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2016 年至 2020 年德国基于导管的左心耳封堵术住院治疗结果。

Catheter based left atrial appendage closure in-hospital outcomes in Germany from 2016 to 2020.

机构信息

Department of Cardiology and Angiology, Faculty of Medicine, University Heart Center Freiburg-Bad Krozingen, University of Freiburg, Hugstetter Straße 55, 79106, Freiburg, Germany.

Institute of Medical Biometry and Statistics, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

出版信息

Clin Res Cardiol. 2024 Oct;113(10):1419-1429. doi: 10.1007/s00392-023-02299-w. Epub 2023 Sep 12.

Abstract

BACKGROUND

New and refined catheter based left atrial appendage (LAA) closure devices have been introduced in the past decade. The procedure can be performed using either an endocardial occlusion device or an epicardial loop stitch. We aimed to analyzed recent procedural safety.

METHODS

Catheter based LAA closures were identified in a complete nationwide German dataset via ICD and OPS codes from 2016 to 2020.

RESULTS

From 2016 to 2020, 28,039 endocardial and 213 epicardial occlusions were performed. Numbers of endocardial procedures increased from 5259 in 2016 to 5917 in 2020 (p = 0.020) in 387 centers with shifting of patients' characteristics towards older age (β = 0.29, p < 0.001), more heart failure (β = 1.01, p < 0.001) and renal disease (β = 0.67, p = 0.001) and without a significant trend for in-hospital safety except more bleeding (β = 0.12, p = 0.05). In-hospital major adverse cardiac and cerebrovascular events (MACCE) or pericardial puncture were independent on center procedure numbers. The loop stitch procedure was performed in 15 centers. Patients were younger (76.17 ± 8.16 vs. 73.16 ± 8.99, p < 0.001) and had a lower comorbidity index (2.29 ± 1.93 vs. 1.92 ± 1.64, p = 0.005). Adjusted risk difference for pericardial effusion (8.04%; 95% CI 3.01-13.08%; p = 0.002) and pericardial puncture (6.60%; 95% CI 3.85-9.35%; p < 0.001) was higher for the loop stitch procedure, while risk of bleeding (- 1.85%; 95% CI - 3.01 to - 0.69%; p = 0.002), intracerebral bleeding (- 0.37%; 95% CI - 0.59 to - 0.15%; p = 0.001) and shock (- 1.41%; 95% CI - 2.44 to - 0.39%; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE.

CONCLUSIONS

Endocardial occlusion was the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 to 2020. In-hospital MACCE was independent on endocardial LAAC center volumes. Conclusions on the comparison between the two procedure types must be made cautious as the LAA loop stitch occlusion was utilized limited in a minor number of centers.

摘要

背景

在过去的十年中,出现了新的和改进的基于导管的左心耳(LAA)封堵设备。该程序可以使用心内膜闭塞装置或心外膜环缝线进行。我们旨在分析最近的手术安全性。

方法

通过 ICD 和 OPS 代码,从 2016 年到 2020 年,在德国的一个完整全国性数据库中确定了基于导管的 LAA 封堵。

结果

2016 年至 2020 年,共进行了 28039 例心内膜和 213 例心外膜封堵术。心内膜手术的数量从 2016 年的 5259 例增加到 2020 年的 5917 例(p=0.020),在 387 个中心进行,患者特征向年龄较大(β=0.29,p<0.001)、心力衰竭(β=1.01,p<0.001)和肾脏疾病(β=0.67,p=0.001)转移,但住院安全性没有明显趋势,除了出血增多(β=0.12,p=0.05)。住院期间主要不良心脏和脑血管事件(MACCE)或心包穿刺与中心手术数量无关。环缝线手术在 15 个中心进行。患者年龄较小(76.17±8.16 岁比 73.16±8.99 岁,p<0.001),合并症指数较低(2.29±1.93 比 1.92±1.64,p=0.005)。心包积液(8.04%;95%CI 3.01-13.08%;p=0.002)和心包穿刺(6.60%;95%CI 3.85-9.35%;p<0.001)的调整风险差异较高为环缝线手术,而出血风险(-1.85%;95%CI -3.01 至-0.69%;p=0.002)、颅内出血(-0.37%;95%CI -0.59 至-0.15%;p=0.001)和休克(-1.41%;95%CI -2.44 至-0.39%;p=0.007)较低。2016 年至 2020 年,住院期间 MACCE 无显著差异。

结论

心内膜闭塞是德国基于导管的 LAA 封堵的主要方法,住院安全性无改善。住院期间 MACCE 与心内膜 LAAC 中心容量无关。由于 LAA 环缝线闭塞仅在少数中心有限使用,因此必须谨慎得出两种手术类型之间的比较结论。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5d09/11420385/c9155f863ac7/392_2023_2299_Fig1_HTML.jpg

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