Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial

Suzanne V. Arnold; George Petrossian; Michael J. Reardon; Neal S. Kleiman; Steven J. Yakubov; Kaijun Wang; James Hermiller; J. Kevin Harrison; G. Michael Deeb; Jian Huang; David J. Cohen

doi:10.1161/CIRCINTERVENTIONS.120.010258

Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial

Suzanne V. Arnold, George Petrossian, Michael J. Reardon, Neal S. Kleiman, Steven J. Yakubov, Kaijun Wang, James Hermiller, J. Kevin Harrison, G. Michael Deeb, Jian Huang, David J. Cohen

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

7 Scopus citations

Abstract

BACKGROUND: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR.

METHODS: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire.

RESULTS: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9]).

CONCLUSIONS: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients.

REGISTRATION: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.

Original language	English (US)
Article number	e010258
Pages (from-to)	E010258
Journal	Circulation: Cardiovascular Interventions
Volume	14
Issue number	6
DOIs	https://doi.org/10.1161/CIRCINTERVENTIONS.120.010258
State	Published - Jun 1 2021

Keywords

aortic valve
health status
quality of life
risk
transcatheter aortic valve disease
Severity of Illness Index
Prospective Studies
Humans
Male
Treatment Outcome
Aortic Valve Stenosis/diagnostic imaging
United States/epidemiology
Time Factors
Aged, 80 and over
Quality of Life
Female
Aged

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1161/CIRCINTERVENTIONS.120.010258

Cite this

Arnold, S. V., Petrossian, G., Reardon, M. J., Kleiman, N. S., Yakubov, S. J., Wang, K., Hermiller, J., Harrison, J. K., Deeb, G. M., Huang, J., & Cohen, D. J. (2021). Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial. Circulation: Cardiovascular Interventions, 14(6), E010258. Article e010258. https://doi.org/10.1161/CIRCINTERVENTIONS.120.010258

Arnold, SV, Petrossian, G, Reardon, MJ , Kleiman, NS, Yakubov, SJ, Wang, K, Hermiller, J, Harrison, JK, Deeb, GM, Huang, J & Cohen, DJ 2021, 'Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial', Circulation: Cardiovascular Interventions, vol. 14, no. 6, e010258, pp. E010258. https://doi.org/10.1161/CIRCINTERVENTIONS.120.010258

@article{c953f7c0f57a45ce8a2e6d514eb21eb4,

title = "Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial",

abstract = "BACKGROUND: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR.METHODS: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire.RESULTS: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9]).CONCLUSIONS: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients.REGISTRATION: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.",

keywords = "aortic valve, health status, quality of life, risk, transcatheter aortic valve disease, Severity of Illness Index, Prospective Studies, Humans, Male, Treatment Outcome, Aortic Valve Stenosis/diagnostic imaging, United States/epidemiology, Time Factors, Aged, 80 and over, Quality of Life, Female, Aged",

author = "Arnold, {Suzanne V.} and George Petrossian and Reardon, {Michael J.} and Kleiman, {Neal S.} and Yakubov, {Steven J.} and Kaijun Wang and James Hermiller and Harrison, {J. Kevin} and Deeb, {G. Michael} and Jian Huang and Cohen, {David J.}",

note = "Funding Information: Dr Reardon reports honoraria from Medtronic for participation on an advisory board. Dr Yakubov reports institutional grants from Medtronic and serves on an advisory board for Medtronic and Boston Scientific. Dr Deeb receives grant support from Medtronic. Dr Cohen receives grant support from Edwards Lifescienc-es, Medtronic, Boston Scientific, Abbott Vascular; consulting fees from Medtronic, Abbott Vascular, and Boston Scientific, and Edwards Lifesciences. Dr Huang is an employee of Medtronic. The other authors report no conflicts. Publisher Copyright: {\textcopyright} 2021 Lippincott Williams and Wilkins. All rights reserved.",

year = "2021",

month = jun,

day = "1",

doi = "10.1161/CIRCINTERVENTIONS.120.010258",

language = "English (US)",

volume = "14",

pages = "E010258",

journal = "Circulation: Cardiovascular Interventions",

issn = "1941-7640",

publisher = "Lippincott Williams and Wilkins",

number = "6",

}

TY - JOUR

T1 - Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial

AU - Arnold, Suzanne V.

AU - Petrossian, George

AU - Reardon, Michael J.

AU - Kleiman, Neal S.

AU - Yakubov, Steven J.

AU - Wang, Kaijun

AU - Hermiller, James

AU - Harrison, J. Kevin

AU - Deeb, G. Michael

AU - Huang, Jian

AU - Cohen, David J.

N1 - Funding Information: Dr Reardon reports honoraria from Medtronic for participation on an advisory board. Dr Yakubov reports institutional grants from Medtronic and serves on an advisory board for Medtronic and Boston Scientific. Dr Deeb receives grant support from Medtronic. Dr Cohen receives grant support from Edwards Lifescienc-es, Medtronic, Boston Scientific, Abbott Vascular; consulting fees from Medtronic, Abbott Vascular, and Boston Scientific, and Edwards Lifesciences. Dr Huang is an employee of Medtronic. The other authors report no conflicts. Publisher Copyright: © 2021 Lippincott Williams and Wilkins. All rights reserved.

PY - 2021/6/1

Y1 - 2021/6/1

N2 - BACKGROUND: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR.METHODS: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire.RESULTS: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9]).CONCLUSIONS: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients.REGISTRATION: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.

AB - BACKGROUND: Older adults with comorbidities who are at extreme risk for surgical aortic valve replacement may be appropriate candidates for transcatheter aortic valve replacement (TAVR). We present the 5-year clinical, echocardiographic, and health status outcomes of such patients treated with CoreValve self-expanding supra-annular TAVR.METHODS: The CoreValve US Extreme Risk Pivotal Trial was a prospective, nonrandomized, single-arm clinical trial of TAVR at 41 sites in the United States. The primary outcome was all-cause mortality or major stroke. Secondary outcomes included echocardiographic parameters and patient-reported health status, assessed with the Kansas City Cardiomyopathy Questionnaire.RESULTS: Between February 2011 and August 2012, 639 patients with severe aortic stenosis at extreme surgical risk underwent attempted TAVR (mean age 82.8±8.4 years, 53% women, mean Society of Thoracic Surgeons Predicted Risk of Mortality 10.4±5.6%, 77% iliofemoral access). The 5-year Kaplan-Meier rate of death or major stroke was 72.6% ([95% CI, 68.4%–76.7%]; death 71.6%, major stroke 11.5%), with no significant differences according to access site. Among patients who survived 5 years, mean transvalvular gradient was 7.5±5.9 mm Hg, and 3.1% had moderate or severe aortic regurgitation. Health status measures improved significantly by 1 month after TAVR through 1 year (mean change in Kansas City Cardiomyopathy Questionnaire–Overall Summary score 24.8 points [95% CI, 22.4–27.2]). Beyond 1 year, the Kansas City Cardiomyopathy Questionnaire–Overall Summary score decreased gradually but remained significantly improved from pre-TAVR through 5 years of follow-up among surviving patients (mean change from baseline, 14.3 points [95% CI, 10.7–17.9]).CONCLUSIONS: Patients with severe aortic stenosis at extreme surgical risk who are treated with self-expanding supra-annular TAVR have high 5-year mortality. However, the short-term benefits of TAVR in terms of valve hemodynamics and quality of life are mostly preserved among surviving patients at 5 years, thereby supporting the continued use of TAVR in these challenging patients.REGISTRATION: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.

KW - aortic valve

KW - health status

KW - quality of life

KW - risk

KW - transcatheter aortic valve disease

KW - Severity of Illness Index

KW - Prospective Studies

KW - Humans

KW - Male

KW - Treatment Outcome

KW - Aortic Valve Stenosis/diagnostic imaging

KW - United States/epidemiology

KW - Time Factors

KW - Aged, 80 and over

KW - Quality of Life

KW - Female

KW - Aged

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U2 - 10.1161/CIRCINTERVENTIONS.120.010258

DO - 10.1161/CIRCINTERVENTIONS.120.010258

M3 - Article

C2 - 34092091

AN - SCOPUS:85108068586

SN - 1941-7640

VL - 14

SP - E010258

JO - Circulation: Cardiovascular Interventions

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ER -

Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial

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