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

[en] 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 inwhomimplantation of theCoreValve Systemwas decided by the Heart Teamwere included. Endpointswere 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 eventswere independently adjudicated based on Valve AcademicResearch Consortiumdefinitions.Atotal 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, theMACCErate was 8.0% (95% CI: 6.3–9.7%), all-cause mortalitywas 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 lifethreatening 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 Euro- SCORE ≤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.

Disciplines :

Cardiovascular & respiratory systems

Author, co-author :

Linke, Axel

Wenaweser, Peter

Gerckens, Ulrich

Tamburino, Corrado

Bosmans, Johan

Bleiziffer, Sabine

Blackman, Daniel

Schäfer, Ulrich

Müller, Ralf

Sievert, Horst

More authors (19 more)

Language :

English

Title :

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

Publication date :

28 March 2014

Journal title :

European Heart Journal

ISSN :

0195-668X

eISSN :

1522-9645

Publisher :

Oxford University Press, Oxford, United Kingdom

Peer reviewed :

Peer Reviewed verified by ORBi

Available on ORBi :

since 06 July 2014

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Bibliography

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