Author + information
- Received February 10, 2013
- Accepted February 13, 2013
- Published online May 20, 2014.
- Jeffrey J. Popma, MD∗∗ (, )
- David H. Adams, MD†,
- Michael J. Reardon, MD‡,
- Steven J. Yakubov, MD§,
- Neal S. Kleiman, MD‡,
- David Heimansohn, MD‖,
- James Hermiller Jr., MD‖,
- G. Chad Hughes, MD¶,
- J. Kevin Harrison, MD¶,
- Joseph Coselli, MD#,
- Jose Diez, MD#,
- Ali Kafi, MD∗∗,
- Theodore Schreiber, MD∗∗,
- Thomas G. Gleason, MD††,
- John Conte, MD‡‡,
- Maurice Buchbinder, MD§§,
- G. Michael Deeb, MD‖‖,
- Blasé Carabello, MD¶¶,
- Patrick W. Serruys, MD, PhD##,
- Sharla Chenoweth, MS∗∗∗,
- Jae K. Oh, MD†††,
- CoreValve United States Clinical Investigators
- ∗Beth Israel Deaconess Medical Center, Boston, Massachusetts
- †Mount Sinai Medical Center, New York, New York
- ‡Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas
- §Riverside Methodist Hospital, Columbus, Ohio
- ‖St. Vincent's Medical Center, Indianapolis, Indiana
- ¶Duke University Medical Center, Durham, North Carolina
- #Texas Heart Institute at St. Luke's Medical Center, Houston, Texas
- ∗∗Detroit Medical Center, Detroit, Michigan
- ††University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- ‡‡Johns Hopkins Medical Center, Baltimore, Maryland
- §§Palo Alto Veterans Administration Medical Center, Palo Alto, California
- ‖‖University of Michigan Medical Center, Ann Arbor, Michigan
- ¶¶Baylor College of Medicine, Houston Texas
- ##Thoraxcenter, Rotterdam, the Netherlands
- ∗∗∗Medtronic, Inc., Minneapolis, Minnesota
- †††Mayo Clinic Foundation, Rochester, Minnesota
- ↵∗Reprint requests and correspondence:
Dr. Jeffrey J. Popma, Interventional Cardiology Clinical Services, Beth Israel Deaconess Medical Center, Harvard Medical School, 185 Pilgrim Road, Boston, Massachusetts 02215.
Objectives This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery.
Background Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy.
Methods We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG).
Results A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis).
Conclusions TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902)
A complete list of the investigators, institutions, and research organizations participating in the CoreValve US Extreme Risk Study is in the Online Appendix. This study was sponsored by Medtronic, Inc. Dr. Popma has received research grants from Abbott Vascular, Abiomed, Boston Scientific, Cordis, Covidien, eV3, and Medtronic; and serves as an advisor to Abbott Vascular, Boston Scientific, Cordis Corporation, and Covidien. Dr. Adams has royalty agreements through Mount School of Medicine with Edwards Lifesciences and Medtronic. Dr. Reardon serves as a consultant to Boston Scientific; provides educational services to Medtronic; and has served on advisory boards for Medtronic. Dr. Yakubov serves as a consultant to Medtronic. Dr. Kleiman provides educational services to Medtronic. Dr. Heimansohn has received lecture fees from Edwards Lifesciences. Dr. Hermiller serves as a speaker and has received honoraria from AstraZeneca and The Medicines Company; and serves as a consultant to Abbott Vascular, Medtronic, and St. Jude Medical. Dr. Hughes serves as a consultant and speaker for Medtronic. Dr. Harrison serves as consultant to Direct Flow Medical and Edwards Lifesciences. Dr. Coselli serves as an advisor to Medtronic; and has received research funding from Medtronic, CoreValve, and Edwards Lifesciences. Dr. Deeb serves as a consultant to Edwards Lifesciences; and as an advisor and consultant to Medtronic but does not receive financial remuneration. Ms. Chenoweth is an employee and shareholder of Medtronic. Dr. Oh received institutional research support. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 10, 2013.
- Accepted February 13, 2013.
- American College of Cardiology Foundation