title: 5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis.
abstract: OBJECTIVE
  The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).
  
  
  BACKGROUND
  There is a paucity of evidence on long-term durability of currently available transcatheter heart valves.
  
  
  METHODS
  Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria.
  
  
  RESULTS
  All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were observed. Valve thrombosis or late valve embolization were not reported.
  
  
  CONCLUSIONS
  TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy. Electronic address: mbarbanti83@gmail.com.
authors.forename: Marco
authors.initials: M
authors.lastname: Barbanti
authors.affiliation: AOU Pisana, Pisa, Italy.
authors.forename: Anna Sonia
authors.initials: AS
authors.lastname: Petronio
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Ettori
authors.affiliation: Scientific Institute S. Raffaele, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Clinical Institute S. Ambrogio, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.affiliation: Niguarda Ca'Granda Hospital, Milan, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: De Marco
authors.affiliation: Ospedale Civile, Legnano, Italy.
authors.forename: Arnaldo
authors.initials: A
authors.lastname: Poli
authors.affiliation: Azienda ASL S. Camillo Forlanini, Rome.
authors.forename: Carla
authors.initials: C
authors.lastname: Boschetti
authors.affiliation: AOU Pisana, Pisa, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: De Carlo
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Fiorina
authors.affiliation: Scientific Institute S. Raffaele, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Clinical Institute S. Ambrogio, Milan, Italy.
authors.forename: Nedy
authors.initials: N
authors.lastname: Brambilla
authors.affiliation: Niguarda Ca'Granda Hospital, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bruschi
authors.affiliation: Ospedale Civile, Legnano, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Martina
authors.affiliation: Azienda ASL S. Camillo Forlanini, Rome.
authors.forename: Claudia
authors.initials: C
authors.lastname: Pandolfi
authors.affiliation: AOU Pisana, Pisa, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Giannini
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Curello
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Sgroi
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Gulino
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Patanè
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Ohno
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Guilherme F
authors.initials: GF
authors.lastname: Attizzani
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Immè
authors.affiliation: Quinario SA, Biostatistics Consultancy, Lugano, Switzerland.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Gentili
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy; ETNA Foundation, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000175:diagnosis / Q000209:etiology / Q000628:therapy; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D010359:Patient Readmission; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: TAVI; long-term outcomes; prosthetic valve failure