title: Transcatheter aortic valve implantation in patients with bicuspid aortic valve: A patient level multi-center analysis.
abstract: OBJECTIVE
  We sought to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with bicuspid aortic valve (BiAV).
  
  
  BACKGROUND
  BiAV remains a relative contraindication to TAVI resulting in exclusion from TAVI trials and thus limiting data on the clinical performance of transcatheter valves in these patients.
  
  
  METHODS
  We conducted an international patient level multicenter analysis on outcomes in patients with BiAV undergoing TAVI. The primary outcome of the study was the combined early safety endpoint--a composite of 30 day mortality, stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction, major vascular complication and valve related dysfunction. Secondary endpoints included the individual components of the primary endpoint as well as post-TAVI paravalvular leak (PVL), rehospitalization, new pacemaker insertion and device success rates at 30 days and 1 year.
  
  
  RESULTS
  A total of 108 patients with BiAV were identified in 21 centers in Canada, Spain, Italy, Poland and Singapore who underwent TAVI between January 2005 and March 2014. The composite primary outcome occurred in one quarter of patients (26.9%)--mainly driven by re-intervention for valve malposition (9.3%). The 30-day and 1 year mortality rates were 8.3% and 16.9% respectively with AR ≥ 3+ occurring in 9.6% of patients. Device success was achieved in 85.2% of cases with pacemaker insertion in 19.4%. While PVL was not associated with an increased risk of 30 day or 1 year mortality--Type I BiAV anatomy with left and right cusp fusion had significantly better outcomes than other valve variants.
  
  
  CONCLUSIONS
  In selected patients with BiAV and severe aortic stenosis, TAVI appears both safe and feasible with acceptable clinical outcomes. Clinical studies of TAVI in this patient population are warranted.
authors.affiliation: Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Altayyeb
authors.initials: A
authors.lastname: Yousef
authors.affiliation: Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Trevor
authors.initials: T
authors.lastname: Simard
authors.affiliation: Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: John
authors.initials: J
authors.lastname: Webb
authors.affiliation: Quebec Heart and Lung Institute, Quebec City, Quebec, Canada.
authors.forename: Josep
authors.initials: J
authors.lastname: Rodés-Cabau
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, Imperial College London, London, United Kingdom.
authors.forename: Charis
authors.initials: C
authors.lastname: Costopoulos
authors.affiliation: Ist Department of Cardiology, The Medical University of Warsaw, Poland.
authors.forename: Janusz
authors.initials: J
authors.lastname: Kochman
authors.affiliation: Hospital Universitario Virgen de la Victoria, Málaga, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Hernández-Garcia
authors.affiliation: Department of Cardiology, National Heart Centre Singapore, The Heart And Vascular Centre, Mount Elizabeth Medical Centre, Singapore.
authors.forename: Paul T L
authors.initials: PT
authors.lastname: Chiam
authors.affiliation: Department of Cardiology, Mazankowski Alberta Heart Institute, University of Alberta, Alberta, Canada.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Welsh
authors.affiliation: Schulich Heart Center, Department of Medicine, Sunnybrok Health Sciences Center, University of Toronto, Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences (ICES), Toronto, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.
authors.forename: Harindra C
authors.initials: HC
authors.lastname: Wijeysundera
authors.affiliation: Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: Eulogio
authors.initials: E
authors.lastname: García
authors.affiliation: Quebec Heart and Lung Institute, Quebec City, Quebec, Canada.
authors.forename: Henrique B
authors.initials: HB
authors.lastname: Ribeiro
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Ist Department of Cardiology, The Medical University of Warsaw, Poland.
authors.forename: Zenon
authors.initials: Z
authors.lastname: Huczek
authors.affiliation: Department of Cardiology, Mazankowski Alberta Heart Institute, University of Alberta, Alberta, Canada.
authors.forename: Miriam
authors.initials: M
authors.lastname: Shanks
authors.affiliation: Department of Cardiology, IRCCS Pol. San Donato, San Donato Milanese, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Testa
authors.affiliation: Peter Munk Center, University Health Network, Toronto, Ontario, Canada; Richard Lewar Centre in Cardiovascular Research, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Farkouh
authors.affiliation: Division of Cardiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Danny
authors.initials: D
authors.lastname: Dvir
authors.affiliation: Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada.
authors.forename: James L
authors.initials: JL
authors.lastname: Velianou
authors.affiliation: Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Buu-Khanh
authors.initials: BK
authors.lastname: Lam
authors.affiliation: Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Ali
authors.initials: A
authors.lastname: Pourdjabbar
authors.affiliation: Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: Glover
authors.affiliation: Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Hibbert
authors.affiliation: Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada. Electronic address: mlabinaz@ottawaheart.ca.
authors.forename: Marino
authors.initials: M
authors.lastname: Labinaz
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D001021:Aortic Valve / Q000002:abnormalities* / Q000000981:diagnostic imaging; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging* / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D000082882:Bicuspid Aortic Valve Disease; D016009:Chi-Square Distribution; D017548:Echocardiography, Transesophageal / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006349:Heart Valve Diseases / Q000150:complications / Q000000981:diagnostic imaging*; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D018570:Risk Assessment; D012737:Sex Factors; D016019:Survival Analysis; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods* / Q000401:mortality; D016896:Treatment Outcome
keywords: Aortic valve stenosis; Bicuspid aortic valve; Congenital aortic valve stenosis; Transcatheter aortic valve implantation (TAVI)