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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Percutaneous Left Atrial Appendage Closure With a Novel LAA Occluder for Stroke Prevention in Atrial Fibrillation
Xiaochun Zhang1,2, Shiqiang Hou1,2, Weijing Liu3
1Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Disease, Shanghai, People's Republic of China.
Insights
Left atrial appendage closure using the Leftear device is safe and effective for preventing strokes in patients with nonvalvular atrial fibrillation. The novel occluder demonstrated high success rates and favorable outcomes over 12 months.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Over 90% of thromboses in nonvalvular atrial fibrillation (NVAF) patients originate from the left atrial appendage (LAA).
- Stroke prevention is critical in NVAF patients, with risk often assessed by CHA 2 DS 2 -VASc scores.
Purpose of the Study:
- To evaluate the safety and efficacy of the Leftear device for LAA closure in NVAF patients.
- To assess the primary safety endpoint of serious adverse events and the primary composite endpoint of stroke, systemic embolism, or death.
Main Methods:
- A prospective, multicenter, registry-based study involving 200 NVAF patients with CHA 2 DS 2 -VASc scores ≥2.
- Assessed immediate procedural success, serious adverse events, and a 1-year composite endpoint including stroke, embolism, and death.
Main Results:
- The Leftear device was implanted in 196 patients with a 100% immediate success rate.
- Serious adverse events occurred in 4.5% of patients, primarily in the 1-stop LAA closure group.
- The 1-year composite endpoint risk was 1.6%, achieving statistical noninferiority, with no major bleeding or device-related thrombus.
Conclusions:
- LAA closure with the Leftear disc-like occluder demonstrates high procedural success, safety, and efficacy for stroke prevention in NVAF.
- Single LAA closure appears more tolerable than 1-stop LAA closure, suggesting a potentially safer approach.
Background:
More than 90% of thromboses originate from the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation (NVAF).
Objectives:
This study was designed to investigate the safety and efficacy of LAA closure with the Leftear device (Pulse Scientific) in NVAF patients.
Methods:
A prospective, multicenter, registry-based study was conducted in 200 NVAF patients with CHA2DS2-VASc (congestive heart failure, hypertension, age, diabetes, previous stroke/transient ischemic attack, vascular disease, female sex) scores ≥2. The primary safety endpoint was defined as any serious adverse events. Efficacy was assessed by a primary composite endpoint of hemorrhagic or ischemic stroke, systemic embolism, and cardiac or unexplained death at 1 year of follow-up.
Results:
The device was implanted in 196 patients, with 1-stop LAA closure combined with atrial fibrillation ablation implemented in 133 patients. The immediate success rate was 100%. There were serious adverse events in 9 patients (4.5%; 95% CI: 1.6%-7.4%), which mainly occurred in 1-stop LAA closure. All pericardial tamponades occurred in 6 patients with 1-stop LAA closure. No patient experienced a major bleeding event or acute device-related thrombus. During the 12-month follow-up period, the risk of the primary composite endpoint was 1.6% (95% CI: 0.3%-4.5%), and statistical noninferiority was achieved (the upper bound of 95% CI: 4.5% < the prespecified maximum annual incidence of 8.0%). Ischemic stroke occurred in 1 patient, 3 patients had incomplete LAA sealing, and no delayed device-related thrombus was found.
Conclusions:
LAA closure with the novel disc-like occluder shows high procedural success, satisfactory safety, and encouraging efficacy for stroke prevention in patients with NVAF. Compared with 1-stop LAA closure, single LAA closure may be more tolerable. (A multicenter, single-arm clinical trial to evaluate the efficacy and safety of left atrial appendage system for left atrial appendage occlusion in patients with non-valvular atrial fibrillation; ChiCTR1900023035).
