- 作者：Lutz Buellesfeld MD ; Lutz.Buellesfeld@insel.ch ; Ulrich Gerckens MD† ; ; Gerhard Schuler MD‡ ; ; Raoul Bonan MD§ ; ; Jan Kovac MD ; Patrick W. Serruys MD¶ ; ; Marino Labinaz MD# ; Peter den Heijer MD ; Michael Mullen MD† ; † ; ; Wayne Tymchak MD‡ ; ‡ ; ; Stephan Windecker MD ; Ralf Mueller MD† ; ; Eberhard Grube MD§ ; § ;
- 关键词：aortic valve stenosis ; long-term follow-up ; transcatheter aortic valve implantation
- 刊名：Journal of the American College of Cardiology
- 出版年：2011
- 出版时间：19 April 2011
- 年：2011
- 卷：57
- 期：16
- 页码：1650-1657
- 全文大小：1516 K
Objectives
The 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).Background
The role of TAVI in the treatment of calcific aortic stenosis evolves rapidly, but mid- and long-term results are scarce.
Methods
We 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.
Results
In 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.
Conclusions
The 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.