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

Linke, Axel; Wenaweser, Peter Martin; 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; ... (2014). Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study. European Heart Journal, 35(38), pp. 2672-2684. Oxford University Press 10.1093/eurheartj/ehu162

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Wenaweser, Peter Martin and Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0195-668X

Publisher:

Oxford University Press

Language:

English

Submitter:

Judith Liniger

Date Deposited:

05 Feb 2015 10:37

Last Modified:

25 Oct 2019 21:44

Publisher DOI:

10.1093/eurheartj/ehu162

PubMed ID:

24682842

Uncontrolled Keywords:

Aortic stenosis, CoreValve, Mortality, Transcatheter aortic valve implantation, Valvuloplasty

BORIS DOI:

10.7892/boris.62131

URI:

https://boris.unibe.ch/id/eprint/62131

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