The New England Journal of Medicine reported this month that, for patients with severe aortic stenosis who are not candidates for surgery, Transcatheter Aortic-Valve Implantation (TAVI) using the Edwards SAPIEN valve significantly reduced mortality compared to standard treatment. At one year, the rate of death from any cause was 30% with TAVI vs. 50.7% with standard treatment. However, this method had a higher incidence of strokes and major vascular complications compared to standard treatment.
The implantation procedure involves accessing a femoral artery, performing balloon valvuloplasty, then advancing the device across the native valve. During rapid right ventricular pacing, a balloon is inflated to deploy the valve and the frame.
Edwards is running another part of the trial comparing this valve with traditional open-heart aortic valve replacement.
Press release: The New England Journal of Medicine Publishes Transcatheter Heart Valve Trial Results
Abstract in NEJM: Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery
Related: Edwards Receives Approval to Begin U.S. Clinical Trial of Next-Generation Transcatheter Valve
Product page: Edwards SAPIEN Transcatheter Heart Valve