title: Pre-Implantation Balloon Aortic Valvuloplasty and Clinical Outcomes Following Transcatheter Aortic Valve Implantation: A Propensity Score Analysis of the UK Registry.
abstract: Aortic valve predilation with balloon aortic valvuloplasty (BAV) is recommended before transcatheter aortic valve implantation (TAVI), despite limited data around the requirement of this preprocedural step and the potential risks of embolization. This study aimed to investigate the trends in practice and associations of BAV on short-term outcomes in the UK TAVI registry.
  
  
  
  Eleven clinical endpoints were investigated, including 30-day mortality, myocardial infarction, aortic regurgitation, valve dysfunction, and composite early safety. All endpoints were defined as per the VARC-2 definitions. Odd ratios of each endpoint were estimated using logistic regression, with data analyzed in balloon- and self-expandable valve subgroups. Propensity scores were calculated using patient demographics and procedural variables, which were included in the models of each endpoint to adjust for measured confounding. Between 2007 and 2014, 5887 patients met the study inclusion criteria, 1421 (24.1%) of whom had no BAV before TAVI valve deployment. We observed heterogeneity in the use of BAV nationally, both temporally and by center experience; rates of BAV in pre-TAVI workup varied between 30% and 97% across TAVI centers. All endpoints were similar between treatment groups in SAPIEN (Edwards Lifesciences Inc., Irvine, CA) valve patients. After correction for multiple testing, none of the endpoints in CoreValve (Medtronic, Minneapolis, MN) patients were significantly different between patients with or without predilation.
  
  
  
  Performing TAVI without predilation was not associated with adverse short-term outcomes post procedure, especially when using a balloon-expandable prosthesis. Randomized trials including different valve types are required to provide conclusive evidence regarding the utility of predilation before-TAVI.
authors.affiliation: Health e-Research Centre, University of Manchester, Manchester, United Kingdom.
authors.forename: Glen P
authors.initials: GP
authors.lastname: Martin
authors.affiliation: Health e-Research Centre, University of Manchester, Manchester, United Kingdom.
authors.forename: Matthew
authors.initials: M
authors.lastname: Sperrin
authors.affiliation: Division of Cardiology, Department of Medicine, London Health Sciences Centre, University Hospital Western University, London, Ontario, Canada.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Bagur
authors.affiliation: James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Mark A
authors.initials: MA
authors.lastname: de Belder
authors.affiliation: Health e-Research Centre, University of Manchester, Manchester, United Kingdom.
authors.forename: Iain
authors.initials: I
authors.lastname: Buchan
authors.affiliation: Royal Stoke Hospital, University Hospitals North Midlands, Stoke-on-Trent, United Kingdom.
authors.forename: Mark
authors.initials: M
authors.lastname: Gunning
authors.affiliation: Queen Elizabeth Hospital, Birmingham, United Kingdom.
authors.forename: Peter F
authors.initials: PF
authors.lastname: Ludman
authors.affiliation: Health e-Research Centre, University of Manchester, Manchester, United Kingdom mamasmamas1@yahoo.co.uk.|Royal Stoke Hospital, University Hospitals North Midlands, Stoke-on-Trent, United Kingdom.|Keele Cardiovascular Research Group, Keele University, Stoke-on-Trent, United Kingdom.
authors.forename: Mamas A
authors.initials: MA
authors.lastname: Mamas
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D009017:Morbidity / Q000639:trends; D011183:Postoperative Complications / Q000453:epidemiology*; D057216:Propensity Score; D012042:Registries; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology
keywords: aortic stenosis; balloon valvuloplasty; balloon‐expandable; self‐expandable; transcatheter aortic valve implantation