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

被引：174

作者：

Linke, Axel ^{[1
]}

Wenaweser, Peter ^{[3
]}

Gerckens, Ulrich ^{[4
]}

Tamburino, Corrado ^{[5
]}

Bosmans, Johan ^{[6
]}

Bleiziffer, Sabine ^{[7
]}

Blackman, Daniel ^{[8
]}

Schaefer, Ulrich ^{[9
]}

Mueller, Ralf ^{[10
]}

Sievert, Horst ^{[11
]}

Sondergaard, Lars ^{[12
]}

Klugmann, Silvio ^{[13
]}

Hoffmann, Rainer ^{[14
]}

Tchetche, Didier ^{[15
]}

Colombo, Antonio ^{[16
]}

Legrand, Victor M. ^{[17
]}

Bedogni, Francesco ^{[18
]}

lePrince, Pascal ^{[19
]}

Schuler, Gerhard ^{[1
]}

Mazzitelli, Domenico ^{[7
]}

Eftychiou, Christos ^{[8
]}

Frerker, Christian ^{[9
]}

Boekstegers, Peter ^{[10
]}

Windecker, Stephan ^{[3
]}

Mohr, Friedrich-Wilhelm ^{[2
]}

Woitek, Felix ^{[1
]}

Lange, Ruediger ^{[7
]}

Bauernschmitt, Robert ^{[20
]}

Brecker, Stephen ^{[21
]}

机构：

[1] Univ Leipzig, Ctr Heart, Dept Internal Med & Cardiol, D-04289 Leipzig, Germany

[2] Univ Leipzig, Ctr Heart, Dept Cardiothorac Surg, D-04289 Leipzig, Germany

[3] Univ Hosp Bern, CH-3010 Bern, Switzerland

[4] Gemeinschaftskrankenhaus, Bonn, Germany

[5] Univ Catania, Ferrarotto Hosp, Catania, Italy

[6] Univ Antwerp Hosp, Antwerp, Belgium

[7] Tech Univ Munich, German Heart Ctr, D-80290 Munich, Germany

[8] Leeds Gen Infirm, Leeds, W Yorkshire, England

[9] St Georg Hosp Hamburg, Hamburg, Germany

[10] Helios Herzzentrum Siegburg, Siegburg, Germany

[11] CardioVasc Ctr Frankfurt, Frankfurt, Germany

[12] Rigshosp, DK-2100 Copenhagen, Denmark

[13] Osped Niguarda Ca Granda, Milan, Italy

[14] Univ Aachen, Aachen, Germany

[15] Clin Pasteur, Toulouse, France

[16] Fdn Ctr San Raffaele, Milan, Italy

[17] CHU Liege, Liege, Belgium

[18] IRCCS, Ist Clin S Ambrogio, San Donato Milanese, Italy

[19] Grp Hosp Pitie Salpetriere, F-75634 Paris, France

[20] Medtronic Inc, Minneapolis, MN USA

[21] St George Hosp, London, England

来源：

EUROPEAN HEART JOURNAL | 2014年 / 35卷 / 38期

关键词：

Aortic stenosis; Transcatheter aortic valve implantation; CoreValve; Valvuloplasty; Mortality; AMERICAN-HEART-ASSOCIATION; EUROPEAN-ASSOCIATION; PERMANENT PACEMAKER; RISK PATIENTS; TASK-FORCE; IMPLANTATION; OUTCOMES; REPLACEMENT; CARDIOLOGY; SOCIETY;

D O I：

10.1093/eurheartj/ehu162

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

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. End-point- 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.

引用

页码：2672 / 2684

页数：13

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