1-Year Safety and Effectiveness of a Next-Generation Dual-Seal Left Atrial Appendage Occluder

BACKGROUND: Left atrial appendage occlusion (LAAO) is a stroke prevention alternative for patients with atrial fibrillation (AF) intolerant to long-term oral anticoagulation (OAC). The next-generation dual-seal device was designed to improve operator ease of use while maintaining effective LAAO of the predicate device. OBJECTIVES: The purpose of this analysis was to evaluate the safety and effectiveness of a next-generation device through 1 year. METHODS: VERITAS is a single-arm, prospective, global, multicenter study. Patients with nonvalvular AF with an increased thromboembolism risk seeking a nonpharmacologic alternative to OAC were enrolled. One-year descriptive endpoints are provided, including mortality, neurological events, major bleeding, and device-related complications. One-year cardiac imaging was assessed for peridevice leak and device-related thrombus (DRT). RESULTS: Complete left atrial appendage (LAA) closure (0 mm leak) was observed in 91.1% (95% CI: 87.9%-93.7%) of patients by either transesophageal echocardiography (TEE) or cardiac computed tomography and 96.3% (95% CI: 93.2%-98.2%) by TEE alone. The cumulative DRT rate was 3.3% (95% CI: 2.0%-5.3%) with only 0.4% (95% CI: 0.1%-1.5%) deemed clinically relevant. One-year key clinical outcome rates are as follows: all-cause mortality: 3.9% (95% CI: 2.4%-6.3%); cardiovascular mortality: 1.9% (95% CI: 0.9%-3.8%); major bleeding: 6.6% (95% CI: 4.5%-9.2%); ischemic stroke or systemic embolism: 1.8% (95% CI: 0.8%-3.3%); pericardial effusion requiring intervention: 0.9% (95% CI: 0.3%-2.1%). No (0%) device embolization occurred. Median follow-up was 365 days (IQR: 349-380 days). CONCLUSIONS: The VERITAS study results support the 1-year safety and effectiveness of the next-generation device. (Abbott Medical-VERITAS Study; NCT06707688).