title: The risk and extent of neurologic events are equivalent for high-risk patients treated with transcatheter or surgical aortic valve replacement.
abstract: OBJECTIVE
  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.
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pa. Electronic address: gleasontg@upmc.edu.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Gleason
authors.affiliation: University of Pittsburgh School of Medicine, Pittsburgh, Pa.
authors.forename: John T
authors.initials: JT
authors.lastname: Schindler
authors.affiliation: Department of Surgery Mount Sinai Medical Center, New York, NY.
authors.forename: David H
authors.initials: DH
authors.lastname: Adams
authors.affiliation: Houston-Methodist-Debakey Heart and Vascular Center, Houston, Tex.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Reardon
authors.affiliation: Houston-Methodist-Debakey Heart and Vascular Center, Houston, Tex.
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Mass.
authors.forename: Louis R
authors.initials: LR
authors.lastname: Caplan
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Md.
authors.forename: John V
authors.initials: JV
authors.lastname: Conte
authors.affiliation: University of Michigan, Ann Arbor, Mich.
authors.forename: G Michael
authors.initials: GM
authors.lastname: Deeb
authors.affiliation: Duke University Medical Center, Durham, NC.
authors.forename: G Chad
authors.initials: GC
authors.lastname: Hughes
authors.affiliation: Medtronic, Inc, Minneapolis, Minn.
authors.forename: Sharla
authors.initials: S
authors.lastname: Chenoweth
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, Mass.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
mesh_terms: D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000601:surgery*; D003943:Diagnostic Techniques, Neurological; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology*; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects*
keywords: aortic stenosis; neurologic outcomes; stroke; surgical aortic valve replacement; transcatheter aortic valve replacement