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左心耳封堵中 Lambre 与 Amplatzer 封堵器的晚期临床结局。

Late clinical outcomes of lambre versus amplatzer occluders for left atrial appendage closure.

机构信息

Department of Cardiology, Klinikum Coburg, Coburg, Germany.

Department of Cardiology, The 4th Hospital of Harbin Medical University, Harbin, China.

出版信息

J Cardiovasc Electrophysiol. 2020 Apr;31(4):934-942. doi: 10.1111/jce.14398. Epub 2020 Mar 12.

Abstract

INTRODUCTION

The LAmbre (LifeTech Scientific, Shenzhen, China) is a novel occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation. This study compares late clinical outcomes of LAmbre and the established Amplatzer devices (Abbott, St Paul, MN).

METHODS

Between 2012 and 2018, 265 consecutive patients underwent LAAC with LAmbre and Amplatzer devices at a single center. After a 3:1 propensity score matching, 40 (LAmbre) vs 107 (Amplatzer) patients were compared by the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major periprocedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all the above-mentioned hazards.

RESULTS

The mean age 75.6 ± 8.9 (LAmbre) vs 75.5 ± 9.0 (Amplatzer) years, CHA DS -VASc score 4.8 ± 1.7 vs 4.8 ± 1.7 and HAS-BLED score 3.1 ± 0.9 vs 3.2 ± 0.8 were similar. After 3.6 ± 1.9 vs 2.5 ± 1.4 years, the clinical efficacy (12/146, 8.2% [LAmbre] vs 28/266, 10.5% [Amplatzer]; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.38-1.40; P = .34) and safety (5/146, 3.4% vs 14/266, 5.3%; HR, 0.47; 95% CI, 0.14-1.6; P = .22), as well as the combined hazard endpoint (15/146, 10.3% vs 36/266, 13.6%; HR, 0.67; 95% CI, 0.36-1.25; P = .21) were comparable.

CONCLUSION

In the presented report, in patients with nonvalvular atrial fibrillation, the LAmbre offered similar long-term efficacy and safety in comparison to Amplatzer devices.

摘要

简介

LAmbre(LifeTech Scientific,深圳,中国)是一种用于房颤患者左心耳封堵术(LAAC)的新型封堵器。本研究比较了 LAmbre 和已建立的 Amplatzer 装置(雅培,圣保罗,明尼苏达州)的晚期临床结果。

方法

在 2012 年至 2018 年间,在一家中心,265 例连续患者接受了 LAmbre 和 Amplatzer 装置的 LAAC。经过 3:1 的倾向评分匹配,通过主要疗效终点(全因卒、全身性栓塞和心血管/不明原因死亡)、主要围手术期并发症和主要出血事件的主要安全性终点,以及联合危险终点(所有上述危险的综合)比较了 40 例(LAmbre)与 107 例(Amplatzer)患者的情况。

结果

平均年龄 75.6±8.9 岁(LAmbre)与 75.5±9.0 岁(Amplatzer),CHA2DS2-VASc 评分 4.8±1.7 与 4.8±1.7,HAS-BLED 评分 3.1±0.9 与 3.2±0.8 相似。在 3.6±1.9 年与 2.5±1.4 年后,临床疗效(12/146,8.2%[LAmbre]与 28/266,10.5%[Amplatzer];危险比[HR],0.73;95%置信区间[CI],0.38-1.40;P=0.34)和安全性(5/146,3.4%与 14/266,5.3%;HR,0.47;95% CI,0.14-1.6;P=0.22)以及联合危险终点(15/146,10.3%与 36/266,13.6%;HR,0.67;95% CI,0.36-1.25;P=0.21)相似。

结论

在本报告中,在非瓣膜性房颤患者中,LAmbre 与 Amplatzer 装置相比,提供了相似的长期疗效和安全性。

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