Batko Jakub, Litwinowicz Radosław, Kapelak Boguslaw, Bartuś Krzysztof
Department of Anatomy, Jagiellonian University Medical College, 31-008 Krakow, Poland.
CAROL-Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 30-688 Krakow, Poland.
J Clin Med. 2024 Dec 5;13(23):7417. doi: 10.3390/jcm13237417.
In patients with atrial fibrillation and contraindications for oral anticoagulation, in which an increased risk of stroke remains, a left atrial appendage exclusion should be considered for elimination, because the left atrial appendage is the most common site of thrombus. The aim of this study is to present the first-in-human study results of the Sierra Aegis Left Atrial Appendage Ligation System, a new epicardial-only left atrial appendage closure system. This study was a prospective, first-in-human, single-center study evaluating the effectiveness and safety of the Sierra Aegis Left Atrial Appendage Ligation System device for epicardial left atrial appendage closure. Seven patients (mean age: 57.3 ± 10.6 years, 71.4% male) were qualified for a left atrial appendage closure because of an increased risk of bleeding with the need for lifelong anticoagulation pharmacology due to an increased risk of stroke. The patients' preoperative and intraoperative characteristics were collected. Patients were observed during their 1-month, 3-month, 6-month, and 1-year follow-up. The mean procedure time was 21.2 ± 8.2 min. All patients spent 3 days in the hospital including monitoring, the performance of preoperative CT scans, and anatomical evaluation. No tamponade, bleeding, thrombus, or left atrial appendage leakage were observed during the procedure or in-hospital stay. During the 1-month, 3-month, 6-month, and 1-year follow-up visits, none of the patients reported any complications. No tamponade, leakage, or left atrial appendage thrombus were observed. This first-in-human study regarding Sierra use for left atrial appendage closure shows promising results regarding the effectiveness and safety of the Sierra device for use in humans.
对于患有心房颤动且存在口服抗凝治疗禁忌证、卒中风险仍然增加的患者，应考虑进行左心耳封堵以消除风险，因为左心耳是血栓形成最常见的部位。本研究的目的是展示Sierra Aegis左心耳结扎系统的首例人体研究结果，这是一种新型的仅用于心外膜的左心耳封闭系统。本研究是一项前瞻性、首例人体、单中心研究，评估Sierra Aegis左心耳结扎系统用于心外膜左心耳封闭的有效性和安全性。7例患者（平均年龄：57.3±10.6岁，71.4%为男性）因出血风险增加且因卒中风险增加需要终身抗凝药物治疗而符合左心耳封闭条件。收集了患者的术前和术中特征。在患者1个月、3个月、6个月和1年的随访期间对其进行观察。平均手术时间为21.2±8.2分钟。所有患者住院3天，包括监测、术前CT扫描和解剖评估。手术过程中及住院期间未观察到心包填塞、出血、血栓或左心耳渗漏。在1个月、3个月、6个月和1年的随访中，所有患者均未报告任何并发症。未观察到心包填塞、渗漏或左心耳血栓。这项关于Sierra用于左心耳封闭的首例人体研究显示，Sierra装置在人体应用中的有效性和安全性方面取得了有前景的结果。
