Thevathasan Tharusan, Degbeon Sêhnou, Paul Julia, Wendelburg Darius-Konstantin, Füreder Lisa, Gaul Anna Leonie, Scheitz Jan F, Stadler Gertraud, Rroku Andi, Lech Sonia, Buspavanich Pichit, Huemer Martin, Attanasio Philipp, Nagel Patrick, Reinthaler Markus, Landmesser Ulf, Skurk Carsten
Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité (DHZC), Campus Benjamin Franklin, Hindenburgdamm 30, 12203 Berlin, Germany.
Berlin Institute of Health, Anna-Louisa-Karsch-Straße 2, 10178 Berlin, Germany.
J Clin Med. 2023 Jul 9;12(14):4573. doi: 10.3390/jcm12144573.
Percutaneous left atrial appendage closure (LAAC) has emerged as a non-pharmacological alternative for stroke prevention in patients with atrial fibrillation (AF) not suitable for anticoagulation therapy. Real-world data on peri-procedural outcomes are limited. The aim of this study was to analyze outcomes of peri-procedural safety and healthcare resource utilization in 11,240 adult patients undergoing LAAC in the United States between 2016 and 2019. Primary outcomes (safety) were in-hospital ischemic stroke or systemic embolism (SE), pericardial effusion (PE), major bleeding, device embolization and mortality. Secondary outcomes (resource utilization) were adverse discharge disposition, hospital length of stay (LOS) and costs. Logistic and Poisson regression models were used to analyze outcomes by adjusting for 10 confounders. SE decreased by 97% between 2016 and 2019 [95% Confidence Interval (CI) 0-0.24] ( = 0.003), while a trend to lower numbers of other peri-procedural complications was determined. In-hospital mortality (0.14%) remained stable. Hospital LOS decreased by 17% (0.78-0.87, < 0.001) and adverse discharge rate by 41% (95% CI 0.41-0.86, = 0.005) between 2016 and 2019, while hospital costs did not significantly change ( = 0.2). Female patients had a higher risk of PE (OR 2.86 [95% CI 2.41-6.39]) and SE (OR 5.0 [95% CI 1.28-43.6]) while multi-morbid patients had higher risks of major bleeding ( < 0.001) and mortality ( = 0.031), longer hospital LOS ( < 0.001) and increased treatment costs ( = 0.073). Significant differences in all outcomes were observed between male and female patients across US regions. In conclusion, LAAC has become a safer and more efficient procedure. Significant sex differences existed across US regions. Careful considerations should be taken when performing LAAC in female and comorbid patients.
经皮左心耳封堵术（LAAC）已成为不适合抗凝治疗的心房颤动（AF）患者预防中风的一种非药物替代方法。关于围手术期结局的真实世界数据有限。本研究的目的是分析2016年至2019年在美国接受LAAC的11240例成年患者的围手术期安全性结局和医疗资源利用情况。主要结局（安全性）为住院期间缺血性中风或系统性栓塞（SE）、心包积液（PE）、大出血、器械栓塞和死亡。次要结局（资源利用）为不良出院处置、住院时间（LOS）和费用。使用逻辑回归和泊松回归模型，通过调整10个混杂因素来分析结局。2016年至2019年期间，SE下降了97%[95%置信区间（CI）0 - 0.24]（P = 0.003），同时确定了其他围手术期并发症数量有下降趋势。住院死亡率（0.14%）保持稳定。2016年至2019年期间，住院LOS下降了17%（0.78 - 0.87，P < 0.001），不良出院率下降了41%（95% CI 0.41 - 0.86，P = 0.005），而住院费用没有显著变化（P = 0.2）。女性患者发生PE（OR 2.86 [95% CI 2.41 - 6.39]）和SE（OR 5.0 [95% CI 1.28 - 43.6]）的风险较高，而多病患者发生大出血（P < 0.001）和死亡（P = 0.031）的风险较高，住院LOS较长（P < 0.001），治疗费用增加（P = 0.073）。在美国各地区，男性和女性患者在所有结局方面均存在显著差异。总之，LAAC已成为一种更安全、更有效的手术。美国各地区存在显著的性别差异。在对女性和合并症患者进行LAAC时应谨慎考虑。
