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.
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).
  
  
  OBJECTIVE
  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 cm(2). 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).
authors.affiliation: MonashHEART, Monash Health, and Monash University, Clayton, Victoria, Australia. Electronic address: ian.meredith@myheart.id.au.
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith Am
authors.affiliation: The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Darren L
authors.initials: DL
authors.lastname: Walters
authors.affiliation: Pôle Cardiovasculaire et Métabolique, Centre Hospitalier Universitaire Rangueil, Toulouse, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Dumonteil
authors.affiliation: Royal Adelaide Hospital, Adelaide, South Australia, Australia.
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Worthley
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Tchétché
authors.affiliation: Royal Victoria Hospital, Belfast, United Kingdom.
authors.forename: Ganesh
authors.initials: G
authors.lastname: Manoharan
authors.affiliation: Leeds General Infirmary, Leeds, United Kingdom.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Blackman
authors.affiliation: Hôpital Cardiologique, Hospices Civils de Lyon, Lyon, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Rioufol
authors.affiliation: Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, United Kingdom.
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.affiliation: St. Vincent's Hospital (Melbourne), Fitzroy, Victoria, Australia.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Whitbourn
authors.affiliation: Institut Cardiovasculaire, Paris Sud, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: Deutsches Herzzentrum München, München, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
authors.affiliation: HELIOS Klinikum Siegburg, Siegburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Müller
authors.affiliation: Guys and St. Thomas' NHS Foundation Trust, London, United Kingdom.
authors.forename: Simon
authors.initials: S
authors.lastname: Redwood
authors.affiliation: Boston Scientific Corporation, Marlborough, Massachusetts.
authors.forename: Dominic J
authors.initials: DJ
authors.lastname: Allocco
authors.affiliation: Boston Scientific Corporation, Marlborough, Massachusetts.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Dawkins
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000601:surgery* / Q000628:therapy*; D002114:Calcinosis / Q000601:surgery / Q000628:therapy; D004867:Equipment Design; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012306:Risk; D016896:Treatment Outcome
keywords: TAVR; aortic regurgitation; aortic valve stenosis; transfemoral