• Lutz Buellesfeld, Ulrich Gerckens, Gerhard Schuler, Raoul Bonan, Jan Kovac, Patrick W Serruys, Marino Labinaz, Peter den Heijer, Michael Mullen, Wayne Tymchak, Stephan Windecker, Ralf Mueller, and Eberhard Grube.
• Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. Lutz.Buellesfeld@insel.ch
• J. Am. Coll. Cardiol. 2011 Apr 19; 57 (16): 1650-7.

ObjectivesThe purpose of this study was to evaluate the safety, device performance, and clinical outcome up to 2 years for patients undergoing transcatheter aortic valve implantation (TAVI).BackgroundThe role of TAVI in the treatment of calcific aortic stenosis evolves rapidly, but mid- and long-term results are scarce.MethodsWe conducted a prospective, multicenter, single-arm study with symptomatic patients undergoing TAVI for treatment of severe aortic valve stenosis using the 18-F Medtronic CoreValve (Medtronic, Minneapolis, Minnesota) prosthesis.ResultsIn all, 126 patients (mean age 82 years, 42.9% male, mean logistic European System for Cardiac Operative Risk Evaluation score 23.4%) with severe aortic valve stenosis (mean gradient 46.8 mm Hg) underwent the TAVI procedure. Access was transfemoral in all but 2 cases with subclavian access. Retrospective risk stratification classified 54 patients as moderate surgical risk, 51 patients as high-risk operable, and 21 patients as high-risk inoperable. The overall technical success rate was 83.1%. Thirty-day all-cause mortality was 15.2%, without significant differences in the subgroups. At 2 years, all-cause mortality was 38.1%, with a significant difference between the moderate-risk group and the combined high-risk groups (27.8% vs. 45.8%, p = 0.04). This difference was mainly attributable to an increased risk of noncardiac mortality among patients constituting the high-risk groups. Hemodynamic results remained unchanged during follow-up (mean gradient: 8.5 ± 2.5 mm Hg at 30 days and 9.0 ± 3.4 mm Hg at 2 years). Functional class improved in 80% of patients and remained stable over time. There was no incidence of structural valve deterioration.ConclusionsThe TAVI procedure provides sustained clinical and hemodynamic benefits for as long as 2 years for patients with symptomatic severe aortic stenosis at increased risk for surgery.Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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