title: Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience.
abstract: OBJECTIVE
  Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion.
  
  
  BACKGROUND
  Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis.
  
  
  METHODS
  We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach.
  
  
  RESULTS
  A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events.
  
  
  CONCLUSIONS
  Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes.
authors.affiliation: Interventional Cardiology Unit, San Raffaele Institute, Milan, Italy. cosmogodino@gmail.com
authors.forename: Cosmo
authors.initials: C
authors.lastname: Godino
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.forename: Iassen
authors.initials: I
authors.lastname: Michev
authors.forename: Rasha
authors.initials: R
authors.lastname: Al-Lamee
authors.forename: Marta
authors.initials: M
authors.lastname: Bande
authors.forename: Marco
authors.initials: M
authors.lastname: Mussardo
authors.forename: Francesco
authors.initials: F
authors.lastname: Arioli
authors.forename: Alfonso
authors.initials: A
authors.lastname: Ielasi
authors.forename: Micaela
authors.initials: M
authors.lastname: Cioni
authors.forename: Maurizio
authors.initials: M
authors.lastname: Taramasso
authors.forename: Irina
authors.initials: I
authors.lastname: Arendar
authors.forename: Antonio
authors.initials: A
authors.lastname: Grimaldi
authors.forename: Pietro
authors.initials: P
authors.lastname: Spagnolo
authors.forename: Alberto
authors.initials: A
authors.lastname: Zangrillo
authors.forename: Giovanni
authors.initials: G
authors.lastname: La Canna
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000628:therapy*; D001366:Axillary Artery; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D005260:Female; D005263:Femoral Artery; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D017052:Hospital Mortality; D006801:Humans; D007558:Italy; D016015:Logistic Models; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D016019:Survival Analysis; D015996:Survival Rate; D013908:Thoracotomy; D013997:Time Factors; D016896:Treatment Outcome