Sanfilippo Claudio, Frazzetto Marco, Costa Giuliano, Contrafatto Claudia, Giacalone Chiara, Briguglio Francesco, Barbera Chiara, De Santis Jessica, Sanfilippo Maria, Castania Giuseppe, Salvo Maria Elena Di, Scandura Salvatore, Attizzani Guilherme, Filby Steven, Tamburino Corrado, Barbanti Marco, Grasso Carmelo, Capodanno Davide
Division of Cardiology, Centro Cuore Morgagni, Catania, Italy.
School of Medicine, University Hospitals Harrington Heart & Vascular Institute, Case Western Reserve University, Cleveland, Ohio, USA.
Catheter Cardiovasc Interv. 2025 Jul;106(1):734-741. doi: 10.1002/ccd.31613. Epub 2025 May 20.
Percutaneous left atrial appendage closure (LAAC) is usually performed after a pre-procedural evaluation by transesophageal echocardiography (TOE) or cardiac computed tomography angiography (CCTA). Nevertheless, these ad-hoc examinations imply an additional use of hospital resources and time spending.
To investigate long-term clinical outcomes, effectiveness and safety of performing LAAC procedures without pre-procedural imaging assessment in patients with high and very high thromboembolic risk based on CHADS-VASc score.
From January 2016 to January 2023, 227 consecutive patients undergoing LAAC following an optimized pathway that removed the use of pre-procedural TOE or CCTA imaging assessment, were enrolled in this single-center, retrospective study. Patients were divided into two groups based on thromboembolic risk: 94 had CHADS-VASc scores ≥ 5 and 133 had CHADS-VASc scores < 5). The primary endpoint was a composite of all-cause death, stroke, systemic embolization, or bleeding events at 2 years. Co-primary endpoints were device success, device-related thrombosis (DRT) and peri-device leaks (PDL) ≥ 3 mm at TOE follow-up.
At 2 years, no significant differences were observed between groups in the primary composite endpoint (KM est. 24.81% vs. 20.21%, p = 0.7; aHR 0.85, CI: 0.48-1.50, p = 0.58). Device success was 98.7% overall, with no significant differences between groups (aOR 0.32% CI: 0.03-3.80; p = 0.37). DRT and PDL ≥ 3 mm rates were low (4.3% vs. 1.5%, p = 0.26% and 3.2% vs. 2.3%, p = 0.75, respectively). In-hospital complications were low and comparable in both groups.
In a consecutive series of patients undergoing LAAC, a simplified approach without pre-operative imaging assessment showed comparable results at 2-year for the primary composite endpoint of all-cause death, stroke, systemic embolization, or bleeding events in patients with CHADS-VASc score ≥ 5 and those with CHADS-VASc score < 5.
经皮左心耳封堵术（LAAC）通常在经食管超声心动图（TOE）或心脏计算机断层血管造影（CCTA）进行术前评估后实施。然而，这些临时检查意味着额外使用医院资源和花费时间。
探讨基于CHADS-VASc评分具有高和非常高血栓栓塞风险的患者在无术前影像学评估的情况下进行LAAC手术的长期临床结局、有效性和安全性。
从2016年1月至2023年1月，227例连续接受LAAC手术的患者纳入本单中心回顾性研究，这些患者遵循优化路径，不再使用术前TOE或CCTA影像学评估。根据血栓栓塞风险将患者分为两组：94例CHADS-VASc评分≥5，133例CHADS-VASc评分<5。主要终点是2年时全因死亡、卒中、全身性栓塞或出血事件的复合终点。共同主要终点是器械成功率、器械相关血栓形成（DRT）以及TOE随访时器械周围漏血（PDL）≥3mm。
2年时，两组在主要复合终点方面未观察到显著差异（Kaplan-Meier估计值24.81%对20.21%，p = 0.7；调整后风险比0.85，可信区间：0.48 - 1.50，p = 0.58）。总体器械成功率为98.7%，两组间无显著差异（调整后比值比0.32，可信区间：0.03 - 3.80；p = 0.37）。DRT和PDL≥3mm发生率较低（分别为4.3%对1.5%，p = 0.26%以及3.2%对2.3%，p = 0.75）。两组住院并发症发生率均较低且相当。
在连续一系列接受LAAC手术的患者中，对于CHADS-VASc评分≥5和CHADS-VASc评分<5的患者，一种不进行术前影像学评估的简化方法在2年时全因死亡、卒中、全身性栓塞或出血事件的主要复合终点方面显示出相似的结果。
