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LARIAT 装置经现实世界经验证实的左心耳封堵术的长期临床结果。

Long-term clinical outcomes from real-world experience of left atrial appendage exclusion with LARIAT device.

机构信息

Department of Electrophysiology, Baptist Health System, San Antonio, Texas.

Department of Cardiovascular Surgery and Transplantology, John Paul II Hospital, Jagiellonian University, Krakow, Poland.

出版信息

J Cardiovasc Electrophysiol. 2019 Dec;30(12):2849-2857. doi: 10.1111/jce.14229. Epub 2019 Oct 21.

Abstract

BACKGROUND

Left atrial appendage closure (LAAC) with LARIAT has emerged as one of the alternatives to oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF). Our aim was to study long-term outcomes in patients undergoing LARIAT procedure.

METHODS

We analyzed patients screened for LARIAT device in four centers between December 2009 and June 2012. Out of these, patients who didn't undergo LAAC with the LARIAT device due to unfavorable LAA morphology and other preprocedural contraindications were included in control group. We analyzed thromboembolism, bleeding events, and mortality between LAA and control group.

RESULTS

About 153 patients were screened. Out of these, 108 (70.6%) patients underwent LARIAT placement (LAA arm) and 45 (29.4%) excluded patients were included in control arm. There were no differences in CHADS and CHA DS -VASc score. Mean HAS-BLED score was significantly higher in the LARIAT group (3.5 ± 1.06 vs 3.09 ± 1.22, P = .04). Mean follow-up time (in years) was 6.56 ± 0.84 in LAA and 6.5 ± 1.26 in control arm. During follow-up period, the LARIAT group was associated with significantly less thromboembolic events (1.9% vs 24%, P < .001), bleeding events (9.2% vs 24.4%, P = .03), and mortality (5.6% vs 20%, P = .01) as compared with the control group.

CONCLUSIONS

Long-term data from routine clinical practice from our study suggests that LAA exclusion with LARIAT device is an effective treatment in management of nonvalvular AF patients with high risk of stroke, bleeding, and mortality. Further randomized trials, such as aMAZE, will provide more insight in this expanding field.

摘要

背景

左心耳封堵术(LAAC)与 LARIAT 已成为非瓣膜性心房颤动(AF)患者替代口服抗凝治疗(OAC)的方法之一。我们的目的是研究 LARIAT 手术患者的长期结果。

方法

我们分析了 2009 年 12 月至 2012 年 6 月期间在四个中心接受 LARIAT 设备筛选的患者。在这些患者中,由于左心耳(LAA)形态不佳和其他术前禁忌证而未行 LARIAT 装置 LAAC 的患者被纳入对照组。我们分析了 LAA 和对照组之间的血栓栓塞、出血事件和死亡率。

结果

共筛选出约 153 例患者。其中 108 例(70.6%)患者行 LARIAT 置管术(LAA 组),45 例(29.4%)排除患者纳入对照组。CHADS 和 CHA DS -VASc 评分无差异。LARIAT 组平均 HAS-BLED 评分显著升高(3.5±1.06 比 3.09±1.22,P=0.04)。LAA 组平均随访时间(年)为 6.56±0.84,对照组为 6.5±1.26。在随访期间,LARIAT 组血栓栓塞事件(1.9%比 24%,P<0.001)、出血事件(9.2%比 24.4%,P=0.03)和死亡率(5.6%比 20%,P=0.01)明显低于对照组。

结论

我们的研究来自常规临床实践的长期数据表明,LARIAT 装置行 LAA 封堵术是一种有效的治疗方法,可用于管理非瓣膜性 AF 患者,这些患者有较高的卒中、出血和死亡风险。进一步的随机试验,如 aMAZE,将为这一不断发展的领域提供更多的见解。

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