TY - JOUR
T1 - The risk and extent of neurologic events are equivalent for high-risk patients treated with transcatheter or surgical aortic valve replacement
AU - Gleason, Thomas G.
AU - Schindler, John T.
AU - Adams, David H.
AU - Reardon, Michael J.
AU - Kleiman, Neal S.
AU - Caplan, Louis R.
AU - Conte, John V.
AU - Deeb, G. Michael
AU - Hughes, G. Chad
AU - Chenoweth, Sharla
AU - Popma, Jeffrey J.
N1 - Funding Information:
This work was funded by Medtronic, Inc.
Funding Information:
T.G.G., J.T.S., G.M.C., and N.S.K. have received institutional research grants from Medtronic but no personal income. D.H.A. has received institutional grants and institutional royalties for patents with Medtronic, and institutional royalties for patents with Edwards Lifesciences, and serves on a medical advisory board for Boston Scientific. M.J.R. has received institutional research grants from and serves on a medical advisory board for Medtronic. J.V.C. receives grant support and fees from Medtronic, Boston Scientific, and Sorin and has received institutional grants from Medtronic, but no personal income. G.C.H. has no disclosures. S.C. is an employee and shareholder of Medtronic. J.J.P. has received institutional research grants from Medtronic, Boston Scientific, and Direct Flow Medical. The other author has nothing to disclose with regard to commercial support.
Publisher Copyright:
© 2016 The American Association for Thoracic Surgery.
PY - 2016/7/1
Y1 - 2016/7/1
N2 - Objectives This study was designed to characterize the incidence of new clinically detectable neurologic events, or any comparative change in indices of higher cognitive function following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) within the framework of a prospective, randomized clinical trial for high-risk patients. Methods High-risk patients (predicted SAVR mortality 15%) with severe aortic stenosis (n = 750) were randomized 1:1 to TAVR or SAVR and underwent evaluation using the National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale assessment at each follow-up and any suspected event. Neurologic outcomes were ascertained by a neurologist and further evaluated by Mini-Mental State Examination (MMSE), visual fields testing, gait assessment, hand function, writing evaluation, and drawing assessment. Results The 30-day, 1-year, and 2-year stroke rates were 4.9%, 8.7%, and 10.9%, respectively, for TAVR and 6.2%, 12.5%, and 16.6%, respectively, for SAVR (P =.46,.11, and.05, respectively). All-cause mortality in patients with a major stroke was 83.3% for TAVR and 54.5% for SAVR at 2 years (P =.29). Late major stroke was disproportionately higher (23.8% at 2 years) among patients with poor iliofemoral access randomized to SAVR. Peripheral vascular disease and falls within 6 months predicted early stroke, and severe aortic calcification and high Charlson score (≥5) predicted 1-year stroke post-TAVR. NIHSS and MMSE scores trended higher after SAVR than after TAVR. Lack of dual antiplatelet therapy use during and after TAVR was associated with early stroke. Conclusions This study defines an equivalent postprocedural stroke risk, stroke extent, and degree of cognitive change after TAVR or SAVR in a high-risk population, and also defines several predictors of stroke after TAVR.
AB - Objectives This study was designed to characterize the incidence of new clinically detectable neurologic events, or any comparative change in indices of higher cognitive function following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) within the framework of a prospective, randomized clinical trial for high-risk patients. Methods High-risk patients (predicted SAVR mortality 15%) with severe aortic stenosis (n = 750) were randomized 1:1 to TAVR or SAVR and underwent evaluation using the National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale assessment at each follow-up and any suspected event. Neurologic outcomes were ascertained by a neurologist and further evaluated by Mini-Mental State Examination (MMSE), visual fields testing, gait assessment, hand function, writing evaluation, and drawing assessment. Results The 30-day, 1-year, and 2-year stroke rates were 4.9%, 8.7%, and 10.9%, respectively, for TAVR and 6.2%, 12.5%, and 16.6%, respectively, for SAVR (P =.46,.11, and.05, respectively). All-cause mortality in patients with a major stroke was 83.3% for TAVR and 54.5% for SAVR at 2 years (P =.29). Late major stroke was disproportionately higher (23.8% at 2 years) among patients with poor iliofemoral access randomized to SAVR. Peripheral vascular disease and falls within 6 months predicted early stroke, and severe aortic calcification and high Charlson score (≥5) predicted 1-year stroke post-TAVR. NIHSS and MMSE scores trended higher after SAVR than after TAVR. Lack of dual antiplatelet therapy use during and after TAVR was associated with early stroke. Conclusions This study defines an equivalent postprocedural stroke risk, stroke extent, and degree of cognitive change after TAVR or SAVR in a high-risk population, and also defines several predictors of stroke after TAVR.
KW - aortic stenosis
KW - neurologic outcomes
KW - stroke
KW - surgical aortic valve replacement
KW - transcatheter aortic valve replacement
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U2 - 10.1016/j.jtcvs.2016.02.073
DO - 10.1016/j.jtcvs.2016.02.073
M3 - Article
C2 - 27085389
AN - SCOPUS:84964318915
VL - 152
SP - 85
EP - 96
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
SN - 0022-5223
IS - 1
ER -