Use of Cerebral Embolic Protection in High-Risk Patients Undergoing Left Atrial Appendage Occlusion
Abstract
Atrial fibrillation (AF) is the most common cardiac arrhythmia affecting more than 33 million people worldwide. Patients with AF are at an increased risk of cardioembolic stroke, making oral anticoagulation the standard of care in this patient population. However, a significant proportion of patients with AF are unable to tolerate anticoagulation. Endocardial left atrial appendage occlusion (LAAO) using the WATCHMAN device (Boston Scientific, Marlborough, MA) was approved by the FDA in patients who are not suitable for long-term anticoagulation. Peri-procedural stroke was an important safety end-point in both randomized trials of WATCHMAN with a rate of 1.1% and 0.7%, respectively, in PROTECT-AF and PREVAIL. The use of a cerebral protection device (SentinelTM CPSVR, Claret Medical, Inc., Santa Rosa, CA) has been shown in multiple studies to be safe and effective in capturing calcified debris during transcatheter aortic valve replacement (TAVR). We hypothesized that the use of embolic protection in a high-risk patient population undergoing LAAO would reduce peri-procedural stroke risk. SentinelTM CPSVR cerebral protection device was used on 10 high-risk patients treated with percutaneous left atrial appendage occlusion device at two tertiary referral centers (University of Iowa Hospitals & Clinics and Mayo Clinic, Rochester). Patients’ selection to receive a Sentinel cerebral protection device was based on clinical judgment regarding high risk of peri-procedural embolism. All…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 33 participants or records.
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