Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study.
Ian T Meredith Am, Darren L Walters, Nicolas Dumonteil, Stephen G Worthley, Didier Tchétché, Ganesh Manoharan, Daniel J Blackman, Gilles Rioufol, David Hildick-Smith, Robert J Whitbourn, Thierry Lefèvre, Rüdiger Lange, Ralf Müller, Simon Redwood, Dominic J Allocco, Keith D Dawkins
Journal of the American College of Cardiology | Published : 2014
BACKGROUND: Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR). OBJECTIVES: The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis. METHODS: Patients (n = 12..View full abstract