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Updated: May 10, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Transfabric Leaks After Percutaneous Left Atrial Appendage Occlusion Procedures with the WATCHMAN FLX Device
Nicholas J C Bauer1,2, Abdullah F Alfawaz1,3,4, Lan-Chau Kha1,3
1Schulich Heart Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Insights
Transfabric leaks (TFLs) are common after left atrial appendage occlusion (LAAO) procedures, occurring in 27-52% of patients. Predictors and significant clinical events associated with TFLs remain unclear.
Area of Science:
- Cardiology
- Medical Imaging
- Interventional Cardiology
Background:
- Contrast-enhanced cardiac computed tomography (CT) is increasingly used for imaging left atrial appendage occlusion (LAAO) devices.
- Transfabric leaks (TFLs), or contrast flow across an LAAO device, may indicate incomplete endothelialization.
- Limited data exists on the incidence, predictors, and clinical impact of TFLs.
Purpose of the Study:
- To determine the rate, predictors, and clinical events associated with transfabric leaks (TFLs) after WATCHMAN FLX left atrial appendage occlusion (LAAO) device implantation.
- To evaluate the significance of TFLs in patients undergoing LAAO procedures.
Main Methods:
- Single-center retrospective cohort study including 56 patients who received a WATCHMAN FLX LAAO device and post-implantation CT scan.
- Patients were classified based on three proposed definitions of TFL.
- Exploratory univariate logistic regression was used to identify predictors of TFL.
Main Results:
- The rate of TFL ranged from 27% to 52%, depending on the definition used.
- No significant patient or procedural differences were found between groups with and without TFL.
- No predictors of TFL were identified; six deaths and one stroke occurred during follow-up.
Conclusions:
- Transfabric leaks (TFLs) are common following left atrial appendage occlusion (LAAO) procedures.
- Complete endothelialization in humans may differ from animal models.
- Further research is needed to establish optimal imaging for TFL detection and clarify their clinical significance.
Background:
Cardiac computed tomography imaging with contrast is being used increasingly to image left atrial appendage occlusion (LAAO) devices. Contrast flow across a device, also known as a transfabric leak (TFL), may indicate a lack of complete LAAO-device endothelialization. The data on the rate, predictors, and clinical events associated with TFL are limited.
Methods:
All patients who underwent an LAAO-device implantation with a WATCHMAN FLX device and received a postimplantation computed tomography scan were included in this single-centre retrospective cohort study. Patients were classified as either having or not having a TFL, according to 3 currently proposed definitions of TFL. Clinical and procedural differences between the 2 groups were determined. An exploratory univariate logistic regression model to evaluate predictors of TFL was constructed.
Results:
A total of 56 individuals were included in the cohort. The rate of TFL varied from 27% to 52%, depending on the radiographic definition employed. No clinically important patient or procedural characteristics were noted between the groups with vs without TFL. No predictors of TFL were identified. Six deaths and one stroke occurred during a median follow-up period of 673 days.
Conclusions:
TFLs occur commonly post-LAAO procedures, suggesting that complete endothelialization of LAAO devices in humans may not be similar to that reported in animal models. Additional study into the best imaging approach to identify TFLs, and clinical events associated with TFLs, is necessary to clarify the significance of TFLs.
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