title: Four-year experience with the CoreValve transcatheter heart valve.
abstract: OBJECTIVE
  Our aim was to evaluate the long-term device performance and clinical outcomes of patients with symptomatic, severe aortic valve stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) with the CoreValve bioprosthesis.
  
  
  RESULTS
  The CoreValve CE Pivotal Study was a prospective, multicentre, single-arm TAVI trial using the CoreValve system. Valve performance, patient quality of life (QoL), New York Heart Association (NYHA) class, and mortality at four years were analysed in 126 patients (mean age 82.4 years, 42.9% male, mean logistic EuroSCORE 23.4%) with severe AS. Mean aortic valve gradient decreased from 46.9±16.1 mmHg at baseline to 9.8±4.1 mmHg at discharge and to 7.8±2.7 mmHg at four years. Mean effective orifice area increased from 0.7±0.2 cm2 to 1.8±0.4 cm2 after TAVI and was 1.6±0.5 cm2 at four years. There were no reports of structural valve deterioration or valve migration. There was sustained improvement in QoL and NYHA class in surviving patients. All-cause and cardiac survival was 45.3% and 62.6%, respectively, at four years.
  
  
  CONCLUSIONS
  The CoreValve bioprosthesis demonstrates long-term durability, stable haemodynamic function, and no evidence of structural deterioration. Most surviving patients continued to have improved NYHA class and QoL at four years.
authors.affiliation: Cardiovascular Biomedical Research Unit, University of Leicester, Leicester, United Kingdom.
authors.forename: Jan
authors.initials: J
authors.lastname: Kovac
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gerckens
authors.forename: Ralf
authors.initials: R
authors.lastname: Müller
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.forename: Raoul
authors.initials: R
authors.lastname: Bonan
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: Eberhard
authors.initials: E
authors.lastname: Grube
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D001705:Bioprosthesis; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012720:Severity of Illness Index; D015996:Survival Rate; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods*; D016896:Treatment Outcome