心血管植入型电子器械围术期不同抗栓策略的对比研究

Comparison of different antithrombotic strategies in the perioperative period of cardiac implantable electronic devices

目的比较不同抗血小板药物和抗凝药物应用策略对心血管植入型电子器械(CIED)术中和术后出血风险的影响.方法 2016年9月至2018年4月,前瞻性连续入选于复旦大学附属中山医院100例拟植入ClED的患者,其中70例正在接受双联抗血小板治疗(阿司匹林+氯吡格雷),30例口服华法林治疗.采用随机数字表法将前者随机分为双联抗血小板药物组(n=23)、阿司匹林组∞=23)和停用抗血小板药物组(n=24);后者随机分为继续华法林组(n=14)和停用华法林组(n=16).比较各组术中需钳夹或缝扎止血的频次、因术中出血导致手术时间延长的发生率、术后囊袋血肿发生率及住院天数等指标.结果双联抗血小板药物组和阿司匹林组术中出血需钳夹或缝扎止血的频次较停用抗血小板药物组显著增多(P<0.05),因术中出血导致手术时间延长者分别占52.2%、26.1%和8.3%(P<0.01).双联抗血小板药物组术后囊袋血肿发生率显著高于停用抗血小板药物组(26.1%对4.2%,P<0.05),术后住院观察时间亦显著延长[(4.26±1.96)d对(2.96±1.08)d,P<0.01];而单用阿司匹林并不增加术后囊袋出血发生率和住院天数(P>0.05).继续华法林组术中出血需钳夹或缝扎止血的频次(P<0.05)及手术时间延长发生率(50.0%对12.5%,P<0.05)均显著高于停用华法林组;但继续华法林组术后囊袋出血发生率(14.3%对6.3%,P>0.05)和术后住院观察天数[(3.86±1.88)d对(2.88±1.15)d,P>0.05]并未显著增加.结论 CIED围术期持续应用双联抗血小板药物增加术中出血和术后囊袋血肿的风险,单用阿司匹林或华法林仅增加术中出血风险,术中充分钳夹、缝扎止血可有效预防术后囊袋血肿发生.

Objective The present study aims to assess the risk of intra-procedural and post-operative bleeding undergoing cardiac implantable electronic device (CIED) implantation under different antithrombotic strategies.Methods From September 2016 to April 2018,a total of 70 patients receiving dual antiplatelet therapy and 30 cases on warfarin referred for CIED implantation were studied in Zhongshan Hospital.Patients administrated with dual antiplatelet therapy (DAPT) were randomly assigned to continuous DAPT group (n=23),aspirin therapy group (n=23) and antiplatelet interruption group (n=24).Those treated with warfarin were randomized to warfarin continuation group (n=14) versus warfarin interruption group (n=16).Intra-procedural bleeding was evaluated by frequency of hemorrhage necessitating hemostasis by clamps or ligatures,and subsequently prolonged operation time.Post-operative bleeding was determined by device-pocket hematoma requiring prolonged hospitalization within one month after the procedure.Results Compared with antiplatelet interruption group,cases in DAPT and aspirin therapy groups required more frequent intra-procedural hemostasis by clamps or ligatures (P<0.05),and subsequently higher incidence of prolonged operation time (52.2% vs.26.1% vs.8.3%,respectively,P<0.01).Significantly more devicepocket hematoma (26.1% vs.4.2%,P<0.05) and longer post-operative hospitalization [(4.26±1.96) dvs.(2.96± 1.08) d,P<0.01] could be observed in DAPT than antiplatelet interruption;while aspirin therapy did not increase post-operative hematoma or prolong hospitalization (P>0.05).More frequent intra-procedural hemostasis by clamps or ligatures (P<0.05) and higher incidence of operation prolongation (50.0% vs 12.5%,P<0.05) occurred in warfarin continuation group,as compared with warfarin interruption group.However,there was no significant difference regarding the incidence of post-operative pocket haematoma (14.3% vs 6.3%,P>0.05) and post-operative hospital day [(3.86± 1.88) d vs (2.88±1.15) d,P>0.05)] between the warfarin continuation and warfarin interruption groups.Conclusion DAPTwas associated with increased risk of intraprocedural and post-operative bleeding during CIED implantation.While aspirin therapy alone or warfarin only increased intra-procedural bleeding.Adequate intra-procedural hemostasis helped to prevent post-operative bleeding complications.