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Updated: Jul 1, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Cerebral Embolic Protection in Patients Undergoing Left Atrial Appendage Closure
Julia Seeger1,2, Philipp Seppelt3, Mario Iturbe-Orbe1
1Department of Cardiology and Intensive Care, Medical Campus Lake Constance, 88048 Friedrichshafen, Germany.
Insights
Cerebral embolic protection during left atrial appendage (LAA) closure with the WATCHMAN FLX device captured minimal debris, primarily thrombi. This procedure showed no periprocedural strokes, indicating a safe and effective method for LAA occlusion.
Area of Science:
- Cardiology
- Neurology
- Medical Devices
Background:
- Cerebral ischemic lesions are reported in approximately one-third of patients post-left atrial appendage (LAA) closure.
- Stroke events often occur during the periprocedural period of LAA closure.
Purpose of the Study:
- To evaluate the characteristics of embolized debris captured by the SENTINEL cerebral embolic protection system during LAA closure.
- To assess the safety and efficacy of LAA occlusion using the WATCHMAN FLX device.
Main Methods:
- Sixty filters from 30 patients undergoing LAA closure with the WATCHMAN FLX device were analyzed.
- Histopathology and histomorphometry were used to examine captured debris.
- Clinical outcomes, including stroke within 72 hours, were monitored.
Main Results:
- The majority of filters contained no captured material.
- Predominant debris consisted of acute or organized thrombi (33.3% of patients).
- Heart tissue particles were found in 20% of patients; foreign material in 3.3%.
- No disabling or non-disabling strokes occurred.
- The number of captured particles was significantly lower compared to other procedures like TAVR.
Conclusions:
- Left atrial appendage occlusion with the WATCHMAN FLX device is associated with a very low embolic load.
- The SENTINEL dual-filter embolic protection system effectively captured debris.
- No periprocedural strokes were observed, suggesting a safe intervention.
Abstract:
(1) Background: Cerebral magnetic resonance imaging has reported new cerebral ischemic lesions after left atrial appendage (LAA) closure in about one- third of patients. Stroke occurs predominantly periprocedurally. This study evaluated the characteristics of embolized debris captured by the SENTINELTM cerebral embolic protection system in patients undergoing LAA closure; (2) Methods: Sixty filters of 30 consecutive patients undergoing LAA closure with the WATCHMAN FLXTM device were collected and captured debris was analyzed by histopathology and histomorphometry. Clinical outcome measures were disabling and non-disabling stroke within 72 h; (3) Results: In most filters, no material was captured. The predominant captured debris was acute or organized thrombi. The most common pattern was acute fibrin-rich thrombus, which was detected in 11/30 (33.3%) patients. Particles of heart tissue were seen in 6/30 (20%) patients, and foreign material was seen in one (3.3%) patient. The number of particles ranged from 0 to 52 per patient with a maximum of 31 in the distal and 21 in the proximal filter. Particle diameter ranged from 131 to 2614 µm. By logistic regression analysis, only protected time remained a multivariable predictor for larger particles (p = 0.039). There was no disabling or non-disabling stroke. Compared to transfemoral aortic valve replacement, the number of particles is only about 1.5%. (4) Conclusion: LAA occlusion with the WATCHMAN FLXTM was associated with a very low number of embolized particles captured with the double-filter SENTINELTM embolic protection system and no periprocedural stroke.
