title: Single-center experience and short-term outcome with the JenaValve: a second-generation transapical transcatheter aortic valve implantation device.
abstract: OBJECTIVE
  We present the post-CE(Conformité Européenne)-mark single-center implantation experience and short-term outcome with the second-generation transapical JenaValve transcatheter aortic valve implantation system.
  
  
  METHODS
  Patients [N = 27; 9 women; mean (SD) age, 80.3 (5.5) years] were operated on between November 2011 and August 2012. Via a transapical approach, the valve was positioned, in some cases, repositioned, and finally implanted. All data were collected during the hospital stay.
  
  
  RESULTS
  The implantation success rate was 100%; the mean (SD) operation time was 124.7 (43.2) minutes; and the size of the implanted prosthesis was 23 mm (n = 6), 25 mm (n = 14), and 27 mm (n = 7). The in-hospital major adverse cardiac and cerebrovascular events were as follows: intraoperative resuscitation with subsequent aortic rupture (n = 1), postoperative hemorrhage needing revision (n = 1), myocardial infarction (n = 1), atrioventricular block needing a definitive pacemaker (n = 1), new-onset renal failure needing hemodialysis (n = 1), and stroke (n = 1). The 30-day mortality was 11.1% (n = 3). The mean (SD) intensive care unit/total stay was 2.2 (1.7)/11.7 (7.9) days. Postoperative echocardiography [day 6.7 (4.8)] revealed residual paravalvular leakage of trace to grade 1 in 12 patients (44.5%) and no leakage in 15 patients, with a mean (SD) transvalvular pressure gradient of 11.6 (5.6) mm Hg with significant reduction by 36.0 (17.7) mm Hg (P = 0.0001, Wilcoxon signed rank test).
  
  
  CONCLUSIONS
  This second-generation repositionable transcatheter aortic valve implantation device could safely and successfully be implanted with a fast learning curve, significant reduction in pressure gradients, overall clinical improvement at discharge, as well as an acceptable morbidity and mortality rate in this highest-risk patient cohort.
authors.affiliation: From the Departments of *Cardiac Surgery, †Cardiology, and ‡Anesthesiology, University Hospital Basel, Basel, Switzerland.
authors.forename: Oliver
authors.initials: O
authors.lastname: Reuthebuch
authors.forename: Devdas Thomas
authors.initials: DT
authors.lastname: Inderbitzin
authors.forename: Florian
authors.initials: F
authors.lastname: Rüter
authors.forename: Raban
authors.initials: R
authors.lastname: Jeger
authors.forename: Christoph
authors.initials: C
authors.lastname: Kaiser
authors.forename: Peter
authors.initials: P
authors.lastname: Buser
authors.forename: Jens
authors.initials: J
authors.lastname: Fassl
authors.forename: Friedrich S
authors.initials: FS
authors.lastname: Eckstein
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery; D006328:Cardiac Catheterization; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods* / Q000401:mortality; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D061646:Operative Time; D011183:Postoperative Complications; D013908:Thoracotomy