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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Incidence, impact and predictors of residual device patency after left atrial appendage closure with the LACbes
Peng-Cheng Yao1, Zhen-Tao Fei1, Mu Chen1
1Department of Cardiology, Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Insights
Residual device patency after left atrial appendage closure (LAAC) with the LACbes device in atrial fibrillation (AF) patients was evaluated. Peri-device leak at the lobe, not residual patency, predicted adverse events, with antiplatelet therapy showing a protective effect.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Cardiology
Background:
- Residual device patency (RDP) after left atrial appendage closure (LAAC) using the LACbes device in atrial fibrillation (AF) patients remains under-explored.
- Cardiac computed tomography angiography (CCTA) is utilized for post-procedural surveillance.
Purpose of the Study:
- To investigate the incidence, impact, and predictors of RDP detected by CCTA following LAAC with the LACbes device.
- To assess the association between RDP and major adverse events (MAEs) in AF patients.
Main Methods:
- Prospective enrollment of AF patients who received the LACbes device for LAAC.
- CCTA surveillance at 3 months post-procedure to evaluate RDP.
- Monitoring of MAEs, including stroke, transient ischemic attack, major bleeding, and all-cause death.
Main Results:
- Out of 141 patients, 60.3% exhibited RDP, while 39.7% showed no visible leak.
- RDP itself was not linked to increased MAEs (aHR: 4.07, p=0.196).
- Peri-device leak (PDL) at the device lobe was significantly associated with higher MAE risk (aHR: 6.85, p=0.009).
- Antiplatelet therapy beyond 6 months independently predicted reduced MAEs in patients with PDL at the lobe (HR: 0.20, p=0.038).
- Current smoking (OR: 7.52, p<0.001) and larger LAA orifice diameter (OR: 1.16, p=0.048) predicted PDL at the lobe.
Conclusions:
- Peri-device leak at the device lobe, identified by CCTA 3 months post-LAAC with the LACbes device, is linked to adverse outcomes in AF patients.
- The presence of PDL at the lobe, rather than general RDP, is a critical factor for prognosis.
- Early identification and management of PDL may be crucial for improving patient outcomes.
Background:
The residual device patency (RDP) after left atrial appendage closure (LAAC) with the LACbes device has not been specifically explored in atrial fibrillation (AF) patients. This study aims to explore the incidence, impact and predictors of RDP detected by cardiac computed tomography angiography (CCTA) post LAAC.
Methods:
AF patients implanted with the LACbes device were prospectively enrolled. CCTA device surveillance was performed at 3 months post-procedure. Major adverse events (MAEs), including stroke/transient ischemic attack, major bleeding and all-cause death, were evaluated.
Results:
Among 141 patients with CCTA surveillance, 56 (39.7%) showed no visible leak and 85 (60.3%) showed RDP. During the median follow-up of 443 [232, 706] days, the presence of RDP was not associated with an increased risk of MAEs (adjusted hazard ratio [HR]: 4.07, 95% confidence interval [CI]: 0.49-34.24, p = 0.196), while peri-device leak (PDL) at the lobe was associated with heightened risks of MAEs (adjusted HR: 6.85, 95% CI: 1.62-28.89, p = 0.009). In patients with PDL at the lobe, antiplatelet after 6 months (HR: 0.20, 95% CI: 0.05-0.91, p = 0.038) was independent protective predictor of MAEs. Besides, current smoking (odds ratio [OR]: 7.52, 95% CI: 2.68-21.08, p < 0.001) and maximum diameter of LAA orifice (OR: 1.16, 95% CI: 1.00-1.34, p = 0.048) were independent predictors of PDL at the lobe.
Conclusions:
Presence of PDL at the device lobe detected by CCTA at 3-month post LAAC with LACbes is associated with unfavorable prognosis in AF patients.
Clinical Trial Registration:
ClinicalTrials.gov Identifier: NCT03788941.
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