title: Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA).
abstract: OBJECTIVE
  The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA).
  
  
  METHODS
  From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center).
  
  
  RESULTS
  All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm(2). These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases.
  
  
  CONCLUSIONS
  TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.
authors.affiliation: Division of Cardiac Surgery, University of Padova, Padova, Italy. adonofrio@hotmail.it
authors.forename: Augusto
authors.initials: A
authors.lastname: D'Onofrio
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
authors.forename: Melissa
authors.initials: M
authors.lastname: Fusari
authors.forename: Loris
authors.initials: L
authors.lastname: Salvador
authors.forename: Francesco
authors.initials: F
authors.lastname: Musumeci
authors.forename: Mauro
authors.initials: M
authors.lastname: Rinaldi
authors.forename: Ettore O
authors.initials: EO
authors.lastname: Vitali
authors.forename: Mattia
authors.initials: M
authors.lastname: Glauber
authors.forename: Roberto
authors.initials: R
authors.lastname: Di Bartolomeo
authors.forename: Ottavio R
authors.initials: OR
authors.lastname: Alfieri
authors.forename: Elvio
authors.initials: E
authors.lastname: Polesel
authors.forename: Marco
authors.initials: M
authors.lastname: Aiello
authors.forename: Riccardo
authors.initials: R
authors.lastname: Casabona
authors.forename: Ugolino
authors.initials: U
authors.lastname: Livi
authors.forename: Claudio
authors.initials: C
authors.lastname: Grossi
authors.forename: Mauro
authors.initials: M
authors.lastname: Cassese
authors.forename: Aniello
authors.initials: A
authors.lastname: Pappalardo
authors.forename: Tiziano
authors.initials: T
authors.lastname: Gherli
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Stefanelli
authors.forename: Giuseppe G
authors.initials: GG
authors.lastname: Faggian
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000503:physiopathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality; D016009:Chi-Square Distribution; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D006439:Hemodynamics; D006761:Hospitals; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D059032:Learning Curve; D016015:Logistic Models; D008297:Male; D016017:Odds Ratio; D011446:Prospective Studies; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome