Author + information
- Received July 3, 2018
- Accepted July 20, 2018
- Published online January 7, 2019.
- Stanley J. Chetcuti, MDa,
- G. Michael Deeb, MDb,∗ (, )
- Jeffrey J. Popma, MDc,
- Steven J. Yakubov, MDd,
- P. Michael Grossman, MDa,
- Himanshu J. Patel, MDb,
- Alfred Casale, MDe,
- Harold L. Dauerman, MDf,
- Jon R. Resar, MDg,
- Michael J. Boulware, PhDh,
- Jessica L. Dries-Devlin, PhDh,
- Shuzhen Li, PhDh,
- Jae K. Oh, MDi and
- Michael J. Reardon, MDj
- aDepartment of Internal Medicine, Division of Cardiology, University of Michigan, Ann Arbor, Michigan
- bDepartment of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan
- cDepartment of Internal Medicine, Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts
- dDepartment of Cardiology, Riverside Methodist Hospital, Columbus, Ohio
- eDepartment of Cardiothoracic Surgery, Geisinger Health System, Danville, Pennsylvania
- fDepartment of Cardiology, University of Vermont Medical Center, Burlington, Vermont
- gDivision of Cardiology, Johns Hopkins University School of Medicine, Baltimore, Maryland
- hCoronary and Structural Heart Clinical Department, Medtronic, Mounds View, Minnesota
- iDepartment of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- jDepartment of Cardiothoracic Surgery, Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas
- ↵∗Address for correspondence:
Dr. G. Michael Deeb, Department of Cardiac Surgery, University of Michigan Hospitals, 1500 East Medical Center Drive, Ann Arbor, Michigan 48109-5864.
Objectives The authors sought to compare clinical and hemodynamic outcomes in patients receiving transcatheter aortic valve replacement (TAVR) for low-gradient (LG) aortic stenosis in the CoreValve EUS (Expanded Use Study) versus those with high-gradient (HG) aortic stenosis from the CoreValve U.S. Pivotal Extreme Risk Trial and CAS (Continued Access Study).
Background The EUS examined the impact of TAVR in patients unsuitable for surgical aortic valve replacement who were excluded from the U.S. Pivotal Extreme Risk Trial due to LG aortic stenosis.
Methods EUS patients were stratified by left ventricular ejection fraction: normal (≥50%, LG–normal ejection fraction), and low (<50%, did not respond to dobutamine by generating a mean gradient >40 mm Hg and/or velocity >4.0 m/s, “nonresponders”), and compared with extreme-risk patients from U.S. Pivotal and CAS that had either low resting gradient and responded to dobutamine (“responders”), or a high resting gradient (HG) or velocity. The primary endpoint was all-cause mortality or major stroke at 1 year. Hemodynamics and quality of life are reported at 30 days and 1 year.
Results At 30 days, patients with LG/low left ventricular ejection fraction (nonresponders and responders) had significantly higher rates of all-cause mortality or major stroke, all-cause mortality, and cardiovascular mortality than both HG and LG–normal ejection fraction patients. At 1 year, only the responders had higher rates of these outcomes in comparison to the other 3 groups. Mean gradient and effective orifice area improved significantly in all patients and were maintained through 1 year. New York Heart Association functional classification and Kansas City Cardiomyopathy Questionnaire overall summary scores improved (p < 0.05) in all cohorts through 1 year. When all 4 subgroups were pooled, both decreasing mean gradient and stroke volume index were associated with increased mortality. Pre-procedural mean gradient was the only hemodynamic independent predictor of 1-year mortality by multivariate analysis.
Conclusions In this study, TAVR provided EUS patients significant hemodynamic relief with both 1-year survival and quality of life outcomes comparable to Pivotal and CAS patients (Safety & Efficacy Study of the Medtronic CoreValve System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement, NCT01675440; 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; Safety and Efficacy Continued Access Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement, NCT01531374)
- aortic stenosis
- heart valves
- low gradient aortic stenosis
- mean gradient
- stroke volume
- transcatheter aortic valve replacement
This work was supported by Medtronic, Minneapolis, Minnesota. Dr. Chetcuti has received grants from MDT, Edwards Lifesciences, and Gore; and has received personal fees from MDT and Jena. Dr. Deeb has served on the advisory board, screening committee, steering committee, and as a principal investigator on the Pivotal trial for Medtronic. Dr. Popma has received grants from Medtronic, Boston Scientific, Direct Flow Medical, and Abbott Vascular; has served on the medical advisory board for Boston Scientific; and has served as a consultant for Direct Flow Medical. Dr. Yakubov has received grants from Medtronic, Boston Scientific, and Direct Flow Medical. Dr. Grossman has received grants from Edwards Lifesciences, Medtronic, Blue Cross Blue Shield of Michigan, and the National Institutes of Health, and served as a proctor and consultant for Medtronic. Dr. Patel has received personal fees from Medtronic, Edwards Lifesciences, Terumo, and W.L. Gore. Dr. Casale has received grants from Medtronic; and has received personal fees from Edwards Lifesciences. Dr. Dauerman has received grant support from Medtronic and Boston Scientific, and has served as a consultant for Medtronic, Abbott Vascular, and Boston Scientific. Dr. Resar has received proctoring fees from Medtronic and serves on the Physician Advisory Board for Boston Scientific. Drs. Boulware, Dries-Devlin, and Li are employees and shareholders of Medtronic. Dr. Oh has received grants from Medtronic. Dr. Reardon has received personal fees from and served on the advisory board for Medtronic.
- Received July 3, 2018.
- Accepted July 20, 2018.
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