Fulltext

Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study

Linke, Axel ; Wenaweser, Peter ; Gerckens, Ulrich ; Tamburino, Corrado ; Bosmans, Johan ; Bleiziffer, Sabine ; Blackman, Daniel ; Schäfer, Ulrich ; Müller, Ralf ; Sievert, Horst ; Søndergaard, Lars ; Klugmann, Silvio ; Hoffmann, Rainer ; Tchétché, Didier ; Colombo, Antonio ; Legrand, Victor M. ; Bedogni, Francesco ; lePrince, Pascal ; Schuler, Gerhard ; Mazzitelli, Domenico ; Eftychiou, Christos ; Frerker, Christian ; Boekstegers, Peter ; Windecker, Stephan ; Mohr, Friedrich-Wilhelm ; Woitek, Felix ; Lange, Rüdiger ; Bauernschmitt, Robert ; Brecker, Stephen

In: European Heart Journal, 2014, vol. 35, no. 38, p. 2672-2684

Ajouter à la liste personnelle
    Titre
    • Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study
    Auteur
    • Linke, Axel. Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Struempellstrasse 39, 04289 Leipzig, Germany
    • Wenaweser, Peter. Bern University Hospital, Bern, Switzerland
    • Gerckens, Ulrich. Gemeinschaftskrankenhaus, Bonn, Germany
    • Tamburino, Corrado. Ferrarotto Hospital, University of Catania, Catania, Italy
    • Bosmans, Johan. University Hospital Antwerp, Antwerp, Belgium
    • Bleiziffer, Sabine. German Heart Center, Technical University Munich, Munich, Germany
    • Blackman, Daniel. Leeds General Infirmary, Leeds, UK
    • Schäfer, Ulrich. Sankt Georg Hospital Hamburg, Hamburg, Germany
    • Müller, Ralf. Helios Herzzentrum Siegburg, Siegburg, Germany
    • Sievert, Horst. CardioVascular Center Frankfurt, Frankfurt, Germany
    • Søndergaard, Lars. Rigshospitalet, Copenhagen, Denmark
    • Klugmann, Silvio. Ospedale Niguarda, Milan, Italy
    • Hoffmann, Rainer. University Aachen, Aachen, Germany
    • Tchétché, Didier. Clinique Pasteur, Toulouse, France
    • Colombo, Antonio. Fondazione Centro San Raffaele, Milan, Italy
    • Legrand, Victor M.. CHU de Liège, Liege, Belgium
    • Bedogni, Francesco. Istituto Clinico S. Ambrogio, IRCCS, San Donato, Italy
    • lePrince, Pascal. Groupe Hospitalier La Pitié-Salpêtrière, Paris, France
    • Schuler, Gerhard. Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Struempellstrasse 39, 04289 Leipzig, Germany
    • Mazzitelli, Domenico. German Heart Center, Technical University Munich, Munich, Germany
    • Eftychiou, Christos. Leeds General Infirmary, Leeds, UK
    • Frerker, Christian. Sankt Georg Hospital Hamburg, Hamburg, Germany
    • Boekstegers, Peter. Helios Herzzentrum Siegburg, Siegburg, Germany
    • Windecker, Stephan. Bern University Hospital, Bern, Switzerland
    • Mohr, Friedrich-Wilhelm. Department of Cardiothoracic Surgery, University of Leipzig Heart Center, Struempellstrasse 39, 04289 Leipzig, Germany
    • Woitek, Felix. Department of Internal Medicine and Cardiology, University of Leipzig Heart Center, Struempellstrasse 39, 04289 Leipzig, Germany
    • Lange, Rüdiger. German Heart Center, Technical University Munich, Munich, Germany
    • Bauernschmitt, Robert. Consultant to Medtronic, Inc., Minneapolis, MN, USA
    • Brecker, Stephen. St George's Hospital, London, UK
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • European Heart Journal, 2014, vol. 35, no. 38, p. 2672-2684. Oxford University Press
    Autre version électronique
    Identifiant OAI-PMH
    • oai:doc.rero.ch:291750
    Summary
    Aim 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. Methods and 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. Conclusion 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