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Repositionable percutaneous aortic valve implantation with the LOTUS valve : 30-day and 1-year outcomes in 250 highrisk surgical patients

Meredith, Ian T.; Dumonteil, Nicolas; Blackman, Daniel J.; Tchétché, Didier; Walters, Darren L.; Hildick-Smith, David; Manoharan, Ganesh; Harnek, Jan LU ; Worthley, Stephen G. and Rioufol, Gilles, et al. (2017) In EuroIntervention 13(7). p.788-795
Abstract

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... (More)

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.

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publication status
published
subject
keywords
Aortic stenosis, Clinical trials, Femoral, Transcatheter aortic valve implantation
in
EuroIntervention
volume
13
issue
7
pages
8 pages
publisher
Société Europa Edition
external identifiers
  • scopus:85028565175
ISSN
1774-024X
DOI
10.4244/EIJ-D-16-01024
language
English
LU publication?
no
id
56068231-6204-4aeb-b4e2-7d671ac479fc
date added to LUP
2018-01-25 09:14:24
date last changed
2018-01-26 03:00:02
@article{56068231-6204-4aeb-b4e2-7d671ac479fc,
  abstract     = {<p>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&lt;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.</p>},
  author       = {Meredith, Ian T. and Dumonteil, Nicolas and Blackman, Daniel J. and Tchétché, Didier and Walters, Darren L. and Hildick-Smith, David and Manoharan, Ganesh and Harnek, Jan and Worthley, Stephen G. and Rioufol, Gilles and Lefèvre, Thierry and Modine, Thomas and Van Mieghem, Nicolas M. and Feldman, Ted and Allocco, Dominic J. and Dawkins, Keith D. and , },
  issn         = {1774-024X},
  keyword      = {Aortic stenosis,Clinical trials,Femoral,Transcatheter aortic valve implantation},
  language     = {eng},
  month        = {09},
  number       = {7},
  pages        = {788--795},
  publisher    = {Société Europa Edition},
  series       = {EuroIntervention},
  title        = {Repositionable percutaneous aortic valve implantation with the LOTUS valve : 30-day and 1-year outcomes in 250 highrisk surgical patients},
  url          = {http://dx.doi.org/10.4244/EIJ-D-16-01024},
  volume       = {13},
  year         = {2017},
}