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Updated: Jun 4, 2025
Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
First-in-Human Percutaneous Epicardial-Only Left Atrial Appendage Closure Using Sierra Left Atrial Appendage Ligation
Jakub Batko1,2, Radosław Litwinowicz3, Boguslaw Kapelak3
1Department of Anatomy, Jagiellonian University Medical College, 31-008 Krakow, Poland.
Insights
The Sierra Aegis system offers a safe and effective epicardial left atrial appendage closure for patients with atrial fibrillation who cannot use oral anticoagulation. This first-in-human study showed no complications during follow-up.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Innovation
Background:
- Atrial fibrillation patients with contraindications for oral anticoagulation face a persistent stroke risk.
- The left atrial appendage is a common source of thrombus formation in these patients.
- Left atrial appendage exclusion is a potential stroke risk mitigation strategy.
Purpose of the Study:
- To evaluate the safety and effectiveness of the Sierra Aegis Left Atrial Appendage Ligation System.
- To present the first-in-human results of this novel epicardial-only left atrial appendage closure device.
Main Methods:
- Prospective, first-in-human, single-center study.
- Seven patients with high bleeding risk and stroke risk underwent epicardial left atrial appendage closure.
- Patients were monitored for 1 year post-procedure.
Main Results:
- The mean procedure time was 21.2 minutes.
- No device-related complications such as tamponade, bleeding, thrombus, or leakage were observed during the procedure or follow-up.
- All patients completed the 1-year follow-up without adverse events.
Conclusions:
- The Sierra Aegis system demonstrates promising safety and effectiveness for epicardial left atrial appendage closure in humans.
- This novel device offers a potential alternative for stroke risk reduction in high-risk atrial fibrillation patients.
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.
