title: Evaluation of the Edwards Lifesciences SAPIEN transcatheter heart valve.
abstract: Severe aortic stenosis is a common valvular disease and is associated with both morbidity and mortality. Surgical aortic valve replacement was the only available therapeutic option until technological advances allowed for the development of a transcatheter heart valve system. The first available THV was the Edwards SAPIEN. The merits of this system in terms of safety and efficacy were explored in the pivotal Placement of AoRTic TraNscathetER (PARTNER) randomized trial whose results then led to the approval of this device for commercial use in the US. The valve is now indicated for inoperable patients and may be considered an alternative for surgery for high-risk patients. Two successive models, the XT and more recently the S3, were developed with the intent to improve procedural outcomes. In this article, the SAPIEN transcatheter heart valve family is described in terms of technology, scientific data and future directions.
authors.affiliation: Interventional Cardiology, MedStar Washington Hospital Center, 110 Irving Street, NW, Suite 4B-1, Washington, DC 20010, USA.
authors.forename: Sa'ar
authors.initials: S
authors.lastname: Minha
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D001021:Aortic Valve / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000601:surgery*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D019317:Evidence-Based Medicine; D006350:Heart Valve Prosthesis; D006801:Humans; D019919:Prosthesis Implantation / Q000379:methods*; D013673:Technology Assessment, Biomedical
keywords: SAPIEN; aortic stenosis; transcatheter aortic valve replacement