Author + information
- Received August 31, 2010
- Revision received October 14, 2010
- Accepted November 9, 2010
- Published online April 19, 2011.
- Lutz Buellesfeld, MD⁎,⁎ (, )
- 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† and
- Eberhard Grube, MD§§
- ↵⁎Reprint requests and correspondence:
Dr. Lutz Buellesfeld, Swiss Cardiovascular Center Bern, Bern University Hospital, Bern CH-3010, Switzerland
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.
Drs. Buellesfeld, Gerckens, Schuler, Bonan, Kovac, Serruys, Labinaz, den Heijer, Windecker, and Grube are consultants and/or proctors for Medtronic. Dr. Kovac is a consultant to St. Jude. Dr. Mullen is a proctor for Edwards Lifesciences. Dr. Windecker receives lecture and consultant fees from Abbott, Biosensors, Boston Scientific, Cordis, Edwards Lifesciences, and Medtronic. All other authors have reported that they have no relationships to disclose. Dr. Buellesfeld and Gerckens contributed equally to this work.
- Received August 31, 2010.
- Revision received October 14, 2010.
- Accepted November 9, 2010.
- American College of Cardiology Foundation