慢性肾脏病伴左心耳封堵的心房颤动患者应用 WATCHMAN 装置后发生的脑血管事件、出血并发症和器械相关血栓
Cerebrovascular events, bleeding complications and device related thrombi in atrial fibrillation patients with chronic kidney disease and left atrial appendage closure with the WATCHMAN™ device.
机构信息
Department of Cardiology and Intensive Care Medicine, Johannes Wesling University Hospital, Ruhr University Bochum, Hans-Nolte-Str. 1, 32429, Minden, Germany.
Department of Internal Medicine, Division of Cardiology and Angiology, Magdeburg University, Leipzigerstr 44, 39120, Magdeburg, Germany.
出版信息
BMC Cardiovasc Disord. 2019 May 15;19(1):112. doi: 10.1186/s12872-019-1097-0.
BACKGROUND
Impaired renal function increases the bleeding risk, leading to a conservative prescription and frequent discontinuation of oral anticoagulation in atrial fibrillation patients with chronic kidney disease (CKD). Interventional left atrial appendage closure (LAAC) might be an alternative therapeutic strategy for these patients.
METHODS
We aimed to prospectively assess cerebrovascular (CE) and bleeding events, as well as peri-procedural and long-term complications in a cohort of consecutive patients undergoing interventional LAAC using the WATCHMAN™ device, with focus on CKD patients.
RESULTS
One hundred and eighty-nine consecutive patients undergoing interventional LAAC were included in this analysis; 171 (90.5%) patients had a reduced estimated glomerular filtration rate (eGFR; patients for each CKD stage: II = 66; IIIa = 32; IIIb = 43; IV = 18; V = 12). During a follow-up of 310 patient years three (1.0%) patients suffered a CE (two strokes, one transitory ischemic attack) and five (1.6%) other ones a bleeding complication. The observed stroke rate was more than two-thirds and the bleeding risk more than half lower than expected. Device related thrombi (DRT) were detected in twelve (6.5%) patients; women had significantly more DRT than men (12.5% vs. 2.6%; p = 0.009). Patients with an eGFR< 30 ml/min/1.73m showed a trend to a higher DRT rate as compared to the opposite group (13.3% vs. 5.1%; p = 0.10). Thrombus resolved with temporary oral anticoagulation therapy in ten patients without sequelae; thrombus consolidation was confirmed by serial TEE controls in the remaining two patients.
CONCLUSIONS
Atrial fibrillation patients with CKD have low CE and bleeding rates after LAAC with the WATCHMAN™ device. DRT risk is higher in female and patients with severe CKD. More frequent post-interventional TEE controls might be justified for early DRT detection and safe management of patients at high DRT risk.
TRIAL REGISTRATION
(German Clinical Trials Register ID: DRKS00 010768 ; Registration Date 07.07.2016).
背景
肾功能受损会增加出血风险，导致慢性肾脏病（CKD）合并心房颤动的患者抗凝治疗方案保守，且经常停药。介入性左心耳封堵术（LAAC）可能是这些患者的另一种治疗策略。
方法
我们旨在前瞻性评估使用 WATCHMAN™装置进行介入性 LAAC 的连续患者队列中的脑血管（CE）和出血事件，以及围手术期和长期并发症，重点关注 CKD 患者。
结果
这项分析共纳入 189 例连续接受介入性 LAAC 的患者；171 例（90.5%）患者估算肾小球滤过率（eGFR）降低（每个 CKD 阶段的患者数：II=66；IIIa=32；IIIb=43；IV=18；V=12）。在 310 患者年的随访期间，有 3 例（1.0%）患者发生 CE（2 例中风，1 例短暂性脑缺血发作）和 5 例（1.6%）其他出血并发症。观察到的卒中发生率超过三分之二，出血风险降低一半以上。12 例（6.5%）患者检测到器械相关血栓（DRT）；女性的 DRT 发生率明显高于男性（12.5% vs. 2.6%；p=0.009）。与相反组相比，eGFR<30 ml/min/1.73m 的患者的 DRT 发生率有升高趋势（13.3% vs. 5.1%；p=0.10）。10 例患者通过临时口服抗凝治疗使血栓溶解，无后遗症；在其余 2 例患者中，通过连续 TEE 检查证实了血栓的巩固。
结论
使用 WATCHMAN™装置进行 LAAC 的 CKD 合并心房颤动患者的 CE 和出血发生率较低。女性和严重 CKD 患者的 DRT 风险较高。对于 DRT 风险较高的患者，更频繁的术后 TEE 检查可能有助于早期检测 DRT 并安全管理。
试验注册
（德国临床试验注册 ID：DRKS00010768；注册日期 2016 年 7 月 7 日）。
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