title: Outcome of patients treated with Engager transapical aortic valve implantation: one-year results of the feasibility study.
abstract: OBJECTIVE
  The aim of this study was to investigate the short-term and midterm outcome of the Engager transcatheter aortic valve implantation (TAVI) system, a transapical self-expanding valve device with anatomic orientation.
  
  
  METHODS
  Transapical aortic valve implantation with the Engager valve prosthesis was performed in 10 patients. Endpoints were defined according to the Valve Academic Research Consortium recommendations for reporting outcomes of TAVI in clinical trials. Follow-up has been completed after 30 days and 1 year.
  
  
  RESULTS
  All patients underwent the implantation procedure successfully. No device-related or delivery system-related complications were observed. One patient died of non-device-related reasons at postoperative day 23 in multiorgan failure. At 30-day follow-up, no more than mild transvalvular and paravalvular aortic regurgitation were seen. After 1 year, no transvalvular regurgitation was observed as assessed by transthoracic echocardiography. None of the patients had more than mild paravalvular leakage. The mean ± SD gradient was 15.3 ± 4.2 mm Hg. New York Heart Association class decreased one degree in mean and sustained until 1-year follow-up. No more patients died until 1-year follow-up.
  
  
  CONCLUSIONS
  Application of the Engager TAVI system is safe and reliable. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and successful in all patients. No device-related or delivery system-related complications occurred. Procedural, short-term, and midterm results up to 1 year concerning the aortic valve performance are promising, with stable mean gradients and low rates of even mild regurgitation.
authors.affiliation: From the *Division of Cardiovascular Surgery, and †Division of Cardiology, University Hospital Zurich, Zurich, Switzerland; ‡Department of Cardiac Surgery, and §Department of Cardiology, Heart Center Leipzig, Leipzig, Germany; and ∥Department of Cardiovascular Surgery, German Heart Centre Munich, Munich, Germany.
authors.forename: Simon H
authors.initials: SH
authors.lastname: Sündermann
authors.forename: Jürg
authors.initials: J
authors.lastname: Grünenfelder
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.forename: Ardawan J
authors.initials: AJ
authors.lastname: Rastan
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
authors.forename: Volkmar
authors.initials: V
authors.lastname: Falk
authors.forename: Sabine
authors.initials: S
authors.lastname: Bleiziffer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000453:epidemiology; D001024:Aortic Valve Stenosis / Q000601:surgery; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods; D006801:Humans; D008297:Male; D016896:Treatment Outcome