Edwards-Sapien valve

Two percutaneous aortic valves have recently received CE Mark approval (CoreValve in May 2007 and Edwards-Sapien in September 2007) and several other valved stent designs are in development with first-in-man reports or in preclinical testing. Only the Edwards-Sapien valve is currently undergoing evaluation in a randomized multicenter clinical trial against surgery in the Elnited States. 

The current generation of the Cribier-Edwards valve has been renamed the Edwards-Sapien valve (Figure 7.11). Instead of equine tissue, this iteration incorporates bovine pericardium within a similar stainless-steel frame, and the surrounding fabric now extends further to improve coaptation with the annulus... 

FIGURE 7.11 The Edwards-Sapien valve. (Edwards Lifesciences, Inc., with permission.)... 

The Edwards-Sapien valve is currently in a phase 3 clinical trial in the United States, the ongoing Placement of AoRTic traNscathetER valve (PARTNER) trial is a prospective randomized multicenter study to assess the safety and efficacy of the Edwards-Sapien valve in the treatment of severe aortic stenosis in high-risk patients. Participants of the study are randomized within two... 

Currently, the two most commonly used percutaneous aortic valves are the Edwards Sapien valve and the Medtronic CoreValve. The Edwards Sapien valve is a balloon-expandable valve made of a cobalt chromium frame and bovine pericardial leaflets. The Medtronic CoreValve is a self-expanding... 

FIGURE 77.9 (Top) Photograph of the Edwards Sapien valve depicting the leaflets and the stainless-steel frame (bottom) the valve placed in the aortic root after expansion, and crimped onto the catheter before expansion. (From Padala, M. et al.. An engineering review of transcatheter aortic valve technologies. Cardiovasc Eng Technoh 2010. 1(1) p. 77 87.)... 

Although no study observed structural valve deterioration during the short time of follow-up reported thus far (maximum two years), the lifespan of the valve remains to be determined. The Cribier-Edwards valve has a 2% failure rate at 12 years and 4% at 20 years (47). It remains to be seen whether the Edwards-Sapien and CoreValve implants will be as durable. The question of therapeutic options in the event of device failure also remains to be answered, although there have been... 

Figure 4.14 Portions of the Edwards SAPIEN transaortic valve replacement system [59]. Bottom center the introducer used to gain safe access to the apex of the left ventricle. Insert close-up of the valve stent and inflatable balloon. Top the primary introducer device, retrofitted with a magnetic sensor (red cable).

Briefing Document for the Circulatory Systems Device Panel Advisory Committee, 2011, The Edwards SAPIEN THV transcatheter heart valve system for patients with severe aortic stenosis who are not candidates for conventional open-heart aortic valve replacement surgery. Food Drug Administration, p. 300. 

Tzamtzis, S. et al., A direct in vitro comparison of the Edwards SAPIEN and Medtronic Core Valve transcatheter aortic valve Implantation (TAVl) devices and a surgical counterpart. Sixth Biennial Meeting of The Society for Heart Valve Disease. 2011. Barcelona, Spain. 

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