A newly designed disk-lobe occluder with isogenous barbs for left atrial appendage closure: Initial multicenter...

Area of Science:

• Cardiology
• Medical Devices
• Interventional Procedures

Background:

• Left atrial appendage closure (LAAC) success rates have improved, but complex cases require novel solutions.
• Anatomically challenging anatomies and procedural complexities remain in LAAC.
• New left atrial appendage occluders may simplify procedures and improve outcomes.

Purpose of the Study:

• To evaluate the safety and efficacy of a new left atrial appendage occluder.
• The device features isogenous barbs designed to enhance LAAC procedures.
• Assessing the performance of this novel device in a clinical setting.

Main Methods:

• A prospective study involving 175 patients across eight centers in China (July 2016 - April 2018).
• Safety and efficacy assessed through peri- and post-procedural evaluations, including transesophageal echocardiography (TEE).
• Device implantation success rate and adverse events were meticulously monitored.

Main Results:

• Successful device implantation in 98.9% of patients (173/175).
• Low incidence of perioperative complications, with clinically relevant pericardial effusion in 1.7% of patients.
• At 12-month follow-up, significant reductions in estimated annual thromboembolism (90%) and major bleeding (81%) rates were observed. Device-related thrombus occurred in 1.2%.

Conclusions:

• The novel barbed device for LAAC is effective and safe.
• High rates of anatomic closure were achieved with the new device.
• The device demonstrates potential for simplifying LAAC and improving clinical outcomes.