UO Cardiologia Diagnostica ed Interventistica, Fondazione Toscana G. Monasterio, Ospedale del Cuore, Massa, Italy.
UO Cardiologia Generale, Azienda Ospedaliero-Universitaria di Careggi, Firenze FI, Italy.
Int J Cardiol. 2017 Dec 1;248:103-107. doi: 10.1016/j.ijcard.2017.07.052. Epub 2017 Jul 16.
Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER™ devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding.
From December 2008 to April 2015 613 NVAF patients (75.1±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset.
AMPLATZER™ devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively.
In this large, multicenter, single-nation study, LAAO with the AMPLATZER™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism.
经证实，左心耳封堵术（LAAO）可有效预防非瓣膜性心房颤动（NVAF）患者的中风。我们旨在评估 AMPLATZER™装置在一个高卒中风险和出血风险的 NVAF 患者的大型、多中心、单一国家队列中的安全性和疗效。
2008 年 12 月至 2015 年 4 月，15 家意大利中心的 613 例 NVAF 患者（75.1±8.0 岁，62.5%为男性）接受了 AMPLATZER™装置的 LAAO。对于适应证、术前规划、装置植入、药物治疗和随访，没有任何个人/机构方案的限制。所有基线特征、影像学、手术和随访数据均收集在一个单一的数据集中。
AMPLATZER™装置在 95.4%的病例中成功植入。38 例（6.2%）出现主要并发症，包括更多的大出血（3.3%）和心包填塞（2.0%）。平均随访 20 个月后，总的年卒中发生率和血栓栓塞事件发生率分别为 1.67%和 2.90%，与基于风险的预期相比，卒中及 TIA 发生率降低了 66%。在 218 例接受 6 个月随访的经食管超声心动图检查的患者中，1.8%的患者存在装置血栓形成，0.5%和 11.9%的患者分别存在显著或轻度至中度的装置周围漏。
在这项大型、多中心、单一国家的研究中，LAAO 联合 AMPLATZER™装置显示出了高的手术成功率、早期安全性和中期预防 NVAF 相关血栓栓塞的疗效。
