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 Kuen Oh, Michael J. Reardon

Research output: Contribution to journalArticle

4 Citations (Scopus)

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. 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)

Original languageEnglish (US)
Pages (from-to)67-80
Number of pages14
JournalJACC: Cardiovascular Imaging
Volume12
Issue number1
DOIs
StatePublished - Jan 1 2019

Fingerprint

Aortic Valve Stenosis
Aortic Valve
Mortality
Hemodynamics
Stroke Volume
Stroke
Quality of Life
Safety
Dobutamine
Transcatheter Aortic Valve Replacement
Patient Safety
Cardiomyopathies
Surgical Instruments
Comorbidity
Therapeutics
Multivariate Analysis
Survival

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

Cite this

Chetcuti, S. J., Deeb, G. M., Popma, J. J., Yakubov, S. J., Grossman, P. M., Patel, H. J., ... 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

Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis. / Chetcuti, Stanley J.; Deeb, G. Michael; Popma, Jeffrey J.; Yakubov, Steven J.; Grossman, P. Michael; Patel, Himanshu J.; Casale, Alfred; Dauerman, Harold L.; Resar, Jon R.; Boulware, Michael J.; Dries-Devlin, Jessica L.; Li, Shuzhen; Oh, Jae Kuen; Reardon, Michael J.

In: JACC: Cardiovascular Imaging, Vol. 12, No. 1, 01.01.2019, p. 67-80.

Research output: Contribution to journalArticle

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
Chetcuti, Stanley J. ; Deeb, G. Michael ; Popma, Jeffrey J. ; Yakubov, Steven J. ; Grossman, P. Michael ; Patel, Himanshu J. ; Casale, Alfred ; Dauerman, Harold L. ; Resar, Jon R. ; Boulware, Michael J. ; Dries-Devlin, Jessica L. ; Li, Shuzhen ; Oh, Jae Kuen ; Reardon, Michael J. / Self-Expanding Transcatheter Aortic Valve Replacement in Patients With Low-Gradient Aortic Stenosis. In: JACC: Cardiovascular Imaging. 2019 ; Vol. 12, No. 1. pp. 67-80.
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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 Kuen

AU - Reardon, Michael J.

PY - 2019/1/1

Y1 - 2019/1/1

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. 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)

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. 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)

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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