Primary endpoint results of the REPRISE NGDS First Human Use Study: Percutaneous aortic valve implantation with the next generation of a fully repositionable and retrievable aortic valve.

Aims: The Lotus Valve Next Generation Delivery System (Lotus NGDS) incorporates the same innovative performance and safety features from the currently available Lotus Valve, but uses a new delivery system to provide enhanced deliverability. Key changes to the Lotus NGDS include: 1) removal of the pre-formed J-curve to increase catheter flexibility; 2) reduced proximal shaft profile to improve deliverability; and 3) reduced overall multi-lumen catheter diameter to further enhance deliverability. The goal of the first human use REPRISE NGDS study is to evaluate the safety and performance of the Lotus NGDS. Methods and Results: This prospective, single-arm study has enrolled 10 surgical-high-risk patients with symptomatic aortic valve stenosis (defined as an initial aortic valve area <=1.0 cm or aortic valve area index of <=0.6 cm/m and either a mean pressure gradient >=40 mm Hg or a jet velocity >=4 m/s, as measured by echocardiography), and New York Heart Association Functional Class >=II at 2 Australian sites. The primary endpoint of the study was technical success (defined as successful vascular access, delivery, positioning, and deployment of one Lotus NGDS with uncomplicated delivery system retrieval). Secondary endpoints included device performance endpoints (successful repositioning/retrieval if attempted), paravalvular regurgitation at discharge/7 days, mean aortic valve pressure gradient and effective orifice area, and VARC safety and efficacy endpoints (including mortality, stroke, myocardial infarction, bleeding, and vascular complications). Patient follow-up was at baseline, peri- and post-procedure, discharge/7 days, and 30 days, and will continue through six months and one year. Independent core laboratories assessed echocardiography, angiography, and histopathology, and an independent clinical events committee has adjudicated clinical events. Conclusion(s): The REPRISE NGDS is a first human use study designed to evaluate outcomes with LOTUS NGDS. Primar