First-in-Human Percutaneous Epicardial-Only Left Atrial Appendage Closure Using Sierra Left Atrial Appendage Ligation System

Abstract

Background: 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. Methods: 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. Results: 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. Conclusions: 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.