Cohen Joshua A, Heist E Kevin, Galvin Jennifer, Lee Hang, Johnson Matthew, Fitzsimons Michael, Slattery Kathryn, Ghoshhajra Brian, Sakhuja Rahul, Ha Grace, Forsch Margaux, Shi Linsheng, Danik Jacqueline, Dal-Bianco Jacob, Sanborn Danita, Hung Judy, Ruskin Jeremy, Gurol M Edip, Mansour Moussa
Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
Corrigan Minehan Heart Center, Massachusetts General Hospital, Boston, Massachusetts.
Pacing Clin Electrophysiol. 2019 Oct;42(10):1304-1309. doi: 10.1111/pace.13796. Epub 2019 Sep 17.
Left atrial appendage closure (LAAC) is an alternative to long-term anticoagulation for thromboembolic protection in patients with atrial fibrillation (AF) and high bleeding risk. Short-term Warfarin use following LAAC is well-studied, while data pertaining to novel oral anticoagulant (NOAC) use in this setting is less robust. Specifically, data regarding the safety and efficacy of postprocedural NOAC use in high-risk patients is lacking.
To compare the safety and efficacy of Warfarin and NOAC use in a high-risk patient population undergoing LAAC with the WATCHMAN device.
From November 2015 to October 2017, 97 patients underwent LAAC with the WATCHMAN device. All patients were discussed at a multidisciplinary meeting prior to device implantation. Longitudinal data were collected and analyzed for a composite endpoint of stroke and death at 8 months, and major bleeding at 3 and 6 months.
Among the 90 patients included in the safety and efficacy analysis, 43 were prescribed Warfarin and 47 were prescribed NOACs. Baseline characteristics were comparable between study groups. There were no procedural complications and no significant differences in the incidence of death and stroke at 8 months or major bleeding at 3 and 6 months.
For patients with AF at high risk of both thromboembolic and hemorrhagic events, NOACs as compared to Warfarin, seem to be safe and effective for short-term anticoagulation following LAAC with the WATCHMAN device. Further validation in large randomized controlled trials is required.
对于心房颤动(AF)且出血风险高的患者,左心耳封堵术(LAAC)是一种替代长期抗凝以预防血栓栓塞的方法。LAAC术后短期使用华法林已得到充分研究,而在这种情况下使用新型口服抗凝药(NOAC)的数据则不那么充分。具体而言,缺乏关于高风险患者术后使用NOAC的安全性和有效性的数据。
比较在使用WATCHMAN装置进行LAAC的高风险患者群体中使用华法林和NOAC的安全性和有效性。
2015年11月至2017年10月,97例患者使用WATCHMAN装置进行了LAAC。所有患者在装置植入前均在多学科会议上进行了讨论。收集并分析纵向数据,以评估8个月时中风和死亡的复合终点以及3个月和6个月时的大出血情况。
在纳入安全性和有效性分析的90例患者中,43例被处方使用华法林,47例被处方使用NOAC。研究组之间的基线特征具有可比性。没有手术并发症,8个月时的死亡和中风发生率或3个月和6个月时的大出血发生率没有显著差异。
对于血栓栓塞和出血事件风险均高的AF患者,与华法林相比,NOAC在使用WATCHMAN装置进行LAAC后的短期抗凝似乎是安全有效的。需要在大型随机对照试验中进一步验证。