Outcomes of Left Atrial Appendage Occlusion With a Coated Device

BACKGROUND: Left atrial appendage closure (LAAC) is a proven strategy for stroke prevention in patients with atrial fibrillation, yet procedural challenges and postimplant considerations remain key barriers to optimal outcomes. The next-generation WATCHMAN FLX Pro device introduces 3 significant advances: 1) enhanced visualization through radiopaque markers; 2) a novel fluoropolymer coating designed to facilitate endothelization; and 3) expanded anatomical coverage with a 40-mm size option. OBJECTIVES: The HEAL-LAA (Post-Market Real World Outcomes in WATCHMAN FLX Pro Left Atrial Appendage Closure Device) is a prospective, multicenter, post-market-approval study designed to assess the safety and effectiveness of the novel device. METHODS: This study enrolled 500 patients indicated for LAAC across 32 centers in the United States. The primary effectiveness endpoint was peridevice leak >5 millimeters at 45 days on transesophageal echocardiography, with a performance goal of