Tag Archives: HSNIK

The brand new balloon-expandable Edwards SAPIEN 3 THV has significant design

The brand new balloon-expandable Edwards SAPIEN 3 THV has significant design improvements requiring modifications in the implantation technique when compared with the previous era SAPIEN XT. external skirt of the SAPIEN 3. In 165 consecutive SAPIEN 3 individuals, 89.7% (n?=?145) had non-e or a trace PVL and there have been no individuals with moderate or severe PVL. The new generation SAPIEN 3 valve allows more challenging anatomies to be treated, requires less oversizing, and can reduce PVL. Introduction The rapid evolution of transcatheter aortic valve implantation (TAVI) from an innovative procedure to an established, alternative treatment for patients with severe aortic stenosis was followed by significant efforts to further improve clinical outcomes. A special emphasis was put on minimizing procedure complications through improved patient selection, refined procedures, and enhanced device designs.1 The Edwards transcatheter heart valve (THV) technology was primarily focused on device iterations addressing paravalvular leak (PVL) and vascular access complications. The Edwards SAPIEN 3 THV is the newest generation balloon expandable valve. It received the CE mark approval on January 27, 2014 and is commercially available in the 129-56-6 EU. The New SAPIEN 3 Design Significant design improvements have been incorporated in the newest generation Edwards SAPIEN 3 THV when compared to the earlier generation SAPIEN XT THV. Lower profile delivery systems were introduced to enable less traumatic implantation via the transfemoral, transapical, and transaortic access routes. More importantly, these changes were aimed to facilitate percutaneous access and closure even in patients with smaller iliofemoral arteries. The Commander Delivery System (transfemoral) 129-56-6 has an ultra-low profile and is compatible with the 14 French eSheath for the 23 and 26?mm valve and the 16 French eSheath for the 29?mm valve. A dual articulation of the distal end with an angulation of 180 facilitates a correct coaxial positioning even in challenging anatomies. A new handle allows for fine controlling and final adjustments of the height of the valve. The Certitude Delivery System (transapical) is compatible with the low profile 18 French Certitude sheath for the 23 and 26?mm valve and the 21 French Certitude sheath for the 29?mm valve. It has an integrated 129-56-6 pusher to streamline the procedure and an articulation feature to facilitate the coaxial positioning. Since major vascular complications are inversely correlated with reduced delivery profile,2,3 this design change is anticipated to translate into a significant clinical benefit. However, the most important changes are related to the SAPIEN 3 frame and the new outer skirt. The SAPIEN 3 frame is designed to enhance structural performance maintaining circularity, yet allowing for low profile in the crimped state. The SAPIEN 3 is currently available in the same 3 sizes (23, 26, and 29?mm) as the SAPIEN XT but the height of the frame is taller in both the expanded and crimped state as compared to the SAPIEN HSNIK XT (Table?(Table1).1). The frame consists of 5 rungs and 12 cells, where the upper cells are larger, allowing for postprocedure coronary access, in cases of high positioning (Fig. 1). The large angles between the struts and the interwoven rows of cells allow for distribution of the leaflet material along the longer height when the valve is crimped, while maintaining radial strength when the valve is fully deployed. The difference in the.