Sapien 3: A Triple Threat to Aortic Stenosis.

SEE PAGE 1809 T ranscatheter aortic valve replacement (TAVR) is an established treatment for patients with severe aortic stenosis (AS) deemed to be at high risk for surgery (1,2). The firstgeneration balloon-expandable SAPIEN (Edwards Lifesciences, Irvine, California) transcatheter heart valve (THV) was the first device to be approved by the U.S. Food and Drug Administration (FDA) for inoperable, and subsequently, high-risk patients with AS. Limitations of the first-generation SAPIEN device included access-site related vascular complications, inconsistent positioning, paravalvular aortic valve regurgitation, and periprocedural strokes. Subsequent iterations of the SAPIEN THV included modifications in device design translating to improved performance and clinical outcomes. The EdwardsSAPIEN 3 (S3) is the fifth-generation balloon-expandable THV device. The valve and delivery system contain a number of improvements designed to reduce the risk of access site vascular injury, facilitate consistent and accurate positioning, and mitigate paravalvular regurgitation. The valve comprises a cobalt chromium stent, bovine pericardial leaflets, and an inner and outer polyethylene terephthalate sealing cuff. The unique cell design of the frame allows an ultra-low delivery profile while maintaining radial strength for circularity. The outer sealing skirt acts to minimize paravalvular regurgitation. The delivery system allows distal flex to help cross in challenging anatomies and control coaxiality, and has a handle that reflects degree of articulation, to ensure precise deployment. The valve comes in 4 sizes (20, 23, 26,