Author + information
- Received February 16, 2015
- Revision received July 15, 2015
- Accepted July 16, 2015
- Published online September 22, 2015.
- Steven J. Yakubov, MD∗∗ (, )
- David H. Adams, MD†,
- Daniel R. Watson, MD∗,
- Michael J. Reardon, 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¶,
- Theodore Schreiber, MD#,
- Thomas G. Gleason, MD∗∗,
- John Conte, MD††,
- G. Michael Deeb, MD‡‡,
- Jian Huang, MD§§,
- Jae Oh, MD‖‖,
- Timothy Byrne, MD¶¶,
- Michael Caskey, MD¶¶,
- Jeffrey J. Popma, MD##,
- CoreValve United States Clinical Investigators
- ∗Riverside Methodist Hospital, Columbus, Ohio
- †Mount Sinai Health System, New York, New York
- ‡Houston-Methodist-DeBakey Heart and Vascular Center, Houston, Texas
- §St. Vincent’s Heart Center of Indiana, 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
- ‡‡University of Michigan Medical Center, Ann Arbor, Michigan
- §§Medtronic, Minneapolis, Minnesota
- ‖‖Mayo Clinic Foundation, Rochester, Minnesota
- ¶¶Banner Good Samaritan Hospital, Phoenix, Arizona
- ##Beth Israel Deaconess Medical Center, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. Steven J. Yakubov, OhioHealth, Riverside Methodist Hospital, 3705 Olentangy River Road, Columbus, Ohio 43214.
Background We reported favorable 1-year outcomes in patients unsuitable for surgery who underwent self-expanding transcatheter aortic valve replacement (TAVR) compared with an objective performance goal. Longer-term outcomes in these patients are not known.
Objectives This study sought to evaluate the 2-year safety and efficacy in patients with severe aortic stenosis (AS) at extreme risk of surgery treated with self-expanding TAVR.
Methods We performed a prospective, multicenter, controlled, nonrandomized investigation of self-expanding TAVR in patients with severe AS and prohibitive surgical risk. We report the 2-year clinical outcomes in these patients.
Results A total of 489 extreme-risk patients were treated transfemorally with a self-expanding aortic bioprosthesis at 41 centers. The rate of all-cause mortality or major stroke was 38.0% at 2 years (all-cause mortality, 36.5%; major stroke, 5.1%). The rates of all-cause mortality, cardiovascular mortality, and major stroke were 36.6%, 26.2%, and 5.1%, respectively, at 2 years. Between 1 and 2 years, the incremental all-cause mortality, cardiovascular mortality, and major stroke rates were 12.3%, 7.9%, and 0.8%, respectively. Multivariable predictors of all-cause mortality at 2 years included the presence of coronary artery disease and admission from an assisted living center. A Society of Thoracic Surgeons score >15% was also predictive of 2-year all-cause mortality. At 2 years, 94% of patients had New York Heart Association functional class I or II symptoms. The frequency of moderate or severe paravalvular regurgitation (4.3% at 1 year; 4.4% at 2 years) was unchanged between the first and second year.
Conclusions Patients with severe AS at extreme surgical risk treated with self-expanding TAVR continued to show good clinical outcomes and hemodynamic valve performance at 2 years. The presence of comorbid conditions rather than valve performance affected 2-year outcomes in these patients. (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)
Medtronic, Minneapolis, Minnesota, sponsored this study. Dr. Yakubov has received institutional research grants from Boston Scientific, Direct Flow Medical, and Medtronic; and serves on an Advisory Board for Boston Scientific and Medtronic. Dr. Adams has received institutional grants and institutional royalties for patents from Medtronic; and institutional royalties for patents from Edwards Lifesciences. Dr. Reardon serves on an Advisory Board for Medtronic. Dr. Kleiman provides educational services to Medtronic. Dr. Heimansohn serves as a proctor for Sorin Biomedical. Dr. Hermiller has received institutional research grants from Medtronic. Dr. Hughes serves as a consultant and speaker for Medtronic. Dr. Harrison has received institutional research grants from Boston Scientific, Direct Flow Medical, Edwards Lifesciences, and Medtronic; serves on an Advisory Board for St. Jude Medical; and is on a DSMB for CardiAQ. Dr. Coselli serves as an advisor to Medtronic. Dr. Gleason has received institutional research grants from Medtronic. Dr. Conte serves on the Surgery Advisory Board for Medtronic and Sorin; and has received research support from Boston Scientific, Medtronic, and St. Jude Medical. Dr. Deeb serves as a consultant for Edwards Lifesciences; and as an advisor and consultant for Medtronic. Dr. Huang is an employee of and shareholder in Medtronic. Dr. Oh has received institutional research grants from Medtronic. Dr. Caskey serves as a consultant for Medtronic. Dr. Popma has received institutional research grants from Boston Scientific, Direct Flow Medical, and Medtronic; and serves on a Medical Advisory Board for Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Antonio Colombo, MD, served as Guest Editor for this paper.
- Received February 16, 2015.
- Revision received July 15, 2015.
- Accepted July 16, 2015.
- American College of Cardiology Foundation