Aims: The REPRISE IIE trial aimed to evaluate outcomes following transcatheter aortic valve implantation of the fully repositionable and retrievable LOTUS valve with a unique seal designed to minimise paravalvular leak (PVL). Methods and results: This prospective, multicentre study enrolled 250 patients with severe aortic stenosis considered high-risk for surgery by a multidisciplinary Heart Team. An independent clinical events committee adjudicated events per Valve Academic Research Consortium criteria. Mean age was 84 years; 77% were in NYHA Class III/IV. LOTUS valve implantation produced significant haemodynamic improvements at one year without valve embolisation, ectopic valve deployment, or additional valve implantation. Primary endpoints were met as the 30-day mortality rate in the extended cohort (4.4%, N=250), and mean valve gradient in the main cohort (11.5±5.2 mmHg, N=120) were below (p<0.001) their predefined performance objectives. At 30 days, disabling stroke was 2.8% and new pacemaker implantation was 28.9% in all patients and 32.0% in pacemaker-naïve patients. By one year, all-cause mortality was 11.6%, disabling stroke was 3.6%, 95% of patients alive were in NYHA Class I/II, and there was no core laboratory-adjudicated moderate/severe PVL. Conclusions: LOTUS valve implantation produced good valve haemodynamics, minimal PVL, sustained significant improvement in functional status, and good clinical outcomes one year post implant.

Additional Metadata
Keywords Aortic stenosis, Clinical trials, Femoral, Transcatheter aortic valve implantation
Persistent URL dx.doi.org/10.4244/EIJ-D-16-01024, hdl.handle.net/1765/108062
Journal EuroIntervention
Rights No Subscription
Citation
Meredith, I, Dumonteil, N, Blackman, D.J. (Daniel J.), Tchetche, D, Walters, D.L. (Darren L.), Hildick-Smith, D, … Dawkins, K.D. (2017). Repositionable percutaneous aortic valve implantation with the LOTUS valve: 30-day and 1-year outcomes in 250 highrisk surgical patients. EuroIntervention, 13(7), 788–795. doi:10.4244/EIJ-D-16-01024