Malagù Michele, Trevisan Filippo, Scalone Antonella, Marcantoni Lina, Sammarco Giuseppe, Bertini Matteo
Department of Cardiology, University of Ferrara, S. Anna Hospital, Ferrara, Italy.
Department of Cardiology, University of Ferrara, S. Anna Hospital, Ferrara, Italy.
Am J Cardiol. 2017 Apr 1;119(7):1036-1040. doi: 10.1016/j.amjcard.2016.12.012. Epub 2017 Jan 6.
In patients undergoing cardiac device implantation, anticoagulant and antiplatelet therapy are associated with an increased risk of pocket hematoma. In case of vitamin K antagonist therapy, a strategy of continued warfarin with no heparin bridge showed a reduction of pocket hematoma. Evidence regarding antiplatelet therapy management is limited. This is a single-center observational study which reflects our systematic approach to the problem. In 2012, we proposed an improved management protocol for anticoagulant and antiplatelet therapy (no-bridge protocol) based on individual thromboembolic risk stratification, noninterruption of oral anticoagulation, no bridge with heparin and elastic adherence compression bandage. The primary end point was the incidence of clinically significant pocket hematoma in the first 30 days after implantation. A total of 1,035 patients were enrolled, of whom 522 received the standard management and 513 the new protocol. The primary end point occurred in 34 patients of the standard management group and 8 patients of the no-bridge protocol group (6.5% vs 1.6%, p <0.001). Patients in the standard management group had a higher incidence of pocket infections (2.3% vs 0.6%, p = 0.02), lead dislodgements (4.8% vs 2.1%, p = 0.02), and thromboembolic events (1.3% vs 0.0%, p <0.01). On a multivariate analysis, heparin and coronary artery disease were independent predictors of pocket hematoma (relative risk [RR] 3.48, 95% confidence interval [CI] 1.55 to 7.83 and RR 2.43, 95% CI 1.25 to 4.76, respectively), whereas the no-bridge protocol was associated with a reduction of pocket hematoma (RR 0.33, 95% CI 0.14 to 0.76). New anticoagulant and antiplatelet therapy management protocol was associated with a reduced incidence of clinically significant pocket hematomas, thromboembolic events, pocket infections, and lead dislodgements.
在接受心脏装置植入的患者中，抗凝和抗血小板治疗与囊袋血肿风险增加相关。在维生素K拮抗剂治疗的情况下，持续使用华法林且不采用肝素桥接的策略可降低囊袋血肿的发生率。关于抗血小板治疗管理的证据有限。这是一项单中心观察性研究，反映了我们对该问题的系统处理方法。2012年，我们基于个体血栓栓塞风险分层、不中断口服抗凝治疗、不使用肝素桥接以及弹性贴合压迫绷带，提出了一种改进的抗凝和抗血小板治疗管理方案（无桥接方案）。主要终点是植入后前30天内具有临床意义的囊袋血肿发生率。共纳入1035例患者，其中522例接受标准管理，513例接受新方案。标准管理组34例患者和无桥接方案组8例患者出现主要终点事件（6.5%对1.6%，p<0.001）。标准管理组患者囊袋感染发生率更高（2.3%对0.6%，p = 0.02）、导线移位发生率更高（4.8%对2.1%，p = 0.02）以及血栓栓塞事件发生率更高（1.3%对0.0%，p<0.01）。多因素分析显示，肝素和冠状动脉疾病是囊袋血肿的独立预测因素（相对风险[RR]分别为3.48，95%置信区间[CI]为1.55至7.83；RR为2.43，95%CI为1.25至4.76），而无桥接方案与囊袋血肿减少相关（RR为0.33，95%CI为0.14至0.76）。新的抗凝和抗血小板治疗管理方案与具有临床意义的囊袋血肿、血栓栓塞事件、囊袋感染和导线移位的发生率降低相关。
