Journal article
Transfemoral aortic valve replacement with the repositionable Lotus Valve System in high surgical risk patients: the REPRISE I study
Ian T Meredith, Stephen G Worthley, Robert J Whitbourn, Paul Antonis, Joseph K Montarello, Andrew E Newcomb, Siohban Lockwood, Nicole Haratani, Dominic J Allocco, Keith D Dawkins
EUROINTERVENTION | EUROPA EDITION | Published : 2014
DOI: 10.4244/EIJV9I11A216
Abstract
AIMS: To assess outcomes with a new fully repositionable and retrievable valve for transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: The Lotus Aortic Valve System is designed to facilitate precise positioning and minimise paravalvular regurgitation. REPRISE I enrolled symptomatic, high-surgical-risk patients with severe aortic stenosis. The primary endpoint (clinical procedural success) included successful implantation without major adverse cardiovascular or cerebrovascular events (MACCE). In all patients (N=11) the first Lotus Valve was successfully deployed. Partial resheathing to facilitate accurate placement was attempted and successfully performed in four patients; non..
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Funding Acknowledgements
The authors thank Carola Alfaro, M.S., and Edmund McMullen, M. Math, for assistance with statistical analyses, Ruth M. Starzyk, Ph.D, for assistance with drafting and editing the manuscript and Blessie Concepcion for critical review of the manuscript (all from Boston Scientific Corporation, Natick, MA, USA). REPRISE I is sponsored and funded by Boston Scientific Corporation.