title: Trans-apical aortic valve implantation using a new self-expandable bioprosthesis: initial outcomes.
abstract: OBJECTIVE
  Trans-apical aortic valve implantation (TA-AVI) has evolved into a standard approach for high-risk, elderly patients using the balloon-expandable Edwards SAPIEN™ prosthesis. As an alternative device, a self-expanding sub-coronary trans-apical bioprosthesis was evaluated.
  
  
  METHODS
  The Symetis Acurate™ trans-catheter heart valve is composed of a porcine biologic valve attached to a self-expandable nitinol stent. It allows for anatomical orientation, and facilitates intuitive implantation providing tactile feedback. Three valves sizes were available to treat patients with an annular diameter between 21 and 27mm.
  
  
  RESULTS
  Since November 2009, a total of 40 patients have been treated at three sites. Patient age was 82.8±4 years, 60% were female, logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) was 21.5±10.9% and Society of Thoracic Surgeons (STS) Score was 9.0±4.6%. All implants were delivered successfully in the intra-annular and sub-coronary position off pump. One patient was converted to conventional surgery due to coronary impingement; post-dilatation was performed in 45% of patients; and two patients required the SAPIEN™ valve in valve implantation. Echocardiographic and angiographic control revealed no/trivial aortic incompetence (AI) in 59%, mild AI in 33.3%, and moderate AI in 7.7% of the patients. Three patients died within 30 days from a non-valve-related cause (respiratory), the patient converted did not recover from right-heart failure, and one patient died on day 19 due to unclear reasons. There was one incidence of new-onset atrioventricular (AV) block requiring pacemaker implantation. Two patients suffered a stroke (one secondary and the other intraprocedural). Transvalvular gradients were maximum 29.4±10.7mmHg and mean 14.3±6.8mmHg.
  
  
  CONCLUSIONS
  The initial clinical results indicate a relatively straightforward implantation procedure and good functional results after trans-apical implantation of the Symetis Acurate™ device.
authors.affiliation: Heartcenter University of Leipzig, Leipzig, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kempfert
authors.forename: Ardawan J
authors.initials: AJ
authors.lastname: Rastan
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.forename: Markus
authors.initials: M
authors.lastname: Schönburg
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Stefan
authors.initials: S
authors.lastname: Sorg
authors.forename: Friedrich-W
authors.initials: FW
authors.lastname: Mohr
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001705:Bioprosthesis; D005260:Female; D005471:Fluoroscopy / Q000379:methods; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation / Q000379:methods; D011474:Prosthesis Design; D015641:Radiography, Interventional / Q000379:methods; D015607:Stents; D016896:Treatment Outcome