title: Five-year haemodynamic outcomes of the first-generation SAPIEN balloon-expandable transcatheter heart valve.
abstract: OBJECTIVE
  Transcatheter aortic valve implantation (TAVI) has gained rapid acceptance for patients with severe aortic stenosis (AS) at high surgical risk for conventional valve replacement. Although TAVI is now a relatively mature technique, limited data about long-term valvular function are available. Our aim was to report the five-year echocardiographic data evaluating valve performance from three early European feasibility studies designed to assess the safety and effectiveness of the first-generation balloon-expandable transcatheter heart valve (SAPIEN THV).
  
  
  RESULTS
  A total of 410 patients were enrolled in the following single-arm, non-randomised, prospective multicentre clinical studies: REVIVE II, TRAVERCE and PARTNER EU. Five-year follow-up was completed in 114 surviving patients. Mean patient age was 82.3±5.6 years; 63.4% were female. The mean logistic EuroSCORE was 28.4±13.3%. NYHA Class III/IV was reported in 92.5%. At five years, the mean effective orifice area (EOA) was 1.6±0.6 cm² (n=34) and the mean gradient was 11.7±5.4 mmHg (n=39). In paired patient data, the difference between discharge and five-year EOA was 0.1±0.7 cm² (p=0.3956) and mean gradient was 2.2±5.7 mmHg (p=0.0900). At discharge and five years, respectively, aortic regurgitation (AR) was evaluated as none/trace in 66.6% (n=162/243) and 55.3% (n=19/38), mild in 28.4% (n=69/243) and 39.5% (n=15/38), and moderate in 4.9% (n=12/243) and 5.3% (n=2/38). No severe AR was reported at follow-up. Valve thrombosis was observed in three patients and occurred within one year. No valve-related explants and no case of structural valve deterioration have been reported.
  
  
  CONCLUSIONS
  Long-term echocardiographic outcomes in high-risk patients with severe AS suggest stable haemodynamic function of first-generation balloon-expandable SAPIEN THVs at five years, with no worsening of AR severity over time.
authors.affiliation: Institut Hospitalier Jacques Cartier, Massy, France.
authors.forename: Fadi
authors.initials: F
authors.lastname: Sawaya
authors.forename: Arie Pieter
authors.initials: AP
authors.lastname: Kappetein
authors.forename: Wilfried
authors.initials: W
authors.lastname: Wisser
authors.forename: Patrick
authors.initials: P
authors.lastname: Nataf
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.forename: Volker
authors.initials: V
authors.lastname: Schächinger
authors.forename: Bernard
authors.initials: B
authors.lastname: De Bruyne
authors.forename: Hélène
authors.initials: H
authors.lastname: Eltchaninoff
authors.forename: Matthias
authors.initials: M
authors.lastname: Thielmann
authors.forename: Dominique
authors.initials: D
authors.lastname: Himbert
authors.forename: Mauro
authors.initials: M
authors.lastname: Romano
authors.forename: Gerhard
authors.initials: G
authors.lastname: Wimmer-Greinecker
authors.forename: Patrick
authors.initials: P
authors.lastname: Serruys
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D004452:Echocardiography; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000706:statistics & numerical data*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation / Q000401:mortality*