title: A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial.
abstract: OBJECTIVE
  In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients.
  
  
  RESULTS
  The study was designed as a randomised controlled trial of a-TAVI (Edwards SAPIEN heart valve system; Edwards Lifesciences, Irvine, CA, USA) vs. SAVR. Operable patients with isolated aortic valve stenosis and an age ≥75 years were included. The primary endpoint was the composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 days. After advice from the Data Safety Monitoring Board, the study was prematurely terminated after the inclusion of 70 patients because of an excess of events in the a-TAVI group. The primary endpoint was met in five a-TAVI patients (two deaths, two strokes, and one case of renal failure requiring dialysis) vs. one stroke in the SAVR group (p=0.07). In the a-TAVI group, one patient was converted to SAVR because of an abnormally positioned heart, and four patients were re-operated with open heart surgery because of annulus rupture (n=1), severe paravalvular leakage (n=2), and blockage of the left coronary artery (n=1). In the SAVR group, one patient was converted to TAVI because of a large intra-thoracic goitre.
  
  
  CONCLUSIONS
  Given the limitations of a small prematurely terminated study, our results suggest that a-TAVI in its present form may be associated with complications and device success rates in low-risk patients similar or even inferior to those found in high-risk patients with aortic valve stenosis. This will probably change in the near future with improved catheter based devices and better pre-procedural assessment.
authors.affiliation: Department of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Denmark.
authors.forename: Hans H M
authors.initials: HH
authors.lastname: Nielsen
authors.forename: Kaj E
authors.initials: KE
authors.lastname: Klaaborg
authors.forename: Henrik
authors.initials: H
authors.lastname: Nissen
authors.forename: Kim
authors.initials: K
authors.lastname: Terp
authors.forename: Poul E
authors.initials: PE
authors.lastname: Mortensen
authors.forename: Bo J
authors.initials: BJ
authors.lastname: Kjeldsen
authors.forename: Carl-Johan
authors.initials: CJ
authors.lastname: Jakobsen
authors.forename: Henning R
authors.initials: HR
authors.lastname: Andersen
authors.forename: Henrik
authors.initials: H
authors.lastname: Egeblad
authors.forename: Lars R
authors.initials: LR
authors.lastname: Krusell
authors.forename: Leif
authors.initials: L
authors.lastname: Thuesen
authors.forename: Vibeke E
authors.initials: VE
authors.lastname: Hjortdal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000601:surgery*; D006328:Cardiac Catheterization; D004452:Echocardiography; D005260:Female; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects; D006801:Humans; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome