title: 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study.
abstract: OBJECTIVE
  This analysis presents the first report of 1-year outcomes of the 120 patients enrolled in the REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance) study.
  
  
  BACKGROUND
  The fully repositionable and retrievable Lotus Valve (Boston Scientific, Marlborough, Massachusetts) was designed to facilitate accurate positioning, early valve function, and hemodynamic stability during deployment and to minimize paravalvular regurgitation in patients undergoing transcatheter aortic valve replacement.
  
  
  METHODS
  The study enrolled 120 symptomatic patients 70 years of age or older at 14 centers in Australia and Europe. Patients had severe calcific aortic stenosis and were deemed to be at high or extreme risk of surgery based on assessment by the heart team.
  
  
  RESULTS
  The mean age was 84.4 ± 5.3 years, 57% (68 of 120) of patients were women, and the mean Society of Thoracic Surgeons score was 7.1 ± 4.6. The mean baseline aortic valve area was 0.7 ± 0.2 cm(2), and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg. All patients were successfully implanted with a Lotus Valve, and 1-year clinical follow-up was available for 99.2% (119 of 120 of patients). The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg, and the mean valve area was 1.7 ± 0.5 cm(2). A total of 88.6% patients had no or trivial paravalvular aortic regurgitation at 1 year by independent core lab adjudication, and 97.1% of patients were New York Heart Association functional class I or II. At 1 year, the all-cause mortality rate was 10.9% (13 of 119 patients), disabling stroke rate was 3.4% (4 of 119 patients), disabling bleeding rate was 5.9% (7 of 119 patients), with no repeat procedures for valve-related dysfunction. A total of 31.9% (38 of 119 patients) underwent new permanent pacemaker implantation at 1 year.
  
  
  CONCLUSIONS
  At 1 year of follow-up, the Lotus Valve demonstrated excellent valve hemodynamics, no moderate or severe paravalvular regurgitation, and significant and sustained improvement in New York Heart Association functional class status, with good clinical outcomes. (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System-Evaluation of Safety and Performance [REPRISE II]; NCT01627691).
authors.affiliation: MonashHeart, Monash Medical Centre and Monash University, Clayton, Victoria, Australia. Electronic address: ian.meredith@myheart.id.au.
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
authors.affiliation: The Prince Charles Hospital, Brisbane and University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Darren L
authors.initials: DL
authors.lastname: Walters
authors.affiliation: Rangueil University Hospital, Cardiovascular and Metabolic Pole, 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 Teaching Hospitals, Leeds, United Kingdom.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Blackman
authors.affiliation: Hôpital Cardiologique de Lyon, Bron, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Rioufol
authors.affiliation: Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom.
authors.forename: David
authors.initials: D
authors.lastname: Hildick-Smith
authors.affiliation: Cardiovascular Research Centre, 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, Munich, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
authors.affiliation: HELIOS Klinikum, Siegburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Müller
authors.affiliation: Guy's and St. Thomas NHS Foundation Trust, London, United Kingdom.
authors.forename: Simon
authors.initials: S
authors.lastname: Redwood
authors.affiliation: NorthShore University HealthSystem, Evanston Hospital, Evanston, Illinois.
authors.forename: Ted E
authors.initials: TE
authors.lastname: Feldman
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* / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001145:Arrhythmias, Cardiac / Q000209:etiology / Q000628:therapy; D001315:Australia; D002114:Calcinosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002304:Cardiac Pacing, Artificial; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: TAVR; aortic stenosis; transcatheter aortic valve implantation; transfemoral