Arrhythmias & electrophysiology
1-Year Safety and Effectiveness of a Next-Generation Dual-Seal Left Atrial Appendage Occluder
Authors' conclusion
The VERITAS study results support the 1-year safety and effectiveness of the next-generation device. (Abbott Medical-VERITAS Study; NCT06707688).
Study context
- Population
- Patients with nonvalvular atrial fibrillation (AF) with an increased thromboembolism risk seeking a nonpharmacologic alternative to oral anticoagulation (OAC)
- Outcome
- Complete left atrial appendage (LAA) closure (0 mm leak)
- Follow-up
- One-year
Main finding
As reported in the abstract
By either transesophageal echocardiography (TEE) or cardiac computed tomography
91.1%
95% CI 87.9%–93.7%
By TEE alone
96.3%
95% CI 93.2%–98.2%
Observational data: associations, not effects.
Further findings
All-cause mortality · One-year
- All-cause mortality
- 3.9% (95% CI: 2.4%-6.3%)
Cardiovascular mortality · One-year
- Cardiovascular mortality
- 1.9% (95% CI: 0.9%-3.8%)
Ischemic stroke or systemic embolism · One-year
- Ischemic stroke or systemic embolism
- 1.8% (95% CI: 0.8%-3.3%)
Follow-up
- Median follow-up
- 365 days (IQR: 349-380 days)
Safety
Device-related thrombus (DRT) · One-year
- Cumulative DRT rate
- 3.3% (95% CI: 2.0%-5.3%)
- Deemed clinically relevant
- 0.4% (95% CI: 0.1%-1.5%)
Major bleeding · One-year
- Major bleeding
- 6.6% (95% CI: 4.5%-9.2%)
Pericardial effusion requiring intervention · One-year
- Pericardial effusion requiring intervention
- 0.9% (95% CI: 0.3%-2.1%)
Device embolization
- Device embolization
- No (0%)
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →