Author + information
- Received August 2, 2018
- Revision received August 27, 2018
- Accepted August 28, 2018
- Published online November 26, 2018.
- Thomas G. Gleason, MDa,∗ (, )@UPMCnews,
- Michael J. Reardon, MDb,
- Jeffrey J. Popma, MDc,
- G. Michael Deeb, MDd,
- Steven J. Yakubov, MDe,
- Joon S. Lee, MDa,
- Neal S. Kleiman, MDb,
- Stan Chetcuti, MDd,
- James B. Hermiller Jr., MDf,
- John Heiser, MDg,
- William Merhi, DOg,
- George L. Zorn III, MDh,
- Peter Tadros, MDh,
- Newell Robinson, MDi,
- George Petrossian, MDi,
- G. Chad Hughes, MDj,
- J. Kevin Harrison, MDj,
- John V. Conte, MDk,
- Mubashir Mumtaz, MDl,
- Jae K. Oh, MDm,
- Jian Huang, MD, MSn,
- David H. Adams, MDo,
- for the CoreValve U.S. Pivotal High Risk Trial Clinical Investigators
- aDepartments of Cardiothoracic Surgery and Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- bDepartments of Cardiothoracic Surgery and Interventional Cardiology, Houston-Methodist-Debakey Heart and Vascular Center, Houston, Texas
- cDepartment of Interventional Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- dDepartments of Cardiac Surgery and Interventional Cardiology, University of Michigan Hospitals, Ann Arbor, Michigan
- eDepartment of Interventional Cardiology, Riverside Methodist–Ohio Health, Columbus, Ohio
- fDepartment of Interventional Cardiology, St. Vincent’s Medical Center, Indianapolis, Indiana
- gDepartments of Cardiothoracic Surgery and Interventional Cardiology, Spectrum Health Hospitals, Grand Rapids, Michigan
- hDepartments of Thoracic Surgery and Interventional Cardiology, The University of Kansas Hospital, Kansas City, Kansas
- iDepartments of Cardiothoracic Surgery and Interventional Cardiology, St. Francis Hospital, Roslyn, New York
- jDepartments of Cardiothoracic Surgery and Interventional Cardiology, Duke University Medical Center, Durham, North Carolina
- kUniversity of Pittsburgh Medical Center-Pinnacle, Wormleysburg, Pennsylvania
- lDepartment of Cardiothoracic Surgery, The Johns Hopkins Hospital, Baltimore, Maryland
- mDivision of Cardiology, Mayo Clinic, Rochester, Minnesota
- nStatistical Services, Medtronic, Minneapolis, Minnesota
- oDepartment of Cardiothoracic Surgery, Mount Sinai Medical Center, New York, New York
- ↵∗Address for correspondence:
Dr. Thomas G. Gleason, University of Pittsburgh School of Medicine, 5200 Centre Avenue Suite 715, Pittsburgh, Pennsylvania 15232.
Background The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality–risk patients.
Objectives The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability.
Methods Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned.
Results A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years.
Conclusions This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (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)
- aortic valve stenosis
- surgical valve replacement
- transcatheter aortic valve implantation
- transcatheter aortic valve replacement
Medtronic (Dublin, Ireland) funded the CoreValve US Pivotal High Risk Trial. Dr. Gleason has received institutional grant support from Medtronic and Boston Scientific; and has served on medical advisory boards for Abbott and Cytosorbents Corporation. Dr. Reardon has received fees from Medtronic for providing educational services. Dr. Popma has received institutional research grants from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, and Direct Flow Medical; and has served on a medical advisory board for Boston Scientific, Cordis Corporation, and Edwards Lifesciences. Dr. Deeb has served on an advisory board for Medtronic; as a proctor for Medtronic and Terumo; as a consultant for Edwards Lifesciences and Terumo; and as a research investigator for Edwards Lifesciences, Medtronic, and Gore Medical. Dr. Yakubov has received institutional research grants from Boston Scientific and Medtronic; has served on steering committees for Medtronic CoreValve trials; and has received proctor fees from Medtronic. Dr. Kleiman has received educational and research grants from Medtronic. Dr. Chetcuti has served as a proctor for Medtronic; has served as a consultant for Jena; and has received grant support from Medtronic, Edwards Lifesciences, and Gore. Dr. Hermiller has received fees for educational services from Medtronic. Dr. Merhi has served on the steering committee of the Medtronic Low Risk Trial. Dr. Zorn has received consulting and proctoring fees from Medtronic and Edwards Lifesciences. Dr. Tadros has received consulting fees, proctoring fees, and research support from Medtronic and St. Jude Medical (Abbott). Dr. Hughes has served as a consultant and speaker for Medtronic. Dr. Harrison has received institutional grants from Medtronic, Boston Scientific, Direct Flow Medical, St. Jude Medical (Abbott), and Edwards Lifesciences; has served on a medical advisory board for Direct Flow Medical; and has served on the data safety monitoring board for CardiAQ. Dr. Conte has served on an advisory board for Medtronic; and has served as a consultant to Boston Scientific and Sorin. Dr. Mumtaz has served as a consultant to Abbott, Atricure, Edwards Lifesciences, Japanese Organization for Medical Device Development, Medtronic, Millipede, and Terumo. Dr. Oh has been the director of the Echocardiography Core Lab for CoreValve/Evolut R; and a consultant for Medtronic. Dr. Huang is an employee and shareholder of Medtronic. Dr. Adams has received other support from Medtronic during the conduct of the study, and from NeoChord and Medtronic outside the submitted work; has received patent royalties from Edwards Lifesciences and Medtronic; and was national co-principal investigator of the Medtronic APOLLO FDA Pivotal Trial and the Medtronic CoreValve US Pivotal Trial. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 2, 2018.
- Revision received August 27, 2018.
- Accepted August 28, 2018.
- 2018 American College of Cardiology Foundation
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