Related Experiment Video
Updated: Sep 12, 2025
Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure
Published on: February 8, 2022
Seven years of follow-up of first-in-human percutaneous epicardial-only left atrial appendage closure using Sierra
Michał Piotrowski1, Julia Izabela Karpierz2, Radosław Litwinowicz3
1CAROL-Cardiothoracic Anatomy Research Operative Lab, Department of Cardiovascular Surgery and Transplantology, Institute of Cardiology, Jagiellonian University Medical College, 31-008 Krakow, Poland.
Insights
The Sierra Aegis Ligation System offers a safe and effective method for left atrial appendage closure, with no complications observed in a 7-year follow-up. This epicardial device shows promising long-term results for preventing stroke in atrial fibrillation patients.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Innovation
Background:
- Atrial fibrillation affects one-third of the population, increasing stroke and thromboembolism risk.
- Left atrial appendage exclusion is crucial for preventing ischemic events in high-risk patients.
- Existing left atrial appendage closure devices have limitations in suitability and anatomical adaptability.
Purpose of the Study:
- To present the long-term outcomes of the Sierra Aegis Left Atrial Appendage Ligation System.
- To evaluate the efficacy and safety of this novel epicardial system in humans for the first time.
Main Methods:
- Prospective, first-in-human study design.
- Investigated the Sierra Aegis Left Atrial Appendage Ligation System for epicardial closure.
- Followed 7 patients for up to 7 years post-procedure.
Main Results:
- No strokes were reported in the study cohort during the 7-year follow-up.
- No device-related leaks or other complications were observed.
- The Sierra Aegis system demonstrated a favorable safety profile.
Conclusions:
- The 7-year follow-up confirms the long-term efficacy and safety of the Sierra Aegis Ligation System.
- This epicardial approach provides a viable option for left atrial appendage closure.
- The device shows significant promise for managing stroke risk in atrial fibrillation.
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.
