Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis

Stanley J. Chetcuti; G. Michael Deeb; Jeffrey J. Popma; Steven J. Yakubov; P. Michael Grossman; Himanshu J. Patel; Alfred Casale; Harold L. Dauerman; Jon R. Resar; Michael J. Boulware; Jessica L. Dries-Devlin; Shuzhen Li; Jae K. Oh; Michael J. Reardon

doi:10.1016/j.jcmg.2018.07.028

Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis

Stanley J. Chetcuti, G. Michael Deeb, Jeffrey J. Popma, Steven J. Yakubov, P. Michael Grossman, Himanshu J. Patel, Alfred Casale, Harold L. Dauerman, Jon R. Resar, Michael J. Boulware, Jessica L. Dries-Devlin, Shuzhen Li, Jae K. Oh, Michael J. Reardon

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	67-80
Number of pages	14
Journal	JACC: Cardiovascular Imaging
Volume	12
Issue number	1
DOIs	https://doi.org/10.1016/j.jcmg.2018.07.028
State	Published - Jan 2019

Keywords

aortic stenosis
heart valves
low gradient aortic stenosis
mean gradient
stroke volume
transcatheter aortic valve replacement

ASJC Scopus subject areas

Radiology Nuclear Medicine and imaging
Cardiology and Cardiovascular Medicine

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10.1016/j.jcmg.2018.07.028

Cite this

Chetcuti, S. J., Deeb, G. M., Popma, J. J., Yakubov, S. J., Grossman, P. M., Patel, H. J., Casale, A., Dauerman, H. L., Resar, J. R., Boulware, M. J., Dries-Devlin, J. L., Li, S., Oh, J. K., & Reardon, M. J. (2019). Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis. JACC: Cardiovascular Imaging, 12(1), 67-80. https://doi.org/10.1016/j.jcmg.2018.07.028

Chetcuti, SJ, Deeb, GM, Popma, JJ, Yakubov, SJ, Grossman, PM, Patel, HJ, Casale, A, Dauerman, HL, Resar, JR, Boulware, MJ, Dries-Devlin, JL, Li, S, Oh, JK & Reardon, MJ 2019, 'Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis', JACC: Cardiovascular Imaging, vol. 12, no. 1, pp. 67-80. https://doi.org/10.1016/j.jcmg.2018.07.028

@article{9908368410544171874d76d89c6ad667,

title = "Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis",

abstract = "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.",

keywords = "aortic stenosis, heart valves, low gradient aortic stenosis, mean gradient, stroke volume, transcatheter aortic valve replacement",

author = "Chetcuti, {Stanley J.} and Deeb, {G. Michael} and Popma, {Jeffrey J.} and Yakubov, {Steven J.} and Grossman, {P. Michael} and Patel, {Himanshu J.} and Alfred Casale and Dauerman, {Harold L.} and Resar, {Jon R.} and Boulware, {Michael J.} and Dries-Devlin, {Jessica L.} and Shuzhen Li and Oh, {Jae K.} and Reardon, {Michael J.}",

note = "Funding Information: 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. Publisher Copyright: {\textcopyright} 2019",

year = "2019",

month = jan,

doi = "10.1016/j.jcmg.2018.07.028",

language = "English (US)",

volume = "12",

pages = "67--80",

journal = "JACC: Cardiovascular Imaging",

issn = "1936-878X",

publisher = "Elsevier Inc.",

number = "1",

}

TY - JOUR

T1 - Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis

AU - Chetcuti, Stanley J.

AU - Deeb, G. Michael

AU - Popma, Jeffrey J.

AU - Yakubov, Steven J.

AU - Grossman, P. Michael

AU - Patel, Himanshu J.

AU - Casale, Alfred

AU - Dauerman, Harold L.

AU - Resar, Jon R.

AU - Boulware, Michael J.

AU - Dries-Devlin, Jessica L.

AU - Li, Shuzhen

AU - Oh, Jae K.

AU - Reardon, Michael J.

N1 - Funding Information: 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. Publisher Copyright: © 2019

PY - 2019/1

Y1 - 2019/1

N2 - 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.

AB - 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.

KW - aortic stenosis

KW - heart valves

KW - low gradient aortic stenosis

KW - mean gradient

KW - stroke volume

KW - transcatheter aortic valve replacement

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Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis

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