Newer-generation Edwards transcatheter heart valve systems demonstrated significant improvement in reducing paravalvular leak and were associated with extremely good clinical outcomes.
Do newer-generation Edwards transcatheter heart valve systems improve clinical outcomes and reduce paravalvular leak in patients with severe symptomatic aortic stenosis?
Newer-generation Edwards transcatheter heart valve systems (SAPIEN 3, CENTERA, SAPIEN 3 Ultra) offer significant improvements in reducing paravalvular leak and achieving excellent clinical outcomes in patients with severe aortic stenosis.
INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future. Areas covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the balloon-expandable Edwards SAPIEN valve in patients deemed in-operable and at high-risk, and later on in intermediate-risk patients using the balloon-expandable SAPIEN-XT valve. These trials had laid the groundwork for advancements incorporated in the balloon-expandable SAPIEN-3 system such as the introduction of the anti-leak skirt and improved delivery system. In this review, we summarize the available data on the SAPIEN-3 transcatheter heart valve system and we highlight the special features of the newly designed self-expanding Edwards CENTERA valve, and the latest generation of balloon-expanable SAPIEN-3 Ultra™ system. A detailed literature search on these devices was undertaken using Ovid, PubMed, and Web of Science. Expert commentary: Data from clinical trials show that TAVI with newer-generation of Edwards transcatheter heart valve systems have shown significant improvement in terms of reduced paravalvular leak and have been associated with extremely good clinical outcomes.
Solomonica et al. (Sat,) conducted a review in severe symptomatic aortic stenosis. Newer-generation Edwards transcatheter heart valve systems (SAPIEN 3, Centera, SAPIEN 3 Ultra) was evaluated. Newer-generation Edwards transcatheter heart valve systems demonstrated significant improvement in reducing paravalvular leak and were associated with extremely good clinical outcomes.