title: Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study.
abstract: OBJECTIVE
  Transcatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre 'real-world' patient population in highly experienced centres.
  
  
  RESULTS
  Patients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively.
  
  
  CONCLUSIONS
  The ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.
authors.affiliation: Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Struempellstrasse 39, 04289 Leipzig, Germany linkea@medizin.uni-leipzig.de.
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.affiliation: Gemeinschaftskrankenhaus, Bonn, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gerckens
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: University Hospital Antwerp, Antwerp, Belgium.
authors.forename: Johan
authors.initials: J
authors.lastname: Bosmans
authors.affiliation: German Heart Center, Technical University Munich, Munich, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Bleiziffer
authors.affiliation: Leeds General Infirmary, Leeds, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Blackman
authors.affiliation: Sankt Georg Hospital Hamburg, Hamburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schäfer
authors.affiliation: Helios Herzzentrum Siegburg, Siegburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Müller
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.affiliation: Rigshospitalet, Copenhagen, Denmark.
authors.forename: Lars
authors.initials: L
authors.lastname: Søndergaard
authors.affiliation: Ospedale Niguarda, Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Klugmann
authors.affiliation: University Aachen, Aachen, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Hoffmann
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Tchétché
authors.affiliation: Fondazione Centro San Raffaele, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: CHU de Liège, Liege, Belgium.
authors.forename: Victor M
authors.initials: VM
authors.lastname: Legrand
authors.affiliation: Istituto Clinico S. Ambrogio, IRCCS, San Donato, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Bedogni
authors.affiliation: Groupe Hospitalier La Pitié-Salpêtrière, Paris, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: lePrince
authors.affiliation: Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Struempellstrasse 39, 04289 Leipzig, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schuler
authors.affiliation: German Heart Center, Technical University Munich, Munich, Germany.
authors.forename: Domenico
authors.initials: D
authors.lastname: Mazzitelli
authors.affiliation: Leeds General Infirmary, Leeds, UK.
authors.forename: Christos
authors.initials: C
authors.lastname: Eftychiou
authors.affiliation: Sankt Georg Hospital Hamburg, Hamburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Frerker
authors.affiliation: Helios Herzzentrum Siegburg, Siegburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Boekstegers
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.affiliation: Department of Cardiothoracic Surgery, University of Leipzig Heart Center, Struempellstrasse 39, 04289 Leipzig, Germany.
authors.forename: Friedrich-Wilhelm
authors.initials: FW
authors.lastname: Mohr
authors.affiliation: Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Struempellstrasse 39, 04289 Leipzig, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Woitek
authors.affiliation: German Heart Center, Technical University Munich, Munich, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
authors.affiliation: Consultant to Medtronic, Inc., Minneapolis, MN, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Bauernschmitt
authors.affiliation: St George's Hospital, London, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Brecker
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000401:mortality; D001024:Aortic Valve Stenosis / Q000401:mortality / Q000601:surgery*; D002423:Cause of Death; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D065467:Transcatheter Aortic Valve Replacement / Q000295:instrumentation* / Q000401:mortality; D016896:Treatment Outcome
keywords: Aortic stenosis; CoreValve; Mortality; Transcatheter aortic valve implantation; Valvuloplasty