Department of Cardiology, AP HP, European Hospital Georges Pompidou, 20 rue Leblanc, 75015 Paris, France.
Université Paris Cité, INSERM, Innovative Therapies in Haemostasis, 4 Rue de l'Observatoire 75006 Paris, France.
Europace. 2023 May 19;25(5). doi: 10.1093/europace/euad057.
The study aims to investigate the impact of direct oral anticoagulant (DOAC) management on the incidence of pocket haematoma in patients undergoing pacemaker or implantable cardioverter-defibrillator implantation.
All consecutive patients receiving DOAC and undergoing cardiac electronic device implantation were included in a large multicentre prospective observational study (NCT03879473). The primary endpoint was clinically relevant haematoma within 30 days after implantation. Overall, 789 patients were enrolled [median age 80 (IQR 72-85) years old, 36.4% women, median CHA2DS2-VASc score 4 (IQR 0-8)], of which 632 (80.1%) received a pacemaker implantation. Antiplatelet therapy was combined with DOAC in 146 patients (18.5%). Direct oral anticoagulants (DOACs) were interrupted 52 (IQR 37-62) h before the procedure and resumed 31 (IQR 21-47) h later. Ninety-six percent of the patients had at least 12 h DOAC interruption before the procedure, and 78% had at least 12 h DOAC interruption after the procedure. Overall, anticoagulation was interrupted for 72 (IQR 48-96) h. Pre- or post-procedural heparin bridging was used in 8.2% and 3.9%, respectively. Timing of DOAC interruption of resumption was not associated with clinically relevant haematoma. Clinically relevant haematoma occurred in 26 patients (3.3%), and thromboembolic events occurred in 5 patients (0.6%).
In this large real-life registry where most patients had DOAC interruption, clinically relevant haematoma was rare. Despite DOAC interruption and high CHA2DS2-VASc score, thromboembolic events occurred seldomly, highlighting that bleeding exceeds thromboembolic risk in this peri-procedural period. Future research is needed to identify risk factors for clinically relevant haematoma and meaningfully guide clinicians in optimizing DOAC management.
本研究旨在探讨直接口服抗凝剂（DOAC）管理对接受起搏器或植入式心律转复除颤器植入患者发生囊袋血肿的影响。
本研究纳入了一项大型多中心前瞻性观察研究（NCT03879473）中接受 DOAC 治疗并接受心脏电子设备植入的所有连续患者。主要终点为植入后 30 天内出现临床相关血肿。共有 789 例患者入组[中位年龄 80（IQR 72-85）岁，36.4%为女性，中位 CHA2DS2-VASc 评分 4（IQR 0-8）]，其中 632 例（80.1%）接受起搏器植入。146 例（18.5%）患者联合应用抗血小板治疗。DOAC 在术前 52（IQR 37-62）小时中断，术后 31（IQR 21-47）小时恢复。96%的患者术前至少有 12 小时 DOAC 中断，78%的患者术后至少有 12 小时 DOAC 中断。总的来说，抗凝治疗中断了 72（IQR 48-96）小时。术前或术后分别有 8.2%和 3.9%的患者使用肝素桥接。DOAC 中断和恢复的时间与临床相关血肿无关。26 例（3.3%）患者发生临床相关血肿，5 例（0.6%）患者发生血栓栓塞事件。
在这项大型真实世界注册研究中，大多数患者的 DOAC 中断，临床相关血肿罕见。尽管 DOAC 中断和高 CHA2DS2-VASc 评分，但血栓栓塞事件很少发生，这表明在这一围手术期内出血风险超过血栓栓塞风险。需要进一步研究以确定临床相关血肿的危险因素，并为临床医生优化 DOAC 管理提供有意义的指导。
Zotero 插件