Department of Cardiology, Klinikum Lichtenfels, Lichtenfels, Germany.
EuroIntervention. 2020 Jun 12;16(2):e173-e180. doi: 10.4244/EIJ-D-19-00442.
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).
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.
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.
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。
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。
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。