Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study

Meredith, Ian T., Walters, Darren L., Dumonteil, Nicolas, Worthley, Stephen G., Tchetche, Didier, Manoharan, Ganesh, Blackman, Daniel J., Rioufol, Gilles, Hildick-Smith, David, Whitbourn, Robert J., Lefevre, Thierry, Lange, Ruediger, Mueller, Ralf, Redwood, Simon, Allocco, Dominic J. and Dawkins, Keith D. (2014) Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. Journal of the American College of Cardiology, 64 13: 1339-1348. doi:10.1016/j.jacc.2014.05.067


Author Meredith, Ian T.
Walters, Darren L.
Dumonteil, Nicolas
Worthley, Stephen G.
Tchetche, Didier
Manoharan, Ganesh
Blackman, Daniel J.
Rioufol, Gilles
Hildick-Smith, David
Whitbourn, Robert J.
Lefevre, Thierry
Lange, Ruediger
Mueller, Ralf
Redwood, Simon
Allocco, Dominic J.
Dawkins, Keith D.
Title Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study
Journal name Journal of the American College of Cardiology   Check publisher's open access policy
ISSN 1558-3597
0735-1097
Publication date 2014-09-30
Year available 2014
Sub-type Article (original research)
DOI 10.1016/j.jacc.2014.05.067
Open Access Status
Volume 64
Issue 13
Start page 1339
End page 1348
Total pages 10
Place of publication San Diego, CA United States
Publisher Elsevier USA
Collection year 2015
Language eng
Formatted abstract
Background

Transcatheter aortic valve replacement provides results comparable to those of surgery in patients at high surgical risk, but complications can impact long-term outcomes. The Lotus valve, designed to improve upon earlier devices, is fully repositionable and retrievable, with a unique seal to minimize paravalvular regurgitation (PVR).

Objectives

The prospective, single-arm, multicenter REPRISE II study (REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System: Evaluation of Safety and Performance) evaluated the transcatheter valve system for treatment of severe symptomatic calcific aortic valve stenosis.

Methods

Patients (n = 120; aortic annulus 19 to 27 mm) considered by a multidisciplinary heart team to be at high surgical risk received the valve transfemorally. The primary device performance endpoint, 30-day mean pressure gradient, was assessed by an independent echocardiographic core laboratory and compared with a pre-specified performance goal. The primary safety endpoint was 30-day mortality. Secondary endpoints included safety/effectiveness metrics per Valve Academic Research Consortium criteria.

Results

Mean age was 84.4 years, 57% of the patients were female, and 76% were New York Heart Association functional class III/IV. Mean aortic valve area was 0.7 ± 0.2 cm2. The valve was successfully implanted in all patients, with no cases of valve embolization, ectopic valve deployment, or additional valve implantation. All repositioning (n = 26) and retrieval (n = 6) attempts were successful; 34 patients (28.6%) received a permanent pacemaker. The primary device performance endpoint was met, because the mean gradient improved from 46.4 ± 15.0 mm Hg to 11.5 ± 5.2 mm Hg. At 30 days, the mortality rate was 4.2%, and the rate of disabling stroke was 1.7%; 1 (1.0%) patient had moderate PVR, whereas none had severe PVR.

Conclusions

REPRISE II demonstrates the safety and effectiveness of the Lotus valve in patients with severe aortic stenosis who are at high surgical risk. The valve could be positioned successfully with minimal PVR. (REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance; NCT01627691)
Keyword Aortic regurgitation
Aortic valve stenosis
TAVR
Transfemoral
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Medicine Publications
 
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