title: Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Balloon-Expandable Transcatheter Heart Valve: A Single-Center Experience.
abstract: OBJECTIVE
  Evaluation of 30-day outcomes after transcatheter aortic valve replacement (TAVR) with the novel balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV) (Edwards Lifesciences, Irvine, California) emphasizing the updated Valve Academic Research Consortium (VARC-2) criteria.
  
  
  BACKGROUND
  Preliminary data on clinical performance with the S3 THV are promising. However, information regarding 30-day outcome is limited.
  
  
  METHODS
  A total of 250 consecutive patients undergoing transfemoral TAVR with the S3 THV at our center were enrolled, and outcomes according to VARC-2 criteria were analyzed at 30 days.
  
  
  RESULTS
  The mean age was 81.0 ± 6.2 years, median logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and Society of Thoracic Surgeons score were 12.1% and 4.4%, respectively. VARC-2-defined device success was achieved in 244 patients (97.6%); moderate paravalvular leakage developed in 5 patients (2.0%). One patient (0.4%) died of a noncardiac cause and 8 patients (3.2%) had a stroke. Life-threatening bleeding and major vascular complications occurred in 12 (4.8%) and 9 (3.6%) of the patients, respectively. From discharge to 30 days, 5 patients (2.0%) were hospitalized due to valve-related symptoms or worsening of heart failure. The VARC-2 composite early safety endpoint was observed in 25 patients (10.0%). Permanent pacemaker implantation rate at 30 days was 15.2%. Myocardial infarction, coronary obstruction requiring intervention, valve-related dysfunction, and endocarditis were not observed.
  
  
  CONCLUSIONS
  We found very good 30-day results using the novel S3 THV with a low rate of clinical events according to VARC-2 criteria. The S3 THV is associated with high procedural success and favorable early safety profile. The need for pacemaker implantations appears to be more frequent than with its predecessor.
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany. Electronic address: oliver.husser@gmail.com.
authors.forename: Oliver
authors.initials: O
authors.lastname: Husser
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors.forename: Costanza
authors.initials: C
authors.lastname: Pellegrini
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Kessler
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors.forename: Christof
authors.initials: C
authors.lastname: Burgdorf
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors.forename: Hannah
authors.initials: H
authors.lastname: Thaller
authors.affiliation: Deutsches Herzzentrum München, Institut für Anästhesiologie, Technische Universität München, Munich, Germany.
authors.forename: N Patrick
authors.initials: NP
authors.lastname: Mayr
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany.
authors.forename: Albert M
authors.initials: AM
authors.lastname: Kasel
authors.affiliation: 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.forename: Heribert
authors.initials: H
authors.lastname: Schunkert
authors.affiliation: 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.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: 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. Electronic address: christian.hengstenberg@gmail.com.
authors.forename: Christian
authors.initials: C
authors.lastname: Hengstenberg
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D002406:Catheterization, Peripheral / Q000379:methods*; D004452:Echocardiography; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D005858:Germany / Q000453:epidemiology; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D008297:Male; D061330:Multidetector Computed Tomography; D011183:Postoperative Complications / Q000453:epidemiology*; D011474:Prosthesis Design; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome
keywords: SAPIEN 3; VARC-2; aortic valve stenosis; outcome; transfemoral transcatheter aortic valve implantation