title: Incidence and predictors of permanent pacemaker implantation following treatment with the repositionable Lotus™ transcatheter aortic valve.
abstract: OBJECTIVE
  To determine the incidence and predictors of permanent pacemaker (PPM) requirement following transcatheter aortic valve replacement (TAVR) with the mechanically expanded LotusTMValve System (Boston Scientific).
  
  
  BACKGROUND
  Pacemaker implantation is the most common complication following TAVR. Predictors of pacing following TAVR with the Lotus valve have not been systematically assessed.
  
  
  METHODS
  Consecutive patients with severe aortic stenosis who underwent Lotus valve implantation were prospectively recruited at a single-centre. Patients with a pre-existing PPM were excluded. Baseline ECG, echocardiographic and multiple detector computed tomography as well as procedural telemetry and depth of implantation were independently analyzed in a blinded manner. The primary endpoint was 30-day incidence of pacemaker requirement (PPM implantation or death while pacing-dependent). Multivariate analysis was performed to identify independent predictors of the primary endpoint.
  
  
  RESULTS
  A total of 104 consecutive patients underwent TAVR with the Lotus valve with 9/104 (9%) with a pre-existing PPM excluded. New or worsened procedural LBBB occurred in 78%. Thirty-day incidence of the primary pacing endpoint was 28%. The most common indication for PPM implantation was complete heart block (CHB) (69%). Independent predictors of the primary endpoint included pre-existing RBBB (hazard ratio [HR] 2.8, 95% CI 1.1-7.0; P = 0.032) and depth of implantation below the noncoronary cusp (NCC) (HR 2.4, 95% CI 1.0-5.7; P = 0.045).
  
  
  CONCLUSIONS
  Almost a third of Lotus valve recipients require pacemaker implantation within 30 days. The presence of pre-existing RBBB and the depth of prosthesis implantation below the NCC were significant pacing predictors. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Monash Cardiovascular Research Centre, Department of Medicine (Monash Medical Centre), School of Clinical Sciences, Monash University.|Cardiovascular Division, Monash Heart, Monash Medical Centre, Melbourne, Victoria, Australia.
authors.forename: Sarah
authors.initials: S
authors.lastname: Zaman
authors.affiliation: Monash Cardiovascular Research Centre, Department of Medicine (Monash Medical Centre), School of Clinical Sciences, Monash University.|Cardiovascular Division, Monash Heart, Monash Medical Centre, Melbourne, Victoria, Australia.
authors.forename: Liam
authors.initials: L
authors.lastname: McCormick
authors.affiliation: Monash Cardiovascular Research Centre, Department of Medicine (Monash Medical Centre), School of Clinical Sciences, Monash University.|Cardiovascular Division, Monash Heart, Monash Medical Centre, Melbourne, Victoria, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Gooley
authors.affiliation: Monash Cardiovascular Research Centre, Department of Medicine (Monash Medical Centre), School of Clinical Sciences, Monash University.
authors.forename: Hashrul
authors.initials: H
authors.lastname: Rashid
authors.affiliation: Monash Cardiovascular Research Centre, Department of Medicine (Monash Medical Centre), School of Clinical Sciences, Monash University.
authors.forename: Satish
authors.initials: S
authors.lastname: Ramkumar
authors.affiliation: Monash Cardiovascular Research Centre, Department of Medicine (Monash Medical Centre), School of Clinical Sciences, Monash University.
authors.forename: Damon
authors.initials: D
authors.lastname: Jackson
authors.affiliation: Monash Cardiovascular Research Centre, Department of Medicine (Monash Medical Centre), School of Clinical Sciences, Monash University.
authors.forename: Samuel
authors.initials: S
authors.lastname: Hui
authors.affiliation: Monash Cardiovascular Research Centre, Department of Medicine (Monash Medical Centre), School of Clinical Sciences, Monash University.|Cardiovascular Division, Monash Heart, Monash Medical Centre, Melbourne, Victoria, Australia.
authors.forename: Ian T
authors.initials: IT
authors.lastname: Meredith
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000401:mortality; D016009:Chi-Square Distribution; D004452:Echocardiography; D004562:Electrocardiography; D005260:Female; D006327:Heart Block / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008297:Male; D061330:Multidetector Computed Tomography; D015999:Multivariate Analysis; D016017:Odds Ratio; D010138:Pacemaker, Artificial; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D014739:Victoria
keywords: aortic valve disease; electron beam CT/multidetector CT; imaging; percutaneous intervention; transcatheter valve implantation