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

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.