率

6.20%

发文量

286

审稿时长

4-8 weeks

期刊介绍： Journal of Cardiothoracic Surgery is an open access journal that encompasses all aspects of research in the field of Cardiology, and Cardiothoracic and Vascular Surgery. The journal publishes original scientific research documenting clinical and experimental advances in cardiac, vascular and thoracic surgery, and related fields. Topics of interest include surgical techniques, survival rates, surgical complications and their outcomes; along with basic sciences, pediatric conditions, transplantations and clinical trials. Journal of Cardiothoracic Surgery is of interest to cardiothoracic and vascular surgeons, cardiothoracic anaesthesiologists, cardiologists, chest physicians, and allied health professionals.