2012 update on the Edwards SAPIENTM transcatheter heart valve.

Last year was the 10th anniversary of the first transcatheter aortic valve implantation (TAVI) performed by Alain Cribier using the Cribier-Edwards transcatheter heart valve (THV). The Edwards SAPIENTM THV (Edwards Lifesciences, Irvine, CA, USA) was the first commercially available balloon-expandable THV to receive CE-Mark certification in Europe for transfemoral and transapical aortic valve implantation in 2007/2008. Outcome of the prospective randomized PARTNER-US trial resulted in FDA approval for TAVI using the Edwards SAPIENTM THV in patients unsuitable for surgery in 2011 and high-risk patients in 2012. This experience, together with results from the SOURCE Registry and National Registries, has resulted in further modifications of valve design and delivery systems, but also improvement in patient selection and procedural techniques. In this manuscript we review the changes made to the newest model of the Edwards SAPIENTM and its delivery systems over time with an emphasis on the SAPIEN XTTM. We also summarize the recent experience presented on the Edwards SAPIENTM and SAPIEN XTTM, new access routes and lessons learned for patient assessment, as well as opportunities for future development of the device.