National Medical Research Center for Therapy and Preventive Medicine, 101990 Moscow, Russia.
E. Meshalkin National Medical Research Center, 630055 Novosibirsk, Russia.
Biomed Res Int. 2020 Nov 7;2020:2352648. doi: 10.1155/2020/2352648. eCollection 2020.
This multicenter, prospective registry evaluated the comparative safety and efficacy of left atrial appendage occlusion (LAAO) using the Watchman device (WD) and the Amplatzer Cardiac Plug (ACP) in patients with nonvalvular atrial fibrillation (NVAF) in real-world clinical practice in Russia.
The study included data from 200 consecutive NVAF patients (66.8 ± 7.8 years, 44.5% female, median CHA2DS2VASc 4, median HAS-BLED 3) who had undergone LAAO implantation using WD ( = 108) or ACP ( = 92) from September 2015 to December 2017 in 5 medical centers in Russia. The primary safety endpoint was the procedure-related major adverse events, and the primary efficacy endpoint was the composite of thromboembolic events, device thrombosis, hemorrhagic events, and unexplained death during the 12-month follow-up.
Successful LAAO was performed in all 92 (100%) patients with ACP and 105 (97.2%) with WD ( = 0.053). At 12 months, primary safety endpoint occurred in 6.5% of patients in the ACP group with no events in the WD group (6.5% vs. 0%, = 0.008). During the 12-month follow-up, the primary efficacy endpoint has occurred in 8.3% of patients in the WD group ( = 9) and 1.1% of patients in the ACP group ( = 1) ( = 0.016).
In this multicenter prospective registry, LAA closure with the WD was associated with significantly higher thromboembolic events rate in NVAF patients. Patients, receiving the ACP, had more procedure-related major adverse events. However, further multicenter studies are necessary to evaluate these findings.
本多中心前瞻性注册研究评估了在俄罗斯真实临床实践中，使用 Watchman 装置（WD）和 Amplatzer 心脏塞（ACP）对非瓣膜性心房颤动（NVAF）患者进行左心耳封堵（LAAO）的安全性和疗效。
该研究纳入了 200 例连续的 NVAF 患者（66.8 ± 7.8 岁，44.5%为女性，CHA2DS2VASc 中位数为 4，HAS-BLED 中位数为 3），这些患者于 2015 年 9 月至 2017 年 12 月在俄罗斯的 5 家医疗中心接受了 LAAO 植入术，分别使用 WD（n = 108）或 ACP（n = 92）。主要安全性终点为与操作相关的主要不良事件，主要疗效终点为 12 个月随访期间血栓栓塞事件、装置血栓形成、出血事件和不明原因死亡的复合终点。
在 ACP 组中，所有 92 例（100%）患者和 WD 组中 105 例（97.2%）患者（ = 0.053）均成功进行了 LAAO。在 12 个月时，ACP 组中有 6.5%的患者发生了主要安全性终点事件，而 WD 组中无事件发生（6.5% vs. 0%， = 0.008）。在 12 个月的随访期间，WD 组中有 8.3%的患者（ = 9）和 ACP 组中有 1.1%的患者（ = 1）发生了主要疗效终点事件（ = 0.016）。
在这项多中心前瞻性注册研究中，与使用 ACP 相比，在 NVAF 患者中使用 WD 进行 LAA 封堵与更高的血栓栓塞事件发生率相关。接受 ACP 的患者发生了更多与操作相关的主要不良事件。然而，需要进一步的多中心研究来评估这些发现。
