title: The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients.
abstract: BACKGROUND
  Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with symptomatic aortic stenosis without open-heart surgery; however, the benefits are mitigated by the potential for neurological events.
  
  
  OBJECTIVE
  This study sought to determine the timing and causes of clinically relevant neurological events after self-expandable TAVR.
  
  
  METHODS
  We enrolled 1,015 patients, of whom 996 underwent TAVR with a self-expandable system at 44 TAVR-experienced centers in Europe, Colombia, and Israel. Neurological events were evaluated for 3 distinct time periods: periprocedural (0 to 1 days post TAVR); early (2 to 30 days); and late (31 to 730 days). In this real-world study, neurological events were first referred to the site neurologist and then reviewed by an independent neurologist.
  
  
  RESULTS
  The overall stroke rate was 1.4% through the first day post-procedure, 3.0% at 30 days, and 5.6% at 2 years. There were no significant predictors of periprocedural stroke or stroke/transient ischemic attack (TIA) combined. Significant predictors of early stroke were acute kidney injury (p = 0.03), major vascular complication (p = 0.04), and female sex (p = 0.04). For stroke/TIA combined, prior atrial fibrillation (p = 0.03) and major vascular complication (p = 0.009) were predictive. Coronary artery bypass graft surgery was the only significant predictor of late stroke (p = 0.007) or late stroke/TIA (p = 0.06).
  
  
  CONCLUSIONS
  Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically relevant neurological events differed on the basis of the timing after TAVR. (CoreValve Advance International Post Market Study; NCT01074658).
authors.affiliation: Antwerp University Hospital, Edegem, Belgium. Electronic address: johan.bosmans@uza.be.
authors.forename: Johan
authors.initials: J
authors.lastname: Bosmans
authors.affiliation: German Heart Center, Technical University Munich, Munich, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Bleiziffer
authors.affiliation: Gemeinschaftskrankenhaus, Bonn, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gerckens
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Wenaweser
authors.affiliation: St. George's Hospital, London, United Kingdom.
authors.forename: Stephen
authors.initials: S
authors.lastname: Brecker
authors.affiliation: Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: University of Leipzig Heart Center, Leipzig, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Linke
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000453:epidemiology / Q000601:surgery*; D001281:Atrial Fibrillation / Q000453:epidemiology; D001026:Coronary Artery Bypass / Q000706:statistics & numerical data; D005260:Female; D006350:Heart Valve Prosthesis; D006801:Humans; D015994:Incidence; D002546:Ischemic Attack, Transient / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D053208:Kaplan-Meier Estimate; D008297:Male; D011183:Postoperative Complications / Q000175:diagnosis / Q000453:epidemiology*; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods
keywords: aortic stenosis; self-expanding transcatheter aortic valve; stroke; transient ischemic attack