title: Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve.
abstract: OBJECTIVE
  This study investigates the influence of implantation depth and prosthesis oversizing on conduction abnormalities (CA) and permanent pacemaker implantation (PPI) after SAPIEN 3 (Edwards Lifesciences, Irvine, California) implantation.
  
  
  BACKGROUND
  CA and PPIs are frequent complications after transcatheter aortic valve replacement with a next-generation balloon-expandable transcatheter heart valve (SAPIEN 3). The potential underlying mechanisms are incompletely understood.
  
  
  METHODS
  Of 244 patients treated with SAPIEN 3,208 without a previous pacemaker and 184 without baseline CA were analyzed. We assessed the association of angiographic implantation depth (% of frame height below the annulus) and degree of oversizing with PPI and CA.
  
  
  RESULTS
  New PPI and new or worsened CA or PPI occurred in 16% (34 of 208) and 31% (57 of 184), respectively. Patients requiring PPI had a higher prevalence of atrial fibrillation (44% vs. 24%; p = 0.017), complete right bundle branch block (27% vs. 5%; p = 0.001), and bradycardia (<60 beats/min, 38% vs. 21%; p = 0.034). In patients with new CA or PPI, implantation depth was lower (at septal side: 29 ± 8% vs. 25 ± 7%; p = 0.003), and rate of oversizing was higher (19% [11 of 57] vs. 6% [8 of 126]; p = 0.007). Independent predictors of new or worsened CA or PPI were implantation depth at septal side (odds ratio [OR]: 1.063 [95% confidence interval (CI): 1.017 to 1.110]; p = 0.006 per % of frame below the aortic annulus), oversizing (OR: 3.489 [95% CI: 1.236 to 9.848]; p = 0.018), and QRS duration (OR: 1.033 [95% CI: 1.011 to 1.056]; p = 0.003 per ms).
  
  
  CONCLUSIONS
  Implantation depth and prosthesis oversizing were associated with a higher rate of new CA or PPI using the SAPIEN 3. Thus, avoidance of deep implantation and extreme oversizing may reduce these complications.
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany. Electronic address: oliver.husser@gmail.com.
authors: Oliver
authors: O
authors: Husser
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors: Costanza
authors: C
authors: Pellegrini
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors: Thorsten
authors: T
authors: Kessler
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors: Christof
authors: C
authors: Burgdorf
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors: Hannah
authors: H
authors: Thaller
authors: Deutsches Herzzentrum München, Institut für Anästhesiologie, Technische Universität München, Munich, Germany.
authors: N Patrick
authors: NP
authors: Mayr
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors: Albert M
authors: AM
authors: Kasel
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
authors: Adnan
authors: A
authors: Kastrati
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
authors: Heribert
authors: H
authors: Schunkert
authors: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz- und Kreislauf-Forschung (DZHK) e.V. (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
authors: Christian
authors: C
authors: Hengstenberg
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery; D001281:Atrial Fibrillation / Q000209:etiology*; D001919:Bradycardia / Q000209:etiology*; D002037:Bundle-Branch Block / Q000209:etiology*; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D061330:Multidetector Computed Tomography; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D011446:Prospective Studies; D017755:Prosthesis Fitting; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects* / Q000379:methods*
keywords: conduction abnormalities; permanent pacemaker implantation; predictors; transcatheter aortic valve replacement