Can We Prevent Periprocedural Stroke in Transcatheter Aortic Valve Replacement?

The first large-scale trial of a cerebral embolic protection device raises as many questions as it answers.

Although outcomes of transcatheter aortic valve replacement (TAVR) have improved substantially, stroke continues to occur in ≈2% of procedures. Most of these strokes are thought to be caused by embolization of debris from the native valve and aortic arch. Although several cerebral embolic protection (CEP) devices have been developed to prevent stroke during TAVR, their efficacy has not yet been evaluated in prospective studies.

In a manufacturer-funded, multicenter clinical trial (NCT04149535), investigators randomized 3000 patients (mean age, 79 years) undergoing transfemoral TAVR to CEP, using the FDA-approved Sentinel device, or no CEP. The primary endpoint was the incidence of any stroke within 72 hours of TAVR or before discharge (which…

Reviewing Author

David J. Cohen, MD, MSc

Disclosures

Consultant/Advisory BoardMedtronic; Edwards Lifesciences; Abbott Vascular; Boston Scientific; St. Francis Hospital

Speaker’s BureauBoston Scientific; ZOLL Medical

Grant/Research SupportEdwards Lifesciences; Abbott Vascular; Boston Scientific; Corvia Medical; National Heart, Lung, and Blood Institute; Phillips, Inc.; St. Paul’s Hospital; V-Wave, Inc; ZOLL Medical; CathWorks, ANCORA

Editorial BoardsJACC; American Heart Journal; EuroIntervention; JSCAI; Structural Heart Journal

Leadership Positions in Professional SocietiesSociety of Thoracic Surgeons/American College of Cardiology TVT Registry (Co-Chair, Risk Model Development Committee); Cardiovascular Research Foundation (Co-Director, TCT Annual Meeting; Co-Director, New York Valves Annual Meeting)