Key result
Both the Edwards Sapien and Medtronic CoreValve devices are effective for transcatheter aortic valve implantation, with no significant difference in overall mortality despite variations in device-specific complications such as pacemaker requirement and paravalvular regurgitation.
Why the study?
What are the differences in indications and clinical outcomes between the Edwards Sapien and Medtronic CoreValve prostheses for transcatheter aortic valve implantation?
What are the differences in indications and clinical outcomes between the Edwards Sapien and Medtronic CoreValve prostheses for transcatheter aortic valve implantation?
The Edwards Sapien and Medtronic CoreValve TAVI prostheses demonstrate comparable mortality outcomes, but differ in design, specific indications, and complication profiles such as pacemaker requirements.
Both devices yield similar TAVI mortality; leaves open individualized selection by complication profile.
Transcatheter aortic valve implantation (TAVI) has emerged as a suitable alternative to surgical valve replacement for patients with severe, symptomatic, calcified aortic stenosis and a background of co-morbidities, which can make surgery a high-risk option. It has also evolved as an alternative for degenerative prosthetic heart valve disease. Since the inception of TAVI in 2002, the two main devices in routine clinical use are the Edwards Sapien valve (since 2006) and the Medtronic CoreValve (since 2007). The more recent Sapien XT valve and Sapien 3 have been in clinical use since 2010 and 2013, respectively. In addition to registry data on these devices, there are a number of completed and ongoing randomised controlled trials, including one comparing the two devices. The aim of this article is to discuss the differences in indications and outcomes between these two prostheses.
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Noorani et al. (2011) conducted a review in Severe calcified aortic stenosis. Edwards Sapien Valve and Medtronic CoreValve vs. Each other, surgical aortic valve replacement, or medical management was evaluated. Both the Edwards Sapien and Medtronic CoreValve devices are effective for transcatheter aortic valve implantation, with no significant difference in overall mortality despite variations in device-specific complications such as pacemaker requirement and paravalvular regurgitation.
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