Left Atrial Appendage Occlusion (LAAO)
Periprocedural stroke is a rare, but potentially devastating, event complicating left atrial appendage (LAAO) occlusion procedures. The PROTECT-AF study showed a clinically-evident stroke rate of 0.9%,1 while the PREVAIL study showed a rate of 0.7%.2 However, the rate of silent cerebral infarction is likely significantly higher, as is the case in many other minimally invasive cardiovascular procedures, such as TAVR and TEVAR. Early work is being done to explore the use of the Sentinel Cerebral Protection System (CPS) in LAAO procedures.
In an early study of five consecutive patients undergoing routine LAAO, the Sentinel CPS was used to protect patients’ brains. Even though thrombus in the atrial appendage was ruled out prior to the procedure by TEE, embolic debris was found in 100% of the procedures post-procedure, with the most common type of debris found being acute and organizing thrombus.
In the study, the Sentinel CPS showed 100% procedural success, with no periprocedural complications and no neurological abnormalities present after the procedure.
The study investigators agreed that a larger study was warranted to investigate the long-term effects of silent cerebral infarct and the impact of Sentinel CPS use during LAAO on mechanistic MRI and clinical outcomes.
- Felix Meincke, Tobias Spangenberg, Felix Kreidel, Elena Ladich, Oscar Sanchez, Karl-Heinz Kuck, Alexander Ghanem Asklepios Klinik St. Georg, Cardiology Department, Hamburg, Germany, Rationale of Cerebral Protection
- Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Clinical Trial and the Continued Access Registry Atrial Appendage System for Embolic Protection in Patients With AF (PROTECT AF) Safety of Percutaneous Left Atrial Appendage Closure: Results From the Watchman Left Atrial Appendage Closure Device. Circulation. 2011;123:417-424.
- Holmes DR, Kar S, Price MJ et al. Prospective Randomized Evaluation of the Watchman Left Atrial Appendage Closure Device in Patients With Atrial Fibrillation Versus Long-Term Warfarin Therapy: The PREVAIL Trial. J Am Coll Cardiol. 2014;64:1–12.
The Sentinel CPS has received the CE Mark and is commercially available in Europe. It is limited to investigational use in the United States.