title: Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve.
abstract: BACKGROUND
  The SAPIEN 3 (Edwards Lifesciences Inc., Irvine, California) transcatheter valve incorporates features designed to address the well-known deficiencies of transcatheter aortic valve replacement (TAVR). An ultra-low-profile delivery system facilitates safe, controlled, and accurate implantation and an external seal minimizes paravalvular regurgitation.
  
  
  OBJECTIVE
  The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis.
  
  
  METHODS
  The prospective study enrolled 150 patients at 16 sites in Europe and Canada. Clinical and echocardiographic outcomes were assessed at baseline, post-procedure, and 30 days. New sizing recommendations were developed during the course of the study.
  
  
  RESULTS
  Patients were 83.6 ± 5.0 years of age, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5% and logistic EuroSCORE of 21.6 ± 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Nontransfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%).
  
  
  CONCLUSIONS
  This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients. (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [SAPIEN3]; NCT01808287).
authors.affiliation: St. Paul's Hospital, University of British Columbia, Vancouver, Canada. Electronic address: john.webb@vch.ca.
authors.forename: John
authors.initials: J
authors.lastname: Webb
authors.affiliation: Policlinico Universitario, Padova, Italy.
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
authors.affiliation: Institut Jacques Cartier, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: St. Paul's Hospital, University of British Columbia, Vancouver, Canada.
authors.forename: Jonathon
authors.initials: J
authors.lastname: Leipsic
authors.affiliation: Royal Victoria Hospital, Belfast, Northern Ireland, United Kingdom.
authors.forename: Mark
authors.initials: M
authors.lastname: Spence
authors.affiliation: St. Thomas' Hospital, London, United Kingdom.
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Universitätsklinikum Essen, Essen, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.affiliation: Universitätsklinikum Eppendorf, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
authors.affiliation: King's College Hospital, London, United Kingdom.
authors.forename: Olaf
authors.initials: O
authors.lastname: Wendler
authors.affiliation: Kerckhoff Clinic, Bad Nauheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D004452:Echocardiography; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D063868:Patient Outcome Assessment; D011446:Prospective Studies; D011474:Prosthesis Design; D017755:Prosthesis Fitting; D020521:Stroke / Q000453:epidemiology
keywords: aortic stenosis; transcatheter aortic valve replacement