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经房间隔穿刺与卵圆孔未闭或房间隔缺损入路行左心耳封堵。

Transseptal puncture versus patent foramen ovale or atrial septal defect access for left atrial appendage closure.

机构信息

Department of Cardiology, Klinikum Lichtenfels, Lichtenfels, Germany.

出版信息

EuroIntervention. 2020 Jun 12;16(2):e173-e180. doi: 10.4244/EIJ-D-19-00442.

Abstract

AIMS

The aim of this study was to compare the periprocedural and late clinical outcomes of left atrial appendage closure (LAAC) with AMPLATZER devices by access through transseptal puncture (TSP) versus a patent foramen ovale (PFO) or an atrial septal defect (ASD).

METHODS AND RESULTS

Between 2009 and 2018, 578 consecutive patients underwent LAAC via TSP or PFO/ASD access in three centres. After a 3:1 propensity score matching, 246 (TSP) versus 91 (PFO/ASD) patients were compared using the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death and the primary safety endpoint of major periprocedural complications and major bleedings at follow-up. Mean age was 75.2±8.7 (TSP) vs 74.4±10.9 (PFO/ASD) years, CHA2DS2-VASc score 4.5±1.6 vs 4.3±1.4 and HAS-BLED score 3.3±1.0 vs 3.3±0.9. Device success (97.6% vs 97.8%, p=0.90) was similar. After 2.5±1.4 vs 2.6±1.6 years, clinical efficacy (46/603, 7.6% [TSP] vs 21/233, 9.0% [PFO/ASD], hazard ratio [HR] 1.2; 95% confidence interval [CI]: 0.69-0.85, p=0.54) and safety (24/603, 4.0% vs 11/233, 4.7%; HR 1.4; 95% CI: 0.52-3.6, p=0.49) did not differ.

CONCLUSIONS

Use of a PFO/ASD access for LAAC with AMPLATZER devices offers similar periprocedural and late clinical outcomes to TSP. Simultaneous PFO/ASD closure for an additional protective benefit does not increase risk.

摘要

目的

本研究旨在比较经房间隔穿刺(TSP)与卵圆孔未闭(PFO)或房间隔缺损(ASD)途径应用 AMPLATZER 装置行左心耳封堵术(LAAC)的围手术期和晚期临床结局。

方法和结果

在三个中心,2009 年至 2018 年间,578 例连续患者经 TSP 或 PFO/ASD 入路行 LAAC。经 3:1 倾向评分匹配后,将 246 例(TSP)与 91 例(PFO/ASD)患者进行比较,主要疗效终点为全因卒中和全身性栓塞以及心血管/不明原因死亡,主要安全性终点为随访时的围手术期主要并发症和大出血。平均年龄分别为 75.2±8.7 岁(TSP)与 74.4±10.9 岁(PFO/ASD),CHA2DS2-VASc 评分为 4.5±1.6 与 4.3±1.4,HAS-BLED 评分为 3.3±1.0 与 3.3±0.9。器械成功率(97.6% vs 97.8%,p=0.90)相似。在 2.5±1.4 年与 2.6±1.6 年后,临床疗效(46/603,7.6%[TSP]与 21/233,9.0%[PFO/ASD],风险比[HR] 1.2;95%置信区间[CI]:0.69-0.85,p=0.54)和安全性(24/603,4.0%与 11/233,4.7%;HR 1.4;95% CI:0.52-3.6,p=0.49)无差异。

结论

应用 AMPLATZER 装置行经房间隔穿刺 LAAC 时,使用 PFO/ASD 入路的围手术期和晚期临床结局与 TSP 相似。同时行 PFO/ASD 封堵以获得额外的保护作用并不会增加风险。

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