title: 2-year follow-up of patients undergoing transcatheter aortic valve implantation using a self-expanding valve prosthesis.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the safety, device performance, and clinical outcome up to 2 years for patients undergoing transcatheter aortic valve implantation (TAVI).
  
  
  BACKGROUND
  The role of TAVI in the treatment of calcific aortic stenosis evolves rapidly, but mid- and long-term results are scarce.
  
  
  METHODS
  We conducted a prospective, multicenter, single-arm study with symptomatic patients undergoing TAVI for treatment of severe aortic valve stenosis using the 18-F Medtronic CoreValve (Medtronic, Minneapolis, Minnesota) prosthesis.
  
  
  RESULTS
  In all, 126 patients (mean age 82 years, 42.9% male, mean logistic European System for Cardiac Operative Risk Evaluation score 23.4%) with severe aortic valve stenosis (mean gradient 46.8 mm Hg) underwent the TAVI procedure. Access was transfemoral in all but 2 cases with subclavian access. Retrospective risk stratification classified 54 patients as moderate surgical risk, 51 patients as high-risk operable, and 21 patients as high-risk inoperable. The overall technical success rate was 83.1%. Thirty-day all-cause mortality was 15.2%, without significant differences in the subgroups. At 2 years, all-cause mortality was 38.1%, with a significant difference between the moderate-risk group and the combined high-risk groups (27.8% vs. 45.8%, p = 0.04). This difference was mainly attributable to an increased risk of noncardiac mortality among patients constituting the high-risk groups. Hemodynamic results remained unchanged during follow-up (mean gradient: 8.5 ± 2.5 mm Hg at 30 days and 9.0 ± 3.4 mm Hg at 2 years). Functional class improved in 80% of patients and remained stable over time. There was no incidence of structural valve deterioration.
  
  
  CONCLUSIONS
  The TAVI procedure provides sustained clinical and hemodynamic benefits for as long as 2 years for patients with symptomatic severe aortic stenosis at increased risk for surgery.
authors.affiliation: Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. Lutz.Buellesfeld@insel.ch
authors.forename: Lutz
authors.initials: L
authors.lastname: Buellesfeld
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gerckens
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Raoul
authors.initials: R
authors.lastname: Bonan
authors.forename: Jan
authors.initials: J
authors.lastname: Kovac
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Marino
authors.initials: M
authors.lastname: Labinaz
authors.forename: Peter
authors.initials: P
authors.lastname: den Heijer
authors.forename: Michael
authors.initials: M
authors.lastname: Mullen
authors.forename: Wayne
authors.initials: W
authors.lastname: Tymchak
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Ralf
authors.initials: R
authors.lastname: Mueller
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design / Q000295:instrumentation* / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome