The SAPIEN-XT and SAPIEN-3 Valves: How to Implant and Obtain the Best Outcomes.

T ranscatheter aortic valve implantation (TAVI) has become the treatment of choice for symptomatic severe aortic stenosis (AS) in “inoperable” patients and is non-inferior to surgical aortic valve replacement (sAVR) in “high-risk” operable patients.1-4 Since the first-in-human (FIΜ) TAVI in 2002 with the Cribier-Edwards valve, the procedure continues to be refined, with technological improvements making the process simpler and clinical results better. The fourth-generation SAPIEN 3 valve of Edwards Lifesciences is currently in use, after the Cribier-Edwards, SAPIEN and SAPIEN XT valves.5-10 Current efforts focus on minimizing access site complications, stroke risk, paravalvular regurgitation (PVR), and atrioventricular (AV) block while facilitating accurate positioning. The SAPIEN valve family has been used in the treatment of more than 70,000 patients globally, most of them treated with the SAPIEN XT. Recently (16 June 2014), the Edwards SAPIEN XT transcatheter aortic heart valve (THV) received approval from the US Food and Drug Administration (FDA) for the treatment of high-risk and inoperable patients suffering from severe AS. The new generation valve SAPIEN 3 (S3) is a further development of the SAPIEN XT and incorporates features to reduce vascular complications and PVR. Furthermore, the new generation delivery system allows easier and more precise aortic valve positioning and implantation. The S3 valve was approved in Europe in January 2014; however, it is an investigational device that is not yet commercially available in the US and is currently being evaluated in the PARTNER-2 Trial.