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

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

doi:10.1093/eurheartj/ehu162

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

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

Department of Drug Design and Pharmacology

164 Citations (Scopus)

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.

Original language	English
Journal	European Heart Journal
Volume	35
Issue number	38
Pages (from-to)	2672-2684
Number of pages	13
ISSN	0195-668X
DOIs	https://doi.org/10.1093/eurheartj/ehu162
Publication status	Published - 7 Oct 2014

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Linke, A., Wenaweser, P., Gerckens, U., Tamburino, C., Bosmans, J., Bleiziffer, S., Blackman, D., Schäfer, U., Müller, R., Sievert, H., Søndergaard, L., Klugmann, S., Hoffmann, R., Tchétché, D., Colombo, A., Legrand, V. M., Bedogni, F., lePrince, P., Schuler, G., ... ADVANCE study Investigators (2014). Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study. European Heart Journal, 35(38), 2672-2684. https://doi.org/10.1093/eurheartj/ehu162

Linke, A, Wenaweser, P, Gerckens, U, Tamburino, C, Bosmans, J, Bleiziffer, S, Blackman, D, Schäfer, U, Müller, R, Sievert, H, Søndergaard, L, Klugmann, S, Hoffmann, R, Tchétché, D, Colombo, A, Legrand, VM, Bedogni, F, lePrince, P, Schuler, G, Mazzitelli, D, Eftychiou, C, Frerker, C, Boekstegers, P, Windecker, S, Mohr, F-W, Woitek, F, Lange, R, Bauernschmitt, R, Brecker, S & ADVANCE study Investigators 2014, 'Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study', European Heart Journal, vol. 35, no. 38, pp. 2672-2684. https://doi.org/10.1093/eurheartj/ehu162

@article{0851d74ec5384336b8ab24149e9d7960,

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

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.",

author = "Axel Linke and Peter Wenaweser and Ulrich Gerckens and Corrado Tamburino and Johan Bosmans and Sabine Bleiziffer and Daniel Blackman and Ulrich Sch{\"a}fer and Ralf M{\"u}ller and Horst Sievert and Lars S{\o}ndergaard and Silvio Klugmann and Rainer Hoffmann and Didier Tch{\'e}tch{\'e} and Antonio Colombo and Legrand, {Victor M} and Francesco Bedogni and Pascal lePrince and Gerhard Schuler and Domenico Mazzitelli and Christos Eftychiou and Christian Frerker and Peter Boekstegers and Stephan Windecker and Friedrich-Wilhelm Mohr and Felix Woitek and R{\"u}diger Lange and Robert Bauernschmitt and Stephen Brecker and {ADVANCE study Investigators}",

year = "2014",

month = oct,

day = "7",

doi = "10.1093/eurheartj/ehu162",

language = "English",

volume = "35",

pages = "2672--2684",

journal = "European Heart Journal",

issn = "0195-668X",

publisher = "Oxford University Press",

number = "38",

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TY - JOUR

T1 - Treatment of aortic stenosis with a self-expanding transcatheter valve

T2 - the International Multi-centre ADVANCE Study

AU - Linke, Axel

AU - Wenaweser, Peter

AU - Gerckens, Ulrich

AU - Tamburino, Corrado

AU - Bosmans, Johan

AU - Bleiziffer, Sabine

AU - Blackman, Daniel

AU - Schäfer, Ulrich

AU - Müller, Ralf

AU - Sievert, Horst

AU - Søndergaard, Lars

AU - Klugmann, Silvio

AU - Hoffmann, Rainer

AU - Tchétché, Didier

AU - Colombo, Antonio

AU - Legrand, Victor M

AU - Bedogni, Francesco

AU - lePrince, Pascal

AU - Schuler, Gerhard

AU - Mazzitelli, Domenico

AU - Eftychiou, Christos

AU - Frerker, Christian

AU - Boekstegers, Peter

AU - Windecker, Stephan

AU - Mohr, Friedrich-Wilhelm

AU - Woitek, Felix

AU - Lange, Rüdiger

AU - Bauernschmitt, Robert

AU - Brecker, Stephen

AU - ADVANCE study Investigators

PY - 2014/10/7

Y1 - 2014/10/7

N2 - 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.

AB - 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.

U2 - 10.1093/eurheartj/ehu162

DO - 10.1093/eurheartj/ehu162

M3 - Journal article

C2 - 24682842

SN - 0195-668X

VL - 35

SP - 2672

EP - 2684

JO - European Heart Journal

JF - European Heart Journal

IS - 38

ER -

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

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