Abstract
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.
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.
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 <5%. The primary safety endpoint was the composite rate of all-cause mortality, stroke, systemic embolism, or major bleeding within 6 months after the index procedure, with a performance goal of <21%. Device seal and safety outcomes were also assessed at 12 months.
Postprocedure antithrombotic regimens included direct oral anticoagulants with or without aspirin in over 50% of patients, whereas 33% received dual antiplatelet therapy. The primary effectiveness endpoint was reached with 0 cases of peridevice leak >5 millimeters at 45-day follow-up and 82.7% achieving complete seal. At 45 days, the rate of patients either having complete seal or small leak ≤3 mm was 99.8%, and at 12 months, this rate was 98.8%. The composite primary safety endpoint was 11.1% at 6 months and 15.3% at 12 months.
The HEAL-LAA study demonstrates that the novel device achieves excellent early closure at 45 days and favorable 6-month clinical outcomes, supporting its safety and effectiveness for LAAC. Safety and effectiveness was sustained through 12 months. Overall, results are similar to the predecessor device, and more targeted studies are needed to assess incremental value of the coating.