title: True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device: impact of learning curve on vascular complications.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the incidence of vascular complications and the predictors of Prostar failure for a "true percutaneous approach" in transfemoral transcatheter aortic valve implantation (TAVI).
  
  
  BACKGROUND
  Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort.
  
  
  METHODS
  Among 264 patients included in our prospective TAVI database (October 2006 to December 2010), transfemoral-TAVI was performed in 170 patients. True percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar was defined as adequate hemostasis without Prostar-related vascular complications. We compared the incidence of vascular complications in our early and late experience.
  
  
  RESULTS
  Patients were 83.0±7.2 years old and with a EuroSCORE of 24.0±11.6%. The Edwards valve (Edwards Lifesciences, Irvine, California) (18- to 24-F) was used in 109 cases and the CoreValve (Medtronic, Minneapolis, Minnesota) (18-F) in 31. The sheath outer diameter to minimal femoral diameter ratio (SFAR) was 0.96±0.14. Successful closure was achieved in 90.7%, and was significantly increased (95.7% vs. 85.7%, p=0.047) in the late experience group. Cross-over to surgery was required in 3.6%. Vascular complications occurred in 20.0%, and were significantly lower in the late experience group (11.4% vs. 28.6%, p=0.012). Major vascular complications (2.9% vs. 14.3%, p=0.018) were decreased in the late experience group. Early experience (hazard ratio [HR]: 3.66, 95% confidence interval [CI]: 1.04 to 13.89, p=0.047) and SFAR (HR: 110.80, 95% CI: 1.15 to 10,710.73, p=0.044) predicted Prostar failure by univariate analysis.
  
  
  CONCLUSIONS
  Experience reduced major vascular complications in a true percutaneous approach for transfemoral-TAVI. Further application of this less invasive strategy is feasible and may be beneficial, in this high-risk patient cohort.
authors.affiliation: Institut Cardiovasculaire Paris Sud, Massy, France.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Hayashida
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.forename: Bernard
authors.initials: B
authors.lastname: Chevalier
authors.forename: Thomas
authors.initials: T
authors.lastname: Hovasse
authors.forename: Mauro
authors.initials: M
authors.lastname: Romano
authors.forename: Philippe
authors.initials: P
authors.lastname: Garot
authors.forename: Darren
authors.initials: D
authors.lastname: Mylotte
authors.forename: Jhonathan
authors.initials: J
authors.lastname: Uribe
authors.forename: Arnaud
authors.initials: A
authors.lastname: Farge
authors.forename: Patrick
authors.initials: P
authors.lastname: Donzeau-Gouge
authors.forename: Erik
authors.initials: E
authors.lastname: Bouvier
authors.forename: Bertrand
authors.initials: B
authors.lastname: Cormier
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology*; D001024:Aortic Valve Stenosis / Q000473:pathology* / Q000601:surgery; D002983:Clinical Competence; D016001:Confidence Intervals; D004868:Equipment Failure; D005260:Female; D006305:Health Status Indicators; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D007858:Learning; D059032:Learning Curve; D008297:Male; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D017211:Treatment Failure