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J. Am. Coll. Cardiol. · Nov 2011
Randomized Controlled Trial Comparative StudyClinical outcomes of patients with severe aortic stenosis at increased surgical risk according to treatment modality.
- Peter Wenaweser, Thomas Pilgrim, Alexander Kadner, Christoph Huber, Stefan Stortecky, Lutz Buellesfeld, Ahmed A Khattab, Fabienne Meuli, Nadja Roth, Balthasar Eberle, Gabor Erdös, Henriette Brinks, Bindu Kalesan, Bernhard Meier, Peter Jüni, Thierry Carrel, and Stephan Windecker.
- Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.
- J. Am. Coll. Cardiol. 2011 Nov 15; 58 (21): 2151-62.
ObjectivesThe aim of this study was to assess the role of transcatheter aortic valve implantation (TAVI) compared with medical treatment (MT) and surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) at increased surgical risk.BackgroundElderly patients with comorbidities are at considerable risk for SAVR.MethodsSince July 2007, 442 patients with severe AS (age: 81.7 ± 6.0 years, mean logistic European System for Cardiac Operative Risk Evaluation: 22.3 ± 14.6%) underwent treatment allocation to MT (n = 78), SAVR (n = 107), or TAVI (n = 257) on the basis of a comprehensive evaluation protocol as part of a prospective registry.ResultsBaseline clinical characteristics were similar among patients allocated to MT and TAVI, whereas patients allocated to SAVR were younger (p < 0.001) and had a lower predicted peri-operative risk (p < 0.001). Unadjusted rates of all-cause mortality at 30 months were lower for SAVR (22.4%) and TAVI (22.6%) compared with MT (61.5%, p < 0.001). Adjusted hazard ratios for death were 0.51 (95% confidence interval: 0.30 to 0.87) for SAVR compared with MT and 0.38 (95% confidence interval: 0.25 to 0.58) for TAVI compared with MT. Medical treatment (<0.001), older age (>80 years, p = 0.01), peripheral vascular disease (<0.001), and atrial fibrillation (p = 0.04) were significantly associated with all-cause mortality at 30 months in the multivariate analysis. At 1 year, more patients undergoing SAVR (92.3%) or TAVI (93.2%) had New York Heart Association functional class I/II as compared with patients with MT (70.8%, p = 0.003).ConclusionsAmong patients with severe AS with increased surgical risk, SAVR and TAVI improve survival and symptoms compared with MT. Clinical outcomes of TAVI and SAVR seem similar among carefully selected patients with severe symptomatic AS at increased risk.Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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