title: Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: feasibility and safety.
abstract: BACKGROUND
  Balloon valvuloplasty has been considered a mandatory step of the transcatheter aortic valve implantation (TAVI), although it is not without risk. The aim of this work was to evaluate the feasibility and safety of TAVI performed without pre-dilation (direct TAVI) of the stenosed aortic valve.
  
  
  METHODS
  Between June 2012 and June 2013, 55 consecutive TAVI performed without pre-dilation at our institution using the self-expandable CoreValve prosthesis (Medtronic, Minneapolis, MN) were analyzed and compared with 45 pre-dilated TAVI performed the previous year. Inclusion criteria were a symptomatic and severe aortic stenosis. Exclusion criteria were defined as presence of pure aortic regurgitation, degenerated surgical bioprosthesis or bicuspid aortic valve and prior procedure of balloon aortic valvuloplasty performed as a bridge to TAVI.
  
  
  RESULTS
  High-burden calcification in the device landing zone, assessed by CT scan, was found in most of the patients. The valve size implanted was similar in both groups. Device success was higher in direct TAVI (85%vs.64%,p=0.014), mostly driven by a significant lower incidence of paravalvular leak (PVL≥2;9%vs.33%,p=0.02). Safety combined end point at 30 days was similar in both groups.
  
  
  CONCLUSIONS
  Compared to TAVI with pre-dilation, direct TAVI is feasible regardless of the presence of bulky calcified aortic valve and the valve size implanted. Device success was higher in direct TAVI, mostly driven by a lower incidence of paravalvular leak. Safety at 30 days was similar in two groups.
authors.affiliation: Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia, Italy. Electronic address: clafiorina@yahoo.it.
authors.forename: Claudia
authors.initials: C
authors.lastname: Fiorina
authors.affiliation: Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Maffeo
authors.affiliation: Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Curello
authors.affiliation: Division of Cardiology, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Felicia
authors.initials: F
authors.lastname: Lipartiti
authors.affiliation: Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Chizzola
authors.affiliation: Division of Cardiology, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: D'Aloia
authors.affiliation: Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Marianna
authors.initials: M
authors.lastname: Adamo
authors.affiliation: Division of Cardiothoracic Anestesiology, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Rosy
authors.initials: R
authors.lastname: Mastropierro
authors.affiliation: Department of Radiology, University of Brescia, Spedali Civili, Brescia, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Gavazzi
authors.affiliation: Division of Cardiology, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Camilla
authors.initials: C
authors.lastname: Ciccarese
authors.affiliation: Division of Cardiology, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Ermanna
authors.initials: E
authors.lastname: Chiari
authors.affiliation: Cardiac Catheterization Laboratory, Cardiothoracic Department, Spedali Civili, Brescia, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Ettori
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D063126:Balloon Valvuloplasty; D001705:Bioprosthesis; D002114:Calcinosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D007558:Italy; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: Balloon valvuloplasty pre-dilation; TAVI