Background: Transcatheter aortic valve replacement is recommended in inoperable patients with severe, symptomatic aortic stenosis (AS), and is an accepted alternative to surgical AVR in high risk patients. However, increased stroke, bleeding, vascular complications and aortic regurgitation (AR) rates may adversely affect outcomes. The repositionable and fully retrievable Lotus Valve is designed to facilitate accurate positioning and minimize paravalvular leakage. Methods: REPRISE I is a prospective, single-arm, 3-center feasibility study to assess acute safety and performance in symptomatic patients with severe AS at high surgical risk. The primary endpoint was clinical procedural success (successful implantation without in-hospital major adverse cardiovascular and cerebrovascular events to discharge or 7 days, whichever came first). Results: The Lotus Valve was implanted in 11 patients with mean STS and logistic euroSCOREs of 4.9±2.5% and 9.5±4.4%, respectively, and high surgical risk due to comorbidities/frailty (cognitive dysfunction in 5/11, gait speed ≥6s in 9/11, grip strength ≤18kg in 7/11). At baseline 6 patients were NYHA Class II and 5 were Class III. Clinical procedural success was achieved in 9/11. One patient experienced a major ischemic stroke (MRS=3 at discharge; final 90-day adjudication pending). A second had a mean post-procedure gradient of 22mmHg (above the 20mmHg VARC threshold) although the valve was functioning well (post-procedure AVA 1.6cm2). Partial resheathing was performed in 4/4 patients; none required full retrieval. Mean aortic gradient was 53.9±20.9mmHg at baseline and 13.7±3.7mmHg at discharge. Mean AVA was 0.7±0.2cm2 at baseline and 1.5±0.2cm2 at discharge. Paravalvular AR was mild in 2 patients, trivial in 1, absent in 8. Conduction disturbance requiring a new pacemaker occurred in 4 patients (2 with complete AV block). There were no deaths or MIs through 7 days. Conclusions: Early feasibility results suggest that the Lotus Valve can be positioned precisely and successfully with virtually no AR and low clinical event rates through discharge, supporting further study in a larger, more rigorous trial. Three-month data will be presented for the first time at TCT 2012.
Meredith, I., Worthley, S., Whitbourn, R., Antonis, P., Montarello, J., Newcomb, A., … Dawkins, K. (2012). TCT-104 Feasibility Study of the Repositionable Lotus Aortic Valve Replacement System: 3-Month Outcomes in 11 Patients at High Surgical Risk (REPRISE I). Journal of the American College of Cardiology, 60(17), B32–B33. https://doi.org/10.1016/j.jacc.2012.08.120