Early Outcomes With a Next-Generation Dual-Seal Left Atrial Appendage Occluder: Results From the VERITAS Study

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Percutaneous left atrial appendage occlusion (LAAO) is an alternative stroke prevention method for atrial fibrillation patients unable to use oral anticoagulation.
• Current LAAO devices may cause peridevice leak and pericardial effusion.
• The VERITAS study investigates Abbott's next-generation dual-seal LAAO device.

Purpose of the Study:

• To evaluate the safety and effectiveness of the next-generation dual-seal LAAO device.
• To assess the VERITAS study's primary endpoints and key clinical outcomes up to 45 days post-procedure.

Main Methods:

• A prospective, global, multicenter, single-arm study involving 400 atrial fibrillation patients.
• Patients underwent LAAO using the Amulet 360 dual-sealing device.
• Primary safety endpoint assessed adverse events within 7 days; primary effectiveness endpoint evaluated LAAO (leak ≤5 mm) at 45 days via transesophageal echocardiography.

Main Results:

• Implant success rate was 99.8% (399/400 patients).
• The primary safety endpoint incidence was 0.0%.
• 100% met the primary effectiveness endpoint, with 93.9% achieving complete LAAO (0 mm leak) at 45 days. Pericardial effusions occurred in 0.5% and device-related thrombus in 2.4%.

Conclusions:

• The VERITAS study confirms high implant success for the next-generation dual-seal LAAO device.
• The device demonstrates a favorable short-term safety and sealing profile.
• This technology presents a potentially improved option for stroke prevention in atrial fibrillation.