Key result
Next-generation dual-seal LAAO device achieves ~91% complete closure with low 1-year stroke rates.
Why the study?
A next-generation dual-seal LAAO device was designed to improve operator ease of use while maintaining effective LAAO, requiring evaluation of its 1-year safety and effectiveness.
Does a next-generation dual-seal left atrial appendage occluder provide safe and effective left atrial appendage closure through 1 year in patients with nonvalvular atrial fibrillation seeking a nonpharmacologic alternative to oral anticoagulation?
Does a next-generation dual-seal left atrial appendage occluder provide safe and effective left atrial appendage closure through 1 year in patients with nonvalvular atrial fibrillation seeking a nonpharmacologic alternative to oral anticoagulation?
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“In an accompanying editorial comment, Emile G. Daoud, MD, called the procedural outcomes 'exceptional,' but noted that data on the device's efficacy at stroke reduction are not yet available. 'In the meantime,' he writes, 'the VERITAS study has taken the first step in its namesake, providing the truth that clinicians need to guide their patients toward freedom from both stroke and the burden of lifelong anticoagulation.'”
The global single-arm VERITAS study demonstrates high 1-year complete closure rates (91.1% overall, 96.3% by TEE) and low complication rates with a next-generation dual-seal LAAO device in patients with nonvalvular AF.
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)
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Lakkireddy et al. (2026) studied Nonvalvular atrial fibrillation. Next-generation dual-seal left atrial appendage occluder was evaluated on Complete left atrial appendage closure (0 mm leak) at 1 year (95% CI 87.9%-93.7%). The next-generation dual-seal LAAO device achieved complete LAA closure in 91.1% (95% CI 87.9%-93.7%) of patients and a 1.8% ischemic stroke or systemic embolism rate at 1 year.
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