Percutaneous left atrial appendage (LAA) closure is increasingly utilized as an alternative to chronic oral anticoagulation therapy in atrial fibrillation patients at high thromboembolic as well as bleeding risk. Nevertheless, there is a lack of clinical outcome data supporting new LAA systems. The primary goal of our study is to investigate the safety and efficacy of a new non-pacifier LAA closure system in patients with non-valvular atrial fibrillation at a high stroke risk.
Effective LAA closure at 6 months and the rate of ischemic stroke at 12 months were evaluated using pre-specified performance measures. This is a prospective, non-randomized, multicenter observational study carried out in 6 hospitals in China. The multicenter study is the first clinical assessment in routine clinical practice of this technology. Follow-up was carried out in patients for a maximum of 12 months after implant to evaluate procedural success, LAA closure, and major clinical outcomes. A total of 187 patients participated in the multicenter study.
The average patient age was 67.7 ± 7.5 years. Baseline risk factors were high in patients, with average scores of CHA2DS2-VASc 4.0 ± 1.6 and HAS-BLED scores of 2.5 ± 1.1, indicating high risk of both thromboembolism and bleeding events. Patients included in the multicenter study all presented with persistent non-valvular atrial fibrillation and were potential candidates for LAA closure.
Key findings
• Implantation was successful in 184 of 187 patients, with a procedural success rate of 98.4%.
• Major procedural complications occurred in 4 patients (2.1%).
• Successful closure of the LAA at 6-month follow-up was 100% of evaluable patients with a one-sided 95% lower confidence boundary of 98.0%, exceeding the performance goal of closing the LAA.
• Ischemic stroke during the 12-month follow-up period occurred in 1 of 176 patients with an incidence of 0.6% with a one-sided 95% upper confidence boundary of 2.9%, meeting the performance goal of preventing ischemic stroke.
• Cumulative incidence of major clinical endpoints of stroke or serious non-stroke events was 6.5% at 11 of 176 patients with 95% confidence interval of 2.9-10.1%.
This is the first clinical assessment, which finds that the new nonpacifier device for LAA closure can be effective in preventing strokes for patients with non-valvular atrial fibrillation, with high success rates, full appendage closure, and minimal incidence of ischemic stroke and adverse events.
Reference:
Hao, Z., Zhang, W., Ning, Z. et al. Left atrial appendage closure with a novel nonpacifier device for stroke prevention in atrial fibrillation. Sci Rep (2026). https://doi.org/10.1038/s41598-025-34554-7
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.