title: Clinical experience with the second-generation 3f Enable sutureless aortic valve prosthesis.
abstract: OBJECTIVE
  The 3f Enable aortic bioprosthesis (ATS Medical, Inc, Minneapolis, Minn) represents a new generation of equine pericardial self-expanding valve designed for sutureless implantation. This study evaluated technical aspects of implantation and safety and effectiveness of the valve in the short term.
  
  
  METHODS
  In an outcome analysis of a consecutive series of 28 patients who underwent aortic valve replacement for aortic stenosis with the 3f Enable during an 18-month period, mean age was 75.7 +/- 6.6 years, 18 patients were female (64.2%), and mean EuroSCORE was 7.1% +/- 1.7%.
  
  
  RESULTS
  Most implanted valves were 23 mm in diameter (19-27 mm). Mean aortic crossclamp time was 39 +/- 15 minutes (29-103 minutes), mean cardiopulmonary bypass time was 58 +/- 20 minutes (41-127 minutes), mean hospital stay was 11 days (7-22 days), and 30-day mortality was 3.5%. Mean and peak intraoperative transvalvular pressure gradients were 6.1 +/- 2.6 and 18 +/- 5 mm Hg, respectively. Trivial and mild paravalvular leaks were observed in 1 patient each. One patient underwent reoperative aortic valve replacement 4 months after initial surgery for severe valve-unrelated paravalvular leakage. Five patients (18.5%) required permanent pacemakers. No patients were unavailable for follow-up. One-year survival was 86.2%.
  
  
  CONCLUSIONS
  The 3-f Enable aortic bioprosthesis can be implanted safely with favorable early hemodynamics. The self-expanding stent allows sutureless implantation with a large valve area. The procedure was fast, although not as fast as expected. This experience has led to continued design and procedural enhancements to facilitate and accelerate future implantation.
authors.affiliation: Department of Cardiovascular Surgery, University Hospital Berne, Berne, Switzerland.
authors.forename: Thierry
authors.initials: T
authors.lastname: Aymard
authors.forename: Alexander
authors.initials: A
authors.lastname: Kadner
authors.forename: Nazan
authors.initials: N
authors.lastname: Walpoth
authors.forename: Volkhart
authors.initials: V
authors.lastname: Göber
authors.forename: Lars
authors.initials: L
authors.lastname: Englberger
authors.forename: Mario
authors.initials: M
authors.lastname: Stalder
authors.forename: Friedrich
authors.initials: F
authors.lastname: Eckstein
authors.forename: Claudia
authors.initials: C
authors.lastname: Zobrist
authors.forename: Thierry
authors.initials: T
authors.lastname: Carrel
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D001705:Bioprosthesis; D002304:Cardiac Pacing, Artificial; D002315:Cardiopulmonary Bypass; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006736:Horses; D006801:Humans; D007902:Length of Stay; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D012086:Reoperation; D013997:Time Factors; D016896:Treatment Outcome