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长期抗凝治疗禁忌患者经导管左心耳封堵术的安全性和有效性

Safety and efficacy of catheter-based left atrial appendage closure in patients with contraindications for long-term anticoagulation.

作者信息

Seidel Adrian, Parwani Abdul S, Krackhardt Florian, Huemer Martin, Attanasio Philipp, Haverkamp Wilhelm, Pieske Burkert, Boldt Leif-Hendrik

机构信息

Department of Cardiology, Campus Virchow-Klinikum, Charité University of Medicine, Berlin, Germany -

Department of Cardiology, Campus Virchow-Klinikum, Charité University of Medicine, Berlin, Germany.

出版信息

Minerva Cardioangiol. 2017 Dec;65(6):545-552. doi: 10.23736/S0026-4725.17.04425-5. Epub 2017 May 31.

Abstract

BACKGROUND

Percutaneous left atrial appendage closure (LAAC) and the role of postinterventional anticoagulation often evokes controversy in daily practice. This study aimed to evaluate LAAC in patients with non-rheumatic atrial fibrillation, high thromboembolic risk and contraindications for long-term anticoagulation in a clinical scenario.

METHODS

Between 2010-2015, LAAC was attempted in 118 patients (47 women).

RESULTS

Devices were successfully implanted in 95% (Watchman™ device: N.=97; Amplatzer™ Cardiac Plug/Amulet: N.=14; Amplatzer PFO Occluder: N.=1). Mean age was 75±8.35 years. Mean HAS-BLED and CHA2DS2VASc scores were 4.3 and 4.9, respectively. Median follow-up was 447 days (IQR: 183-789 days). The primary safety endpoint was defined as major bleeding according to the International Society on Thrombosis and Hemostasis. The combined efficacy endpoint included ischemic strokes, transitory ischemic attacks (TIA) and systemic embolisms. Procedural complication rate was 3.4%. After successful intervention, either a therapy with anticoagulants (N.=62) or dual antiplatelet therapy (DAPT, N.=50) was prescribed temporarily. Medication was reduced if implantation proved satisfying in a 6-week follow-up transesophageal echocardiography, which was the case in 79% of these patients. During follow-up, one patient suffered a TIA (0.6%/year). No other efficacy event was observed. Eleven major bleedings occurred (6.6%/year): one each under DAPT plus phenprocoumon, DAPT plus rivaroxaban, acetylsalicylic acid (ASA) plus rivaroxaban, two under DAPT, two under ASA plus low molecular weight heparin, and four under ASA only.

CONCLUSIONS

In the present study, catheter-based LAA occlusion prevented thromboembolisms with high efficacy. Major bleedings were however common in patients with, but also without anticoagulation, independent from time course.

摘要

背景

经皮左心耳封堵术(LAAC)及介入术后抗凝的作用在日常临床实践中常引发争议。本研究旨在评估在临床场景下,非风湿性房颤、高血栓栓塞风险且有长期抗凝禁忌证患者的LAAC情况。

方法

2010年至2015年间,对118例患者(47例女性)尝试进行LAAC。

结果

95%的患者成功植入封堵装置(Watchman™装置:97例;Amplatzer™心脏封堵器/Amulet:14例;Amplatzer卵圆孔未闭封堵器:1例)。平均年龄为75±8.35岁。平均HAS - BLED和CHA2DS2VASc评分分别为4.3和4.9。中位随访时间为447天(四分位间距:183 - 789天)。主要安全终点根据国际血栓与止血学会的标准定义为大出血。联合疗效终点包括缺血性卒中、短暂性脑缺血发作(TIA)和全身性栓塞。手术并发症发生率为3.4%。成功干预后,临时给予抗凝治疗(62例)或双联抗血小板治疗(DAPT,50例)。如果在6周后的经食管超声心动图检查中显示封堵满意,则减少用药,79%的患者属于这种情况。随访期间,1例患者发生TIA(0.6%/年)。未观察到其他疗效事件。发生了11次大出血(6.6%/年):分别发生在DAPT加苯丙香豆素、DAPT加利伐沙班、阿司匹林(ASA)加利伐沙班治疗过程中各1例,DAPT治疗过程中2例,ASA加低分子肝素治疗过程中2例,仅ASA治疗过程中4例。

结论

在本研究中,基于导管的左心耳封堵术能有效预防血栓栓塞。然而,无论是否进行抗凝,大出血在患者中都很常见,且与时间进程无关。

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