title: Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: first clinical experience.
abstract: OBJECTIVE
  With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus.
  
  
  METHODS
  Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria.
  
  
  RESULTS
  Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 ± 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P < .01). The rate of new pacemaker implantations was 41.7%.
  
  
  CONCLUSIONS
  In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning.
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Freek
authors.initials: F
authors.lastname: Nijhoff
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.affiliation: Medisch Centrum Leeuwarden, Afdeling Hartcatheterisatie, Leeuwarden, The Netherlands.
authors.forename: Hafid
authors.initials: H
authors.lastname: Amrane
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Istituto Clinico Sant'Ambrogio, Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Testa
authors.affiliation: Ospedale Niguarda Ca' Granda, Milan, Italy.
authors.forename: Jacopo A
authors.initials: JA
authors.lastname: Oreglia
authors.affiliation: Ospedale Niguarda Ca' Granda, Milan, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: De Marco
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Mariam
authors.initials: M
authors.lastname: Samim
authors.affiliation: Istituto Clinico Sant'Ambrogio, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Ospedale Niguarda Ca' Granda, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bruschi
authors.affiliation: San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Medisch Centrum Leeuwarden, Afdeling Hartcatheterisatie, Leeuwarden, The Netherlands.
authors.forename: Ad J
authors.initials: AJ
authors.lastname: Van Boven
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands. Electronic address: p.stella@umcutrecht.nl.
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D017052:Hospital Mortality; D006801:Humans; D007558:Italy; D008297:Male; D009426:Netherlands; D011474:Prosthesis Design; D020127:Recovery of Function; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome