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Multicenter Study
. 2014 Oct 7;35(38):2672-84.
doi: 10.1093/eurheartj/ehu162. Epub 2014 Mar 28.

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

Axel Linke  1 , Peter Wenaweser  2 , Ulrich Gerckens  3 , Corrado Tamburino  4 , Johan Bosmans  5 , Sabine Bleiziffer  6 , Daniel Blackman  7 , Ulrich Schäfer  8 , Ralf Müller  9 , Horst Sievert  10 , Lars Søndergaard  11 , Silvio Klugmann  12 , Rainer Hoffmann  13 , Didier Tchétché  14 , Antonio Colombo  15 , Victor M Legrand  16 , Francesco Bedogni  17 , Pascal lePrince  18 , Gerhard Schuler  19 , Domenico Mazzitelli  6 , Christos Eftychiou  7 , Christian Frerker  8 , Peter Boekstegers  9 , Stephan Windecker  2 , Friedrich-Wilhelm Mohr  20 , Felix Woitek  19 , Rüdiger Lange  6 , Robert Bauernschmitt  21 , Stephen Brecker  22 ; ADVANCE study Investigators
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Free article
Multicenter Study

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

Axel Linke et al. Eur Heart J. .
Free article

Abstract

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.

Keywords: Aortic stenosis; CoreValve; Mortality; Transcatheter aortic valve implantation; Valvuloplasty.

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