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: URL: 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: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01240902.
KW - aortic valve
KW - health status
KW - quality of life
KW - risk
KW - transcatheter aortic valve disease
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U2 - 10.1161/CIRCINTERVENTIONS.120.010258
DO - 10.1161/CIRCINTERVENTIONS.120.010258
M3 - Article
C2 - 34092091
AN - SCOPUS:85108068586
VL - 14
SP - E010258
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
SN - 1941-7640
IS - 6
ER -