22 May 2013, Paris, France: The Lotus Valve, a second-generation transcatheter aortic valve implantation (TAVI) device, was successfully implanted in all of the first 60 patients in results from REPRISE II reported at EuroPCR 2013, which showed good device performance and low mortality at 30 days.
"First generation TAVI devices provide significant clinical benefit, but there are opportunities for improvement," explained lead author Ian Meredith, Director of MonashHeart, Southern Health and Professor of Medicine, Monash University, Melbourne, Australia. He suggested that these include controlled deployment, simple, precise and atraumatic aortic/ventricular repositioning, no or trivial paravalvular leakage and lower complication rate.
The Lotus Valve System has been designed to address these issues. The valve is pre-attached to the delivery system, which has a simple handle design, and functions early in deployment for controlled, precise positioning. It is fully retrievable and can be repositioned and has an adaptive seal designed to minimise paravalvular leak.
REPRISE II prospectively evaluated the safety and performance of the Lotus Valve System for TAVI in symptomatic patients with severe calcific aortic stenosis considered high risk for surgical valve replacement. Reporting results for the first 60 patients, Meredith told the conference, "Successful valve implantation was achieved in all patients." The primary endpoint for device performance mean aortic valve pressure gradient at 30 days compared to a performance goal of 18mmHg was met. Mean aortic gradient decreased from 47.5+17.2mmHg before the procedure to 11.3+5.2mmHg at 30 days. At the same time effective orifice area increased from 0.6+0.2mmHg to 1.7+0.4mmHg.
"Results showed successful valve implantation in all 60 patients, meeting the primary device performance endpoint," Meredith said. "Importantly, the rate of moderate or greater aortic regurgitation decreased from 18% at the bas
|Contact: Isabelle Uzielli|
European Society of Cardiology