Author + information
- Received March 2, 2016
- Revision received March 18, 2016
- Accepted March 21, 2016
- Published online June 7, 2016.
- G. Michael Deeb, MDa,∗ (, )
- Michael J. Reardon, MDb,
- Stan Chetcuti, MDa,
- Himanshu J. Patel, MDa,
- P. Michael Grossman, MDa,
- Steven J. Yakubov, MDc,
- Neal S. Kleiman, MDb,
- Joseph S. Coselli, MDd,
- Thomas G. Gleason, MDe,
- Joon Sup Lee, MDe,
- James B. Hermiller Jr., MDf,
- John Heiser, MDg,
- William Merhi, MDg,
- George L. Zorn III, MDh,
- Peter Tadros, MDh,
- Newell Robinson, MDi,
- George Petrossian, MDi,
- G. Chad Hughes, MDj,
- J. Kevin Harrison, MDj,
- Brijeshwar Maini, MDk,
- Mubashir Mumtaz, MDk,
- John Conte, MDl,
- Jon Resar, MDl,
- Vicken Aharonian, MDm,
- Thomas Pfeffer, MDm,
- Jae K. Oh, MDn,
- Hongyan Qiao, PhDo,
- David H. Adams, MDp,
- Jeffrey J. Popma, MDq,
- CoreValve US Clinical Investigators
- aUniversity of Michigan Medical Center, Ann Arbor, Michigan
- bHouston Methodist DeBakey Heart & Vascular Center, Houston, Texas
- cRiverside Methodist Hospital, Columbus, Ohio
- dTexas Heart Institute at St. Luke’s Medical Center, Houston, Texas
- eUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- fSt. Vincent Medical Center, Indianapolis, Indiana
- gSpectrum Health Hospitals, Grand Rapids, Michigan
- hThe University of Kansas Hospital, Kansas City, Kansas
- iSt. Francis Hospital, Roslyn, New York
- jDuke University Medical Center, Durham, North Carolina
- kPinnacle Health, Wormleysburg, Pennsylvania
- lThe Johns Hopkins Hospital, Baltimore, Maryland
- mKaiser Permanente-Los Angeles Medical Center, Los Angeles, California
- nMayo Clinical Foundation, Rochester, Minnesota
- oMedtronic, Minneapolis, Minnesota
- pMount Sinai Health System, New York, New York
- qBeth Israel Deaconess Medical Center, Boston, Massachusetts
- ↵∗Reprint requests and correspondence:
Dr. G. Michael Deeb, Department of Cardiac Surgery, University of Michigan Hospitals, 1500 East Medical Center Drive, Ann Arbor, Michigan 48109-5864.
Background In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery.
Objectives This study sought to determine whether this clinical benefit was sustained over time.
Methods Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure.
Results A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p < 0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p < 0.001). There was no clinical evidence of valve thrombosis in either group.
Conclusions Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (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) provided funding for the present research. Dr. Deeb has served on the advisory board and as a proctor for Medtronic; as a consultant and research investigator for Edwards Lifesciences; as a consultant and proctor for Terumo; and as a research investigator for Gore Medical. Dr. Reardon has received fees from Medtronic for providing educational services, and has served on the advisory council for Medtronic. Dr. Chetcuti has received grant support and sponsorship from Edwards Lifesciences, Boston Scientific, and Medtronic; received research sponsorship from St. Jude Medical; and received proctoring fees from and served as a consultant for Medtronic. Dr. Patel has served as a consultant for Medtronic, WL Gore, and Terumo. Dr. Grossman has received grant support from Edwards Lifesciences, Boston Scientific, and Medtronic; and has received proctoring fees from Medtronic. Dr. Yakubov has received grant support from and served on the advisory board for Medtronic and Boston Scientific; and has received grant support from Direct Flow Medical. Dr. Kleiman has received fees from Medtronic for providing educational services. Dr. Coselli has served as a consultant for, participated in clinical research trials sponsored by, and served on the steering committee for a clinical trial for Medtronic; has served as a consultant for St. Jude Medical; and has participated in clinical research trials sponsored by Edwards Lifesciences. Dr. Gleason has received institutional grant support from Medtronic. Dr. Hermiller has served as a consultant for, received fees for educational services from, and has received research support from Medtronic. Dr. Zorn has served as a consultant and received proctoring fees from Medtronic and Edwards Lifesciences. Dr. Tadros has received consulting fees, proctoring fees, and research support from Medtronic and St. Jude Medical. Dr. Hughes has served as a consultant and speaker for Medtronic. Dr. Harrison has received institutional grant support from Medtronic, Boston Scientific, Direct Flow Medical, St. Jude Medical, and Edwards Lifesciences; and has served on a medical advisory board for Direct Flow Medical and on the data safety monitoring board for CardiAQ. Dr. Maini has served on the Speakers Bureau and advisory boards, has served as a proctor, and has conducted contracted research for Medtronic, Abbott Vascular, Boston Scientific, ABIOMED, Siemens, and St. Jude Medical. Dr. Mumtaz has received consulting fees, proctoring fees, honoraria, and research support from Atricure, Abbott, Edwards Lifesciences, Medtronic, St. Jude Medical, and Direct Flow Medical. Dr. Conte serves on a surgical advisory board for Medtronic and Sorin; and has received research support from Medtronic, Boston Scientific, and St. Jude. Dr. Resar has received proctoring fees and institutional grant support from Medtronic. Dr. Oh has received core laboratory funding from and has served as a consultant for Medtronic. Dr. Qiao is an employee and shareholder of Medtronic. Dr. Adams has received grant support from Medtronic and has royalty agreements through Mount Sinai School of Medicine with Medtronic and with Edwards Lifesciences. Dr. Popma has received institutional grant support from Medtronic, Boston Scientific, Abbott Vascular, and Direct Flow Medical; has served on the medical advisory board for Boston Scientific; and has served as a consultant for Direct Flow Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Deepak Bhatt, MD, served as Guest Editor for this paper. Alec Vahanian, MD, served as Associate Guest Editor for this paper.
- Received March 2, 2016.
- Revision received March 18, 2016.
- Accepted March 21, 2016.
- American College of Cardiology Foundation