The Edwards SAPIEN Transcatheter Heart Valve for Calcific Aortic Stenosis: A Review of the Valve, Procedure, and Current Literature.

Abstract

The Edwards SAPIEN™ transcatheter heart valve (Edwards Lifesciences LLC, Irvine, CA, USA) is approved by the US Food and drug administration for use in the aortic position in patients with severe aortic stenosis who are not surgical candidates. This approval was backed by data from the Placement of AoRTic TraNscathetER Valve (PARTNER) I clinical trial, which showed the valve to be superior to standard medical therapy in high-risk nonoperative patients in cohort B of the trial. Although insertion of the valve is considered to be very safe, stroke, major vascular complications, and conduction abnormalities are the most frequent procedural complications. A dedicated team of physicians trained in structural cardiac interventions, including two interventional cardiologists, an echocardiographer, and a cardiac surgeon, are involved in every case. Improvements in valve design and streamlining of the delivery system, as well as favorable long-term outcomes, will hopefully pave the way for wider patient use in the future.