Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
EuroIntervention. 2024 Jun 3;20(11):e718-e727. doi: 10.4244/EIJ-D-23-00802.
Left atrial appendage occlusion (LAAO) is performed increasingly, but long-term follow-up imaging data are lacking.
The aim of this study was to evaluate the safety and durability of the Amplatzer Amulet device >4 years after LAAO.
This was a prospective observational cohort study including 52 patients implanted with the Amplatzer Amulet device at Aarhus University Hospital, Denmark. A >4-year follow-up cardiac computed tomography (CT) scan after LAAO was performed and compared with the results from the 2-month and 12-month scans. The primary outcome was left atrial appendage (LAA) sealing based on distal LAA contrast patency and peridevice leakage (PDL), stratified into complete occlusion (grade 0 [G0]) and grade 1-3 leakage (G1-3), respectively. Secondary outcomes were low- and high-grade hypoattenuated thickening (HAT), device-related thrombosis (DRT) and device durability.
The median (interquartile range [IQR]) follow-up time from LAAO to the latest CT scan was 5.8 years (4.5; 6.3). At 2-month (n=52), 12-month (n=27) and >4-year CT follow-ups (n=52), rates of both complete occlusion (33%, 37%, 35%) and G2 leaks (52%, 52%, 48%) remained stable. Rates of G1 leaks varied (14%, 4%, 6%) and G3 leaks rose (2%, 7%, 12%) from earliest to latest follow-up. The median left atrial (LA) volume increased from 127 mL (96; 176) to 144 mL (108; 182) and 147 mL (107; 193). No DRT was found. The structural device integrity was preserved.
This study indicates a stable LAA sealing status throughout the follow-up period, emphasising the importance of the procedural result in avoiding PDL. Few patients displayed PDL progression, which might partly be related to LA remodelling with increasing volume. The long-term device durability appears excellent. Larger studies are warranted to confirm these findings.
左心耳封堵术（LAAO）的应用日益增多，但缺乏长期随访的影像学数据。
本研究旨在评估 Amplatzer Amulet 装置在 LAAO 后 >4 年的安全性和耐久性。
这是一项前瞻性观察队列研究，纳入了在丹麦奥胡斯大学医院植入 Amplatzer Amulet 装置的 52 例患者。在 LAAO 后进行了 >4 年的心脏计算机断层扫描（CT）随访，并与 2 个月和 12 个月的扫描结果进行比较。主要结局是基于远端左心耳（LAA）对比显影通畅性和器械相关漏（PDL）评估的 LAA 封堵，分为完全封堵（G0）和 1-3 级漏（G1-3）。次要结局是低和高衰减厚度（HAT）、器械相关血栓（DRT）和器械耐久性。
从 LAAO 到最近的 CT 扫描的中位（四分位间距 [IQR]）随访时间为 5.8 年（4.5；6.3）。在 2 个月（n=52）、12 个月（n=27）和 >4 年的 CT 随访时（n=52），完全封堵率（33%、37%、35%）和 2 级漏（52%、52%、48%）均保持稳定。1 级漏的发生率（14%、4%、6%）有所变化，3 级漏的发生率（2%、7%、12%）则逐渐升高。左心房（LA）容积从 127 mL（96；176）增加到 144 mL（108；182）和 147 mL（107；193）。未发现 DRT。器械结构完整性得以保留。
本研究表明在整个随访期间 LAA 封堵状态稳定，强调了术中结果在避免 PDL 方面的重要性。少数患者出现 PDL 进展，这可能部分与 LA 容积增大导致的重构有关。该装置的长期耐久性似乎极佳。需要更大的研究来证实这些发现。
