Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX...

Area of Science:

• Cardiology
• Medical Devices
• Thrombosis Prevention

Background:

• Left atrial appendage (LAA) occlusion is an alternative to oral anticoagulation for reducing thromboembolic risk in nonvalvular atrial fibrillation (AF).
• The WATCHMAN device, approved in 2015, is the primary LAA closure device used in the US.
• The PINNACLE FLX study investigated the next-generation WATCHMAN FLX device.

Purpose of the Study:

• To evaluate the safety and effectiveness of the WATCHMAN FLX LAA closure device.
• To assess its suitability as a non-pharmaceutical alternative for patients with nonvalvular AF.
• To determine if the device meets predefined safety and efficacy performance goals.

Main Methods:

• Prospective, nonrandomized, multicenter US FDA study.
• Primary safety endpoint: composite of death, stroke, systemic embolism, or device/procedure-related events within 7 days post-procedure.
• Primary effectiveness endpoint: successful LAA closure (peri-device flow ≤5 mm) assessed by echocardiography at 12 months.

Main Results:

• 400 patients enrolled; mean age 73.8 years, mean CHA₂DS₂-VASc score 4.2.
• Primary safety endpoint incidence was 0.5% (performance goal 4.2%), P<0.0001.
• Primary effectiveness endpoint (LAA closure) incidence was 100% (performance goal 97.0%), P<0.0001.

Conclusions:

• Next-generation LAA closure with the WATCHMAN FLX device demonstrated a low incidence of adverse events.
• High rates of successful anatomic LAA closure were observed.
• The device met its predefined safety and effectiveness performance goals.