title: Feasibility of the Engager™ aortic transcatheter valve system using a flexible over-the-wire design.
abstract: OBJECTIVE
  The aim was to investigate the safety and feasibility of the redesigned Engager™ transcatheter aortic valve implantation (TAVI) system.
  
  
  METHODS
  Transapical aortic valve implantation with the Engager™ valve prosthesis was intended in 11 patients, and performed in 10. Endpoints were defined according to the valve academic research consortium recommendations for reporting outcomes of TAVI in clinical trials.
  
  
  RESULTS
  All 10 patients were implanted successfully. No devicerelated or delivery system complications like coronary obstruction or aortic dissection emerged. One patient (10%) died from non-device-related reasons at post-operative day 23 of multi-organ failure. The invasively measured peak-to-peak gradient after valve implantation was 7.1 ± 3.5 mmHg. In 90%, there was no or only trivial (≤grad I) aortic regurgitation due to paravalvular leakage. In 10% of the patients, aortic regurgitation grade I-II was observed. At 30-day follow up, the mean gradient was 15.6 ± 4.9 mmHg, and no more than a mild transvalvular and paravalvular aortic regurgitation was seen as assessed by transthoracic echocardiography.
  
  
  CONCLUSIONS
  Application of the Engager™ TAVI system is safe and feasible. Prosthesis deployment in an anatomically correct position was facilitated by the design of the valve prosthesis and was successful in all patients. No device or delivery-system-related complications emerged. Safety and feasibility endpoints were met. Good results concerning the aortic valve performance after implantation and at 30-day follow up were ascertained. These results encouraged the start of a European Pivotal trial including patients to date.
authors: Division of Cardiac and Vascular Surgery, University Hospital Zurich, Zurich, Switzerland. simon.suendermann@usz.ch
authors: Simon H
authors: SH
authors: Sündermann
authors: Jürg
authors: J
authors: Grünenfelder
authors: Roberto
authors: R
authors: Corti
authors: Ardawan J
authors: AJ
authors: Rastan
authors: Axel
authors: A
authors: Linke
authors: Rüdiger
authors: R
authors: Lange
authors: Volkmar
authors: V
authors: Falk
authors: Sabine
authors: S
authors: Bleiziffer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D057510:Endovascular Procedures / Q000295:instrumentation* / Q000379:methods; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D011183:Postoperative Complications; D011474:Prosthesis Design; D016896:Treatment Outcome