Cerebral embolic protection during transfemoral treatment of valvular heart disease.
BACKGROUND:Neurological complications after transcatheter aortic valve replacement (TAVR) may be reduced with transcatheter cerebral embolic protection (TCEP). Moreovver, stroke is a well-documented potential risk of all structural cardiac interventions. One such intervention is the recently FDA-cleared Sentinel Cerebral Protection System (Sentinel; Claret Medical, Santa Rosa, CA, USA) designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
OBJECTIVES:We will evaluate in an all-comer prospective study the impact of cerebral embolic protection with the Claret Sentinel device (Claret Medical Inc., Santa Rosa, California) in terms of the importance of capturing and removing embolic debris during TAVI; mitral valve repair with MitraClip system, PFO closure, Left atrial appendix closure, and all procedure with transeptal puncture.
METHODS:All percutaneous procedure (TAVI, MitraClip, PFO closure, Left atrial appendix closure, etc) will be performed according to the good clinical practice and standardize procedure. The decision for transcatheter approach will be decided in the interdisciplinary heart team. Patients will be prospectively included in our observational registry and will be collected data about diagnostic evaluation with routine laboratory testing, medical history with current medication, Society of Thoracic Surgeons (STS) score, New York Heart Association functional class, electrocardiography, echocardiography and heart catheterization. The filters and the debries (2 from each patient) will be analyzed.
CONCLUSIONS:We hypothesize that TCEP is safe, capturing embolic debris in an hight rate of patients. In the SENTINEL IDE Study, and in a more recent all-comers trial, Sentinel significantly reduced periprocedural strokes by 63 and 70 % respectively.