Freixa Xavier, Abualsaud Ali, Chan Jason, Nosair Mohamed, Tzikas Apostolos, Garceau Patrick, Basmadjian Arsène, Ibrahim Réda
Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada; Department of Cardiology, Thorax Unit, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain.
Department of Medicine, Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.
Int J Cardiol. 2014 Jul 1;174(3):492-6. doi: 10.1016/j.ijcard.2014.03.154. Epub 2014 Mar 28.
The Amplatzer™ Amulet™ (Amulet) is the evolution of the Amplatzer™ Cardiac Plug, a dedicated device for percutaneous left atrial appendage (LAA) occlusion. The new device has been designed to facilitate the implantation process, improve the sealing performance and further reduce the risk of complications. The objective of the study was to describe the initial experience with the Amplatzer Amulet for percutaneous LAA occlusion.
This was a prospective single-center study of patients undergoing percutaneous LAA occlusion. The indication for LAA closure was a formal contraindication for oral anticoagulation or previous history of stroke due to INR lability. All procedures were done under general anesthesia and transesophageal echocardiography (TEE) guidance. Transthoracic echocardiography was performed 24h after the procedure in order to rule out procedural complications before discharge. Further follow-up was done with a clinical visit and TEE at 1-3 months.
Between July-2012 and June-2013, 25 patients with a mean CHA2DS2-VASC of 4.3 ± 1.7 underwent LAA occlusion with the Amplatzer Amulet. The device was successfully implanted in 24 patients (96%) without any procedural stroke, pericardial effusion or device embolization. None of the patients presented any clinical event at follow-up. Follow-up TEE showed complete LAA sealing in all patients with no residual leaks >3mm and no device embolization. One patient (4.1%) presented a device thrombosis at follow-up without clinical expression.
In this initial series of patients, the Amulet showed a remarkable acute and short-term performance in terms of feasibility and safety as depicted by the high successful implantation rate and the low incidence of complications.
Amplatzer™ Amulet™（Amulet）是Amplatzer™心脏封堵器的升级版，是一种专门用于经皮左心耳（LAA）封堵的装置。这种新装置旨在简化植入过程，提高密封性能，并进一步降低并发症风险。本研究的目的是描述使用Amplatzer Amulet进行经皮LAA封堵的初步经验。
这是一项对接受经皮LAA封堵患者的前瞻性单中心研究。LAA封堵的指征是口服抗凝的正式禁忌证或因国际标准化比值（INR）不稳定导致的既往卒中史。所有手术均在全身麻醉和经食管超声心动图（TEE）引导下进行。术后24小时进行经胸超声心动图检查，以排除出院前的手术并发症。在1 - 3个月时进行临床随访和TEE进一步随访。
在2012年7月至2013年6月期间，25例平均CHA2DS2 - VASC评分为4.3±1.7的患者接受了Amplatzer Amulet LAA封堵术。该装置成功植入24例患者（96%），无任何手术相关的卒中、心包积液或装置栓塞。所有患者在随访期间均未出现任何临床事件。随访TEE显示所有患者的LAA完全密封，无>3mm的残余漏血，且无装置栓塞。1例患者（4.1%）在随访时出现装置血栓形成，但无临床表现。
在这一系列初始患者中，Amulet在可行性和安全性方面显示出显著的急性和短期性能，表现为高成功植入率和低并发症发生率。
