Seven years of follow-up of first-in-human percutaneous epicardial-only left atrial appendage closure using Sierra device.

Background: It is estimated that at least one third of the population will suffer from atrial fibrillation in their lifetime. In order to prevent strokes and thromboembolism, anticoagulation treatment should be administered. In addition, exclusion of the left atrial appendage should be considered in certain cases to prevent fatal ischemic complications. In patients at high risk of intervention, the devices available to close the left atrial appendage are not suitable. In addition, their use is limited by the anatomy of the left atrial appendage, which may not be suitable for any of the available exclusion devices. The aim of this study is to present the long-term results of the Sierra Aegis Left Atrial Appendage Ligation System - a new, exclusively epicardial system for closure of the left atrial appendage - for the first time in a human study.

Methods: This was a prospective, first-in-human study investigating the efficacy and safety of the Sierra Aegis Left Atrial Appendage Ligation System for epicardial closure of the left atrial appendage. 7 patients (mean age: 57.3 ± 10.6 years, 71.4 % male) who underwent left atrial appendage exclusion with the Sierra system were followed for up to 7 years.

Results: No strokes, leaks, or other complications were observed in the study group during the 7-year follow-up period.

Conclusions: This 7-year follow-up of the first-in-human study of the Sierra Aegis Ligation System for left atrial appendage closure shows very good long-term results in terms of the efficacy and safety of this device when used in humans.