Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes
Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes
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DOI：
10.1161/circulationaha.118.035090
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发表时间：
2018-08-28
期刊：
影响因子：
37.8
通讯作者：
Reddy, Vivek Y.
中科院分区：
文献类型：
--
作者：
Dukkipati, Srinivas R.;Kar, Saibal;Reddy, Vivek Y.
背景资料：在房颤患者中，使用Watchman器械封堵左心耳可防止左心耳血栓栓塞;然而，血栓可能在器械的左心房表面形成，然后可能栓塞。在此，我们研究了发生率，预测因素，和临床结果的设备相关的血栓（DRT）使用一个大型系列的临床试验队列的患者接受Watchman implantation.Methods：我们研究了4个前瞻性的美国食品和药物管理局试验的设备武器：（Watchman左心房封堵系统用于房颤患者的栓塞保护）（n=463）; PREVAIL（Watchman左心耳封堵器在房颤患者中的评价与长期华法林治疗的比较）（n=269）; CAP（继续访问房颤登记研究）（n=566）;和CAP 2（继续访问PREVAIL登记研究）（n=578）。所有患者在45天和12个月时进行了经食管超声心动图监测，随机对照试验也在6个月时进行了监测。我们评估了这些经食管超声心动图检查中DRT的发生率，（和其他计划外经食管超声心动图）和术后卒中或全身性栓塞（SSE）的临床结局，并根据CHA（2）DS（2）-VASC和HAS-BLED评分进行调整。（7159患者年随访; CHA（2）DS（2）-VASc=4.0），65例患者（3.74%）出现DRT。合并和不合并DRT的SSE发生率分别为7.46和1.78/100患者-年（校正率比，3.55; 95%置信区间[CI]，2.18-5.79; P
Background: In patients with atrial fibrillation, left atrial appendage closure with the Watchman device prevents thromboembolism from the left atrial appendage; however, thrombus may form on the left atrial face of the device, and then potentially embolize. Herein, we studied the incidence, predictors, and clinical outcome of device-related thrombus (DRT) using a large series of clinical trial cohorts of patients undergoing Watchman implantation.Methods: We studied the device arms of 4 prospective Food and Drug Administration trials: PROTECT-AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) (n=463); PREVAIL (Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) (n=269); CAP (Continued Access to PROTECT AF registry) (n=566); and CAP2 (Continued Access to PREVAIL registry) (n=578). Surveillance transesophageal echocardiographs were performed at 45 days and 12 months in all patients, and also at 6 months in the randomized control trials. We assessed both the incidence of DRT during these transesophageal echocardiographs (and other unscheduled transesophageal echocardiographs), and clinical outcomes of postprocedure stroke or systemic embolism (SSE) and adjusted for CHA(2)DS(2)-VASC and HAS-BLED scores.Results: Of 1739 patients who received an implant (7159 patient-years follow-up; CHA(2)DS(2)-VASc=4.0), DRT was seen in 65 patients (3.74%). The rates of SSE with and without DRT were 7.46 and 1.78 per 100 patient-years (adjusted rate ratio, 3.55; 95% confidence interval [CI], 2.18-5.79; P